move over gnc: crackdown on dietary supplement makers continues

May 10, 2016

By Diane J. Romza-Kutz / Thompson Coburn, LLP

In the fourth quarter of 2015, the dietary supplement industry was reminded that the Department of Justice (DOJ) and the federal Food and Drug Administration (FDA) were watching. This reminder came on the heels of the DOJ indicting 117 companies for selling tainted, misbranded or mislabeled dietary supplement products, as well the Oregon Attorney General suing GNC for knowingly selling supplements that contained FDA-banned ingredients, as reported in an earlier blog post. Although this resounding reminder to the dietary supplement industry that the regulators were watching was not the first, it may have been one of the loudest.

Those reminders that the FDA has and will continue to increase its focus on the dietary supplement industry were reinforced when, on March 31, 2016 and continuing shortly thereafter, the FDA issued seven warning letters to seven dietary supplement companies concerning eight different products. These warning letters were directed at the use of methylsynephrine in those products. This substance, also known as Oxilofrine or p-hydroxyephedrine, is the latest in a series of ingredients that the FDA has identified as: 1) being widely used in dietary supplements but not fitting within the definition of a dietary supplement; 2) not designated as a recognized safe product (GRAS); and 3) not having been the subject of any approved new dietary ingredient or food additive petitions.

This is just the latest in the line of targeted, unapproved dietary ingredients. The other ingredients that the FDA has targeted are most commonly known as BMPEA, Acacia rigidula, DMAA, Picamilon and. The FDA has flagged these ingredients for different reasons, but with one commonality: They are not approved for entry into the marketplace and have not been found to be safe for human use.

Below is some further information on the ingredients that have been subject to high-profile FDA enforcement actions:

  • BMPEA and Acacia rigidula. In April 2015, the FDA issued warning letters concerning eight different products containing BMPEA stating that the agency believed that products containing this were misbranded under 21 U.S.C. 321(ff), as BMPEA was not a dietary supplement as defined by the Dietary Supplement Health and Education Act.
  • Picamilon. This is a synthesized chemical that the FDA has found to cross the blood-brain barrier and accumulate in the brain thereafter. This particular substance not only fails to meet the definition of a dietary ingredient but was the subject of expert statements by the FDA to the Oregon Attorney General in that state’s enforcement actions against dietary supplement sellers. Five companies have received warning letters concerning the use of this chemical in their products.
  • DMAA. As far back as 2013, the FDA targeted products containing DMAA as unsafe for human consumption. Detentions of products containing this substance have occurred, as well as destruction of those products detained. The FDA made very clear statements that this product was unsafe for human consumption and issued 11 warning letters when it first took action against this ingredient.

Now the FDA has another target ingredient in the form of Methylsynephrine. Specifically, the Warning Letters issued by the FDA found that supplements listing Methylsynephrine as a dietary ingredient caused the products to be misbranded in that the label was false and misleading and not a recognized dietary ingredient.

What does this all mean for the supplement industry?

With the FDA’s focus on food safety and the six final rules promulgated under the Food Safety Modernization Act, ensuring a safe food supply for both humans and animals is of its highest priority. As the industry is well aware, dietary supplements are regulated under the umbrella of the FDA’s Center for Food Safety and Applied Nutrition, although through a different set of regulations. The dietary supplement industry should be prepared for a continued heightened level of scrutiny and more FDA enforcement actions.

Companies are going to continue to be held accountable for ensuring that their dietary ingredients are approved and safe and that the finished product is safe for human consumption. The FDA has renewed its outreach to consumers, educating them on important information and the process to report adverse events. In fact, as recently as March of this year, the FDA posted an updated page on how to spot health care fraud scams directed toward the supplement market. Alerts are being followed by product seizures, as was the case this past January with a product containing Kratom.

The dietary supplement industry should consider taking a step back and review its products, both ingredients, as well as the labeling and claims being made surrounding the dietary supplement products being marketed. Regulatory compliance plans should be reviewed quarterly, contain written procedures and verification of the suitability of ingredients and labeling reviews. Marketing and advertising claims should be scrutinized closely in light of the recent Warning Letters and the FDA statements in those letters, as well as the Federal Trade Commission’s truthful advertising requirements. The time when dietary supplement companies were not as closely scrutinized as other FDA-regulated industries is likely coming to a close. It is critical that dietary supplement companies get their “house” in order.  Click here to view the original article.

nsf international expands its dietary supplement services in europe

May 9, 2016

By Victoria White

NSF International is now offering dietary supplement product testing and certification services in Europe, through its German laboratory, NSF Erdman Analytics.

The programme includes GMP auditing, dietary supplement ingredient testing, next-Generation DNA sequencing, and finished product certification. The programme’s flagship NSF Certified for Sport programme also screens supplements on a lot-by-lot basis for over 200 athletic banned substances from the World Anti-Doping Agency (WADA), USADA, NSF Annex B, and many professional sports lists.

The NSF Certified for Sport programme is adhered to by major North American professional sports organisations such as the National Football League (NFL), Major League Baseball (MLB), National Hockey League (NHL), Professional Golf Association (PGA) and Ladies Professional Golf Association (LPGA), as well as the Canadian Centre for Ethics in Sport (CCES), all of whom seek help ensuring the supplements used by their athletes do not contain banned substances.

NSF International is the leading certifier of dietary supplements in the US and globally, having developed the official American National Standard for dietary supplements (NSF/ANSI 173 – Dietary Supplements).  More than 800 supplement products and ingredients are certified to the NSF/ANSI 173 dietary supplement standard. 

NSF International operates a DIN EN ISO/IEC 17025 accredited laboratory in Germany and worldwide. It provides routine product monitoring and specialist requests through state-of-the-art laboratory equipment and skilled, continuously trained expert staff. Services at this laboratory continue to expand into sports nutrition and dietary supplement testing to meet increasingly specialised customer testing and accreditation needs across Europe.

As dietary supplements are produced from a complicated, global supply chain, manufacturers are testing their raw ingredients and certifying their finished product to ensure their safety and quality. NSF International also offers ingredient testing in China via its NSF Shanghai laboratory for companies sourcing ingredients from Asia.

Official launch to take place at Vitafoods Europe

The NSF International dietary supplement testing and certification programme has three components: Good Manufacturing Practices (GMP) registration, NSF dietary supplement certification and NSF Certified for Sport certification.

Manufacturing facilities must pass twice annual audits to earn GMP registration before they can move on to earn NSF International’s dietary supplement certification. The dietary supplement certification process includes label claim, toxicology and contaminant reviews with ongoing monitoring to verify compliance through periodic auditing and testing.

The NSF Certified for Sport Certification is the highest level of NSF certification for dietary supplements.  In addition to the testing and auditing required for GMP and NSF dietary supplement certification, products are also tested on a lot-by-lot basis for over 200 athletic banned substances.

NSF Erdmann Analytics’ scientists have the expertise and instrumentation to evaluate the composition of dietary supplement ingredients including vitamins, minerals, herbs and botanicals, amino acids, sports supplements, concentrates, metabolites, constituents and extracts. The lab’s main testing services include qualitative or quantitative tests of functional components, nutrition labeling, and method development and testing for heavy metals, pesticide residues allergens, microbial contaminants and athletic banned substances.

The lab also provides next-generation DNA sequencing testing which can identify more than 10,000 species of botanicals, animals, fungi and bacteria in raw ingredients and finished products. These tests are the most sensitive on the market for identifying species and quantifying chemical constituents and/or contaminants down to trace levels.

The official launch of the NSF International dietary supplement programmes in Europe will take place May 10 – 12, 2016 at Vitafoods Europe in Geneva, Switzerland.

“More than 800 supplement products and ingredients are certified to the NSF/ANSI 173 dietary supplement standard and to NSF Certified for Sport,” said Dr Robert Pietrowski, Vice President of NSF Global Health Sciences, NSF International. “Retailers and consumers want to know they can trust the safety and quality of supplements and now with NSF International’s dietary supplement testing and certification capabilities at our German laboratory, supplement manufacturers with facilities in and around Europe can save time and cost while they provide safer and high quality dietary and sport supplements.”  Click here to view the original article.

food, dietary supplement & cosmetics regulatory update, vol. III, issue 7

May 9, 2016

By Edgar Asebey, Cristiana Spontoni, Colleen M. Heisey, Jonathan Berman, Katherine M. Llewellyn, Ales Bartl Ph.D

 U.S. and Canada: Comparable Food Safety Systems

On May 4, 2016, FDA announced that both the U.S. and Canada have recognized each other's food safety systems as comparable to each other. This is the second time that FDA has given this recognition to a country, the first being New Zealand in 2012. The FDA, the Canadian Food Inspection Agency ("CFIA"), and the Department of Health Canada ("Health Canada") have used the International Comparability Assessment Tool ("ICAT"), which contains standards to evaluate whether a country's system of protections is similar to the other, and whether their food safety authority or authorities provide similar oversight and monitoring activities for food produced under their jurisdiction. In fact, the ICAT would issue system recognition of only two countries' food safety systems after evaluating the countries' domestic and export food safety system, including its regulatory foundation; training, inspection, program assessment and inspection audit, and compliance and enforcement program; food-related illness and outbreaks; industry and community relations; program resources; international communication and harmonization; and laboratory support. The fact that the described operations are similar helps enhance food safety and facilitates trade between both countries. For instance, FDA states that FDA, CFIA, and Health Canada "have confidence that they can leverage each other's science-based regulatory systems."

FDA Issues Final Guidance on Menu Labeling

At the end of April 2016, FDA released the final guidance on menu labeling providing recommendations on compliance with the menu labeling rule, which requires calorie information to be listed on menus, menu boards, and displays of restaurants and other retail food establishments that are part of a chain of 20 or more locations. This guidance covers many of the topics for which FDA received questions and which were not addressed by the rule on menu labeling or the draft guidance, or for which the information provided was unclear. For instance, FDA answers questions related to covered establishments that are a chain of restaurants that operate under different names depending on location; menu and menu board calorie declaration requirements that apply to catered events, combination meals, "all-you-can-eat" buffets, or grab-and-go items; determination of nutrient values general criteria; whether USDA or FDA caloric or other nutrient determination requirements apply to alcoholic beverages and in which cases; and recordkeeping of substantiation of nutrient values. In addition, FDA clarifies that prisons and mobile vendors are not covered by the final rule.

Release of the final guidance also signals that the countdown to implementation of the final rule on menu labeling will begin soon. The final rule will become effective one year from the publication date of this guidance, as indicated by the FDA's Center for Food Safety and Applied Nutrition ("CFSAN") director at the beginning of March 2016 (see our previous Jones Day Update). Publication in the Federal Register is expected on May 5, 2016.

FDA Issues Guidance on Labeling and Marketing of Animal Food Diets Intended for Treatment or Prevention of Diseases

FDA has issued a guidance for FDA staff intended to ensure animal safety related to direct-to-consumer or retail sales of dog and cat food products intended for use in treatment or prevention of disease. FDA has seen an increase of such products recently. The guidance summarizes FDA's concerns with the safety and effectiveness of these products, which are not evaluated by the FDA, and pet owners' misinterpretation of claims. For example, a pet owner might purchase a food that claims to treat obesity when in fact the product may not be formulated to meet the pet's daily nutrient requirements.

Although animal food products intended to diagnose, cure, mitigate, treat, or prevent diseases are regulated as drugs, and hence need to be registered and listed with and approved by the FDA, FDA has exercised enforcement discretion in the past when those products provided all or most of the nutrient in support of the animal's total required daily nutrient needs, did not claim to treat or prevent disease when made available to the general public, and were distributed only through licensed veterinarians, who know the health history of the pet and the nutrient, food, or drugs (if any) the pet needs to consume. FDA concludes that it will enforce applicable rules as to food manufacturers that sell these products directly to the consumer where the manufacturer makes health claims that are not scientifically substantiated or that could pose a health safety risk to the pet, where the product contains ingredients that are not generally recognized as safe or contain unapproved food additives, or where the product does not comply with food regulations, such as food labeling, establishment registration, or good manufacturing practices.

OSHA Issues Food Safety Whistleblower Rule

The U.S. Occupational Safety and Health Administration ("OSHA") has released a final rule governing the employee protection provision of Section 402 of the FDA Food Safety Modernization Act ("FSMA"), which protects employees against retaliation by an entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food for engaging in certain protected activities. Protection is needed when an employee has provided or is about to provide to his or her employer, the federal government, or the attorney general of a state information relating to any violation of the Federal Food, Drug and Cosmetic Act ("FDCA"); has testified or is about to testify in a proceeding concerning such violation; has assisted or participated, or is about to assist or participate, in such a proceeding; or has objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee reasonably believed to be in violation of any provision of the FDCA. Among other things, the rule establishes procedures and time frames for the handling of retaliation complaints under FSMA and to OSHA, which must be filed within 180 days of the alleged violation, the procedures for the investigation of the complaint by OSHA, appeals of OSHA's determinations to an administrative law judge ("ALJ") for a hearing de novo, hearings by ALJs, review of ALJ decisions by the Administrative Review Board, and judicial review of the Secretary's final decision. The rule further states that the complainant need not show that the conduct complained of constituted an actual violation of law.

U.S. to Profit from China's Termination of Export Subsidies

On April 14, 2016, U.S. Trade Representative ("USTR") Michael Froman announced that the United States and China signed a memorandum of understanding ("MOU") terminating export subsidies provided under China's "Demonstration Bases-Common Service Platform" Program, which provided prohibited export subsidies to Chinese enterprises located in 179 industrial clusters throughout China. The agreement resolves a challenge filed by the United States in the World Trade Organization ("WTO") against the program early last year, in which the United States stated that hundreds of Chinese government legal instruments violated WTO rules. Since then, China has terminated, amended, replaced, or allowed to expire all 175 instruments, and has issued 136 measures to implement the terms of the MOU. The move is expected to benefit American workers across multiple industries, including the agriculture industry, by leveling the global playing field and creating more jobs. According to the USTR, agriculture products that will lose Chinese subsidies include apples, beef, mushrooms, pork, tea, tomatoes, beans, ginseng, poultry, seaweed, and garlic.

EFSA to Review Bisphenol A Safety for the Immune System

On April 26, 2016, the European Food Safety Authority ("EFSA") announced that it would be conducting a study for the potential effects of Bisphenol A ("BPA") on the immune system. The announcement followed the publication of a report by the Dutch National Institute for Public Health and the Environment ("RIVM") that specifically raised concerns on the effects of BPA on the immune systems of fetuses and young children. BPA is a chemical that is frequently used to manufacture plastics and resins to make food containers such as returnable beverage bottles, infant feeding bottles, tableware, and storage containers. BPA can migrate in small amounts into food and beverages.

In December 2014, EFSA's expert Panel on Food Contact Materials, Enzymes, Flavorings and Processing Aids ("CEF Panel") reduced the tolerable daily intake for BPA from 50 micrograms per kilogram of body weight per day (µg/kg bw/day) to 4 µg/kg bw/day, and determined that BPA posed no health risk to consumers of any age group at current exposure levels. The new RIVM report critically examines two studies describing pre- and perinatal effects of BPA on the immune system that were unpublished when EFSA reviewed the available scientific literature for its 2014 risk assessment of BPA. The RIVM report recommends supporting research on alternatives to BPA and advises consumers to reduce exposure to food and other sources that may contain BPA. EFSA aims to issue a statement in the next few months.

European Parliament Urges Restrictions on Reauthorization of Glyphosate

In a nonbinding resolution, members of the European Parliament ("MEP") voted for the European Commission ("EC") to renew the EU market approval for glyphosate, an active substance widely used in herbicides, for only seven years and not 15 as originally proposed, and for professional uses only. Safety of this substance has been recently debated by the World Health Organization ("WHO") and EFSA, which reached differing conclusions on the carcinogenicity of glyphosate (see Jones Day's previous Update). The national experts of the Phytopharmaceuticals Section of the European Commission's ("EC") Standing Committee on Plants, Animals, Food and Feed will vote to adopt or reject the MEP's proposal. If a qualified majority is not reached, the EC will decide on the matter.

Regulatory Updates

FDA Issues CPG on Labeling and Marketing of Certain Dog and Cat Foods

As discussed above, in the May 2, 2016, Federal Register, FDA announced the availability of Compliance Policy Guide ("CPG") Sec. 690.150 titled "Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases." The document provides guidance to FDA staff on issues related to dog and cat diets that are labeled and/or marketed as intended for use to diagnose, cure, mitigate, treat, or prevent diseases and are also labeled and/or marketed to provide all or most nutrients in support of meeting the animal's total daily nutrient requirements. The guide, which finalizes a draft Compliance Policy Guide dated September 10, 2012, lists the factors FDA intends to consider in determining whether to exercise enforcement discretion if the diets are sold or marketed inappropriately.

FDA Issues Compliance Policy Guide on Fresh and Frozen Crabmeat Adulteration

In the April 28, 2016, Federal RegisterFDA announced the availability of revised CPG Sec. 540.275 relating to fresh and frozen crabmeat adulteration with filth involving the presence of Escherichia coli. The CPG clarifies and updates the format of the previously issued CPG on this topic. The CPG provides guidance for FDA staff on the level of E. coli in crabmeat at which FDA may consider the crabmeat to be adulterated with filth. Revisions generally include the addition of sections on Background and Policy, updates to the sections on Regulatory Action Guidance and Specimen Charges, and FDA office names. The CPG also contains information that may be useful to the regulated industry and to the public.

FDA Issues Final Rule Amending Food Additive Regulations

In the April 15, 2016, Federal Register, FDA issued a final rule to amend the food additive regulations at 21 C.F.R. § 172.345 to provide for the safe use of folic acid in corn masa flour at levels not to exceed 0.7 milligrams per pound. The rule was issued in response to a food additive petition filed by Gruma Corporation, a manufacturer of corn flour and tortillas, and others, including health organizations. The rule was effective April 15, 2016.

FDA Issues Exempt Infant Formula Production Guidance

In the April 15, 2016, Federal Register, FDA announced the availability of guidance for industry titled "Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports." The guidance is intended to provide information on FDA's current thinking on the manufacturing of exempt infant formulas, and generally recommends that exempt formulas be produced using manufacturing practices, quality control procedures, audit procedures, and records and reporting protocols that are at least equivalent to those used for products consumed by healthy, full-term infants.

FDA Makes Technical Amendment to the FSVP for Importers of Food for Human and Animals

In the April 28, 2016, Federal RegisterFDA amended final rule "Foreign Supplier Verification Programs ("FSVP") for Importers of Food for Humans and Animals" published in the Federal Register on November 27, 2015. The final rule established requirements for importers to verify that food they import into the U.S. is produced consistent with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the FDCA, is not adulterated, and is not misbranded with respect to food allergen labeling. The final rule was published with some editorial and inadvertent errors. This documentcorrects those errors. The amendments are effective April 28, 2016.

FDA Announces Filing of Food Additive Petition

In the April 29, 2016, Federal RegisterFDA gave notice of the submission of a food additive petition on behalf of 3M Corporation to no longer provide for the use of two different perfluoroalkyl-containing substances as components of paper and paperboard in contact with aqueous and fatty foods. The petitioner requests amendment of the FDA's food additive regulations because these uses have been intentionally and permanently abandoned. Comments are due June 28, 2016.

FDA Extends Comment Period on Risk Assessment of Foodborne Illness Associated with Pathogens from Certain Produce

In the April 22, 2016, Federal Register, FDA announced an extension of the comment period for the notice that appeared in the Federal Register on March 4, 2016, wherein FDA requested scientific data, information, and comments that would assist in the development of a risk assessment for produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin (including raw manure). Comments are due July 5, 2016.

FNS Issues Final Rule Updating Meal Pattern Requirements for the Child and Adult Care Food Program

In the April 25, 2016, Federal RegisterUSDA's Food and Nutrition Service ("FNS") issued a final rule updating the meal pattern requirements for the Child and Adult Care Food Program to better align them with the Dietary Guidelines for Americans, as required by the Healthy, Hunger-Free Kids Act of 2010. This rule requires centers and day care homes participating in the Child and Adult Care Food Program to serve more whole grains and a greater variety of vegetables and fruit, and to reduce the amount of added sugars and solid fats in meals. In addition, this final rule supports mothers who breastfeed and improves consistency with the Special Supplemental Nutrition Program for Women, Infants, and Children and with other Child Nutrition Programs. Several of the changes are extended to the National School Lunch Program, School Breakfast Program, and Special Milk Program. The rule is effective June 24, 2016.

AMS Issues Notice of Public Hearing on Proposed Rulemaking for California Raisins

In the April 22, 2016, Federal Register, USDA's Agricultural Marketing Service ("AMS") announced a public hearing to receive evidence on proposed amendments to Marketing Order No. 989, which regulates the handling of raisins grown in California. Amendments proposed by the Raisin Administrative Committee would (i) authorize production research, (ii) establish new nomination procedures for independent grower and alternate member seats, (iii) add authority to regulate quality, (iv) add authority to establish different regulations for different markets, and (v) add a continuance referenda requirement. In addition, amendments proposed by AMS would remove order language pertaining to volume regulation and reserve pool authority, and would establish term limits for Committee members. The hearing will be held on May 3–4, 2016, in Clovis, CA.

AMS Proposes Amendments to Regulations Governing the Voluntary Grading of Shell Eggs

In the April 20, 2016, Federal Register, USDA's AMS proposed amendments to the regulations governing voluntary grading of shell eggs to clarify the definition of "condition," to remove any food safety implications resulting from the use of the term "wholesomeness," and to clarify that AMS's role in grading and certification of shell eggs is solely for a quality determination. The proposed rule would also prohibit the use of Salmonella Enteritidis-adulterated or recalled shell eggs from being presented to USDA for voluntary grading and certification. Comments are due June 20, 2016.

FSIS Proposes Allowing Poland to Export Poultry Products to the United States

In the April 20, 2016, Federal Register, USDA's Food Safety and Inspection Service ("FSIS") proposed to add Poland to the list of countries eligible to export poultry products to the U.S. After reviewing Poland's poultry laws, regulations, and inspection system as implemented, FSIS tentatively determined that they are equivalent to the Poultry Products Inspection Act ("PPIA"), the regulations implementing this statute, and the U.S. food safety system for poultry. Comments are due June 20, 2016.

FSIS Proposes Allowing Honduras to Export Poultry Products to the United States

In the April 13, 2016, Federal Register, USDA's FSIS proposed to add Honduras to the list of countries eligible to export certain poultry products, such as slaughtered poultry or poultry parts, to the United States. After reviewing Honduras's laws, regulations, and inspection system, FSIS determined that they are equivalent to PPIA and its implementing regulations. Because the United States has assessed only Honduras's poultry slaughter establishments, however, Honduras would be eligible to export only raw poultry products to the United States should the rule become final. Comments are due June 13, 2016.

FNS Issues Final Rule Clarifying Requirements for Distribution and Control of Donated Foods

In the April 19, 2016, Federal Register, USDA's FNS issued a final rule revising and clarifying requirements to ensure that USDA donated foods are distributed, stored, and managed in a safe, efficient, and cost-effective manner. In addition, the rule (i) reduces administrative and reporting requirements for state distributing agencies, (ii) revises and clarifies regulatory provisions relating to accountability for donated foods, and (iii) revises and clarifies specific requirements to conform to related requirements in corresponding regulations and current law. The rule is effective June 20, 2016.

USDA Issues Final Rule Implementing Revised Marketing Order for Tart Cherries

In the April 18, 2016, Federal Register, USDA issued a final rule implementing a recommendation from the Cherry Industry Administrative Board to revise provisions of the marketing order for tart cherries grown in Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin. Specifically, the rule (i) intends to encourage handlers to participate in new market and market expansion activities, (ii) changes the number of years that new market development and market expansion projects are eligible for handler diversion credit from one year to three years, and (iii) revises the composition of the subcommittee that reviews exemption requests. The rule was effective April 19, 2016.

AMS Removes Obsolete Specialty Crop Block Grant Program Regulations

In the April 18, 2016, Federal Register, USDA's AMS issued a final rule rescinding and removing 7 C.F.R. Part 1290, which established regulations for the Specialty Crop Block Grant Program for the fiscal years 2006 to 2008. The rule was effective April 19, 2016.

APHIS Reopens Comment Period for Proposed Apple and Pear Importation

In the April, 15 2016, Federal Register, USDA's Animal and Plant Health Inspection Service ("APHIS") announced it was reopening the comment period for a proposed rule that would amend the regulations to allow for importation of fresh apple and pear fruit from certain countries in the European Union into the continental United States, provided that the fruit is produced in accordance with a systems approach. This rule would provide an alternative to importation under the current preclearance program.Comments are due May 5, 2016.

AMS Proposes Amending Organic Livestock and Poultry Production Requirements

In the April 13, 2016, Federal Register, USDA's AMS proposed to amend the organic livestock and poultry production requirements to add new provisions for livestock handling and transport for slaughter and avian living conditions, and expand and clarify existing requirements covering livestock health care practices and mammalian living conditions. The amendments seek to improve upon the current standards by setting separate standards for mammalian and avian livestock living conditions to better reflect the needs and behaviors of the different species and related consumer expectations. Comments are due June 13, 2016.

FSIS Issues Final Rule Amending Definition for "Roaster" Poultry Class

In the April 13, 2016, Federal Register, USDA's FSIS issued a final rule amending the definition and standard of identity for the "roaster" or "roasting chicken" poultry class to better reflect the characteristics of roaster chickens in the market today. Due to genetic changes and management techniques that have reduced the grow-out period and increased the ready-to-cook ("RTC") weight for roasters, FSIS is amending the "roaster" definition to remove the eight-week minimum age criterion and increase the RTC carcass weight from 5 pounds to 5.5 pounds. The rule is effective January 1, 2018.

Commodity Credit Corporation Issues Final Rule Amending MPP-Dairy Regulations

In the April 13, 2016, Federal Register, USDA's Commodity Credit Corporation issued a final rule amending the regulations for the Margin Protection Program for Dairy ("MPP-Dairy") to allow dairy operations to update their production history when a son, daughter, grandchild, or spouse of a child or grandchild of a current producer participating in the MPP-Dairy program joins the operation. The rule also provides for a later due date for the payment of the entire premium and clarifies that dairy operations that purchase buy-up coverage on less than 90 percent of their production history will also receive catastrophic coverage on the balance, up to 90 percent of the production history. The rule was effective April 13, 2016.

European Regulatory Updates

EFSA Announces Apricot Kernels Pose Risk of Cyanide Poisoning

At the end of April 2016, EFSA published its opinion that eating more than three small raw apricot kernels or less than half of one large kernel in a serving can exceed safe levels of risk of cyanide poisoning. In the case of toddlers, there is a risk of poisoning after ingesting as little as one small apricot kernel. Apricot kernels contain a naturally occurring compound, amygdaline. which converts to cyanide after eating. Cyanide is poisonous and can cause nausea, fever, headaches, insomnia, thirst, lethargy, nervousness, various joint and muscle aches and pains, and falling blood pressure. In extreme cases, it is fatal. EFSA is discussing with EU Member States its scientific opinion and previous assessments of national authorities, and it will decide whether further measures are needed to protect public health from consumption of raw apricot kernels.

EU Sets Emergency Measures for the Import of Citrus Fruits from Certain Non-EU Countries

On April 15, 2016, Member State experts endorsed emergency measures proposed by the Commission with stricter requirements for the importation of citrus fruits from Brazil, South Africa, and Uruguay. The measures are intended to increase the protection against fruits contaminated with citrus black spot, a harmful plant disease not native to Europe.  Click here to view the original article.

newly released dietary supplement may prevent zika symptons

May 9, 2016

By Caribbean News Now

SAN JACINTO, USA -- Bio-Stasis International has released a dietary supplement product, ViraPress™, a new and effective sublingual tablet that enhances the immune system and may increase protection while reducing or eliminating symptoms from various mosquito borne viral infections such as zika. 

Scientific research indicates that some viral infections such as zika, which is linked to Guillain-Barre Syndrome, dengue fever, chikungunya, chicken pox (shingles) and others are associated with a weakened immune system or autoimmune symptoms. 

ViraPress sublingual tablets contain a variety of specific modulating immuno-enhancement glycoproteins, also known as cytokines. Glycoproteins may help the regulation of the immune system’s activity against certain mosquito-borne viral infections and autoimmune disorders. ViraPress is a safe, naturally derived dietary supplement which contains cytokines and growth factors commonly found in bovine serum.

Bio-Stasis International’s founder, Larry Griffin, has devoted years to nutritional and immune health research. While searching current research papers for a natural remedy for an incurable form of pulmonary fibrosis, Griffin found that many researchers believe the cause of pulmonary fibrosis may be associated with a compromised immune system. Weakened immune systems and autoimmune disorders are often associated with poor nutrition and declining environmental conditions. 

Julie Steenhuysen recently wrote in a Reuters report: “Zika has already been linked with the autoimmune disorder Guillain-Barre Syndrome, which attacks peripheral nerves outside the brain and spinal cord, causing temporary paralysis that can in some cases require patients to rely on respirators for breathing. The new discovery now shows zika may provoke an immune attack on the central nervous system, as well. The findings add to the growing list of neurological damage associated with zika.”

The World Health Organization (WHO) designated zika a public health emergency of international concern on February 1, 2016, an action it has taken only three times before, which paves the way for the mobilization of more funding and manpower to fight the mosquito-borne pathogen spreading explosively through the Americas. 

A primary reason noted for rapid spread of the virus is the absence of natural immunity among local populations due to not having been previously exposed to zika. Secondly, the presence of the Aedesmosquitoes in all 61 countries cited is the main vector for Zika transmission. WHO anticipates that zika will continue to spread to countries where Aedes mosquitoes are found.

“ViraPress sublingual tablets contain glycoproteins that may modulate the immune system for protection against viral infections,” explained Griffin, “It is vital to take measures to message one’s immune system in the context of zika outbreaks. At least 13 countries have reported cases of Guillain-Barre Syndrome linked with outbreaks of zika. WHO believes that zika is likely the cause. By taking ViraPress sublingual tablets, one may improve resistance to viral infections, such as zika, as well as outbreaks of other viruses on the rise.”

WHO further reported a possible link between zika and microcephaly in newborn babies. Additionally, infection may cause neurologic conditions in infected adults, including cases of the Guillain-Barré Syndrome. The incubation period (the time from exposure to symptoms) of zika virus disease is not clear, but is likely to be a few days. 

The symptoms are similar to other arbovirus infections such as dengue, West Nile, Japanese encephalitis and yellow fever viruses. Symptoms may include fever, skin rashes, conjunctivitis, muscle and joint pain, malaise, and headache. These symptoms are usually mild and last for two to seven days.

The human immune system is often compromised from a steady use of processed food, poor quality air and use of inadequately clean water. Adverse environmental factors strain the immune system, which may cause susceptibility to viral infections and many autoimmune conditions. ViraPress tablets may provide protection and improve the immune system against mosquito borne viral infections.  Click here to view the original article.

NSF to launch expanded supplement testing, certification services at vitafoods europe

May 7, 2016

By Rachel Adams

NSF International has expanded its reach to offer its dietary supplement product testing and certification services in Europe, through its German laboratory, NSF Erdman Analytics. The official launch of the NSF International dietary supplement programs in Europe will take place at Vitafoods Europe in Geneva, Switzerland, May 10-12.

As dietary supplements are produced from a complicated, global supply chain, manufacturers are testing their raw ingredients and certifying their finished product to ensure safety and quality.

The NSF International dietary supplement testing and certification program has three components: good manufacturing practices (GMP) registration, NSF dietary supplement certification and NSF Certified for Sport® certification.

Specifically, NSF’s program includes GMP auditing, dietary supplement ingredient testing, next-Generation DNA sequencing and finished product certification. The program’s NSF Certified for Sport® program also screens supplements on a lot-by-lot basis for more than 200 athletic banned substances from the World Anti-Doping Agency (WADA), USADA, NSF Annex B, and many professional sports lists.

Manufacturing facilities must pass two annual audits to earn GMP registration before they can move on to earn NSF International’s dietary supplement certification. The dietary supplement certification process includes label claim, toxicology and contaminant reviews with ongoing monitoring to verify compliance through periodic auditing and testing.

NSF International’s Erdman Analytics facility is a DIN EN ISO/IEC 17025 accredited laboratory in Germany and worldwide. It provides routine product monitoring and specialist requests through state-of-the-art laboratory equipment and skilled, trained staff. Services at this laboratory continue to expand into sports nutrition and dietary supplement testing to meet increasingly specialized customer testing and accreditation needs across Europe.

NSF Erdmann Analytics’ scientists have the expertise and instrumentation to evaluate the composition of dietary supplement ingredients including vitamins, minerals, herbs and botanicals, amino acids, sports supplements, concentrates, metabolites, constituents and extracts. The lab’s main testing services include qualitative or quantitative tests of functional components, nutrition labeling, and method development and testing for heavy metals, pesticide residues allergens, microbial contaminants and athletic banned substances.

The lab also provides next-generation DNA sequencing testing which can identify more than 10,000 species of botanicals, animals, fungi and bacteria in raw ingredients and finished products. These tests are the most sensitive on the market for identifying species and quantifying chemical constituents and/or contaminants down to trace levels.

NSF International also offers ingredient testing in China via its NSF Shanghai laboratory for companies sourcing ingredients from Asia. Click here to view the original article.

fda criminal office said to be examining drug ostarine in dietary supplements

May 6, 2016

By Josh Long

FDA’s Office of Criminal Investigations (OCI) has been reportedly looking into complaints that marketers of sports supplements have sold Ostarine in their products, a substance that a biopharmaceutical company has been studying in clinical drug trials for nearly a decade.

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Government probes into Ostarine reflect FDA’s continuing efforts to crack down on marketers of “dietary supplements" that are tainted with pharmaceutical drugs and other illegal substances.

So-called SARMs, or selective androgen receptor modulators, which include Ostarine, have been under development by pharmaceutical companies. Memphis, Tennessee-based GTx, Inc. has been developing SARMs to treat serious diseases including breast cancer, a form of muscular dystrophy and urinary incontinence.

Ostarine is the brand name for the compound enobosarm, and the drug has been tested by GTx in roughly 24 clinical studies involving more than 1,500 subjects in the United States and abroad, said Mary Ann (Mayzie) Johnston, GTx’s vice president of clinical development, in an emailed statement.

FDA has taken the position in at least one warning letter that Ostarine (also known as MK-2866) doesn’t qualify as a dietary supplement. Generally under federal law, dietary supplements cannot include an article that is authorized for an investigation as a new drug and is the subject of substantial clinical investigations that have been publicized.

FDA cited GTx’s clinical investigations dating back to 2007 to treat cancer cachexia or muscle wasting. While the studies to treat cancer patients for muscle wasting were completed in 2013 and did not meet criteria to obtain FDA approval, GTx subsequently has done studies of enobosarm to treat breast cancer and stress urinary incontinence, Johnston noted.

“Depending on the indication for which approval is sought from FDA, and assuming the drug is determined to be safe and effective for the indication, it could take a few to several more years to gain regulatory approval," she said.

Meanwhile, marketers of sports supplements have been accused of selling Ostarine in their products.

“GTx became aware that some companies, primarily through the internet, were offering for sale [an] active pharmaceutical ingredient represented to be enobosarm and dietary supplements purportedly containing enobosarm, all in violation of GTx’s patent and trademark rights and in violation of the Federal, Food, Drug, and Cosmetic Act [FDCA]," said Robert J. Wills, Ph.D., executive chairman of GTx’s board of directors, in an emailed statement.

Wills indicated that after GTx retained outside legal counsel and internet investigators to help identify the wrongdoers, GTx sent cease-and-desist letters to a number of companies as part of a “comprehensive strategy for targeting the illegal conduct." A number of the recipients of the letters agreed to stop selling Ostarine, he noted.

“In addition, GTx has communicated its concerns directly to the U.S. Food and Drug Administration and is engaged with FDA through various channels, including the Office of Criminal Investigations," Wills said.

Nutrition Distribution, LLC, an Arizona-based sports nutrition company that has accused competitors in lawsuits of selling drugs including Ostarine, said it also has been contacted by FDA’s OCI.

FDA didn’t respond Thursday to a request for comment.

As the men’s magazine Maxim noted in a 2015 article, SARMs have been sold online for “research purposes" when in fact bodybuilders have been using them as an alternative to steroids. The federal government has brought criminal charges against individuals who sold drugs including Ostarine but claimed that they were intended for research.

“SARMs have been available online as ‘research chemicals’ for many years, but it is only fairly recently that FDA’s Office of Criminal Investigations … has initiated prosecutions against online companies fraudulently selling SARMs as research chemicals," said Rick Collins, an expert on sports supplements and partner with the New York-based law firm Collins Gann McCloskey & Barry PLLC, who discussed SARMs during a recentHealthy INSIDER Podcast. “I think FDA is just starting to grapple with what to do about the same compounds sold now not as research chemicals, but as dietary supplements."

As was the case with individuals who were prosecuted for selling active ingredients in prescription drugs under the pretext of research, it’s conceivable that marketers of “dietary supplements" containing SARMs who are targeted by FDA will be charged with a felony under the FDCA: namely introducing misbranded drugs into interstate commerce with the intent to defraud and mislead.

“The element of intent to defraud could be a key point contested by the defense, as well as whether principals within the company, as opposed to the company itself, should be charged with any criminal conduct," Collins said in an emailed statement. “These cases may also present complicated issues under the U.S. Sentencing Guidelines."

Pending Appeal in Ninth Circuit

The government is not the only threat to companies that have purportedly marketed SARMs in dietary supplements. At least one sports nutrition company is pressing ahead with litigation against a rival who was accused of selling Ostarine. Last month, a federal judge in California dismissed a lawsuit filed by Nutrition Distribution, LLC against IronMag Labs, LLC. Nutrition Distribution has filed a notice of appeal with the U.S. Court of Appeals for the Ninth Circuit.

In seeking relief under the federal Lanham Act, the lawsuit alleged IronMag Labs falsely advertised as safe its dietary supplements because the products OSTA RX and Super DMZ 4.0 contained a new drug, namely Ostarine. On April 6, U.S. District Judge Manuel Real dismissed the complaint, finding FDA hadn’t made a final determination on whether Ostarine is a new drug.

“Without a final determination or any clear statement by the FDA on this issue, the Court or a jury would have to apply the FDCA definitions to the substances at issue to determine whether OSTA RX and Super DMX 4.0 are or contain a new or prescription drug that may not be sold or included in a dietary supplement," the judge wrote in his order. “Such an expedition requires expertise and uniformity in administration, not practicable through the courts."

IronMag Labs CEO Robert DiMaggio said he was pleased with the court decision and prepared to contest Nutrition Distribution’s appeal. “As I said when this lawsuit was first filed last year we will continue to fight them, and I hope that every other company that has a pending lawsuit against them does the same thing," he said in a statement to PricePlow, a price comparison shopping site for nutritional supplements that reported the court dismissal on its blog.

IronMag Labs stopped selling Ostarine several months ago, DiMaggio told INSIDER Thursday in an email.

Before Real’s ruling, Nutrition Distribution argued in court papers that the outcome of its claims for false advertising “are independent of interpretation of the FDCA."

“The U.S. Supreme Court has recently recognized the importance of Lanham Act cases like this one to supplement the efforts of the FDA in enforcing the FDCA, noting that the Lanham Act and FDCA ‘complement each other’ in a ‘fundamental respect,’" Robert Tauler, a lawyer in Los Angeles representing Nutrition Distribution, wrote in March 14, 2016 court papers opposing IronMag Labs’ request to dismiss the lawsuit.

Tauler, who noted his client has 16 lawsuits pending against other companies, said he was confident the Ninth Circuit would reverse Real’s dismissal of the case.

“In the meantime, we will continue to pursue other companies that break the law whether those complaints reference the FDA or pursue Lanham Act claims or whether we proceed under different laws similarly enacted to protect against illegal activity in the marketplace," said Tauler, a founding partner with the law firm Tauler Smith LLP, in an emailed statement.  Click here to view the original article.

red flag: dietary supplement makers, do you need a finished-product story?

April 29, 2016

By Jennifer Grebow

Like any industry making health-related claims, dietary supplement makers are beholden to FTC requirements to support any marketing claims with “competent and reliable scientific evidence.” Supplements, however, are not held to the same substantiation bar that drugs are, and thus supplement makers are allowed to rely on numerous forms of “competent and reliable scientific evidence,” including studies on individual ingredients they may find in research literature. In short, they are not required to perform a study on their finished product.

In April, however, a court injunction handed to a Santa Monica, CA–based supplements brand, Neurobrands LLC, ordered the firm to conduct at least one human study on each of its four liquid-supplement products: Neuro Sonic, Neuro Bliss, Neuro Daily, and Neuro Sleep. The civil complaint, brought by the Santa Monica City Attorney’s office and the Los Angeles County District Attorney’s office, took issue with a number of marketing claims Neurobrands made, including “supports memory,” “strengthens your focus and creativity,” “provides fuel for the brain,” and “promotes healthy aging.”

Adam Radinsky, Santa Monica’s chief deputy city attorney for consumer protection, says that during the city and county’s investigation, the studies Neurobrands supplied as evidence were ingredient studies the company had culled from the literature. “The studies were studies that were done on various ingredients for the most part that were found in the various drinks,” Radinsky tells Nutritional Outlook. Radinsky did not disclose more details of the studies themselves, but said, “There’s a wide variety of evidence that the company presented, and we concluded overall that it did not sufficiently back the claims that were being made.”

The settlement Neurobrands agreed to in April requires that, within three years, the company either conduct one human study on each of its finished products or discontinue selling that product. Specifically, the orders say, “Defendant will control the design and implementation of these studies and shall provide the published results of all such studies to the People’s counsel.” The injunction’s other stipulations include requiring the firm to re-market some of its products as conventional drinks instead of dietary supplements, as well as to pay $500,000 to the city and county.

So far, Neurobrands—who, in agreeing to the settlement, does not admit to liability or wrongdoing—has published one product study. The company began the study on its Neuro Bliss relaxation product in 2012, before the initial investigation began in 2013. Nutritional Outlook reported on those preliminary study results in July 2015, and the study is now published in the journal Nutrients. In addition, Neurobrands reports it has completed another study, on Neuro Sonic, with results currently being analyzed by noted Canadian contract researcher KGK Synergize. The firm has two additional clinical trials underway, including one on Neuro Sleep.

Finished-Product Studies

This case raises the crucial question of whether or not companies are required to perform studies on their finished products in order to back their claims. First are foremost, by law, the FTC does not require studies on finished products, and the agency does permit studies on individual ingredients as substantiation. “FTC definitely allows ingredient studies to be used to support claims, with the caveat that the study still has be relevant to the product’s specific claim that you’re making, and also they have to show that the absence or the addition of other ingredients wouldn’t affect your ability to rely on that ingredient study,” says Rend Al-Mondhiry, Esq., associate general counsel, Council for Responsible Nutrition (CRN; Washington, DC).

When asked whether there are any laws that require a company to have a finished-product study, city attorney Radinsky says, “I can’t point you to a particular law that says it’s illegal to advertise something if you don’t have a study on that product.” He does point to FTC’s official “Dietary Supplements: An Advertising Guide for Industry," which gives examples of times when individual ingredient studies may not be sufficient to prove a product’s efficacy—for instance, as the guidance states, if “the combination of multiple ingredients might result in interactions that would alter the effect or safety of the individual ingredients.” In this case, FTC’s guidance says, “A better approach would be to investigate the safety of the specific combination of ingredients contained in the product.”

Radinsky says, “Even in the absence of a black-and-white law that says you need a study on the exact same product, there certainly can still be problems.” In the case of Neurobrands, Radinsky would only disclose that the company “did not have sufficient evidence to back the claims under the federal standard” of competent and reliable evidence.

FTC's Standards

In fact, the FTC allows supplement companies to leverage numerous types of scientific evidence as substantiation, as long as the evidence is deemed by experts to be competent and reliable. It’s a standard that legal courts continue to uphold. Among the latest court decisions on the matter, Kristi Wolff, special counsel for the law firm Kelley Drye & Warren LLP (Washington, DC), points to the recent contempt case between the FTC and probiotic-supplement maker Bayer Corp over Bayer’s Phillips Colon Health supplement. Last fall, the courts ruled for Bayer, with the New Jersey federal district court judge citing FTC’s own guidance which affirms that supplement firms are allowed to rely on a “totality of evidence,” including animal studies, in vitro studies, epidemiological studies—and, yes, ingredient studies. In the case of Bayer, the company presented more than 100 scientific articles it cited from scientific literature to supports its product claims.

Red Flag?

Because this is a settlement, CRN’s Al-Mondhiry notes that the parties involved “can negotiate the terms any way they want.” But it’s still worth asking whether the stipulation for finished-product studies is a red flag—beyond FTC requirements—for the supplements industry at large.

Of the settlement terms, Kelley Drye’s Wolff says, “It is remarkably broad in that it addresses claim substantiation, formulation, labeling, notice to vendors, and product shelf placement. I am not aware of a single FTC order or FTC action that covers the same scope.”

It’s also worth pointing out that Neurobrands’ claims such as “supports memory,” “enhances mood,” and “daily dose of immunity” are not are unusual in the dietary supplements structure-function claims space. Chris Noonan, scientific and regulatory advisor for Neurobrands LLC, says, “Anyone with even a rudimentary understanding of the science behind dietary ingredients would recognize those claims as fairly benign.” Noonan adds, “We have three food and drug law firms advising the company. We have a legion of scientific advisors guiding our claim substantiation. Compared to a majority of marketers in the dietary supplement industry, I think you could agree these claims are fairly conservative.”

As for the ingredient studies the company has in hand, Noonan says that “anyone fluent in basic science would understand there is significant scientific evidence in support of such ingredients as caffeine, L-theanine, melatonin, vitamin C, vitamin D, magnesium, selenium, and zinc.” He says, “Even before pursuing clinical research on the products themselves, the company ensured that, at a minimum, the ‘anchor’ ingredients (anchoring the products to efficacy) matched the dosage amounts studied in clinical research.”

Nevertheless, Noonan says Neurobrands decided to enter into settlement to avoid the further pain and cost of a jury trial. “After three years of negotiations, and ultimately with the disregard for the Neuro Bliss clinical trial evidence, it was apparent that no amount of evidence would suffice and only a jury trial would ultimately settle the dispute. Layer in the resources of two separate district attorney’s offices plus the need to publically justify their time, the company decided to settle and move on. Time will tell if it was the correct decision or not.”

Still, the company stands by its ingredient science, which Noonan says is competent and reliable. For instance, of its caffeine product claiming to support memory, he says, “If you were to research caffeine and memory, you would come across hundreds of studies connecting memory with caffeine consumption. The ability of caffeine to bolster memory—specifically, working memory—isn’t even still a debate.” The same, he says, goes for the company’s immunity claims. “How about an immunity claim for a product containing 100% vitamin C, 1000 IU of vitamin D, along with zinc, selenium, vitamin A, and vitamin E? One would logically deduce that among the thousands of scientific studies connecting these nutrients to immune health, there would be no question about a claim for immune health. But, in this instance, the district attorney apparently didn’t consider this evidence sufficient.”

In this case, it seems, the city and district attorneys are holding Neurobrands to a higher standard than what the FTC federally requires. “We would have been tremendously surprised if the FTC or FDA brought a case against us given our strict compliance to the regulations enforced by both agencies,” Noonan says. “As for the district attorney for the republic of Santa Monica, it was more confusion rather than surprise.” Noonan adds that even after his company, in the midst of the investigation, provided its Neuro Bliss clinical study to the city and county attorneys, the attorneys continued to critique the quality of the research. “After Neuro presented its first clinical trial to the Santa Monica district attorney on Neuro Bliss, it became the most scrutinized of all the drinks. Even with statistically significant results in stress reduction, the DA said the study wasn’t big enough, along with other critiques that had even the study investigators scratching their heads in disbelief.”

“The standard they seem to be requesting is analogous to a Phase II/III drug trial, which doesn’t surprise us based on current trends” involving the dietary supplements industry, he says.

Could this case point to a not-so-hidden agenda at the California city and county level against dietary supplement firms? While noting that the state of California, in general, has been “historically very zealous in going after not just dietary supplement companies but the food industry and other industries in California,” Al-Mondhiry says this case is “one we’re obviously going to keep an eye on in California.”

“It’s alarming in that this clearly goes beyond what FTC allows—FTC’s flexible approach to substantiation,” she continues. “I don’t think it’s going to affect how FTC goes about enforcing its standards, so it’s hard to say how much of a larger impact this is going to have.”  Click here to view the original article.

narb: dietary supplement claims lack sufficient support

April 29, 2015

By Jeffrey S. Edelstein, Linda A. Goldstein and Marc Roth

Upholding a determination by the National Advertising Division, a panel of the National Advertising Review Board recommended that Clarion Brands, LLC modify or discontinue certain claims for a dietary supplement that stated or implied it could substantially reduce or eliminate tinnitus.

Clarion's ads for its Lipo-Flavonoid Plus claimed that the dietary supplement "can help provide tinnitus relief" and "Helps ease the ear ringing that characterizes tinnitus." The advertiser also relied on a consumer testimonial video called "Debby's Store of Hope," where a customer spoke about the ringing in her ears. Diagnosed with Meniere's disease (a disorder of the inner ear that causes vertigo, tinnitus, and hearing loss), Debby was told by her doctor that she would eventually go deaf as a result of the disease. But after a friend recommended Lipo-Flavonoid, she has had no tinnitus, vertigo, or hearing loss for two years. The video featured a disclaimer stating, "Individual results may vary."

After considering the advertising, the NAD recommended that the claims and the consumer testimonial be discontinued, as they reasonably conveyed a message that Lipo-Flavonoid can substantially reduce or eliminate tinnitus.

Clarion appealed.

The NARB panel agreed with the NAD, finding that the consumer testimonial "reasonably conveys a message that Lipo-Flavonoid Plus provides significant or complete relief from tinnitus and other symptoms of Meniere's Disease." It cited the Federal Trade Commission's Guides Concerning the Use of Endorsements and Testimonials in Advertising, which states that "consumer statements about their experience with a product will likely be interpreted as representing that the consumer's experience is representative of what consumers will generally achieve with the product." As for the disclaimer, the panel "does not believe that the … disclaimer is sufficient to change this message."

Clarion's efficacy claims for Lipo-Flavonoid met a similar fate. "[I]n the context of the advertising," the panel wrote, the advertising "also reasonably conveys the message that Lipo-Flavonoid Plus provides significant or complete relief from tinnitus." The advertiser offered a number of scientific studies, case reports, and medical articles in support of its claims. But the NARB panel noted that the studies most heavily relied upon by Clarion were not double-blinded, were not placebo-controlled, and were not subject to a statistical analysis.

"For health claims, the reasonable basis must be established by competent and reliable scientific evidence," the panel explained, noting its methodological concerns with Clarion's studies. "While the panel recognized that the FTC and [the Food and Drug Administration] have established a flexible standard for substantiation of dietary supplement claims, studies should use procedures that are generally accepted in the profession to yield accurate and reliable results. At the very least, [the] failure to use a placebo control group or to conduct a statistical analysis raises questions about the reliability of [the] findings."

After considering the totality of the evidence in the record, "the panel finds there is sufficient support for a claim that Lipo-Flavonoid Plus may provide relief for some consumers who suffer from tinnitus." Lacking sufficient support, Clarion's stronger claims should be discontinued.

"This decision does not preclude Clarion from truthfully advertising that Lipo-Flavonoid Plus may provide relief for some people who suffer from tinnitus," the panel added.

To read the NARB's press release about the decision, click here.

Why it matters: While the NARB recognized that the FTC and FDA have established a "flexible standard" for determining whether the competent and reliable scientific standard has been met in substantiating advertising claims for dietary supplements, the panel expressed concern that the studies relied upon by the advertiser had methodological problems because they were not double-blinded, placebo-controlled, or subject to a statistical analysis. "[S]tudies should use procedures that are generally accepted in the profession to yield accurate and reliable results," the panel wrote, noting that both of the federal agencies "generally recognize that the standard may be met by tests, analyses, research, studies or other evidence based on the expertise of professionals using procedures generally accepted in the profession to yield accurate and reliable results."  Click here to view the original article.

dietary supplement undisputed recalled

April 17, 2016

By News Desk

Nubreed Nutrition is voluntarily recalling all lot codes of a dietary supplement called “Undisputed™”, which contains Acacia rigidula. This supplement is marketed as a “pre workout powerhouse.”

Acacia rigidula is a shrub that grows in the southwest. Its addition may mask the addition of BMPEA, a dangerous synthetic amphetamine.

BMPEA is classified as a doping agent by the World Anti-Doping agency. This drug has never been tested on people. Animal tests has shown that it an dangerously increase blood pressure, and it is addictive. In addition, Acacia rigidula doesn’t meet the definition of a dietary ingredient and the product is therefore an unapproved new drug.

Undisputed™ was sold to distributors, wholesalers, retail stores, and direct to consumers, but was discontinued by Nubreed Nutrition in October 2015. The product was sold in white bottles with a white cap, containing forty powder servings. If you purchased this product, return any unused portion to the place of purchase.

No illness or injuries have been reported in connection with the consumption of this product. But consumers who have this product should stop using it immediately. Contact a doctor if you are experiencing any adverse side effects due to the consumption of this supplement. You can report any adverse effects to the FDA’s MedWatch Adverse Event Reporting program.  Click here to view the original article.

crn plans to launch dietary supplement product registry

April 13, 2016

By Josh Long

The Council for Responsible Nutrition (CRN) has been authorized by its board of directors to develop an industry-wide dietary supplement product registry that it plans to introduce by the end of the year, the trade association announced Wednesday.

“Our aspiration for this is that it will give FDA more of a window into the industry," said Steve Mister, president and CEO of CRN, in a phone interview. “It will help them understand who the legitimate players are, what the products are in the market, and what ingredients are in those products."

For no charge, companies will be able to contribute certain product information to the database that will be accessible to anyone including consumers, the trade association noted. Mister described a second tier of the database in which companies can include more detailed information for a small fee, such as special third-party certifications or seals affiliated with a product or facilities where a product was manufactured, for the viewing of specific audiences such as retailers and regulators.

Mister expressed hope that the database would be adopted by the broader dietary supplement industry, not just CRN members. He said he advised other industry trade groups that CRN has been working on the database initiative.

CRN’s announcement symbolizes efforts by industry leaders to implement self-regulatory initiatives following a year of state attorneys general and other critics raising questions about the adequacy of FDA oversight of dietary supplements.

During a United Natural Products Alliance (UNPA) Raw Materials & Supply Chain Summit in February, the industry leaders of CRN, UNPA and the American Herbal Products Association (AHPA) joined together during a panel to discuss self-regulatory initiatives.

“We are really hopeful that those organizations will support this and encourage their members to participate in the registry as we are giving them support for the efforts that they’re doing," Mister said. “We want this to be an industry-wide effort so that we can capture, ‘What does the legitimate dietary supplement industry look like?’"

In the coming weeks, CRN anticipates announcing the vendor who will administer the database.

CRN’s board previously voted to require all CRN members to participate by 2017 in a dietary supplement label database created by the National Institutes of Health’s (NIH) Office of Dietary Supplements (ODS). In spite of CRN’s planned product registry, Mister said the requirement for its members to participate in the ODS database hasn’t changed.

“But as we looked at the ODS database, what we realized was that it did not go far enough for the kinds of information that we want in there and for the audiences that we wanted to serve," said Mister, who explained the ODS database is largely intended to serve researchers and omits details affiliated with products such as third-party seals and certifications. “We felt … there is a place for a broader registry that would be consumer-facing and retail-facing that would have additional information beyond just what’s on the label.

“And we’ve also been concerned that the ODS database has attempted to reach out and grab every label that’s in the marketplace and put it in there even if there’s a history of regulatory problems" such as the presence of illegal ingredients, Mister continued. “Those kinds of things are in the database. We want a registry that represent the legitimate industry."

If a product contained an ingredient FDA considered illegal, it wouldn’t be included in the planned registry, Mister said. However, that means products that are most likely to be on FDA’s radar—for instance, ingredients spiked with pharmaceutical drugs, but marketed as “dietary supplements"—wouldn’t be included in the database.

The planned database “is not intended to solve all of the industry’s problems," Mister acknowledged. “It’s one piece of a much larger puzzle, and we think all of these initiatives collectively help to move the industry forward."

CRN’s plan is distinguishable from a bill that was reintroduced in 2013 by Sens. Dick Durbin (D-Illinois) and Richard Blumenthal (D-Connecticut). The Dietary Supplement Labeling Act would require manufacturers of dietary supplements to register their products with FDA and furnish a description of each product, its ingredients and a copy of the label. Durbin was expected to reintroduce dietary supplement legislation as early as spring 2016.

“This is not being done to create a mandatory registry," Mister said, commenting on CRN’s plans. “But one of the benefits of this could be that if we ever had to agree to a registry that was mandatory, we would already be that much further along … Companies would be in the habit of doing this. We would know a lot more about what that [registry] would look like rather than if it were happening and we were starting at zero."  Click here to view the original article.

crn announces industry-wide dietary supplement product registry

April 13, 2016

By WholeFoods Magazine Staff

Washington, D.C.— In a unanimously authorization by its board, the Council for Responsible Nutrition (CRN) announced today its creation of an industry-wide dietary supplement product registry, which will be launched by the end of the year.

In the beginning, the product registry will serve regulators and the retail community. However, CRN’s definitive goal is to “provide industry accountability to consumers as well.”

“This is one step we’re making to take back our industry from the lawbreakers, from the renegades, (and) from the companies that spurn regulation," states CRN President and CEO Steve Mister. “Our member companies have turned a corner and are fully engaged in efforts to separate the legitimate manufacturers marketing healthful products from the hit-and-run, fly-by-nighters selling quick fixes and illegal drugs wrapped with a supplement label. We need all companies who care about our consumers and the sustained growth of this industry to join with us in this initiative.”

The initiative is just one of the association’s “self-regulatory projects.”

Earlier this year, as a requirement of membership, CRN announced that all members must submit their supplement product labels to the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) Dietary Supplement Label Database (DSLD). CRN is calling this move “a first and necessary step toward improving transparency in the supplement industry.”

Mister noted, “the industry product registry will serve as a companion piece to the ODS Label Database which is an important tool for the scientific research community.”

In an effort to save companies time, Mister also noted that the product registry will connect with the ODS’s database in some way.

The product registry will be developed and managed by a third-party vendor.  Click here to view the original article.

Nutraceuticals Market: Asia Pacific Industry Analysis and Opportunity Assessment 2014 - 2020

November 2015

By Future Market Insights

With improved standard of living and changing lifestyle in Asia-Pacific, market has experienced a sea change in consumer’s food habits and buying pattern. Irregular eating, junk food and hectic lifestyle has resulted in their ill health. Thus, giving rise to a number of diseases, mostly related to nutritional deficiencies. Nutraceuticals can play a vital role in curbing the above mentioned health issues. They provide medicinal and health benefits for the treatment of diseases. The potential of this market is increasing particularly in Asia-Pacific due to the challenging lifestyle of the people who are looking for a modern and quick approach to fight for diseases or to prevent them.

Nutraceuticals promotes longevity and various health benefits. They are easily available and economically affordable. It claims to have a psychological benefits too in diseases like Chronic Inflammatory disorder, degenerative diseases and anti-diabetics. Few nutraceutical products like green tea, omega 3 fatty acids prevents obesity, helps in weight loss, improved glowing skin and cancers too.For example milk is a nutraceutical which is good for the heart and muscles.

Nutraceuticals can be segmented into three major groups - Dietary Supplements, Functional Foods and Functional Beverages. Dietary supplements is sub segmented into vitamin & mineral supplement, herbal supplements like ayurvedic extracts, plant extracts andprotein supplements like protein powder & lifestyle products. Functional Food is sub segmented into may have omega fatty acid foods, probiotic foods and functional beverage market has energy drinks, sports drinks and fortified juices. Few commonly used nutraceuticals in India are Arjuna Sheerapka(for cardio protection), Shatavari Grihta(for women’s health during various physiological states) and Brahma Rasayana (for protection from mental stress).

The market is growing substantially at a healthy CAGR 2015-2020 primarily due to rising demand of the dietary supplements and increasing shift towards preventive therapies. Many companies are entering in this market to meet the consumer demand of the nutraceuticals. In India, it is still at a very nascent stage, however, other Asia Pacific countries such as China, Japan, Brazil and Australia are key growth regions where the demand for nutraceuticals is huge. Also they are the key target markets for manufacturers. Globally, U.S. and Europe are the largest markets. Germany is the largest market in the European region. The biggest driver could be that these countries are the best destination for innovations in the nutraceutical ingredient industry. Strict legislation against the use of chemical ingredients in food products and more usage of ingredients derived from natural products is another reason why these markets are flourishing in this sector.Rising disposable income coupled with growing awareness about health & wellness are also major drivers for augmented nutraceuticals demand in Asia-Pacific countries.

Fortification, alteration, enhancement are few of the technologies which are used for nutraceuticals. To improve the bioavailability of nuetraceuticals, patenting of new delivery systems is a new trend like in nanotechnology which is a rapidly evolving interdisciplinary field based on the manipulation of matter on a submicron scale. Recently it has been found that Cactus plant’s spectrum, which is anti-cancer, anti-viral, anti-diabetic has a rich source of fibre and edible pulp. In cactus pear, taurine is a major contributor, which is fast becoming an active constituent of nutraceuticals. WHO(World Health Organisation)has launched the first Global Strategy to address issues related to traditional medicine. The European Commission has confirmed that health claims would be on their next agenda for disease risk reduction. 

Major players in this industry are Cadilla Healthcare, Pfizer, Nature’s Answer, USA, Celestial Biolabs LtdMagnum, Numico, APS, Omvita.  Link to original post.

global dietary supplements market expected to hit at a cagr of 7.4% from 2014 to 2020

November 2015

By PMR Research

According to a new market report published by Persistence Market Research “Global Market Study on Dietary Supplements: Botanical Supplements To Be The Largest Market by 2020,” the global dietary supplements market was valued at USD 109.8 billion in 2013 and is expected to grow at a CAGR of 7.4% from 2014 to 2020, to reach an estimated value of USD 179.8 billion in 2020.

A growing interest in a healthy lifestyle is leading to an increase in the consumption of healthy food. Dietary supplements are the best choice for consumers looking to adopt a healthy lifestyle. People across various age groups consume dietary supplements to meet their recommended dietary allowances. Dietary supplements are available in different forms, such tablets, pills, powders, capsules, gelcaps, and liquids. Dietary supplements such as vitamin, botanical, mineral and fatty acid help consumers stay healthy and prevent nutritional deficiency diseases. Rising aging population, increasing lifestyle diseases and increasing healthcare cost are some of the important factors driving the growth of the dietary supplements market.

Asia-Pacific is the largest market for dietary supplements globally. Consumer awareness about the benefits of dietary supplements and wide product availability are the major drivers for the market in Asia Pacific. The increase in disposable income allows customers to spend more on healthy food items. According to the National Bureau of Statistics of China, annual per capita disposable income of urban households in China increased from USD 2,271.0 in 2008 to USD 3408.5 in 2012. The overall annual disposable income in India increased from USD 1,366.2 billion in 2010 to USD 1,587.6 billion in 2013. The dietary supplements market in North America is at mature stage compared to that in developing nations in Asia and Africa. In recent years, consumers have become more conscious of their diet.

According to a survey conducted by the Council for Responsible Nutrition (CRN) in 2014, around 68% of adults in the U.S. use dietary supplements; of these, around 50% are regular users. Rising number of elderly people in North America is leading to a rise in demand for dietary supplements products. Over the last few years, the risk of chronic diseases and maintenance of health in old age have been the major health concerns leading to increased spending on dietary supplement products. According to the U.S. Census Bureau, in 2012, 40 million people in the country are aged 65 and above. Europe is the second-largest market for dietary supplement products. Recently, consumers in the region are showing great interest in leading healthy lifestyles, in turn, driving the consumption of healthy food. In the European region, Western Europe is the largest market for dietary supplements. Eastern Europe is considered to have higher future growth potential. Rising aging population, increasing lifestyle diseases, and growing healthcare costs are some of the important factors driving the growth of the dietary supplements market in the region.

The dietary supplements market is bifurcated into product (vitamin, botanical, mineral, fatty acids, and others supplements) by value (USD billion), application (food and beverages, pharmaceuticals, personal care, and others) by value (USD billion), and end user (adult women, adult men, senior citizens, and others) by value (USD billion).

Global dietary supplements market grew from USD 90.6 billion in 2010 to USD 109.8 billion in 2013 at a CAGR of 6.6%. Under regional segment, the Asia Pacific dietary supplements market ( the largest market in 2013) increased by 8.2% CAGR during 2010-2013 to reach USD 34.2 billion in 2013.

Some of the major companies operating in the global dietary supplements market are NBTY, Inc., Koninklijke DSM N.V., Amway, Herbalife Ltd., Omega Protein Corporation, Bayer AG, Naturalife Asia Co., Ltd., Integrated BioPharma, Inc., Nu Skin Enterprises, Inc., BASF SE, Surya Herbal Ltd., Bio-Botanica Inc., The Himalaya Drug Company, Ricola AG, Pharmavite LLC, Blackmores Ltd., Epax AS, and Axellus AS.

clinical trials: two-thirds of supplement companies support research

November 12, 2015

By Steve Myers

Clinical research has become a vital component of dietary supplement development and marketing. As many supplement companies have increased investments in clinical research on their products, several challenges have emerged, including proper study design and use of “borrowed" science.

Careful research design is important to the significance and application of results, especially in the area of claims. While exploring the efficacy, mechanism and safety of a dietary supplement, research needs to keep in mind claims substantiation standards set by regulatory agencies.

Likewise, when a supplement company promotes its product by using research on similar products or ingredients from another company, it can create several issues. The product or ingredient in the borrowed research might have some differences from the product borrowing the science. Depending on the ingredient, this could be in terms of species, dose, concentration, standardization, chelation and/or source, and in terms of finished product this could mean differences in the other ingredients in the formulations, as well as delivery technologies and product type (e.g., liquid versus softgel). Further, using “borrowed" ingredient research for a finished product that contains not only the ingredient studied but other ingredients not in the borrowed study renders the applicability of the research benefit muddy, at best.

Of course, good research costs good money, time and other resources. It costs even more to strive for the so-called “gold standard" of randomized controlled trials (RCTs) established by FTC and other authorities, relative to claims substantiation. Still, there are many types of studies—observational, epidemiological, case studies, animal, in vitro and others—that can provide valuable information on a dietary supplement’s mechanisms, safety and potential clinical efficacy in humans. For many companies, there is a gradually ascending path to RCTs, progressing up the research study hierarchy with each positive finding. Further, these other types of studies can help direct future studies on endpoints not originally considered.

Insider set out to get a snapshot of how supplement companies are currently approaching clinical research, if at all. As the bar inches higher and higher for the quality of research and standards for claims substantiation, the companies with the best research may ultimately rise to the top, or at least have significant advantage to do so.

We looked at whether companies are funding their own research and asked them how they design studies, including if and where they get help in the planning stages. On the research itself, we asked about study endpoints and subject populations. We also inquired about what companies do with the results, whether positive or negative findings, including how they develop marketing and claims based on results and how they ensure claims are legal. More than 100 companies responded to our online survey, which represents insider readers with an error margin of 10 percent (at 95 percent confidence level).

The good news is two-thirds of respondents reported their companies are funding and/or supporting research—26 percent fund their own research, 11 percent support research by supplying product to researchers, and 36 percent of respondents both fund and support research on their products. Piling on the sunshine, 76 percent of respondents are (40 percent) or may be (36 percent) planning to fund clinical trials on their products within the next year.

Download the complete report, “State of the Market Report: Clinical Trials," here.  Link to original article.

fda requests comments on use of "natural" on food labels

November 12, 2015

By Rachel Adams

At the request of both consumers and lawmakers, FDA has requested the public’s input regarding use of the term “natural" in food labeling.

According to FDA, this action is in response, in part, to three citizen petitions asking that the agency define “natural" for use in food labeling and one citizen petition asking that the agency prohibit the term on food labels. 

In addition, FDA indicated that some Federal courts have requested administrative determinations from the FDA regarding whether food products containing ingredients produced using genetic engineering or foods containing high fructose corn syrup (HFCS) may be labeled as “natural."

FDA has yet to establish a formal definition for the term “natural," which has placed manufacturers and marketers that choose to use in the word in a legal grey area. However, FDA points to its “longstanding policy" regarding use of the term, which suggests nothing artificial or synthetic(including all color additives regardless of source) be included in, or be added to, a food that would not normally be expected to be in that food. FDA noted in a release that the policy doesn’t address food production methods, such as the use of pesticides, nor does it explicitly address food processing or manufacturing methods, such as thermal technologies, pasteurization, or irradiation. FDA also noted that the agency did not consider whether “natural" should describe any nutritional or other health benefit. 

Specifically, the FDA asks for information and public comment on questions such as:

  • Whether it is appropriate to define the term “natural";
  • If so, how the agency should define “natural"; and
  • How the agency should determine appropriate use of the term on food labels.

Comments are being accepted through February 10, 2016.  Link to original article.

creatine may be good companion for whey

November 5, 2015

By Steve Myers

If there is one staple to the serious sports nutrition consumer, it is whey protein. This ingredient has dominated the sports market due its touted anabolic benefits including increased muscle protein synthesis and muscle growth.

Researchers from the Center for Sport Science and Human Performance at the University of Greenwich, Kent, England, and the Clinical Research Institute at Texas Tech University Health Sciences Center, Lubbock, Texas, looked at studies on whey protein alone and in combination with other ingredients such as carbohydrates and creatine. Their detailed their meta-analysis and findings, published online ahead of print late last month in Sports Medicine journal, suggest whey protein alone or in multi-ingredient formulas helps to increase lean body mass and improve upper and lower body strength.

They focused on randomized controlled trials (RCTs) featuring adults subjects who underwent at least six weeks of resistance training and took either supplemented with whey protein (alone or in combination formulas) or a control supplement (carb or other non-protein) of equivalent calories. They pooled data from these trials on fat-free mass and lean body mass, as well as maximal strength.

Nine RCTs, involving 11 interventions and 192 subjects, made the cut.

Combined with resistance training, whey protein alone or in multi-ingredient formulas was associated with small gains in lean body mass combined with resistance training, compared to the control supplements. Digging deeper into the data, they found a small advantage to the lean body composition benefits when whey was formulated with other ingredients, especially creatine— with a heavy role in quick energy restoration during early-stage intense exercise, creatine adds fuel to muscle performance and muscle synthesis.

The combos also were a hair better at maximizing upper body strength, while whey alone had a slight edge on lower body strength; both types of whey-containing supplements were better than controls in the strength department.

The researchers noted the primary limitations of the data and analysis were the scarcity of qualifying RCTs with a duration longer than 12 weeks and the inconsistency of dosing and timing of supplementation among the trials included.

Still, this work further solidifies whey protein’s importance to sports nutrition and lends some much-needed positivity to the health benefits of creatine in this area.  Link to original article.

aussie supplement makers booming on china demand

November 5, 2015

By Kaori Takahashi

Australia's nutritional supplement market is showing signs of a boom, thanks to growing demand from increasingly health-conscious Chinese consumers. The industry has grown about 40% in the last five years to an estimated 1 billion Australian dollars ($729 million).

Hundreds of supplements are available, along with advice from sellers, at this pharmacy in Sydney, Australia.

Blackmores, the leading provider of vitamins, mineral supplements and other health-boosting products in Australia, saw its share price jump almost sixfold from a year ago on brisk online sales in China. Rival Swisse Wellness has decided to sell itself to a Chinese company for A$1.67 billion.

"Consumer health consciousness and increasing demand have helped boost the industry," said IBISWorld, a market research firm. "Asian markets, particularly China, are expected to offer significant opportunities, as the burgeoning middle class consumes more imported goods and focuses on greater health awareness." Australian nutritional supplements are so popular that some products are traded for twice their original prices amid shortages.

 IBISWorld estimates sales at Swisse Wellness to be A$325 million for the current fiscal year, nearly five times the level five years ago.

Swisse Wellness was founded in 1972 near Melbourne. Having failed to gain a foothold in the U.S., the privately held company has set its sights on China for its survival. "Our record fiscal 2015 result demonstrates the business has good momentum," said CEO Radek Sali.

In September, the Melbourne-based private company announced that its shareholders will release 83% of their shares to Biostime International Holdings, a leading producer of baby formula in China. The current Swisse Wellness board will stay on. "Under Biostime's ownership Swisse will have access to new capital and capability, so that we can take advantage of multiple growth opportunities, both in Australia and internationally," Sali said. Luo Fei, CEO and chairman of Biostime, said, "The Swisse brand is synonymous with Australia's clean, green and healthy lifestyle."

Strong demand from China boosted profits at Blackmores, which sells over 250 varieties of vitamin supplements. For the year to June, net profit grew 83% year on year to A$46.6 million, while sales increased 36% to A$471.6 million. About a third of the sales were made in Asia, including souvenir purchases by Chinese tourists to Australia.

Blackmores opened a branch in the China (Shanghai) Pilot Free Trade Zone in 2014 and launched full online sales for local consumers in August of this year in partnership with, China's second-largest online direct sales company. Blackmores' shares surged over the year to above A$170.

Vitaco Holdings, another Australian nutritional supplement maker, floated its shares in an initial public offering in September, riding the China momentum.

The boom time for the Australian supplement business came thanks to the Australian government's push to establish free trade agreements with Asian countries. One with its largest trade partner China is expected to take effect by the end of the year with the removal of tariffs likely to push Australian supplement makers ever closer to the Chinese market.  Link to original article.

asia pacific dietary supplements market to stimulate the global market in forthcoming years

November 4, 2015


According to a recent market study by Transparency Market Research (TMR), Dietary supplements basically refer to nutrition or food supplements that are consumed orally by people belonging to different age groups. The global dietary supplements market is mainly driven by factors such as a fast paced lifestyle, urban influence, increasing costs of healthcare, rising healthcare concerns, and economic growth. Other factors that drive the global dietary supplements market are rising disposable incomes, growing geriatric population, and overall population growth.

Dietary supplements are mostly consumed by those who do not receive the required amount of nutrients from their daily intake of food. Dietary supplements come in various forms which include energy bars, capsules, liquid, pills, tablets, powders, granules, and gel caps. According to the U.S. Food and Drug Administration, dietary supplements consist of dietary ingredients that are meant for ingestion. Dietary supplements generally aim to enhance the nutritional value of people’s diet. Metabolites, vitamins, concentrates, herbs, extracts, minerals, and amino acids are some of the popular dietary ingredients that are present in dietary supplements.

Global Dietary Supplements Market – Wide Consumer Base a Significant Growth Driver

The global dietary supplements market is segmented on the basis of types of dietary supplements, forms, consumer category/age, and geography. The various types of dietary supplements in the global market are vitamins, amino acids, enzymes, botanics or herbals, and minerals. As mentioned earlier, dietary supplements come in several forms: tablets, soft gels, capsules, powders, and liquids.

On the basis of consumer category, the global dietary supplements market is categorized into infants, geriatric population, adults, pregnant women, and children. The global market for dietary supplements aims at addressing the nutritional requirements of each and every age group with unique and special nutritional needs. The overall demand for dietary supplements depends either on individual decision of a consumer or medical recommendation. Different types of dietary supplements serve different purposes. For instance, there are some dietary supplements that add vital nutrients to one’s regular diet, and there are those that help in lowering the risks of developing certain diseases and disorders.

Dietary supplements also differ on the basis of composition which in turn depends on the age of the target population. Clinical, lifestyle, and proactive/preventative are the various categories of dietary supplements. The clinical segment includes nutrigenomics and medical food. The lifestyle segment includes dietary supplements for wellbeing, beauty, vitality, and energy. The proactive dietary supplements segment includes dietary supplements meant for infant nutrition, weight management, and age-related.

Heightened Healthcare Awareness and Rising Demand for Nutritional Products to Propel Asia Pacific Market

Regionally speaking, the global dietary supplements market is categorized into Asia Pacific, Europe, North America, and Rest of the World. No two countries have similar nutritional deficiencies or dietary patterns. Geographically, the overall market for dietary supplements is dominated by the dietary supplements markets in India, the U.S., and China. The global dietary supplements market is led by the Asia Pacific market. The two robustly growing regional segments in the Asia Pacific dietary supplements market are China and India.

The Asia Pacific market is primarily propelled by greater preference for nutritional products and greater healthcare awareness. This market is followed by North America. It is anticipated that the Latin America market for dietary supplements will witness substantial growth in the years to come largely owing to weight management.

Key companies in the global dietary supplements market are Abbott Nutrition, Pro Health, BASF Corporation, Advocare International, HORN Nutraceuticals, Novartis AG, NOW Foods, General Nutrition Companies, Omega Protein, Herbalife Ltd, The vitamin Shoppe, Chemi Nutra, Enzymotec USA, A1 Supplements, Biosyntrx, Inc., Bayer Healthcare LLC, Lonza, Inc., NBTY Inc, and Amway.  Link to original article.

beatine market will grow rapidly owing to enhanced demand in nutritional products and dietary supplements from 2015 to 2022: grand view research, inc.

November 3, 2015

By Grand View Research

Global betaine market size is estimated to exceed USD 3.5 billion by 2022 and is expected to grow at an estimated CAGR of over 6% from 2015 to 2022. Increasing nutritional products and dietary supplements demand is expected to drive the market over the forecast period.

Health benefits associated with product consumption such as improved metabolism, muscle strength, power, and endurance is anticipated to fuel product demand over the next seven years. Intrinsic properties such as high water holding capacity promotes its use in cosmetics and toiletries which is expected to have a positive impact on market growth over the foreseeable future.

Betaine is used in feed additives to improve metabolism in animals. Rising nutritional deficiencies in feedstock is expected to spur nutritional value feed additives demand over the forecast period. Although betaine is present in wheat products, certain body abnormalities such as visual abnormalities and developmental delay can be associated with its deficiency.

Over-consumption of the product is expected to pose side effects. This is anticipated to hinder market growth over the forecast period. Recent product developments including product in new hydrochloride form is expected to enhance market growth over the forecast period.

Increasing preference towards substitutes such as DL-Methionine and Dimethylthetin throughout various end-use industries is expected to hamper market growth over the forecast period. DL-Methionine and choline diets are adopted for broilers to enhance their weight and performance. These substitutes pose stiff competition for product market in diet replacement.

On the basis of products, industry has been segmented into natural and synthetic. Synthetic form dominated the global demand in 2014. Natural betaine is expected to gain significance over its synthetic form, owing to its improved characteristics such as enhanced lean growth, tolerance to heat stress, and reduced energy requirements.

Product supplements are expected to gain significance in sports drink and diets owing to the enhanced muscular strength and power while protecting cells from stress-induced damage. Energy supplements and protein powders are expected witness significant growth owing to increasing consumer awareness about healthy diet intake and sport activities.

On the basis of end-use, market has been classified into food & beverage, animal feed and industrial. Other industrial applications include plastics, detergents, cosmetics, paints, and coatings. Food and beverage was the largest end-use segment in 2014 and is expected to drive global demand over the forecast period.  Link to original article.

crn pursuing voluntary supplement registry

November 3, 2015

By Michael Crane

In a move designed to promote transparency and build trust with consumers, the Council for Responsible Nutrition’s (CRN; Washington, DC) Board of Directors has approved in concept a voluntary product registry for dietary supplements. In the coming weeks, CRN will investigate different options for establishing the registry, such as creating a new platform or working with an existing database.

“I firmly believe CRN is uniquely positioned to lead the industry toward developing measures to improve quality and build consumer trust,” said Steve Mister, president and CEO, CRN. “And this database of product information is the first step in that process.”

The CRN Board adopted the proposal for the registry at its October board meeting during the annual CRN Conference, which took place soon after Mister called on CRN members to support the registry during his president’s address. Based on negative media coverage of industry this year, Mister saw this as a critical time for industry to take steps to provide more transparency about dietary supplements in the market.

“If we ignore the signs, we risk becoming irrelevant,” said Mister, during his president’s address. “If we wait too long, we will get left behind. If we consider ourselves impervious, we may get blindsided by our vulnerabilities.”

Moving Forward

Existing databases that could be possibilities for the registry include the ODS database or the Underwriters Laboratories’ Clearview program, said Mister. In the coming month, CRN will be investigating these databases as well as the possibility of creating a new platform, and then provide a report and recommendations based on its investigation at the December Board meeting for a possible Board decision. The Board will also be considering a time frame for implementation, said Mister.

“The Board’s decision to move CRN toward an industry-directed product database of dietary supplements follows nearly a year of discussions and investigations by the Board into a viable system of providing more visibility for regulators into the size of the industry and basic information about products (brand names, ingredients, supplements facts labeling, etc.),” said Mister. “This marks CRN’s determination to voluntarily provide more transparency about dietary supplements in the market.”

Mister added that CRN is also seeking feedback from its members, other stakeholders, and other industry trade associations on this initiative.

Calling on State Attorneys General to Prosecute Bad Players

On a similar note of protecting consumer interests, CRN’s Rend Al-Mondhiry, regulatory counsel, called on 80 assistant state attorneys general (AGs) to support efforts to stop criminals from marketing illegal drugs as dietary supplements.

Speaking before the National Association of Attorneys General (NAAG) Fall Consumer Protection Meeting (St. Louis, MO) on November 2, Al-Mondhiry asked the assistant state AGs to prosecute companies that participate in criminal behaviors like spiking dietary supplement products with illegal drugs.

“These types of activities clearly violate the law and present real risks to public health,” said Al-Mondhiry. “This is where state AGs can be most effective in protecting consumers and can coordinate with FDA to target these illegal products.”

Al-Mondhiry spoke at the meeting on a panel that included Pieter Cohen, MD, assistant professor of medicine at Harvard Medical School, and Maia Kats, director of litigation at the Center for Science in the Public Interest. In addition to asking for support from the AGs, Al-Mondhiry explained some of the measures the industry is currently taking to ensure that the products reaching consumers are safe and have truthful, accurate labeling.

Yet, even with these self-policing efforts, Al-Mondhiry said that the industry still doesn’t have an “enforcement hammer” to go after companies that flout the laws and regulations governing dietary supplements. She suggested that the state AGs, in coordination with FDA, have the opportunity to target these bad players and protect consumers from products that have been spiked with illegal drugs. Link to original article.

opinion: the irony of ncaa rules on dietary supplements

November 2, 2015

By Christian Martin

With more than 170,000 NCAA Division I student-athletes in the United States, one shouldn’t be surprised by the rather large amount of strict rules pertaining to these students and their institutions, particularly when it comes to supplement usage. Some rules can be vague, though — according to the NCAA, taking a certain supplement may be just fine…or it might cause an athlete to lose an entire year of eligibility and scholarship. Information on how to tell the difference is not readily available, and that’s where the problem lies. How are people supposed to follow rules on taking supplements when those rules are beyond challenging to find and understand?

The standard NCAA Banned Substance List appears simple at first, with the average athlete most likely having no moral problem following it. No street drugs, no anabolic agents, no stimulants, no beta-2-agonists and so on. Overall, the rules are clear, especially with informative pamphlets and posters available at most, if not all, Division I institutions. Generally, athletes shouldn’t consume what are colloquially known as “drugs” and should double-check what they’re taking if it requires a prescription.

Yet on the same Banned Substance List lies a warning for all nutritional and dietary supplements — a less specific advisory that taking supplements can lead to a positive drug test. What does that mean?

It took 15 minutes of scouring the Internet just to find the list, but finally, the “not exhaustive” list of impermissible supplements from the NCAA’s statement on nutritional supplements appeared on a small PDF produced for Washington State University.

Four of the 17 banned nutritional and dietary supplements are amino acids and any amino acid chelates, glucosamine, green tea and protein powders. Anyone that has taken some form of basic biology in their lifetime knows that every human being is made up of the standard 20 amino acids. And if one combines biology with a little chemistry, one would learn that most vitamins and minerals are chelated (paired) with an amino acid for easier absorption into the body. Protein powders have a place in most D1 training facilities, glucosamine is a helpful joint aid and green tea is universally known for its high antioxidant count.

I soon discovered that green tea was banned due to its ability to mask marijuana consumption on a drug test. But how much green tea is required to keep an athlete’s poor choice in the clear? Whether it requires drops of extract or cups per day is left undisclosed by the NCAA’s rules. This is where changes need to take place — notifying athletes of the disallowed amount or at least the most dangerous forms of ingestion.

With that idea in mind I met with Laura Anderson, the University of Colorado’s athletic performance dietitian. I voiced my concerns about green tea and its masking abilities and how they closely mirror minor side-effects of cranberry juice. Given this information, how long would it take the NCAA to list cranberry juice as impermissible? What logic do they use to apply such a blanket ban to most dietary supplements?

“Supplements are supplements and foods are foods,” Anderson said. “Foods are substances containing macronutrients to provide energy essential to support human life, used in the body to sustain growth, repair tissue damage and vital processes. Although these [food] products may contain vitamins and minerals, they differ from dietary supplements by the presence of a ‘Nutrition Facts’ panel rather than a ‘Supplement Facts’ panel on the product packaging.”

Other than the packaging facts, one can see where it would be easy to confuse foods and dietary supplements to be within the same category, especially with protein and carbohydrate replenishers listed as supplements.

“Supplements follow other guidelines, defined by the Dietary Supplement Health and Education Act (DSHEA) as any product taken by mouth that is intended to supplement the diet. The ‘dietary ingredients’ in these products may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues and metabolites,” Anderson said.

So what’s wrong with simply listing off amounts allowed for each supplement?

“Listed amounts lead athletes to believe that they can take [a] supplement, then not understand why they just failed their drug test. The proprietary blend in a supplement can be made up of Chinese mushrooms, juju fruit and other ingredients that may or may not be there in their real or false forms,” Anderson said.

Basically, foods are what goes into one’s diet, whereas supplements quite literally supplement the diet. The dangers considered by the NCAA aren’t exactly concerned with an individual’s intake, but rather what that intake may contain. Since supplements are not considered foods or drugs, the FDA does not have to regulate them before they’re sold. This loophole in the industry allows distributors to add potentially harmful ingredients to the overall supplement without listing them.

A clip produced by Supplement 411, a resource of the U.S. Anti-Doping Agency (USADA), titled “Decoding the Dietary Supplement Industry” explains the fears. As the video explains, many supplements are “mostly OK” but a good number are in the “unknown” category and some are “dangerous.” Dietary supplements in the “dangerous” category can contain not only NCAA-banned substances, but generally illegal ones ranging from amphetamine-like stimulants to steroids and hormones, and even a “mostly OK” supplement has been found to contain anabolic steroids. The FDA sometimes steps in and adds further warning to these supplements or issues recalls, but some companies find ways around complying.

Some dietary supplements are safe, and some can really help athletes if they have been tested by a third party (a private non-FDA entity) and carry one of the four main private certification seals, but even then, they can’t always be trusted. What is more frightening is the amount of work required to find and understand these guidelines. The knowledge immediately available to student-athletes is something many D1 institutions and the NCAA as a whole must improve. Supplement information and regulation should be common knowledge to the NCAA athlete, starting with a greater push to educate those working hard to be the best they can be.  Link to original article.

dietary supplement leaders criticize fda for aiding state

October 30, 2015

By Josh Long

Leaders in the dietary supplement industry are questioning the prudence of FDA’s decision to assist state law-enforcement officials with an investigation into an ingredient known as picamilon that is at the center of a lawsuit against GNC.

A written declaration by an FDA official was used by the states in their enforcement activities against picamilon, according to the heads of two trade associations in Washington. In communications addressed to senior FDA officials, industry leaders raised concerns that FDA’s written declaration and cooperation with the states undermined the agency and circumvented the public process.

Daniel Fabricant, Ph.D., executive director and CEO of the Natural Products Association (NPA), asked FDA’s acting commissioner in an Oct. 2 email whether he authorized a supplement official to provide the Sept. 28 written testimony, as federal regulations (21 CFR. 20.1) required. As he pointed out, the regulation authorizes an FDA official to testify if the commissioner or someone he appoints to act on his behalf determine the “testimony will be in the public interest and will promote the objectives of the act and the agency."

But Fabricant argued the written testimony “undermines" the agency rather than bolstering its objectives. Industry leaders noted FDA hasn’t taken any action on picamilon, the ingredient in question, or made a public declaration that it’s illegal in dietary supplements.

“FDA isn't supposed to serve as the states’ witnesses if it undermines the agency's authority," Fabricant, the former director of FDA’s Division of Dietary Supplement Programs (DDSP), said Wednesday in an email toNatural Products INSIDER. “It does here."

Fabricant addressed the email to FDA senior officials, including acting director Stephen Ostroff, M.D. An FDA spokesperson said Thursday she could not comment on the email.

Under the standard set by the federal regulation, “a deposition or other testimony or information sought to undercut the FDA's regulatory decisions are unlikely to be viewed by the agency as ‘promot[ing] the objectives of the act and the agency,’" Fabricant stated in the Oct. 2 email to FDA officials. “As the agency has not taken action against the ingredient in question at present, it does not have any current restrictions from doing so. Should the agency currently find the ingredient violative, which appears to be the case from the affadavit and fail to act, that is very concerning and furthermore it would make this testimony at odds with 21 CFR 20.1(c)."

Earlier this week, the head of the Council for Responsible Nutrition (CRN) expressed “grave concern" that FDA’s determination was made without going through the public process. The declaration that was shared with state attorneys general precluded input from the dietary supplement industry, wrote Steve Mister, CRN’s president and CEO, in an Oct. 27 letter addressed to FDA.

Cara Welch, Ph.D., a former NPA executive who signed the picamilon declaration, is deputy director in the supplement division. State attorneys general used FDA’s declaration as “primary evidence" in a cease-and-desist letter that demanded retailers remove from the market picamilon, according to Mister. In a lawsuit filed last week against GNC, Oregon Attorney General Ellen Rosenblum also attached the declaration. Welch concluded picamilon does not qualify as a dietary ingredient.

“Our difficulty here is with the provision of a declaration privately to a state law enforcement agency on an issue of law that has never been raised by FDA," Mister wrote in the three-page letter. “CRN believes this sets a dangerous precedent regarding the cooperation between FDA and state law enforcement on matters of federal law not previously noted to the industry."

Mister said FDA hasn’t issued consumer advisories on picamilon or sent warning letters on it, and to CRN’s knowledge, picamilon hasn’t been the source of anything that indicates the substance poses a safety concern.

“This process did not occur in a public forum, and therefore precluded any input from the industry in response to FDA’s characterization of the ingredient or the chance to present its own evidence as to why this ingredient can qualify as a legal dietary ingredient," Mister wrote.

Separately, Mister raised concerns in the letter that were previously articulated by Fabricant: namely that FDA was improperly delegating its authority over dietary supplements to the states.

“The FDA has an obligation to evaluate the interests of the agency in preserving its supremacy over the regulation of products under its jurisdiction," Mister wrote. “Providing testimony to a state agency on a matter in which the agency has not spoken undermines the interests of the FDA rather than promoting it."

The agency responded to such criticism last week. Although FDA can take action under existing law to remove a dietary supplement from the market, it must first establish the product is adulterated, misbranded or not made in accordance with current good manufacturing practices (cGMPs)," Marianna Naum, an FDA spokeswoman, said in an emailed statement. 

“The FDA prioritizes enforcement actions," she explained, “based on available resources and the level of safety concern identified." Naum cited the agency’s “limited resources to monitor the marketplace for potentially harmful dietary supplements."

During an interview Oct. 8 at Informa Exhibitions’ SupplySide West conference and exposition in Las Vegas, Welch expressed support for the actions of other groups, including industry, academia, and state and federal agencies, in ensuring compliance with the law and safe products.

“We are looking to work with all of those groups to make sure that the products that are on the market are compliant: compliant with labeling, compliant with manufacturing, compliant with ingredient status [and] ingredient safety," said Welch, who served as interim director of the supplement division for four months.  Link to original article.

fda under fire for role in lawsuit between gnc and oregon attorney general

October 28, 2015

By Michael Crane

It may be Oregon Attorney General Ellen Rosenblum who filed a lawsuit against supplement retailer GNC last week, but now it’s FDA that’s coming under fire from industry trade associations for its role in the dispute.

On October 22, Rosenblum filed a lawsuit against GNC, alleging that the retailer violated Oregon’s Unlawful Trade Practices Act by selling products that contained the “illegal ingredients” picamilon and beta-methlyphenylethylamine (BMPEA) over the course of several years. The lawsuit alleges that both ingredients were “unapproved drugs that may not be lawfully sold in the United States as a dietary supplement,” and that GNC was aware of the ingredients’ illegal status.

GNC, however, believes the lawsuit is “without merit” and rejects the notion that GNC should have known these ingredients were not legal for use in dietary supplements during that time. The retailer says it stopped selling products containing picamilon and BMPEA upon learning FDA did not view them as legal dietary ingredients, but that notice of FDA’s stance came at the end or after the period of time described in the lawsuit (January 2013—June 2015 for picamilon; January 2013—May 2015 for BMPEA).

“Neither picamilon nor BMPEA were included in a previous FDA warning letter or other FDA notification,” says GNC, in a press release. “Further, GNC took action to remove BMPEA and picamilon products even though FDA did not raise any safety concerns with respect to these ingredients, and neither notice constituted a legally binding FDA action on the legal status of these ingredients.”

Although FDA had known about BMPEA adulteration in dietary supplements for more than a year, the agency first took action against the amphetamine-like stimulant in April 2015, when it sent warning letters to five companies that listed BMPEA as a dietary ingredient in dietary supplements. GNC says it did not receive direct notice from FDA concerning BMPEA, but still stopped selling products containing the ingredient when it indirectly learned of FDA’s stance.

Picamilon, an ingredient created by synthetically combining niacin with gamma-aminobutyric acid (GABA), is a different story. GNC claims it only learned of FDA’s stance on the ingredient when Rosenblum filed the suit last week, which has led some supplement industry trade associations to criticize FDA for failing to publicize its stance and for abdicating its authority.

CRN Calls Out FDA for Setting “Dangerous Precedent”

On Tuesday, the Council for Responsible Nutrition (CRN; Washington, DC) questioned FDA’s handling of the picamilon issue in a letter to Ted Elkin, deputy director for regulatory affairs, Center for Food Safety and Applied Nutrition, FDA. In particular, CRN criticized the agency for privately sharing its stance on picamilon with certain state attorneys general without making any public statements about the ingredient.

On September 28, Cara Welch, PhD, acting deputy director of the Division of Dietary Supplement Programs at FDA, wrote a signed declaration to certain state attorneys general, with the conclusion that picamilon “does not fit any of the dietary ingredient categories” under the law. But, to date, CRN says it is not aware of FDA ever communicating publicly about picamilon in any regard.

“Our difficulty here is with the provision of a declaration privately to a state law enforcement agency on an issue of law that has never been raised by FDA,” says Steve Mister, president and CEO, CRN. “CRN believes this sets a dangerous precedent regarding the cooperation between FDA and state law enforcement on matters of federal law not previously noticed to the industry.”

In his letter to FDA, Mister also expressed concern that “the lack of public notice deprived industry of the ability to participate in the regulatory process and does a disservice to an industry that is seeking to comply fully with the laws and regulations.”

Instead of privately sharing its stance with the attorney generals, Mister says FDA should have issued a warning letter explaining why picamilon is not a legal dietary ingredient after becoming aware of its presence on the marketplace. Or, Mister suggests, FDA could have “declared the products containing this ingredient adulterated under Section 402(f)(1)(B) as a new dietary ingredient (NDI) which requires notification.”

Mister also criticized FDA for “what appears to be an abdication of federal authority under the [Food, Drug, & Cosmetic Act] by FDA to state law enforcement.” He called on FDA to evaluate the efforts of state law enforcement agencies more closely when it comes to dietary supplements, and avoid providing testimony to state agencies for matters on which FDA has not publicly spoken.

“While we appreciate FDA’s use of enforcement discretion and the need to prioritize resources, we respectfully urge the agency to reconsider the use of declarations or other testimony in state actions to which it is not a party and where the industry could benefit from FDA’s direct engagement,” says Mister.

NPA Slams FDA for “Delegating Responsibility”

The Natural Products Association (NPA; Washington, D.C) was also quick to criticize FDA for failing to use its enforcement power to restrict picamilon when it became aware it was not a legal dietary ingredient and instead leaving it to the Oregon Attorney General to take action.

“FDA has both the authorities and tools in place to take action against harmful ingredients,” says Dan Fabricant, PhD, executive director and CEO, NPA. “It is concerning to us that FDA is delegating its responsibilities to the states instead of using its own enforcement authority. If FDA finds an ingredient to violate the law, then it should take immediate administrative action, not use taxpayer dollars to fund a state priority.”

Fabricant also pointed to FDA’s handling of BMPEA as an example of when the agency did take the appropriate step by issuing warning letters. He concluded that NPA would encourage a similar type of action in response to picamilon, rather than FDA “delegating its regulatory and enforcement authority to states.”  Link to original article.

dietary supplement industry takes exception to recent fda action

October 27, 2015

By Michael Johnsen

Dietary supplement associations this week took exception with the Food and Drug Administration for declaring the ingredient picamilon an "illegal" dietary supplement ingredient in an declaration made available to state lawmakers in September. It wasn't the fact that FDA expressed a concern that picamilon was available on the market, however, it was the way the agency went about communicating the action without affording the industry an opportunity to weigh in. 

"[The Council for Responsible Nutrition] believes there are substantial policy implications stemming from this declaration, not only for dietary supplements, but for other FDA-regulated products as well," warned CRN president and CEO Steven Mister in a letter to FDA sent Tuesday. "The lack of public notice deprived industry of the ability to participate in the regulatory process and does a disservice to an industry that is seeking to comply fully with the law and regulations," he wrote. "It undermines the supremacy of the [Food, Drug and Cosmetics Act] and the ability of FDA to implement and enforce that law. While we appreciate FDA’s use of enforcement discretion and the need to prioritize resources, we respectfully urge the agency to reconsider the use of Declarations or other testimony in state actions to which it is not a party and where the industry could benefit from FDA’s direct engagement."

Acting Deputy Director of the Dietary Supplement Programs at the Food and Drug Administration Cara Welch wrote in a signed affidavit on Sept. 28 that picamilon “does not fit any of the dietary ingredient categories” under the law. That affidavit was distributed to lawmakers and led to an action by the Oregon Attorney General's office. The AG's office filed a lawsuit against GNC, for selling nutritional and dietary supplements containing what the AG defined as illegal ingredients - picamilon and BMPEA - based on testimony supplied by FDA. The lawsuit alleged that the company violated the Oregon Unlawful Trade Practices Act by misrepresenting certain products as lawful dietary supplements when they are actually unapproved drugs.

The action, specifically regarding picamilon, came as a surprise to industry, however, as the agency has not yet issued any warning letters or other public indication that picamilon should not be sold as a dietary supplement. 

"FDA has never made any public statements with regard to picamilon: it has not released any warning letters to the companies marketing picamilon, issued any recall on this ingredient, or announced any consumer advisories on it," Mister noted. "In fact, we are not aware that FDA has ever communicated publicly about picamilon in any regard. Moreover, we are not aware that picamilon has been the source of any significant number of adverse event reports or any other signals that it may present a public health or safety concern. Rather, the matter of picamilon’s status as a new dietary ingredient, or even as a dietary ingredient at all, is purely a matter of legal interpretation deserving of due notice to industry," he wrote. "Given FDA’s position on so many other issues — that the public interest and FD&CA are best served by providing adequate notice to industry prior to beginning an enforcement action — it is difficult to understand how that interest is served here."

“The FDA has both the authorities and tools in place to take action against harmful ingredients,” stated Dan Fabricant, executive director and CEO of the Natural Products Association. “It is concerning to us that the FDA is delegating its responsibilities to the states instead of using its own enforcement authority. If the FDA finds an ingredient to violate the law, then it should take immediate administrative action, not use taxpayer dollars to fund a state priority.”  Link to original article.

the dietary supplements industry won the bayer case, but still needs to watch the ftc, leaders ward

By Jennifer Grebow

October 27,2015

In a year of regulatory strife, it’s nice to celebrate positive news for a change. The dietary supplements industry is enjoying a moment of triumph following Bayer Corp.’s recent victory over the FTC in a court case over probiotic structure-function claims.

A New Jersey federal district court judge ruled in September that Bayer met its “competent and reliable scientific evidence” burden and affirmed that randomized controlled trials (RCTs) aren’t required for structure-function claims. The bottom line: supplements are not to be regulated as drugs, the judge said. More importantly, he ruled that the FTC cannot, by way of regulatory creep, introduce new substantiation standards for supplements that run counter to the laws governing supplements, to FTC’s own guidance governing supplements, and to language already instated in existing consent decrees. (Click here to read about the case and the opinion's key points.)

“This was a great moment for industry in dealing with what has been, as an agency, one of our more rigorous opponents,” said attorney Marc Ullman of Rivkin Radler LLP during a SupplySide West panel in October.

For Jonathan Cohn of Sidley Austin LLP, one of the attorneys who argued the case on behalf of Bayer, the takeaway is simple: Industry should fight more cases when the FTC is trying to sidestep the appropriate route for changing legal statute.

“Try more cases,” he urged, speaking at October’s Council for Responsible Nutrition (CRN) annual conference. “Bottom line, industry can win. We did it before, and we can do it again."

Others are happy, but cautious. "Don’t take this as the end of the issue,” Ullman said. FTC will almost certainly try to flex its muscles again in the future, and it also has 60 days to appeal the Bayer case.

“What’s going to come next? Well, what I think is going to come next is more specific orders,” said attorney John Villafranco of Kelley Drye & Warren LLP, also speaking at the CRN event. He pointed to prior statements made by David Vladeck, former director of FTC's Bureau of Consumer Protection, that FTC believes consent orders are more enforceable and stronger in court if they spell out specific types of tests.

New FTC consent orders will provide hints of what’s to come, industry leaders say. And industry should monitor those orders closely.

Speaking to CRN conference attendees, FTC’s Mary Engle, associate director for advertising practices, Bureau of Consumer Protection, likewise advised companies to examine FTC’s complaints. While consent decrees only bind the companies under order, “they may provide some guidance as to where we’re drawing the line between when you need clinical trials and what broader claims that you may not necessarily need clinical trials [for].”

“Sometimes competent and reliable scientific evidence is randomized controlled trials,” she added. And while the agency has “pretty much stopped putting in our order provisions [a requirement for] at least two RCTs, what you’ll see instead is simply the requirement that the court put in the [consent order for] POM Wonderful [in its FTC case over disease claims] that they have clinical testing, without specifying that number.”

Companies should not take the Bayer case as a cue to relax; just the opposite. They should be more vigilent of their claims substantiation, said Michael McGuffin, president of the American Herbal Products Association, at the SupplySide West panel. “What the court’s decision did not do is tell us that we don’t have to have substantiation. We still need to have substantiation for our claims.”

“FTC is not going to go away,” said panelist Dan Fabricant, PhD, CEO and executive director of the Natural Products Association. “[The Bayer case] is limited to one jurisdiction. Even if the judge’s language is somewhat of an endorsement of Bayer’s procedure, that’s not going to get you real far. They’re going to find another jurisdiction to keep bringing these sorts of cases. They’ve already shown that from the start.”

In terms of RCTs, said Villafranco, FTC’s “thinking is really starting to evolve, and it’s becoming crystallized.” Even if we do not see orders delineating two RCTs in most cases, he said, pay attention to the fact that the FTC does not seem to flinch at requiring two RCTs for highly scrutinized categories like weight-loss supplements.

“Not a lot of companies have the conviction that Bayer had here or the resources or time to really dig in” and take the FTC on in court, Villafranco added. For most companies, the path forward will be vigilance, careful stepping, and the sense not to become complacent when it comes to the FTC.  Link to original article.

structure function claims win in bayer vs the ftc case

By Jennifer Grebow

October 27, 2015

Bayer Corp. celebrated a landmark victory in late September when a U.S. district court judge ruled in the company’s favor in a Federal Trade Commission case seeking to hold the company in contempt for its probiotic-supplement health claims. In his written opinion, New Jersey federal district court judge Jose Linares ultimately affirmed that dietary supplement structure-function claims must have “competent and reliable scientific evidence,” but that the evidence does not necessarily require randomized controlled trials.


Back in September 2014, the U.S. Department of Justice, on behalf of the FTC, filed a motion of contempt against Bayer alleging that Bayer violated the terms of a 2007 FTC-issued consent order over Bayer’s One-A-Day WeightSmart vitamin. That 2007 consent order prohibited Bayer from making any future weight-loss or disease claims without supporting “competent and reliable scientific evidence”—the FTC’s requirement for claims substantiation. The motion of contempt filed in 2014 accused Bayer of again making unsubstantiated structure-function claims, this time for its Phillips’ Colon Health probiotic supplement.

According to the FTC, the company did not possess adequate evidence to support its advertising claims that the product “helps defend against occasional constipation, diarrhea, gas, and bloating.” These are implied claims to prevent, treat, or cure constipation, diarrhea, gas, and bloating, the FTC suggested.

For its expert witness, the agency enlisted gastroenterologist Loren Laine, MD, a professor at Yale University School of Medicine. Laine asserted that in order to support the claims, Bayer should have conducted two randomized, double-blind human clinical trials (RCTs) in the target population on a product comprising the same combination of bacterial strains in the Phillips’ Colon Health product.

Bayer did not have two randomized, double-blind human clinical trials, but the company did point to more than 100 scientific articles in the public domain that it used to support the structure-function claims for its probiotic species. At this point, one should note that these types of probiotic claims are not unique to Bayer; other probiotic supplement companies have long made similar claims in the past.

Bayer presented its own experts in the case—M. Brian Fennerty, MD, an expert in gastroenterology and clinical trial design, and Daniel J. Merenstein, MD, an expert in medicine, clinical trial design, and probiotics. Both testified that the experts in their field would not require gold-standard RCTs to serve as necessary evidence to substantiate Bayer’s claims.

Supplements Are Not Drugs

This September, Judge Linares ultimately ruled for Bayer, finding that the company’s evidence was “competent and reliable” to support its structure-function claims. The judge’s opinion strongly upholds the right of structure-function claims to rely on the totality of evidence. He also definitively affirmed that the law governing supplements, the Dietary Supplement Health and Education Act (DSHEA) of 1994 amendment to the Federal Food, Drug, and Cosmetic Act, permits dietary supplements to make structure-function claims and that there is a distinct line between the substantiation required for drug claims and the “lower substantiation” requirement for supplement claims.

“Recognizing the health benefits of dietary supplements,” he wrote, “Congress enacted DSHEA to ensure that supplements can be marketed and sold without following the stringent requirements imposed on drugs. Although new drugs must be preapproved by the Food and Drug Administration…and traditionally must be supported by randomized, placebo-controlled, double-blind clinical trials…dietary supplements need not.”

Here are some key takeaways from Judge Linares’s opinion:

Totality of Evidence

“For dietary supplements, the only substantiation requirement is that claims be ‘truthful and not misleading,’” Linares wrote. As long as a supplement does not make drug-type “diagnose, mitigate, treat, cure, or prevent” claims, “it is not regulated like a drug,” he said.

Linares confirmed that DSHEA does not specify what types of studies or evidence are needed to support a non-drug structure-function claim; moreover, he underlined, the FTC’s own advertising guidance for dietary supplements only states that supplement claims must hold “competent and reliable scientific evidence,” which the agency defines as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”

In short, Linares wrote, structure-function claims do not require the type of RCTs required for drug claims. “[T]he FTC Guidance makes clear that this standard is not the drug standard,” he wrote. FTC’s own guidance states that there is “no fixed formula” for the types and number of studies required. The agency’s guidance states that while RCTs are “the most reliable form of evidence,” they are not required, and other types of evidence should also be considered, including animal studies, in vitro studies, and epidemiological studies.

Linares also pointed out that experts in the field confirmed that the 100-plus scientific articles Bayer used to substantiate its claims were adequate; moreover, he said, the company did not need to possess physical copies of those studies, which the company accessed through subscriptions to scientific journal databases. His opinion went into great detail describing Bayer’s process of reviewing the science in the public domain, which included reading new studies weekly to make sure its claims were substantiated, on an ongoing basis.

Other takeaways from the opinion: A company is not required to perform studies on its exact product formulation or target population, Linares said, pointing out that FTC’s guidance states that companies can use tests done on a “similar formulation” and to “extrapolate” between populations.

Also of note: In discussing some of the studies presented, Linares pointed out that even if one of the studies Bayer referenced did not include enough subjects to generate a statistically significant benefit, “the study does not undercut Bayer’s substantiation of [Phillips’ Colon Health] because many successful products, including FDA-approved drugs, have neutral studies.”

Disclaimers Matter

The judge also repeatedly mentioned Bayer’s use of the industry-standard disclaimer, “This product is not intended to diagnose, treat, cure, or prevent any disease.” He pointed out that the Phillips’ Colon Health packaging and advertisements all carry this disclaimer, which would contradict any suggestions that the company was making explicit or implicit drug claims. Additionally, he pointed out that the company’s ads depict only healthy people, not sick people.

Experts Matter

Judge Linares heavily questioned the expertise of the FTC witness, Dr. Laine. On the stand, Laine admitted that he had never written any articles or books on probiotics, had never conducted a probiotics study, and had no knowledge of the regulations governing dietary supplements and how the requirements for structure-function claims differ from those for drug claims. In fact, Laine said, he wasn’t aware of any dietary supplements with evidence meeting his prescribed study design, which he said in itself does not distinguish at all between supplements and drugs.

Judge Linares contrasted Laine’s lack of pertinent expertise in the case with that of Bayer’s own medical witnesses, who did have expertise in the field, and pointed out that both witnesses testified that a majority of their colleagues would disagree with Laine’s argument that RCTs are required to substantiate probiotic claims like Bayer’s.

Constipation, Diarrhea, Gas, and Bloating Are Not Disease Claims

Bayer’s probiotic claims are not disease claims, Judge Linares stated. But he went further than that.

“Even if Bayer made implied claims regarding prevention, treatment, or cure, they are not disease claims,” he wrote. “Although the words ‘prevent, treat, and cure’ often signal a disease claim, the Government has not proven that Bayer advertised [Phillips’ Colon Health] to prevent, treat, or cure any disease. Instead, the government asserts that Bayer advertised [Phillips Colon Health] to prevent, treat, or cure constipation, diarrhea, gas, and bloating. These are not diseases, but rather variations of the normal state of health.”

Claims of supporting or promoting digestive health are structure-function claims, he said, and claims of alleviating symptoms like gas and bloating are structure-function in nature because they do not characterize a specific disease.  

Bayer’s probiotic claims, he noted, are quite common within the industry. “The Government has not pointed to any instance when it has asserted that these claims are disease claims,” he wrote. “If these claims were disease claims, then many of the most popular probiotic supplements on the market would be in violation of the law, and subject to seizure by the FDA.”

No Rewriting History

Most importantly, Judge Linares pointed out that the agency cannot, at this later date, reinterpret its own 2007 consent orders by instructing that “competent and reliable scientific evidence” must now take the form of two RCTs. “The Government’s position that Laine-level RCTs are required is found nowhere within the four corners of the consent decree,” he wrote. “The consent decree that Bayer agreed to in January of 2007 speaks only of ‘competent and reliable scientific evidence.’”

As a result, Linares said, “the Government cannot try to reinvent this standard through expert testimony”—namely, the sole opinion of Dr. Laine—especially when what the FTC now asserts is necessary runs counter to what supplement laws and the agency’s own guidance state are required for supplement claims.

Industry Celebrates

The dietary supplement industry cheered the denial of contempt at industry events this fall.

“I think we should just take a moment and say thank you,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC), at a SupplySide West trade show roundtable in October. While he noted that the FTC has 60 days to appeal the decision, “it is a great moment for the industry because it does set the FTC back on their heels once again and tells them that you cannot superimpose the RCT standard over supplements making structure-function claims that, by guidance and of long history, have been allowed to have a variety of evidence in place.”

It’s also a win for probiotics, pointed out Ray Matulka, PhD, director of toxicology at Burdock Group (Orlando, FL), during his SupplySide West presentation on probiotic regulations. “This claim of helping to defend against occasional constipation and other issues is typically considered a structure-function clam in that it is about how the probiotic is helping change your body by the structure or function of the body. [This case] was a very good thing for probiotics in general because it is really helping to set the stage that the FTC cannot extend a drug-type terminology to probiotics when the claim itself is of a structure-function nature.”

Natural Products Association (NPA; Washington, DC) CEO and executive director Dan Fabricant, PhD, who was also part of the SupplySide West roundtable, said via press release, “This case is evidence that the FTC is willing to try and expand their authority through enforcement decisions, even with a bad case which they had from the start, and this remains one of the biggest, if not the biggest, concern for the industry…NPA felt the FTC would have set a dangerous precedent had the overbearing standards it was seeking become affirmed.”

Supplement leaders also encouraged industry members to read the judge’s opinion. “The decision discusses what Bayer does—really endorsed it—and is a roadmap for both methods and content that the substantiation allows,” said attorney Marc Ullman of Rivkin Radler LLP during the SupplySide West roundtable. “So if any of you are involved in making claims, I really do urge you to read that opinion.”  Link to original article.

supplement usage and confidence holding steady in 2015 consumer survey, use age gap narrows

By Michael Crane

October 27, 2015

In the wake of negative media attention earlier this year, U.S. dietary supplement usage and consumer confidence has remained strong in 2015, according to new data from the Council for Responsible Nutrition’s (CRN; Washington, DC) 2015 Consumer Survey on Dietary Supplements.

Overall, 84% of U.S. adults expressed “confidence in the safety, quality, and effectiveness of dietary supplements,” and 68% of U.S. adults reported taking dietary supplements in 2015—findings that are largely consistent with the past several years.

However, certain segments of the market did experience some noteworthy shifts.

CRN shared a few of the survey results at last week’s 2015 CRN Workshop and Conference, including the finding that 33% of supplement users reported they had stopped taking some or all supplements due to negative publicity.  On the other hand, 52% of users reported they had started taking supplements due to positive publicity. Given the varying but significant influence of media attention, it may not be surprising that 60% of consumers said they were confused by conflicting information about supplements.

With the new 2015 survey, CRN now has 11 years of data based on the same set of questions posed to consumers about their attitudes toward dietary supplements, said Randi Neiner, PhD, director of market research, Shaklee (Pleasanton, CA), who presented the results at the CRN Conference.

“I think these are good numbers,” said Neiner. “Despite what’s going on we’re still holding.”

Consumer Age Gap Closing

One area where there does seem to be a shift is the evaporation of different usage habits by age group, especially among men. In 2010, 72% of male consumers aged 55 and over used supplements, compared with 60% of male consumers aged 34-54 and 57% of male consumers aged 18-34. But that gap between the age groups has steadily narrowed in the last five years as younger men have increased use while older men have decreased use.

“You’re really seeing that in 2015, there’s no significant difference in age by the men taking supplements,” said Neiner.

In fact, the younger generations may be even more likely than those over age 55 to use supplements. The 2015 survey suggested that 66% of both the 18-34 and 34-54 aged cohorts were using supplements, while 64% of the aged 55 and over cohort said the same. Neiner suggested further research may be necessary to understand why older men were decreasing use, but she suggested that sports nutrition may be responsible for some, but not all, of the uptick in supplement use among younger men.

“[Younger men] are just as likely as the general population to take a multi[vitamin], so it’s not just energy, it’s not just sports,” said Neiner. She added that in the 18-34 cohort, men are just as likely to take supplements as woman—another surprising finding given that women tend to take supplements at a higher rate in the general population.

By comparison, usage differences by age remain substantial among U.S. women, with 77% of female consumers aged 55 and over using supplements, compared to 71% of female consumers aged 34-54 and 65% of female consumers aged 18-34. Clearly, men are primarily driving these age-related changed to the market.

“The differences by age are not as great as they used to be,” said Neiner. “So we’re really seeing a strong millennial possibility for our industry, which is great news.”

How Do Consumers React to Negative Publicity?

Also at the CRN Conference, an onstage focus group explored how nine real supplement consumers react to negative and positive media coverage, including the ongoing investigation by New York Attorney General Eric Schneiderman into purportedly fraudulent supplements. The consumers watched negative news clips about the industry and were then asked to respond and discuss their perceptions

Many of the consumers expressed concerns after hearing the negative publicity and several said they would rethink their supplement usage habits. However, the majority of the focus group members seemed undeterred by the negative reports or expressed a general skepticism toward both news reports and advertising materials. Instead of relying on the media, many of the consumers said they base their supplement decisions on recommendations from doctors or friends.

Additionally, almost all of the focus group members believed supplements should not be regulated like pharmaceuticals.

“FDA regulates prescriptions and people still die or it doesn’t work for them, and it will just make a higher co-pay on your insurance,” said one focus group member. “[Supplement regulations] shouldn’t change for that.”

The focus group host, Michael Maslansky, communication and language strategy expert and CEO of Maslansky + Partners, said he was struck by the positivity of the consumer response.

“I do a lot of these. I’m surprised,” said Maslansky. “You’ve got a group of consumers who very much give the industry the benefit of the doubt.”

Maslansky, who has conducted similar public opinion work for the pharmaceutical industry, the financial industry, and the food industry, said the results of the dietary supplements focus group was “in contrast to what we often see in a lot of these situations.”

“What we saw is that when you have the benefit of the doubt, there was a lot of desire to reaffirm what [consumers] like about the industry,” said Maslansky.

But even if current supplement users may not be turned away by negative publicity, it may not be attracting new converts. For instance, one member of the onstage focus group had been supplement user in the past but had stopped because he didn’t feel any effect. He said the negative publicity had done little to encourage him to begin using supplements again.

Growth by Supplement Categories

CRN’s 2015 Consumer Survey also investigated perceptions of different supplement categories and found that the “vitamins and minerals” category continues to have the highest usage compared to other categories with 98% of supplement users in 2015. Compared to 2014, the “vitamins and minerals” and “specialty supplements” categories remained consistent by use in 2015, but usage of the “herbals and botanicals” and “sports nutrition and weight management” categories grew by 5% or more in the last year.

The gender gap for supplement usage remained consistent from last year’s survey, with 71% of U.S. women reporting they used supplements and 65% of U.S. men reporting supplement use.

The 2015 survey was funded by CRN and conducted by Ipsos Public Affairs (Washington, DC) from August 20–24, 2015. It included a national sample of 2,016 adults 18 and older, and the sampled was weighted to ensure the survey accurately reflects the overall U.S. population according to Census data. CRN plans to continue releasing findings from the survey throughout the next year.  Link to original article.

oregon sues gnc over some nutritional supplements

By Associated Press

October 22, 2015

Oregon Attorney General Ellen Rosenblum has filed a lawsuit against GNC, accusing the retailer of selling dietary and nutritional supplements that contain ingredients not approved for sale in the U.S.

The lawsuit filed Thursday in Portland zeroes in on two ingredients — picamilon and BMPEA.

Picamilon is a synthetic chemical used as a prescription drug in some countries to treat neurological conditions. BMPEA is chemical similar to amphetamine and the World Anti-Doping Agency has banned its use by athletes.

GNC responded Thursday by saying it no longer sells products containing those ingredients. The company said it took that step in response to Food and Drug Administration statements about the regulatory status of the ingredients.

Another retailer, Vitamin Shoppe, reached an agreement with Rosenblum earlier this year in which it agreed to stop selling products that contain BMPEA.  Link to original article.

Protein Ingredients Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2015 - 2023

By Transparency Market Research

October 21, 2015

Proteins are polymers of amino acids joined together by peptide bonds. Proteins are constantly synthesized and degraded through metabolic processes for energy recovery and storage. From a nutritional perspective, protein ingredients have diverse applications in health and wellness industry such as pre workout fuel, post workout replenishment, and help in protection of muscles. In addition, it is also used in heath supplements, food and beverages, pharmaceuticals and some cosmetic products. 

The global protein ingredients market is growing at a rapid pace, predominantly due to the increasing adoption of protein supplements in the light of different advantages they represent such as high calorie intake. Growing application of protein ingredients in nutraceuticals, food and beverage, and wellness industries is expected to fuel the market growth in the coming years. In addition, increasing number of health conscious consumers, growing number of fitness centers and health clubs, and rising demand for energy drinks and processed foods are also expected to boost the global protein ingredients market. According to a report published by International Health, Racquet & Sports Club Association (IHRSA), the number of health and wellness centers has risen from 128,500 to 153,000 in the U.S. in the last four years. However, animal protein ingredients market is now challenged by plant derived proteins due to price differences and quality fluctuations. Furthermore, consumer attitude particularly towards gluten-free protein products is also expected to boost the growth of plant derived protein products market. 

The global protein ingredients market segmentation can be analyzed on the basis of source, applications and geography in order to provide a comprehensive picture of the market. On the basis of source, the protein ingredients market is broadly classified into two categories, namely, animal protein ingredients and plant protein ingredients. Animal protein ingredients can be further categorized into dairy protein ingredients, egg proteins and gelatin. Diary protein ingredients represent the largest market by revenue among animal derived protein ingredients. The plant derived protein ingredients include soy protein, wheat protein, pea protein and others. 

Based on geography, the protein ingredients market is segmented into four major regions such as North America, Europe, Asia-Pacific and Rest of the World (RoW). North America by far, accounts for the largest consumer share for protein ingredients owing to the high growth health and wellness industry in the region. Europe is the second largest consumer market primarily due to high adoption rates of protein-based energy products by consumers, improved productivity and increased product value. England, France, Belgium, Italy and Germany are the key countries contributing to the European protein ingredients market. Western Europe is expected to witness an escalation in gelatin demand due to a favorable regulatory framework and high consumer awareness on gelatin based products. Asia-Pacific is expected to be a high growth potential market for protein ingredients owing to growing awareness about health and increasing disposable income in the region.

The protein ingredients market is highly fragmented, with a lot of competition for shelf space in the retail market. The key players in the global protein ingredients market include Nestlé S.A., Unilever, PepsiCo Inc., Abbott Nutrition, Hilmar Cheese Company, Hostess Brands, Inc., Showa Sangyo Co., Ltd., STERLING GELATIN, Ben & Jerry's Homemade Holdings Inc., BEECHNUT, Milk Specialties Global, Weider Global Nutrition, Dean Foods, Nellson Nutraceutical LLC, Davisco Foods International, Inc., and Maple Island, Inc.  Link to original post.

Global Tea Polyphenols Market has been witnessing strong growth over the Segment Forecasts To 2020

By Hexa Research

Industry Insights

Tea polyphenols market has been witnessing strong growth over the past few years on account of increasing demand from food and beverage industry, and the trend is expected to continue over the forecast period. Rising purchasing parity of consumers coupled with changing life style has increased the consumption of tea polyphenols over the last few years and it is anticipated to fuel the market growth in near future. Growing health concerns over the last few years resulted in increasing demand for green tea and other nutraceutical products, which in turn expected to drive tea polyphenols market over the forecast period. Innovation in functional beverage’s industry owing to rising demand for healthy drinks is anticipated to drive the market growth over the next six years. Growing dietary supplements demand coupled with increasing awareness towards the health benefits from tea polyphenols consumption is anticipated to complement the market growth over the foreseeable period. Tea polyphenols have ability to cure health problems like obesity, heart diseases, cancer and diabetes. These advantageous factors are likely to augment the market growth in near future.

Product Insights

All tea polyphenols are extracted from the same plant called Camellia Sinensis but processed differently in order to achieve required level of oxidation. Green tea polyphenols are zero oxidized leaves, black tea polyphenols are completely oxidized tea leaves, whereas oolong tea polyphenols are semi oxidized.

Green tea polyphenols market is the most dominant product segment followed by oolong and black tea polyphenols. Increasing obesity and cancer patient during the last few years has been driving green tea polyphenols market at a good pace, and the trend is expected to continue over the forecast period. Oolong tea polyphenols are consumed mainly to avoid diabetes which is the most threatened disease over the last five years. Increasing diabetes patients across the globe is anticipated to increase the consumption of oolong tea polyphenols which in turn expected to drive the market over the forecast period.

Application Insights

Functional foods and beverages was the largest and fastest growing application segment for tea polyphenols market over the recent past, and the trend is expected to continue over the forecast period. Increasing demand for functional foods and health drinks has been driving tea polyphenols market in this sector. In addition, growing health concerns and rising disposable income of consumers motivating them to spend more on health beneficial products which is expected to boost the market demand over the forecast period. Dietary food supplements industry is the second major market for tea polyphenols owing to increasing health problems like obesity, diabetes and heart diseases.

Regional Insights

Asia Pacific was the largest market for tea polyphenols over the recent past in terms of production and consumption. Owing increasing population in countries such as China and India, the demand for tea polyphenols is expected to grow at a good pace over the forecast period. Increasing disposable income and changing life styles of consumers in this region coupled with growing concern towards health is also a key driving factor for tea polyphenols market. North America is expected to witness significant growth on account of increasing demand from foods & beverages industry in this region. However, Europe has been witnessing sluggish growth over the past few years due to some side effects of green tea polyphenols consumption.

Competitive Insights

Tea polyphenols market is highly concentrated with less number of manufacturing companies leading the global market of tea polyphenols over the last decade. Scope for new entrants in tea polyphenols market is very less, so there is a huge scope for existing players to increase their capacity levels to fulfill the increasing demand across the globe over the forecast period. Additionally, improving R&D activities by major key players to use tea polyphenols in medical sector is anticipated to open new opportunities to this market over the next six years. Some major players in this market include Ajinomoto OmniChem, Amax NutraSource Inc., Indena Spa and Guilin Layn Natural Ingredients Inc.  link to original post.

clean label trends in the supplement industry

By Kevin Agrawal

October 20,2015

Chemicals are the number one food safety issue for Americans. According to the 2015 Food and Health Survey conducted by the International Food Information Council (IFIC) Foundation, more than one-third of Americans surveyed expressed concern about chemicals in their food – more so than foodborne illness. These figures show a growing awareness of chemicals in food and the trend towards natural solutions is on the rise.

What is a clean label?

While the words “clean label” are becoming more familiar and mainstream within the supplement industry, the Food and Drug Administration (FDA) has not defined this term just like they have not defined the word “natural”. The definition, therefore, is one defined by consumers. Some characteristics of these so-called “clean label” products include no artificial flavors, colors or preservatives; no GMO ingredients; and no banned substances – especially in sports nutrition products.

A clean label should make it easy for the consumer to understand what is in the product. Consumers are demanding maximum transparency through a shorter list with more recognizable ingredients. So the demand for clean labeling has now brought about the need for clear labeling, according to Innova Market Insights that cites this asthe top trend for 2015.

Clean labels and dietary supplements

Clean labels are one of the latest consumer food trends presenting a great opportunity for supplement business owners as seen in the results of a 2014 Gallup Study of the U.S. Market for Vitamins and Other Dietary Supplements cited by Nutraceutical World. Here is what consumers looked for on a supplement label. About 43% of those surveyed said they used supplements with clean labels.

The trend towards clean label products is backed up by sales in a number of supplement categories. According to the Nutrition Business Journal, sales of supplements derived from herbs and botanicals reached an unprecedented high in 2014 marking a continuous 10-year growth. The whole-food supplements sector was one of the fastest-growing in the supplement industry with sales predicted to rise to $2.7 billion by 2017.  The fruit/vegetable supplement sector has seen double-digit growth for past 3 years.

Supplement business owners who want to improve sales in these areas might want to add a range nutraceuticals to their product line. Clean labels have the potential to set your supplements apart from the competition and boost sales.

According to Sloan Trends Inc, consumers in the 50+ age group are the most interested in these labels. Packaged Facts says two-thirds of the projected growth of the dietary supplement industry from 2015 to 2020 will be because of the elderly, ergo, those in the age group of 65+.

Formulation is one key aspect to procuring a clean label. The other crucial aspect is finding a clean supply chain so that the ingredients used in the making of your product are ”clean” as well. Another important aspect is what the brand writes on the label so that it clearly conveys to consumers that your product is ”clean”.  Link to original post.

millennial marketing strategies: supplyside west report

By Michael Crane

October, 16 2015

With 83 million Americans now between the ages of 18 and 38, the millennial generation accounts for a greater slice of the population than any other consumer group by age. It’s no wonder that nutraceutical marketers are increasingly turning their attention to this younger generation of consumers. And while there are challenges in reaching this Internet-savvy, sustainability-minded generation, there are also opportunities for lifelong loyalty.

“We need to understand who [millennials] are. They are the future of your business, and they have a lot of different attitudes,” said Maryellen Molyneaux, president and managing partner, the Natural Marketing Institute (NMI; Harleysville, PA). Molyneaux shared new market data from NMI on millennial consumers during her SupplySide West presentation, “Targeting Millennials via Product Development, Marketing & More.”

Millennials currently account for 36% of dietary supplement users, compared to the 36% comprised of baby boomer users (aged 51-69), the 18% comprised of generation X users (aged 39-50), and the 10% comprised of mature users (aged 70 and up), according to NMI. But one thing that sets millennials apart from other supplement users may be their perception of the role supplements play in living a healthy life.

“When we talk to millennials about using supplements, one of the things we find out is a high number of them use them only when they need them,” said Molyneaux. “So when they’re feeling sick or feel themselves getting sick, it’s almost one-third that say that’s when they use them.”

Food or Gummies, not Pills

Millennials are also more likely than other consumers to prefer getting all their nutrition from foods and beverages, rather than supplements, according to NMI’s data. That preference has, in part, given rise to the functional foods market. While baby boomers and mature consumers decreased their usage of functional foods between 2006 and 2014, generation X and millennial consumers have increased their usage of functional foods. That’s especially true for millennials, with 76% of them reporting they had used a functional food product in 2014, according to Molyneaux.

“They want to take fewer pills, because pills are associated with sickness and with aging and the elderly,” said Therese Dolan, global and North America marketing manager, BASF Nutrition & Health (Florham Park, NJ). Dolan shared the stage with Molyneaux for the SupplySide presentation on millennials.

Instead of capsules, supplement companies may want to start thinking more about gummies and other alternative delivery methods to better meet the preferences of millennials, said Dolan. Functional foods may also play a key role in reaching these consumers, with millennials reporting they are “willing to pay more for food fortification,” according to Dolan.

The Internet Generation

Talk of the Internet lifestyle is never far away in any conversation about millennials, but how does the web affect this generation’s attitude toward supplements? For one, it offers them a constantly-accessible resource in making health decisions.

“One of the things we have to keep in mind is that they are not blindly trusting whatever is on the label and whatever is being told to them,” said Dolan. “They are doing their research. They have instant access to information.”

For that reason, Dolan advised companies to share details about their products and ingredients in the most transparent ways possible. Now more than ever, it’s important to offer well-researched ingredients and be aware of media perceptions, she said.

Another big opportunity the Internet offers marketers comes from social media, where millennials may share their dietary choices with hundreds of friends and followers.

“They will share that information with their friends,” said Dolan. “You have a huge opportunity to grow exponentially once you have that consumer on board.”

Choosing Sustainable

Along with that desire for transparency and more information, millennials are also showing much more interest in sustainable products than other generations. When asked if they make a decision based on an understanding of how it will effect the world, its environment, and its people, 55% of millennials say they agree with that sentiment. That’s compared to 40% of generation X, 34% of baby boomers, and 28% of mature consumers who would say the same.

Molyneaux compared the sustainable enthusiasm among millennials to the way baby boomers rallied around the concept of organic before them.

“Now you have millennials who are saying ‘Tell me more, tell me how things are made from the ground up. I want to know more about you and I want to be able to trust you more’,” said Molyneaux. She advised that sustainability will continue to be a key priority of these consumers for the foreseeable future.

Health Priorities

Setting aside their many differences with older consumers, millennials do actually have something in common with other generations. Like other age groups, millennials are concerned about certain health areas, chief among them being brain health, heart health, weight loss, and lack of energy/fatigue.

But they may not be acting on those concerns. For instance, 73% of millennials say they are concerned “a lot/a little” about heart health, while only 23% are currently managing or treating those symptoms. Nonethless, Molyneaux said she was actually struck by how many millennials are acting on their health concerns.

“I was really amazed at that number [of 23%],” said Molyneaux. “We continue to see heart health as a big opportunity, even with millennials, that there’s an interest in preventing. The interest is high and the need is relatively high for this sized group.”

What’s more, it may make the work easier on marketers knowing that this younger generation actually shares many of the same health concerns as all other consumers.

“The top concerns of millennials are really no different from those that you’d find in older generations,” said Dolan. “You don’t necessarily have to build a whole new campaign for them. You might want to maybe tweak the messaging slightly to appeal to this younger generation.”

Dolan advised that educating millennials about the importance of a diet with a preventive health focus in mind, rather that just taking supplements when they get sick, could also be crucial to building the consumer base.

Consumers for Life

It may seem daunting to consider all the differences in the millennial market, but it also has the potential for long-term rewards. If nutraceutical companies are able to incorporate these many priorities and earn the loyalty of millennial consumers, they may be able to keep these consumers onboard for many years to come.

“As they start to really believe in it, it’s something that they will do over the long term,” said Dolan. “And since they are such a young generation, you have an opportunity to pull them all the way through their life.”  Link to original article.



October 15, 2015

The global Nutraceuticals product market has shown steady growth during the past few years. Increasing consumer spending on nutritious, healthy, functional food, beverages, and dietary supplements worldwide will be driving the market in the next few years. 

The rise in demand for dietary supplements is the principal growth factor for the Global Nutraceuticals Market. However, functional foods and beverages comprise a significant market share which includes Nutraceuticals / Nutritional or functional foods that are slated to have physiological benefits, or provide relief from numerous chronic diseases and ailments to the consumers. 

Dietary supplements, isolated nutrients, and herbal products to specific diets and processed foods and beverages constitute Nutraceuticals range.Due to the relatively high margins and minimal regulatory requirements involved, these are extremely attractive to food and beverage companies. 

The major drivers contributing to the growth of this market are factors like rising health concerns, growth of key demographics, and increasing consumer desire to lead a healthy life and avoid dependence on synthetic drugs.New product launches, mergers and acquisitions, and Nutraceuticals aimed at improving cardiac health are additional factors that are driving the growth of this market. 

The growing demand for Nutraceuticals in recent years is accorded to all these properties mentioned above. 

In addition to the basic nutrition value present in food items, Nutraceuticals are the products that provide health and nutrition benefits to an individual. In the present context, consumer are more health conscious, more aware, and better informed on nutrition-enabled products. 

A physical performance booster and disease prevention option is one of the major reasons that dietary supplements are consumed apart from meeting the recommended daily intake of nutrients. 

Medicines and products that are obtained from organic foods and ingredients and which are obtained from non-genetically modified organism (non-GMO) extracts, are gaining more popularity than the ones that are available in the form of synthetic ingredients to organic foods and ingredients.

One of the major drivers behind the rising demand for Nutraceutical ingredients is the growing market of vitamins and minerals-enriched herbal shampoos and creams. 

The dietary supplements are available in the form of capsules, tablets, and liquids. Nutraceutical ingredients include probiotics and prebiotics, vitamins, proteins, minerals, Omega 3, fibers, amino acids, structured lipids, and various other ingredients. 

Grains, cereals, nuts, fruits, vegetables, dairy products, poultry products, seafood, and confectionery items are the major areas where Nutraceutical ingredients find application apart from non-alcoholic beverages such as energy drinks, juices, and sports drinks.  Link to original post.

Global Dairy Nutritional and Nutraceutical Ingredients Market: Asia Pacific is expected to be the most dominating market by 2021

By Persistant Market Research

October 7, 2015

Dairy product is an important source of nutrition which primarily includes calcium, protein and whole host of other minerals, vitamins and nutrients. Thus, dairy ingredients provides number of health benefits and many of them possesses nutraceutical potential such as lactobacilli, bifidobacteria probiotics enables to improve gastrointestinal health & systemic immunity, a-Lactoglobulin whey protein helps in increasing tryptophan & serotonin activity in brain and others. Increasing health consciousness among the people has led them to get inclined towards the consumption of more healthy and functional food which is expected to support the growth of dairy nutritional and nutraceutical ingredients market across the globe.

Dairy Nutritional and Nutraceutical Ingredients Market Segmentation

Dairy nutritional and nutraceutical ingredients market is segmented on the basis of ingredient type which includes bio active peptides, main milk protein, nutritional hydrolyzed proteins, prebiotics (lactose and its derivatives), purified milk fractions, minerals, vitamins, colostrum, nucleotides and others. Among all these segments prebiotics is expected to hold a potential market in terms of revenue contribution followed by milk proteins. Increased application of prebiotics such as it is fiber enriched and also helps in replacement of sugar, fat and calorie, which is expected to support its growth in near future.

Milk protein segment is further sub segmented as milk proteins, whey proteins and casein. Among all these sub segments whey protein is expected to occupy the major market share of the pie in dairy nutritional and nutraceutical ingredients market. Furthermore, purified milk fractions is also sub segmented as alpha-lactalbumin, beta-lactoglobulin, lactoperoxidase, lactoferrin and others (proteose – peptone and lysozyme). Moreover, probiotics is sub segmented as lactulose, lactitol, lactobionic acid and galacto oligo saccharides.

Dairy nutritional and nutraceutical ingredients market is also segmented on the basis of application which includes beverages, dairy products, bakery and confectionery, snacks, dietary supplements and dietetic products, cosmetics, oral care, infant formula and clinical nutrition. Among all these segments dairy product is expected to contribute major share in terms revenue in dairy nutritional and nutraceutical ingredients market. Increased consumption of functional yoghurts, milk and other dairy products due to health benefits is expected to support the growth of dairy nutritional and nutraceutical ingredients market during the forecast period.

The global market for dairy nutritional and nutraceutical ingredients is expected to show a healthy growth during the forecast period. This growth has been supported by the increasing demand for healthy and nutritious food among the health conscious consumer across the globe. Among all the regions Asia Pacific is expected to be the most dominating market in terms of growth. Growing demand for health food coupled with increasing baby boomer population in Asia Pacific is expected to drive the growth of dairy nutritional and nutraceutical ingredients market in the region. Among all the countries in Asia Pacific excluding Japan is expected to be the prominent contributor during the forecast period. Moreover other region such as North America is expected to be one of the major contributor followed by Europe. Market growth for dairy nutritional and nutraceutical ingredients in North America is boosted by rising demand for healthy and functional food among the consumers.

Dairy Nutritional and Nutraceutical Ingredients Market Drivers

Dairy nutraceutical ingredients are widely used in infant formulas. Thus increased demand for specific infant formulas such as hypoallergenic, pre-term formulas or formulas to prevent diarrhea using milk hydrolysate and other is expected to support the demand of dairy nutritional and nutraceutical ingredients market in the near future. Moreover, increased consumption of food supplements and medical foods, which are specially formulated using milk protein ingredient and possesses distinctive nutritional needs that cannot be fulfilled by normal diet alone is also expected to support the demand of dairy nutritional and nutraceutical ingredients market during the forecast period.

Dairy Nutritional and Nutraceutical Ingredients Market Key Players

Some of the major players operating in dairy nutritional and nutraceutical ingredients market includes  Fonterra Co-Operative Group, FrieslandCampina, Groupe Lactalis, Murray goulburn Co-operative co. Limited, Glanbia PLC, Groupe Lactalis among others.  Link to original post.

Global Pet Food Nutraceutical Market - Growth, Trends & Forecasts (2015-2020) - Reportlinker Review

By Reportlinker

October 7, 2015

The health conscious consumer sees nutrition enabled foods as an alternative to healthcare costs and thus has been the rising the global nutraceutical market at a CAGR of 7.5% to reach $260 billion. The fastest growing segment in the food sector is the pet food industry which is driven by increasing number of people adopting pets and consumer attitudinal change towards pets with interest on their nutrition and health. The global pet food market with a growing CAGR of 4.5% is estimated to be valued at $ 86.3 billion by 2020. The pet food industry accounts only 12% towards value based foods with rest accounted for by general pet foods. Also, with increasing ageing population of and growing acceptance for supplements by veterinary community, the global pet food nutraceutical market is estimated to reach nearly $6 billion by 2020 growing with a CAGR of 4% from 2015 to 2020.

Increasing urbanization, growing disposable incomes, and changing lifestyles have led to lower birth rates and increasing rates of single person families. This is leading to consideration of pets as family members and a number of households owning dogs, cats and others animals. Thus, driving the pet food market and consumers preference for nutrition enabled pet food further growing the pet food nutraceutical market. In US, the baby boomer generations preference for smaller pets accounts to 52% households owning them. Other major drivers include companies adopting channel specific product development. This is explained by the increasing number of households owning small and larger animals, where brands are created for the age specific group and this category wise product development is a reason for uptick in demand. The consumer has expanded his pet related purchases from basic necessities to functional treats and healthcare pet supplements. The trend of consumers enriching the pets foods with functional ingredients such as vitamins, minerals, probiotics for boosting their pets joints health, coat and heart health are an indication for expected growth in the pet nutraceutical market.

The type of pets owned around the world varies. Based on type, Pets are categorized as Dogs, Cats, Birds and Others. Dogs and Cats are accounted to be the most adopted pets globally. Pet foods are rapidly increasing due to their demand coming from the veterinary use as dietary supplements and for their therapeutic use. The key therapeutic application include pain relief, weight management, digestive health, Immune system, eye care, food allergies and others. Based on the Ingredient type, the pet nutraceutical market is segmented as Omega 3 fatty acids, Probiotics, Proteins and Peptides, Plant based enzymes, Antioxidants among others. The popular ingredients include Glucosamine, Omega fatty acids, and Probiotics, along with trendier ingredients such as Bee pollen, Green tea, and elk velvet antler. The demand is driven largely by age related diseases in pets like joints deterioration and cognitive dysfunction.

In the Pet food market Asia posted a growth of 3.2% in 2013.Customers from China, Taiwan and Thailand with their increasing levels of pet humanization perceive pet food as quick and easy solution to provide nutrition to their pets. This drives the demand for pet food nutraceutical in these markets. High percentage of US households recorded high numbers in small dogs when compared to medium and large dogs. The retail sales for pet supplements and nutraceutical treats recorded $1.3 billion in US. Japan is a matured market in this category and sees flat sales. The emerging economies are seeing high demand in the branded pet food category thus driving the branding strategies of pet food manufacturers.

The leading players in this market are Diana group, DSM, BASF, Merial, Nutraceutical International LLC and Kemin. The application areas of these companies are in the area of Digestive health, weight management and beauty (coat and skin). In spite of growing pet population, the companies are seeing stagnant revenues. Hence it is important for the companies to focus on segment wise production of nutritional foods. The major constraint the market sees in the regulatory environment. The Functional pet foods manufacturers claims for the nutritional supplements and therapeutic functioning as drugs do not seem to comply with the drug regulations and the regulatory body is overlooking the claims. The need of the hour is the stringent regulatory guidelines to protect the pet health. Bringing awareness among the veterinary community will help in prescribing the right supplements for the animal health.  Link to the original post.

consumers prefer "premium" when it comes to pets

By Tanya Gazdik Irwin

September 27, 2015

So-called “premium” products are tops on consumers lists in the pet market, even when it comes to the $5.4 million market for treats and chews, according to a report from Packaged Facts.

For over a decade, premiumization has been driving much of the pet market growth, according to “Pet Treats and Chews in the U.S.”

The pet overall market has been seeing little expansion in terms of dollar and volume sales, but what gains there have been are primarily a result of higher-priced, higher-quality products entering the market, according to David Sprinkle, research director, Packaged Facts.

“Absent any other galvanizing factors toward increased pet ownership, ongoing premiumization is crucial if pet market dollar sales are to continue to rise," Sprinkle says in a release.

“Premium” and “super premium” products are those that contain special nutraceutical ingredients and those offering "human-quality" ingredients adopted from human food market trends, such as superfruits, ancestral grains, and exotic proteins.

In the pet food arena, margins on super premium foods can reach 40%, compared with 30% for premium brands and 20% or less for standard brands, according to the report.

Nutraceutical treats in particular are of increasing significance to the premium pet products segment, especially because the "graying" of America's pet population is an important driver of increased pet market spending in many areas. The treats contain supplements such as glucosamine and claim to improve pets’ health while minimizing aches and pains, such as those from arthritis. 

For pet food and treat marketers interested in offering pet owners nutraceutical benefits in a format pets will enjoy, nutraceutical treats and chews are the perfect middle ground between treats and supplements, according to the report.

Consumers are better able to rationalize any extra expense associated with premium nutraceutical products because they are perceived to offer "2 in 1" in the form of treats that provide treatment for health conditions.

According to Packaged Facts' January 2015 pet owner survey, 65% of dog owners and 55% of cat owners agree that pet treats offering special nutrition can be beneficial to pets with specific health conditions.  Among pet owners polled, one-third strongly agreed and one-quarter somewhat agreed that pet treats played an important role in their pets' health.

The report also looks at future trends, including the importance of product safety, the encroachment of natural products in mass-market outlets, the impact of humanization on the treat market, and growth of functional and grain-free treat options.  Link to original article.

as industry considers new controls, nutraceutical makers must focus on qa

By Jeffrey J. Russell, Esq.

September 22, 2015

A recent flood of negative news about the safety and integrity of nutraceuticals has drawn the attention of politicians, consumers and lawyers, and prompted at least one industry leader to adopt new quality controls. To help mitigate their risks and reassure retailers and the public, nutraceutical manufacturers need to have clear quality assurance (QA) practices in place.  

Investigation bruises industry credibility
The recent problems started in early February, when the NY attorney general’s office announced that it had tested store-brand herbal supplements sold at GNC, Walgreens, Walmart and Target, and the tests showed most of the products did not contain the ingredients listed on their labels. Some also allegedly contained ingredients, such as soy and wheat, that were not listed on the label.

The attorney general subpoenaed the retailers for evidence proving their product claims and threatened legal action; in response, the four pulled the supplements from their NY stores. The attorney general’s office also requested ingredient and quality control information from four product manufacturers.   

Industry trade groups countered that the investigation was politically motivated and based on flawed science: The supplements were tested via DNA barcode testing, which isn’t appropriate for the herbal extracts many of the products contained, because the extraction process destroys DNA. After nutraceutical groups pointed out this problem and asked to see the details of the report, the attorney general’s office refused to release it.  

Flawed or not, the investigation triggered a firestorm of bad publicity for the accused retailers and the industry in general.  GNC had its supplements and manufacturing processes independently evaluated and confirmed as safe and compliant, but that wasn’t enough. In late March, GNC announced that it had reached an agreement with the attorney general and would expand its testing and supply chain traceability processes, including using DNA barcode testing before extraction. The company also agreed to provide semiannual reports to the attorney general’s office. (So far the other three retailers have not announced any similar agreements.)

States ask Congress to increase FDA oversight
GNC’s action did not put the matter to rest. In April, attorneys general from 14 states asked Congress to investigate the supplements industry and consider a stronger oversight role for the FDA, which currently is authorized to take action against unsafe products only after they reach the market.

The attorneys general want Congress to look into the adequacy and effectiveness of existing processes for verifying the source, identity, purity, potency and quality of ingredients, as well as the identity, composition, purity, potency and quality of finished products.  They also want congressional leaders to consider directing the FDA to develop enhanced manufacturing and supply-chain management requirements, as well as uniform, industrywide QA and verification processes.

Under the existing rules, manufacturers are responsible for following FDA good manufacturing practices (GMPs) and making safe nutraceuticals, but they don’t need FDA approval before they can sell a product, and they don’t have to register products with the agency. Manufacturers are required to notify the FDA before they start selling a product that contains a “new dietary ingredient,” which is an ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994; they also have to submit evidence of the new ingredient’s safety.

The industry may add its own standards
It’s too soon to tell whether Congress will take any action to increase the FDA’s oversight. However, the recent events may spur the nutraceutical industry to create its own additional QA standards, in order to take the lead on consumer safety.

In mid-May, the NY attorney general’s office and the Natural Products Association, the industry’s largest nonprofit trade group, agreed to work together to ensure the safety and authenticity of herbal products, including supporting the use of DNA barcode testing before an ingredient’s extraction. The two also said they plan to work with major manufacturers and retailers to promote a model for product safety, authenticity and transparency. (The industry’s general position on regulation has been that the existing FDA oversight is sufficient, although the FDA should do more to get rid of companies that ignore safe practices.)

Quality controls are crucial
In addition to generating damaging headlines, the NY investigation has led to numerous class action lawsuits. Anxious to guard against similar lawsuits and reassure consumers, nutraceutical retailers are likely to want proof that their suppliers have strong quality controls. More than ever, supplement manufacturers will need to be able to demonstrate that they have stringent QA processes in place. 

Well-documented processes will help manufacturers show that they are meeting regulatory requirements. The FDA doesn’t have the same kind of clearly defined “bright-line” rules for nutraceuticals that it has for pharmaceuticals or medical devices, so compliance can be a gray area. This vagueness makes the rules dangerously open to subjective interpretation by companies, FDA inspectors and auditors. 

Nutraceutical companies can leverage their ERP system to help address these gray areas from a regulatory and risk mitigation standpoint. The key is having systems in place to track quality events such as out-of-specification reports, deviations, non-conformances, corrective actions and complaints.

These ERP capabilities help manufacturers put preventive systems in place to capture things like irregularities in raw materials and vendor or production issues.  Leveraged properly, these reportable systems can significantly help a nutraceutical company maintain adequate internal controls. If there is a reportable event, and the FDA steps in to do an audit, the ERP quality systems will provide the company with concrete answers and data to support their actions.

Documenting everything that happens in the manufacturing environment and staying on top of any resulting actions is an ongoing challenge, so nutraceutical makers also need an integrated means of handling quality events, which can generate changes in other areas.  A business may record a deviation that leads to a corrective action, for example, and the corrective action may reveal a flawed procedure that also causes a change to a standard operating procedure —launching an associated training and verification task to prove the corrective action/modified process has resolved the issue.

An ERP system can support integrated quality controls and help manufacturers mitigate their risks, prove their regulatory compliance and demonstrate the integrity of their products. As Congress and the nutraceutical industry consider additional oversight, these strong QA processes can also help manufacturers address any new requirements that come their way.  Link to original post.

nutraceuticals market to surpass $278 billion globally by 2021

By Transparency Market Research

September 23, 2015

The global nutraceuticals product market has shown steady growth during the past few years. This trend is anticipated to continue during the forecast period due to increasing consumer spending on nutritious and healthy functional food, beverages, and dietary supplements worldwide. Nutraceuticals provide health benefits and help in the prevention and healing of diseases. The global nutraceuticals market is primarily growing due to rise in demand for dietary supplements; however, functional foods and beverages comprise a significant market share . Nutraceuticals are nutritional or functional foods that are slated to have physiological benefits, or provide relief from numerous chronic diseases and ailments to the consumers.

Nutraceuticals range from dietary supplements, isolated nutrients, and herbal products to specific diets and processed foods and beverages. These are extremely attractive to food and beverages companies due to the relatively high margins and minimal regulatory requirements involved. Factors such as rising health concerns, growth of key demographics, and increasing consumer desire to lead a healthy life and avoid dependence on synthetic drugs are the major drivers contributing to the growth of this market. In addition, factors such as new product launches, mergers and acquisitions, and nutraceuticals aimed at improving cardiac health are expected to enhance the growth of this market. All these properties mentioned above have led to the growing demand for nutraceuticals in recent years.

Nutraceuticals are the products that provide health and nutrition benefits in addition to the basic nutrition value present in food items. Nowadays, consumers are more health conscious, more aware, and better informed on nutrition-enabled products. Furthermore, dietary supplements are not only consumed in order to meet the recommended daily intake of nutrients, but also as a physical performance booster and disease prevention option. In addition, there is a shift in the preference of consumers from synthetic ingredients to organic foods and ingredients, which are obtained from non-genetically modified organism (non-GMO) extracts.

The nutraceuticals market mainly constitutes food; beverages; dietary supplements; personal care and pharmaceutical products. The growing market of vitamins and minerals-enriched herbal shampoos and creams is also one of the major drivers behind the rising demand for nutraceutical ingredients. The dietary supplements are available in the form of capsules, tablets, and liquids. Nutraceutical ingredients include probiotics and prebiotics, vitamins, proteins, minerals, Omega 3, fibers, amino acids, structured lipids, and various other ingredients. Nutraceutical ingredients find application in grains, cereals, nuts, fruits, vegetables, dairy products, poultry products, seafood, and confectionery items apart from non-alcoholic beverages such as energy drinks, juices, and sports drinks. Few examples of functional foods and drinks enriched with proteins include herb blends, yogurts with probiotics, and soy beverages.

In this report, the global nutraceuticals product market is categorized into two segments: (i) by product type; (ii) by geography. Based on product type, the market has been categorized into functional food, functional beverages, dietary supplements, personal care, and pharmaceutical segments. Functional food is further segmented into probiotic fortified food, branded wheat flour, branded ionized salt, and omega fatty acid fortified food among other functional food. In addition, functional beverages segment has been sub-segmented into fruit & vegetable juices and drinks, non-carbonated drinks, and dairy and dairy alternative drinks among others. Dietary supplements are divided into vitamins and minerals, proteins and peptides, and herbals and non-herbals among others. The report also covers the drivers, restraints, and opportunities (DROs) of the nutraceuticals product market. The study highlights the current market trends and provides forecast for the period from 2015 to 2021. We have also covered the current market scenario for global nutraceuticals, and highlighted future trends that are likely to affect its demand.

By geography, the market has been segmented into North America, Europe, Asia Pacific, and Rest of the World (RoW). Each region has been further bifurcated country-wise to highlight the respective market share of nutraceuticals in each country. The study covers major countries such as the U.S., Canada, and Mexico in North America; Japan, China, and India in Asia Pacific; the U.K., Italy, and France in Europe; and Latin America, Africa, and the Middle East in RoW. The size and forecast for these markets for the period from 2015 to 2021 has been provided in the report.

Under the scope of this report, different influencing and inhibiting growth factors of the nutraceuticals product market have been analyzed. The market attractiveness analysis provided in the report highlights the key investing areas in this industry. The report will help nutraceuticals manufacturers, suppliers, and distributors to understand the current and future trends in this market and formulate their business strategies accordingly.

Some of the key players in this market include BASF SE, Cargill Incorporated, Royal DSM N.V., Nestle S.A., Archer Daniels Midland Company (ADM), Groupe Danone, Pepsico Inc., and DuPont.  Link to original post.

sec charges musclepharm with string of violations

By Steve Myers

September 10, 2015

It has been a good news, bad news kind of week for MusclePharm. Last week, we reported on a new study showing the company’s caffeine-rich thermogenic supplement Shred Matrix is safe, but this week came news the Securities and Exchange Commission (SEC) charged the company (OTC:MSLP) with several accounting and disclosure violations, including failure to disclose nearly half a million dollars in executive perks.

The case is part of ongoing efforts by SEC to focus on reporting issues as well as the responsible accounting and auditing personnel.

SEC charged MusclePharm, its CEO Brad Pyatt and two former chief financial officers, L. Gary Davis and Lawrence Meer, with a number of violations and misconduct after an investigation revealed omitted or understated perks given to executives, including US$244,000 paid to Pyatt for cars, clothes, food, country club fees and Pyatt’s personal tax and legal expenses.

“Executive compensation is material information for investors, and companies must ensure that perks it pays for executives are properly recorded and disclosed in public filings," said Andrew J. Ceresney, director of the SEC’s Division of Enforcement.

MusclePharm opened its own internal review of the disclosure issues, but even after its audit committee chair Donald Prosser became involved, the company continued to file financial statements that failed to disclose expenses/compensation for use of jets, cars and golf club memberships.

So, SEC also charged Prosser. “Prosser, MusclePharm’s audit committee chair, subjected himself to liability when he substituted his wrong interpretation of SEC rules for the views of experts the company had hired, resulting in an incorrect disclosure," Ceresney explained.

The complete list of violations includes:

  • Failure to disclose third-party transactions with a major customer;
  • Failure to implement sufficient policies to identify and disclose related party transactions;
  • Failure to disclose bankruptcies related to two executive officers;
  • Misstating that no members of the board of directors or other executives had been involved in any bankruptcy proceedings;
  • Improperly accounting for advertising and promotional related costs and, consequently, overstating revenue;
  • Failure to disclose continuing sponsorship commitments for which the company eventually made payments totaling $6.9 million;
  • Understating rent expense by failing to disclose $100,000 related to an aircraft lease agreement; and,
  • Failure to implement internal accounting controls for perks and other areas where it committed accounting and disclosure violations.

In addition to these disclosure and accounting violations, SEC found MusclePharm issued stock without a registration statement by agreeing to give company stock to third parties that would pay Musclepharm vendors in cash. According to the SEC, MusclePharm was short on funds to pay its vendors approximately $1.1 million owed for outstanding invoices.

MusclePharm, Pyatt and the other three executives agreed to settle the case by paying fines but not admitting or denying any of the allegations. MusclePharm agreed to pay US$700,000 and hire an independent monitor for one year, while Pyatt agreed to pay US$150,000. Prosser and Davis will each pay US$30,000. Both Davis and Meer agreed to a suspension from practicing accounting for any SEC-related companies; Davis can reapply after two years, Meer after three years.

In a statement, MusclePharm said the SEC investigation focused on disclosure and internal control deficiencies from 2010 to 2013, which have since been revised. “MusclePharm has previously instituted new and expanded disclosure controls and procedures that addressed many of the issues described in the SEC order," a MusclePharm spokesman said. “The company is pleased with the outcome of the proceedings and looks forward to putting this behind it."  Link to original article.

caffeine-rich multi-ingredient sports supplement deemed safe

By Steve Myers

September 4, 2015

As FDA continues to express concern over caffeine dosing and availability in consumer products, a multi-ingredient sports supplement containing numerous sources of caffeine has been deemed safe by new research published online ahead of print in Food & Nutrition Research journal.

MusclePharm researchers—some of whom are also affiliated with the Department of Human Performance at Concordia University Chicago and the U. S. Sports Academy, Daphne, Alabama—cited previous thermogenic formulas pulled from the market as reason for this recent study on the safety of the company’s Shred Matrix® supplement. The supplement, designed to benefit energy and metabolism, contains numerous sources of caffeine (e.g. guarana, caffeine, green tea and kola nut) as well as thermogenics such as yerba mate, capsaicin and yohimbe.

In the randomized study, 11 male and 12 female recreationally active adults (average age of 27 years, average BMI of 26) either took the supplement (n=9) or not (n=14) for 28 days. The subjects maintained their regular exercise and dietary regimens throughout the trial period, and researchers measured and analyzed blood panels, blood pressure and heart rate both before and after the supplementation period.

The researchers reported significant differences diastolic blood pressure, creatinine, HDL (high-density lipoprotein) and other parameters before and after supplementation in the supplement group, but they assured all variables measured were within accepted physiological ranges and were, thus, not clinically significant. They concluded Shred Matrix is safe for consumption by adults in a 28-day period.

More details of the study are available at both the journal’s site and PubMed which also has the product’s Supplement Facts information.  Link to original article.

sports supplements linked to male eating disorders?

By Steve Myers

August 7, 2015

New research presented today at the American Psychological Association (APA) annual convention suggested overuse of certain sports supplements may contribute to eating disorder in men struggling to attain society’s ideal male physique.

A pair of psychologists, Richard Achiro, Ph.D., and Peter Theodore, Ph.D., from the California School of Professional Psychology at Alliant University, Los Angeles, surveyed 195 men over the age of 18 who worked out twice per week and had taken legal appearance- and performance-enhancing drugs (APEDs) in the 30 days prior to the study.

I must note they list the APEDs in this study as creatine, glutamine and protein powders/bars. I think it is misleading to call these dietary supplements “drugs." I do agree with them that these supplements are often marketed specifically toward men who want to achieve an ideal fat-to-muscle ratio.

The survey asked for information on eating behaviors, legal APED use and various psychological “constructs." The data was analyzed using a scale to determine risky APED use that was developed specifically for this study and reportedly found to be valid and reliable for this study’s endpoints and subject population.

According to the abstract presented, “structural equation modeling revealed that internalization of cultural standards of attractiveness (i.e., the degree to which one has internalized the body ideal perpetuated by media representations of lean and muscular men), self-esteem, gender role conflict, and body dissatisfaction each play significant roles in determining risky body change behaviors (i.e., excessive legal APED use and disordered eating) in gym-active men."

Translation: men take society’s ideal male physique to heart and adopt risky behaviors to attain this “perfect" physique.

Another model used by the researchers suggested where a man is in his training (bulking, cutting, maintaining, etc.) is an important factor in seasonal shifts in risky behavior.

“Overall, the current findings suggest that excessive legal APED use may represent a variant of disordered eating that threatens the health of gym-active men," they concluded. “Clinical implications include the importance of helping clients struggling with excessive APED use to develop insight regarding psychological factors other than body dissatisfaction that may contribute to over-reliance on these supplements (e.g., gender-based conflicts, core beliefs about being unworthy or fundamentally unattractive)."

I reached out to Dr. Achiro but did not receive a response by press time. I will update this blog post when I get some info and comments from him.

In released statements, Achiro explained these sports supplements have become ubiquitous in this male demographic, and their marketing tries to take advantage of underlying insecurities of masculinity.

“The most critical implication for these findings is to put risky/excessive legal supplement use on the map as an issue facing a significant number of men," Achiro said, noting body-conscious men driven by psychological factors to attain a level of physical or masculine ‘perfection’ are prone to use these supplements and drugs in a manner that is excessive and which was demonstrated in this study to be a variant of disordered eating. “As legal supplements become increasingly prevalent around the globe, it is all the more important to assess and treat the psychological causes and effects of excessive use of these drugs and supplements."

Are dedicated gym guys frequent abusers of sports supplements? If so, does this constitute an emerging eating disorder? I'd love to hear your thoughts.

Achiro noted 29 percent of men polled in the study admitted they were concerned about the level of their supplement use, and 9 percent said their doctor had requested they stop or cut back on supplements due to existing or potential adverse health problems.

I think there are some interesting questions raised by this research, but far more research must be conducted on larger populations before any broad conclusions should be made or the public alerted.  Link to original article.

amino acid ingredient improves performance, endurance

By Steve Myers

July 17, 2015

The research on Sustamine® is piling up. Last month we learned the amino acid ingredient helped improve recovery by protecting muscles from post-workout protein degradation, and now a new study has found the branded ingredient may increase endurance and stave off exhaustion.

Sustamine is a dipeptide combining two amino acids, L-glutamine and L-alanine. According to the supplier Kyowa Hakko, this bonded pair is smaller than complete protein and thus can be more efficiently absorbed.

Where the study reported last month involved rats, this current study featured 12 healthy male endurance athletes (20 to 27 years old) performing a series of endurance trials in the Human Performance Lab at the University of Central Florida, Orlando.  Before the trials, the athletes visited the lab two times to gather baseline data, including height, weight, 24-hour food log, urine analysis for normal daily body water content, and peak VO2 level. It is important to note VO2peak is the highest volume of oxygen used during an exercise, while the maximum attainable oxygen volume is called VO2max.

Each separate endurance session consisted of an hour of treadmill running at 75-percent of VO2peak followed by an hour treadmill run to exhaustion at 90 percent VO2peak. Sweat loss was measured after each running session.

Now each session (one per lab visit, with seven days between each visit) featured a different approach to hydration during the trials. In the first trial there was no hydration, in order to confirm participants met sweat rate criteria for the study. During the remaining three visits, athletes were randomized (double blind) to different hydration beverages: Pepsi’s Gatorade G2 (21 cal., 4.9 g carbs, 113 mg sodium and 32 mg potassium per 250 ml serving); and either a low (300mg) or high (1 g) dose of Kyowa’s Sustamine mixed in with Gatorade. All participants completed the trials and finished the sports drinks.

For more on this ingredient, visit

You can check out the detailed results in the full publication online ahead of print in the Journal of the American College of Nutrition, but the bottom line is  taking Sustamine showed increased levels of plasma glutamine, with levels lasting longer in the high dose trial, while both low- and high-dose trials had significantly increased time-to-exhaustion (43.5 percent and 52.6 percent, respectively), compared to the no hydration trial. The high dose of Sustamine resulted in a 12.-percent increase in time to exhaustion compared to the Gatorade trial.

The researchers noted, “Although not significant, this 12.7-percent improvement in performance could make a difference in a competitive endurance event." They added considering the difference between Sustamine and Gatorade was not deemed significant, rehydration alone must be considered a possible cause of improvements to run performance.

They were not able to figure out the exact mechanism of improved performance due to Sustamine, but said it may be related to enhanced electrolyte uptake in the skeletal muscles and to alanine’s gluconeogenic effect (glucose generation from non-carbs). Link to original article.

legal, regulatory forum covers spectrum of supplement issues

By Steve Myers

July 2, 2015

Last week in New York City, dietary supplement industry regulatory and legal experts gathered to learn more about and discuss current industry issues. The 3rd Annual Dietary Supplement Legal, Regulatory and Compliance Forum was hosted by the American Conference Institute (ACI) in partnership with the Council for Responsible Nutrition (CRN). The sessions covered a broad range of legal and regulatory topics, including the political climate in state and federal governments; trends in class-action lawsuits; challenges with GMPs (good manufacturing practices) and quality compliance; potential impacts of key FTC cases on claims substantiation; details on the looming influence of FSMA (Food Safety Modernization Act) on ingredient suppliers; and the ever-changing legal landscape of California’s Proposition 65 regulations.

Forum Co-Chair Diane McEnroe, a partner in New York at international law firm Sidley Austin LLP, called the event an opportunity to “get ahead of some issues" instead of just “constantly putting out fires." She said it has been difficult for regulatory and legal experts to counsel supplement companies because of the shifting regulatory climate.

Her co-chair, CRN President and CEO Steve Mister, described the supplement industry as being in a precarious position: “We are somewhat wounded right now, and some [critics] may want to pile on." Mister was referring to the recent debacle surrounding the New York Attorney General’s (NY AG) investigation of herbal dietary supplements, which seemingly has given energy to industry adversaries in Congress (e.g., Democratic Sens. Dick Durbin of Illinois and Richard Blumenthal of Connecticut) and a stampede of class-action lawsuits, not to mention media outlets intent on covering half the story of supplement regulation and safety (here’s looking at you HBO “Real Sports"!) Mister also cited intentional adulteration as a prime contributor to this vulnerable moment in the industry.

Lasting Effects of NY AG Case

CRN’s Regulatory Counsel Rend Al-Mondhiry detailed the NY AG case that has dominated industry discussions of late, and she touched on the key points including lack of transparency around the actual testing data, how the AG’s action moved beyond the applicability of DNA testing for extracts, and why GNC’s agreement with the AG was bad for industry (hint: think “unnecessary" and “redundant.")

The AG case’s alarming outcome is a reminder that class action might be a scarier notion than FTC action, as Al-Mondhiry noted more than 70 virtually identical actions were filed in several states based on the AG investigation. She said there are efforts to consolidate some of these cases as multidistrict litigation (MDL) for quicker resolution. Last month, 35 proposed class-action lawsuits filed against Walgreen Co., Wal-Mart Stores, Inc., GNC Holdings, Inc. and Target Corp. were consolidated and transferred to a federal judge in Illinois

Testing and Quality Control

John Travis, senior research scientist at NSF International, said the spotlight the AG investigation put on DNA testing and the scope of the GNC agreement will certainly impact lab testingby driving the further development and implementation of the testing technology. Using DNA barcoding appropriately on botanicals will require continued development of DNA databases and methods, improved expertise in performing careful DNA sequencing, and top-notch quality control to ensure accurate results. He noted while the AOAC and numerous supplement companies have been working on DNA methods and database development, a lot of work still needs to be done before DNA testing can realize its full potential as a complement in the supplement GMP testing toolbox. “Science takes longer than marketing," he quipped.

In discussing how companies should choose the best test, whether genetic or chemical, for the purpose at hand, Amway Chromatography Sciences Group Manager Amit Chandra, Ph.D., suggested companies pay attention to regulatory responsibilities in the increasingly complicated supply chain. “GNC should be focused on chain of custody instead of agreeing to DNA testing," he remarked.

Justin Prochnow, a shareholder in Denver at the international law firm Greenberg Traurig LLP, said the days of handshake agreements are over, and brand owners need to carefully create quality agreements with contractors, including manufacturers, packagers and labs. “[Brand owners] cannot contract out responsibility under GMPs," he reminded. “If your name is on the label, the FDA is likely going to look at you for assurances of compliance."  He noted in the past two years FDA has sent warning letters to 29 own label distributors (OLDs) for GMP non-compliance.

Nicky Jacobs, founder of Jacobs Compliance Services, said chain of custody and the potential legal ramifications are bigger issues than DNA testing. “OLDs have an overwhelming need to get consumer confidence and keep it," she said. A lot of supplement companies are struggling with GMP requirements for testing the identity, purity, strength and composition of ingredients and finished products, so Jacobs provided some advice on setting specifications. Many companies have specs but can’t control them on the production line, according to JacobsShe urged companies to avoid creating too many specs, to consider setting “characteristics" instead of specs, and to challenge very old specs.

David Morrison, vice president of scientific and regulatory affairs at Vitamin Shoppe, offered up his company’s use of a Compliance Triumvirate including regular auditing, product testing and contracts with outside labs. The company generates a scorecard of key compliance areas to find what may need improvement. He recommended agreements with contract manufacturers should allow OLDs access to, not necessarily permanent possession of, batch and manufacturing records crucial to ensuring GMP compliance.

Discussions between panelists and the audience highlighted the chain of custody challenges proprietary blends and premixed ingredients pose to contract manufacturers, which need to test under GMPs. All in attendance agreed this issue needs more attention and better solutions for both OLDs and contractors.

State and Federal Agency Issues

Regulatory compliance is crucial for minimizing legal exposure to both government agencies and plaintiffs’ lawyers. Where FDA has been increasingly focused on quality issues, FTC has undertaken some landmark claims substantiation court cases. In its case against POM Wonderful over misleading advertising claims, the agency won most of its arguments, but the court ruled the agency cannot impose a blanket requirement of two RCTs (randomized controlled trials) to prove claims substantiation. Paul Rubin, a partner in Washington at the international law firm Ropes & Gray LLP, noted under First Amendment protection, companies can make truthful and non-misleading claims without meeting RCT substantiation requirements. “If POM had used effective qualifying language and disclaimers, FTC would have considered it," he said. “FTC admitted such."

Miriam Guggenheim, a partner in Washington at the international law firm Covington & Burling LLP, thoroughly outlined the FTC case against Bayer over whether the company meets the “competent and reliable scientific evidence" standard for claims made on a probiotic dietary supplement. She noted this standard has been touted by the agency as being flexible and requiring no fixed formula for the number and types of studies for substantiation. This could allow companies to survey the literature and use bridging evidence to substantiate claims, but it could also open the door for FTC to secure an expert witness who only marginally fits the broad area of expertise in the case—such as any gastroenterologist for a probiotic claim even if the expert knows nothing about probiotics and supplements.

Guggenheim explained the agency’s expert in the Bayer case may set a new standard that requires human clinical trials on the specific product bearing the claim—in this case, benefits of one strain of probiotic cannot be extrapolated to another strain in the same species. Further, the trials would have to be conducted on populations targeted by the structure-function claim. Guggenheim noted this creates a conundrum as structure-function claims cannot be made to impaired populations or FDA will consider the product an unapproved drug. Further, this gastroenterology expert’s standard would apply to all supplements generally, not just gastrointestinal-related products/claims. She questioned whether this standard would go against DHSEA (Dietary Supplement Health and Education Act) by holding supplements to a drug standard.

Another federal agency issue detailed during the forum concerned pending FSMA requirements. Marc Ullman, a partner at the New York-based law firm Ullman, Shapiro & Ullman LLP, outlined the GMP and hazard analysis preventive control final rules that are due out by October 2015 [GH2] and would apply not only to foods but also to dietary supplement ingredient suppliers. “It applies to all ingredient suppliers not subject to dietary supplement GMPs," he warned. “It’s going to fundamentally change the way you do business."

One key aspect of FSMA is the responsibility for imported foods and ingredients. Ullman noted the assignment of responsibility for imports starts with whichever U.S.-based party owns the imported food/ingredients but would go to the U.S. consignee (if there is no owner) and then any U.S.-based agent/rep for the foreign supplier (if there is no consignee). As part of FSMA’s Foreign Supplier Verification Program (FSVP) for importers of food for humans and animals, importers would be responsible for ensuring the imported food meets U.S. safety standards, with verification based on risk—written procedures must be established for this risk assessment. A Voluntary Qualified Importer Program could ease importing of foods.

On a state level, AG actions are heating up, but the biggest state-level pain for dietary supplement companies still may be California’s Proposition 65, which has been a haven for bounty hunter lawyers to draw companies into costly settlements. Prop 65 mandates warning labels for consumer products that contain carcinogens or reproductive toxins above a certain level determined by the State of California and its Office of Environmental Health Hazard Assessment (OEHHA). Many industry experts have argued the levels pertaining to dietary supplements—lead is the primary culprit—are unjustifiably too low, even compared to federal limits, yet OEHHA and state officials are currently trying to change the regulations and lower some of these limits, according to a meticulous presentation by Trent Norris, a senior partner in San Francisco at the international law firm Arnold & Porter LLP.

Norris alarmingly noted there have been about 25,000 claims made by plaintiffs’ lawyers (on behalf of California citizens), but only 10 cases have gone to trial; most have settled. Of the cases in trial, some key methods of defense are being challenged. In the case involving Beech Nut, there is a battle over the method of determining average exposure to a Prop 65 toxin. Plaintiffs and the state prefer to average just one day’s max exposure, while defendants and industries have argued this should cover more than one day and more than one product or even lot. There is also a debate on whether the arithmetic or geometric mean should be used, as there can be a big difference in result between the two.

One big question with Prop 65 is whether consumers are generally weary of all the warnings, including signs in well-respected businesses. Norris outlined the case against Starbucks over acrylamide, which is generated when coffee beans are roasted. Starbucks argued its stack of epidemiological evidence shows coffee does not cause cancer, making any Prop 65 warning compelled false speech. A decision in the case, which closed arguments in April 2015, is due soon but had not yet been rendered at the time of the forum. However, Norris noted Starbucks preemptively put up Prop 65 warning signs a while back, although the signs do not appear to have deterred its loyal customers.

Norris further expressed concern that while Naturally Occurring Allowances (NOAs) for many chemicals were established back in 2009, OEHHA has never explained how NOAs can be established, and there have been many Prop 65 settlements without NOAs.

Drawing Positives

In the sea of all these challenges and negatives, Mister pointed out a few positives for the supplement industry. He said dietary supplement use is up among Americans, even with the negative media surrounding the NY AG case, and there is renewed interest in Congress for altering the Flex Spending Account (FSA) rules to allow for the purchase of dietary supplements. Congress also recently passed the Designer Anabolic Steroid Act (DASCA) in December 2014, which allows the Department of Justice to more quickly schedule and act against new steroids and analogs that often adulterate products marketed as dietary supplements and hurt the industry’s reputation. Also, the tough loss of departing congressional champions Sens. Tom Harkin (D-Iowa) (last year) and Orrin Hatch (R-Utah) (in 2016) will be mitigated by a number of members of Congress who might not come to the industry’s defense on each issue but generally support dietary supplements legislatively.  Link to original article.


By Dr. Tomislav Mestrovic, MD, Phd

March 30, 2015

Nutraceuticals are products isolated from foods that are generally sold in medicinal forms. They are defined as any food (or part thereof) which provides health benefits – including prevention and treatment of disease – in addition to the basic nutritional value found in foodstuff. Nutraceuticals are of particular interest as a way to reduce the expensive, high-tech disease treatment approaches currently employed in developed countries.

The nutraceutical industry represents a dynamic, evolving entity that offers novel opportunities to merge scientific discovery with growing consumer interest in health-enhancing foods. It tracks and monitors consumer trends, thus the products of this industry can represent a direct response to their demands. The nutraceutical industry encompasses three main segments which include functional foods, dietary supplements, and herbal/natural products.

Global demand for nutraceuticals

The global nutraceutical market has experienced maximum growth in the last decade. Although nutraceuticals as an industry emerged in the early 1990s, the world has witnessed its explosive growth in the first decade of this century. From 1999 to 2002 the industry grew at an annual average growth rate of 7.3 percent, while in this century the rate doubled to 14.7 percent.

Today, global nutraceutical market is estimated at 117 billion USD. Personalization and customization are current trends in the development of nutraceuticals, especially in developed markets of the world. Investment in research and development to find innovative approaches, verifying health claims of the products and market research represent key strategies for the industry.

A primary impetus for such growth is consumer demand; consumers are looking to follow healthy lifestyles and obtain optimum nutrition to keep diseases such as diabetes, high blood pressure and obesity at bay. Although the US, European Union and India are currently the world's largest nutraceuticals markets, China is likely to surpass them all by 2030.

Industry in different countries

The US nutraceutical market still represents the largest nutraceutical market in the world. Companies are looking to diversify their products and move towards natural nutraceutical ingredients in their product offering. The latter is a consequence of the push from US consumers, who are extremely health conscious and demand specific ingredients in the products they consume.

The market for nutraceuticals in Europe is witnessing heavy consolidation, with a focus on innovation and new product development. A result is a considerable increase in research and development – from 0.24% at the beginning of the century to 1 percent in 2010. Germany, Netherlands and Sweden have emerged as the key nutraceutical innovation hubs of Europe, whereas Spain and Great Britain act as decisive test markets for new products.

According to a recent report, total market for nutraceuticals in India is growing at 21 percent per year. It is currently a nascent market trying to incorporate traditional herbal ingredients (most often ayurvedic) into the nutraceutical portfolio. Still, its growth has surpassed global rates in recent years, mostly driven by functional food and beverages categories.  Link to the original post.

mlb players partner with nutraceutical company

By Tanya Gazdik Irwin

July 16, 2015

The Major League Baseball Players Association has entered into what it is calling a first-of-its-kind partnership with nutritional supplement company Klean Athlete. 

The partnership aims to clean up the image of the sport of baseball, enabling the MLBPA to close the chapter on doping scandals of the past and refocus its efforts on a more holistic approach, according to a spokesperson.

Featuring new training methods and promoting a comprehensive nutrition program designed to optimize players’ overall health and well-being, the premise is that a healthy player is also a more effective player, less prone to injury and more consistently at his best.

Klean Athlete is a line of 10 nutritionalsupplements certified to be 100% free of all banned substances and features foundational products for everyday use, such as Klean Multivitamin, Klean Omega, Klean Probiotic and Klean-D to meet the unique needs of athletes to stay healthy throughout training.

The partnership achieves what the company set out to do by offering players nutritional support to promote overall health and wellness and help them perform at their optimal levels throughout the season, says Timothy Monk, senior vice president of sales and marketing for Klean Athlete.

The MLBPA’s partnership with Klean Athlete is an example of the organization’s interest in working with players to support a more holistic approach to nutrition and wellness, says MLBPA Chief of Business Affairs Tim Slavin.

“Baseball players endure one of the most grueling schedules in all of professional sports, and Klean Athlete is committed to providing players with products that are not only safe, but effective in helping athletes meet their nutritional needs,” Slavin says in a release.  Link to original post.

survey reveals encouraging consumer attitudes on role of multivitamins, vitamin d, calcium

By Nutritional Journal

July 7, 2015

An overwhelming majority of U.S. consumers recognize the value of multivitamins, calcium, and/or vitamin D supplements to fill nutrient gaps in the diet, according to a new survey conducted on behalf of the Council for Responsible Nutrition (CRN; Washington DC). But more than 80% of consumers realize that those supplements are just one part of a healthy diet and should not replace healthy eating or lifestyle habits.

The online survey asked 2,159 Americans aged 18 and older to share their opinions on the role that multivitamins, calcium, and vitamin D supplements play in maintaining a healthy lifestyle. Respondents were asked to indicate their level of agreement or disagreement with statements that suggest these supplements fill nutrient gaps in the diet, these supplements are not meant to replace a healthy diet, and that people should consult their physician about supplement use.

88% of respondents agreed that calcium and vitamin D supplements can help support bone health when dietary intake is not sufficient, and 87% of respondents agreed that multivitamins and mineral supplements can help meet nutrient needs if people don’t get enough nutrients from food alone.

Beyond widespread acceptance of the role these supplements can play in filling nutrient gaps, 82% of respondents agreed that people should talk with their physician before using a high-dose, single nutrient supplement, and 80% agreed that “a multivitamin should not be used to replace healthy diet and lifestyle habits.”

The authors of an article on the survey—published in Nutrition Journal—suggest these findings should reassure physicians and policy makers about the way consumers perceive the role of dietary supplements.

“Our data suggest that policy makers and health professionals can recommend dietary supplements to help improve nutrient intakes without being concerned that this will cause consumers to discount the importance of eating a healthy diet,” says Annette Dickinson, PhD, CRN consultant and author of the survey, in a press release.

The survey also revealed that “three-fourths of respondents agreed that multivitamins are not intended to cure disease, and two-thirds agreed that multivitamins are not medicine,” according to the article in Nutrition Journal.

The online survey was conducted on behalf of CRN, designed and analyzed by FoodMinds, and fielded in October 2014 using Toluna’s On-line Omnibus. Survey quotas for age, gender, race/ethnicity, education, region, and household income were used and responses were weighted as necessary to establish the survey population as representative of the larger U.S. population.

“As Americans continue to seek ways to stay healthy, dietary supplements play an important role,” says Douglas (Duffy) MacKay, ND, senior vice president, scientific and regulatory affairs, CRN. “Therefore, it’s important for our industry, as well as those in scientific, academic, health care practitioner, and policy circles, to understand how consumers view that role.”  Link to original article.

dietary supplement and natural product brand building: from lightbulb to launch

By Kimberly J. Decker

April 23, 2015

When Jeff Hilton says “fascinating things” are happening in the supplement space, grab a chair and take notes. An old hand at health-and-wellness branding, the chief marketing officer and cofounder of BrandHive (Salt Lake City) has had both a front-row seat and a backstage pass to the industry’s evolution since Ronald Reagan was in the White House.

So when he predicts that we’re “in the early stages” of a major shift in how consumers approach health, he does so with some authority. And what his privileged perspective tells him is that an “entrepreneurial surge” is bringing about a bumper crop of brands backed by compelling stories, creativity, and resourcefulness to spare.

But those budding brands—and the industry as a whole—face a very different playing field than the one that existed back when nutritional supplementation meant taking the multivitamin you picked up at the grocery store. “We’re going through a thought revolution and a new-product revolution,” Hilton says, and the theme he sees underlying both is convergence: of channels, media, dayparts—even of foods and beverages with supplements themselves. It’s uncharted territory, for sure, but brands that follow these five key strategies will find “huge opportunity,” Hilton promises, as they navigate it.

Tip 1: Eat, Drink, and Be Healthy

“If you look at the landscape for supplements, foods, and beverages over the next 10 years,” Hilton says, “where the excitement and opportunity are is in the food and beverage sector.” That should come as no surprise to anyone who’s scanned a functional snack or smoothie label and realized there’s not much separating them nutritionally from the multivitamins of yore.

To nascent brands that already embrace edible and potable platforms for functionality, that’s encouragement to keep up the good work. But for old-school supplement marketers, “I think it’s a bit of a wake-up call,” Hilton says. “If I were a supplement manufacturer—and I tell my clients this—I’d be watching my back because I think the big-picture trend is away from popping pills and more toward adding functionality to what we’re already consuming.”

Need proof? Just ask a Millennial, who isn’t “going to pop 30 pills a day,” he says. Even Boomers, he adds, are “increasingly pill averse.” And while capsules and tablets aren’t going the way of the dodo just yet, consumers’ desire to make nutrition not just quick and convenient but an experience that’s “natural” and hedonically appealing explains why demand for functional bars, shots, gels, drinks, and snacks “is going through the roof,” Hilton says.

And remember: “The whole three-meal-a-day paradigm is dead or dying,” Hilton declares. Any brand that grasps how consumers are redefining traditional dayparts—turning breakfast, lunch, and dinner into the midmorning nosh, post-lunch perk, pre-workout refueling, trans-commute nibble, and so on—will meet those consumers where it matters.

Tip 2: Tell ‘Em a Story

And speaking of what matters, consumers don’t just insist on functional options that fit their lifestyles; they want products that fit their psychological and emotional constructs of what health and wellness really mean. That’s a cue to write a backstory for your brand that engages consumers. As Hilton says, “The brands that are succeeding are the ones that are trying to educate.”

It’s a lesson that Janie Hoffman, CEO and founder, Mamma Chia (Carlsbad, CA), knows by heart. “The greatest brands in the health-and-wellness space often come from an authentic place—a desire to better the world or enable people to live healthier lives. It’s this authenticity that can resonate with consumers and create a loyal following.” For her, authenticity involved sharing the benefits of chia with a wider audience. “Those tiny little seeds had a dramatic effect on my health and vitality,” she says, “and it was my passion for them that drove me to create Mamma Chia.”

In a happy coincidence, putting her brand narrative on the table made it easier to stand out on a crowded shelf. “We think less about our competition and focus our efforts more on making delicious, healthy, chia-based products and creating a sustainable and conscious company,” she says. “When your values align with your customers’ and your products fulfill their needs, sales will follow.”

That said, it still doesn’t hurt to stand out, and Hoffman wasn’t shy about giving consumers a product they’d notice. Her flagship chia drink “was unlike anything that existed at the time,” she says. Appearances helped, too, and she chose “a beautiful bottle with bright, eye-catching packaging that drew in consumers.” She’s taken a similar approach with her new Chia Granola Clusters and Vitality Bars, enveloping them in “bright packaging with strong, clear statements about the products’ attributes.”

Tip 3: Make Functionality Worth It

Strong, clear statements about a product’s attributes are as much a part of the “education” mission that Hilton associates with success as are those feel-good product backstories. And given the proliferation of products bidding for consumers’ trust with good-for-you claims, you can understand why.

“Right now,” Hilton says, “I think one of the challenges for the consumer is that they’re trying to figure out the value of functionality.” While they’ll buy the idea of enhanced protein, fiber, probiotics, and omega-3s, do they have the tools to calculate its actual monetary value? As Hilton asks, “Am I willing to pay an extra fifty cents for a yogurt because it’s got nutrients in it versus a salty snack that’s not going to do me any good?”

While that’s the consumer’s decision to make, “we as brands have to put out that knowledge and help create that value by telling them that they’re getting something special,” Hilton says. “We have to do our part in promoting value.”

And to the extent that “value” comes from delivering the nutrition your product promises, Hilton warns against providing what he calls “storefront functionality: a little hint of this or that, but nothing that’ll make a substantive difference” to wellness. Not only is the practice sneaky; consumers are growing increasingly savvy at asking the tough questions to suss it out, too.

Tip 4: Blind Them (Figuratively) with Science

The best shield against that kind of consumer skepticism is evidence-based formulation. “The separation of the wheat from the chaff,” Hilton says, “is going to come from products that are offering true functionality that’s valid and related to science.” That means telling consumers how much of an ingredient your product truly delivers and educating them about the studies demonstrating its efficacy. As Hilton says, “Science is key. It helps differentiate the real products from the imposters.”

It also attracts the attention of capital, while warding off that of regulators. As Grant Ferrier, founder and CEO, Nutrition Capital Network (NCN; San Diego), says, “Investors are skeptical of claims that may not hold up or that may cause FDA or FTC woes. And they certainly view a significant part of the value of a company as being locked up in its intellectual property, not just top-line sales or bottom-line EBITDA”—finance-speak for earnings before interest, taxes, depreciation, and amortization.

“There are still examples of marketing-based companies that show some success with relatively little scientific backing, or with borrowed science based on one ingredient or formula,” Ferrier concedes. “But the true pioneers”—and those companies with the highest potential for profit—“have either a proprietary application of a naturally occurring compound, or a formula that’s been properly tested in the lab, in animals, and, ultimately, in humans in a clinical-trial environment.”

Know Your Channel, Know Your Consumer

That’s a tall order, the precise height of which will vary with the claims a marketer wants to make and the benefits a product proposes to deliver. But the growing role that researchers, investors, and other “outsiders” now play underscores just how many forces are converging on the health-and-wellness sector.

As further proof that “convergence” is a sign of the times, Hilton refers to what he calls “channel convergence”: that blurring of the lines between retail, online, multilevel marketing—all the venues available for making health-and-wellness purchases. Hilton notes that medical practitioners are even getting into the channel game, dispensing supplements in their practices.

So, he continues, “the fact that consumers have control over where and how they buy supplements has turned the paradigm upside down by allowing them to circumvent the retailers entirely.” While this could stymie brands unfamiliar with outlets beyond retail, those with new-channel and new-media chops should find channel convergence an opportunity to get ahead.

That’s how Hoffman sees it. “Social media has been an important marketing strategy for us from the very beginning,” she says. “Engaging your core customers personally and directly engenders brand loyalty and creates a coalition of ‘ambassadors’ who willingly share their love for your brand with the world. And by truly listening to those audiences, you can gain valuable insights that can help drive product development and line extensions.”

And Millennials, for now at least, dominate those online audiences. That being the case, Hilton can’t emphasize enough: “They’re not looking for the same experience or engagement as Boomers.” The ways in which the two groups apprehend health and wellness “are more different than they are alike,” he notes, with the upshot being that “you’ve really got to look at these markets individually.”

Take Millennials’ general opinion that bigger isn’t always better, especially when it comes to the companies that make and market their favorite products. “We know that Millennials love niche brands,” he points out. “Many are actually big-brand averse and would just as soon buy from a small brand because they feel like they can own it and have a part in it.”

And for brands that aren’t trying to conquer the world, that sounds fine. “We don’t believe in being all things to all people,” Hoffman says. “The key to success lies in having a product whose attributes are desirable to a sizeable audience but that aren’t so generic that you’re unable to generate demand.”

And she should know. The changing marketplace converged with her willingness to take a risk at just the right time. “The health-and-wellness industry changes almost daily,” she says. “Smaller, entrepreneurial organizations tend to be more nimble, allowing companies to introduce products faster and self-correct as needed. And don’t underestimate the power of passion! It often requires tenacious perseverance tosucceed in a crowded marketplace.”


What Comes First: The Ingredient or the Market?

So you want to break into the health-and-wellness market? Well, no matter what, make sure you secure a blockbuster functional ingredient first, and then develop a string of products that direct it at a handful of wellness need states…Or, wait. Maybe you should do the market analysis first, find out which health concerns are top of mind, and then build a stable of ingredients that address them…

…Or does it even matter?

To find the straightest route to success, we asked a few industry insiders what they thought. Not surprisingly, their answers depended on where within the industry they stand.

“Most developers are successful because they’ve devoted scientific research and product-development time to an ingredient or family of ingredients and have honed a formula or process to isolate or stabilize a blend of bioactive compounds. ‘Ingredient-driven’ is the answer. By all means, a developer also has to have an endpoint in mind for a need state with significant market-share potential to validate the business prospects of all their technical work. But starting from market demand and fishing about for a technical solution rarely works for an entrepreneur, although it’s often precisely what the big companies and well-funded investors look to do—i.e., identify five or six major need states and search a portfolio of potential technical solutions to evaluate and possibly invest in, buy, or license.”

—Grant Ferrier, founder and CEO, Nutrition Capital Network (NCN; San Diego)

“Building our brand around an ingredient has been the key to our success. Chia seeds are one of the world’s healthiest foods, with attributes that apply to a variety of different audiences. With chia, we could appeal to athletes, fitness and outdoor enthusiasts, and wellness seekers, as well as to those concerned with energy, weight loss, and heart health. This gave us a broad platform from which to build our brand.”

—Janie Hoffman, CEO and founder, Mamma Chia (Carlsbad, CA)

“I definitely have a bias for outside-in development. Looking to the market is what I do; others may not feel that way. But I think success can come both ways. [Ideally, both approaches] kind of meet in the middle. But my personal bias is always that the marketplace should speak to the opportunity. It doesn’t matter what widget you have if there’s no demand for it.”

—Jeff Hilton, chief marketing officer and cofounder, BrandHive (Salt Lake City)  Link to original article.


By Dr. Tomislav Mestrovic, MD, Phd

March 30, 2015

Nutraceuticals are natural, bioactive chemical compounds that have health-promoting, disease-preventing or general medicinal properties. This category encompasses vitamins, minerals, herbal supplements, and certain animal products. In addition, nutraceuticals also include “functional foods” – i.e. foods that tout a specific health benefit based on their ingredients.

Regulation presents noteworthy challenge to the globalization of nutraceuticals, with murky and somewhat dissimilar definition of these products in different countries. For example, in Japan, functional foods are defined according to their use of natural ingredients. On the other hand, functional foods in the US can contain ingredients that are products of biotechnology.

In general, the goals of nutraceutical regulation have been focused on safety and labeling with a lesser emphasis (as compared to pharmaceuticals) on product claims and intended use. This is accomplished through Good Manufacturing Practice (GMP) regulations and a recent increase in enforcement.

Consumers are largely responsible for determining the usefulness and value offered by nutraceuticals. Still, increased regulation related to quality and safety of these products will benefit the industry on the whole and help mitigate the risk of regulatory backlash.

Regulatory rules in different countries

In the USA, the Food and Drug Administration (FDA) regulates nutraceuticals under a different set of regulations when compared with those covering “conventional” foods and drug products. According to the Dietary Supplement Health and Education Act from 1994 (DSHEA), it is the manufacturer's responsibility to ensure that a nutraceutical is safe before it is marketed.

FDA is authorized to take action against any unsafe product after it reaches the market. Manufacturers have to make sure that the information on the product label is truthful and not misleading, but they are not obliged to register their products with the FDA nor get FDA approval before producing or selling nutraceuticals.

In the European Union, food legislation is largely under the umbrella of European Food and Safety Authority (EFSA). This legislation focuses on “food supplements”, which are defined as concentrated sources of nutrients (e.g. proteins, minerals and vitamins) and other substances with a beneficial nutritional effect. The main EU legislation related to food supplements is Directive 2002/46/EC.

New products from Europe are presumed to have passed stringent European development and quality requirements. As a result, European nutraceutical companies, which are generally considered leaders in innovation, enjoy a perception of producing the highest quality products. In Canada and Australia, nutraceuticals are regulated more closely as a drug than food category.

As with other countries, Indian legislation does not actually ascribe any specific legal status to nutraceuticals. Regulations for nutraceuticals of the Government of India include the Food Safety and Standards Act (FSSA), which was passed in 2006, and is yet to be implemented.

Global market entry requirements

For the majority of countries, nutraceuticals are regulated as a category of food. In some regions or countries, there is an explicit set of regulations for supplements (e.g.United States, European Union, and Association of South East Asian Nations) and nutraceuticals (India), which stem from a food-based regulatory paradigm. Therefore some form of a registration or notification-based system is needed to bring new products to market.

In Latin America, the market entry requirements for nutraceuticals vary, with registration-based approaches employed in Colombia, Brazil, and Argentina, and notification-based approaches in Mexico and Chile. In countries such as Brazil, China and Taiwan, the regulators require animal and/or human clinical studies as a requirement of the product registration requirement.

Bringing nutraceutical products to market usually follows three basic approaches. The notification-based approach ideally balances pre-market resources, consumer access, and consumer safety. Nevertheless, a key aspect to guarantee product safety and quality in the marketplace (regardless of the pre-market requirements) is robust post-market surveillance.  Link to the original post.

What are nutraceuticals

By Dr. Tomislav Mestrovic, MD, Phd

March 30, 2015

Nutraceuticals is a broad umbrella term that is used to describe any product derived from food sources with extra health benefits in addition to the basic nutritional value found in foods. They can be considered non-specific biological therapies used to promote general well-being, control symptoms and prevent malignant processes.

The term “nutraceutical” combines two words – “nutrient” (a nourishing food component) and “pharmaceutical” (a medical drug). The name was coined in 1989 by Stephen DeFelice, founder and chairman of the Foundation for Innovation in Medicine, an American organization located in Cranford, New Jersey.

The philosophy behind nutraceuticals is to focus on prevention, according to the saying by a Greek physician Hippocrates (known as the father of medicine) who said “let food be your medicine”. Their role in human nutrition is one of the most important areas of investigation, with wide-raging implications for consumers, health-care providers, regulators, food producers and distributors.

Categories of nutraceuticals

The definition of nutraceuticals and related products generally depends on the source. They can be classified on the basis of their natural sources, pharmacological conditions, as well as chemical constitution of the products. Most often they are grouped in the following categories: dietary supplements, functional food, medicinal food, farmaceuticals.

A dietary supplement represents a product that contains nutrients derived from food products, and is often concentrated in liquid, capsule, powder or pill form. Although dietary supplements are regulated by the FDA as foods, their regulation differs from drugs and other foods.

According to their generally accepted definition, functional food is a category which includes whole foods and fortified, enriched or enhanced dietary components that may reduce the risk of chronic disease and provide a health-benefit beyond the traditional nutrients it contains.

Medical food is formulated to be consumed or administered internally, under the supervision of a qualified physician. Its intended use is a specific dietary management of a disease or condition for which distinctive nutritional requirements are established by the medical evaluation (on the basis of recognized scientific principle).

Farmaceuticals are medically valuable components produced from modified agricultural crops or animals. The term is a combining of the words “farm” and “pharmaceuticals”. Proponents of this concept are convinced that using crops (and possibly even animals) as pharmaceutical factories is much more cost effective than conventional methods, with higher revenue for agricultural producers.

Potential health benefits

Over the years nutraceuticals have attracted considerable interest due to their potential nutritional, safety and therapeutic effects. They could have a role in a plethora of biological processes, including antioxidant defenses, cell proliferation, gene expression, and safeguarding of mitochondrial integrity.

Therefore nutraceuticals may be used to improve health, prevent chronic diseases, postpone the aging process (and in turn increase life expectancy), or just support functions and integrity of the body. They are considered to be healthy sources for prevention of life threatening diseases such as diabetes, renal and gastrointestinal disorders, as well as different infections.

A wide range of nutraceuticals have been shown to impose crucial roles in immune status and susceptibility to certain disease states. They also exhibit diseases modifying indications related to oxidative stress including allergy, Alzheimer's disease, cardiovascular diseases, cancer, eye conditions, Parkinson's diseases and obesity.  Link to the original post.

who is the dietary supplement shopper today

By Kimberly J. Decker

March 13, 2015

Is there a singular supplement shopper out there? No, to an extent. As Michele Michielini, senior director of consumer insights, NBTY Inc. (Ronkonkoma, NY), points out, “There really isn’t a ‘typical’ supplement shopper. Shoppers vary based on many factors, including gender, age, income, and individual need states—such as those trying to support heart health or eye health.”

If drawing a fine bead on the target consumer seems a daunting task, that’s because it is. But with Big Data in hand, today’s supplement marketers do know more about who their customer is. Nutritional Outlook spoke to a few industry experts who shared their insights on just what’s trending in the supplement world—and with whom.

It’s My Generation?

The Council for Responsible Nutrition’s (CRN; Washington, DC) 2014 Consumer Survey on Dietary Supplements1 revealed a clearer demographic sorting of supplement-use patterns. Michielini says that though the survey found equally high multivitamin use among all age groups, for instance, “‘specialty’ supplements skewed more toward elders—age 65-plus—while sports nutrition and weight management skewed more toward Generations X and Y.”

Mature shoppers—those born before 1945—“are more oriented toward supplementation for specific issues,” agrees Steve French, managing partner, NMI (Natural Marketing Institute; Harleysville, PA), sharing insights from NMI’s Supplements/OTC/Rx Database, a survey of 2,300 general-population adults in the United States. Omega-3s appeal to these folks concerned about heart health, and glucosamine gains traction with those tending to aching joints. As for Baby Boomers, French says, “They index high for antioxidants and probiotics as well as joint health and cholesterol.”

Then there are the Millennials, whose impact on the industry could be as significant as it is on society at large. According to French, between 2009 and 2013, supplement use increased among all generations, but Millennials showed the largest growth. For Millennials, the share of those who used a supplement in the past 30 days rose from 50% in 2009 to 68% in 2013.

Millennials have upped their average intake more than other generations, too, going from 1.8 supplements per day in 2009 to 2.8 just four years later. And as for which supplements they’re turning to, French points to “a wide array of supplement categories, including single vitamins and minerals, herbals/botanicals, condition-specifics, homeopathics, and ayurvedics.” Versus the general public, Millennials index high for antioxidants and energy supplements and are also more likely to take supplements for detoxification purposes.

Today’s youth-driven infatuation with social media also influences supplement choices, with 18% of all supplement users and fully 45% of Millennial users giving social media some credit in swaying purchase decisions.

The Gender Gap Is Closing?

Gender gaps still persist among supplement shoppers, who still by and large are women. (Both NMI’s database and the CRN consumer survey confirm this fact.)  “Women are significantly more likely to be heavier users,” French says, because women tend to be more proactive in maintaining health overall.

But NBTY’s Michielini notes that in the three years between the latest CRN survey and the survey the year before, that gap shrank, as purchases by “women directionally declined from 74% to 71% and men increased from 62% to 65%.”

Socioeconomic Factors

While supplement usage patterns track more closely with education than income—32% have at least a college education, and median user income is $63,900, per NMI numbers—“the economy has impacted supplement purchases,” French concedes. As Michielini notes, supplements are often discretionary purchases, “so if a family needs to make a choice between a necessity—food, for example—or a supplement, the food, of course, takes priority.”

Seeking Food First

That may not be the only case in which food takes priority. “Consumers overwhelmingly prefer to get nutrients from the foods they eat rather than take a supplement in pill form,” French says. Indeed, the percentage in this camp rose recently to 60% from 54% in 2011.

But this preference hasn’t upended the supplement market, Michielini insists. The emergence of functional foods and beverages—not to mention novel supplement delivery options—may have actually broadened supplements’ audience. “Functional foods have certainly been successful in providing consumers with a variety of alternate means of ingesting certain nutrients,” she says. “Making these nutrients available in other forms allows for a more convenient way to consume them.”

NMI’s database bears this opinion out, with 38% of Millennials and 35% of “energy managers” driving the fortified-beverage and shot market, French says. And the increase in preference for alternative formats from 2009 to 2013 pans out thusly: soft gels up from 30% to 37%, chewables from 22% to 26%, and soft chews from 18% to 24%. Other alternative formats with more stable growth include liquid-filled capsules at 28%, gummies at 22%, liquid at 18%, fast-dissolve tablets at 18%, nutritional bars at 16%, and ready-to-drink beverages at 16%, he adds.

Wellness Overall

If there is one commonality broadscale supplement users share, it is that they take supplements for overall health and wellness. No wonder so many see even the good ol’-fashioned multivitamin as a “nutrient ‘insurance policy,’” as French says. “Self-responsibility for health is high as consumers look to take back control of their own health,” he says. Tellingly, NMI’s research says that 83% of the general public claims to be “taking more responsibility for their health” than the percentage that made that claim 10 years ago.

Even better, the past half-decade has seen more supplement users believing that they can manage their health issues through supplementation, “revealing a stronger integration of supplements into maintenance of a healthy lifestyle,” he continues. To strengthen that integration even further, keep the communications clear to “help consumers sort through any confusing media messages and help boost loyalty and compliance to a specific supplement,” he advises.

And remember that the more we plumb the data and the better we get at turning it into actionable knowledge, the more empowered we’ll be to meet all of our shoppers where it matters most.  Link to original article.

Jamaica launches national nutraceutical industry

By Jamaica Observer

March 8, 2015

Prime Minister Portia Simpson Miller says Jamaica is poised to gain a significant share of the fast-growing global nutraceutical industry, which is estimated at US$270 billion.

"I am a firm supporter of the nutraceutical industry in Jamaica. My firm belief in, and unshakable support for this industry, is anchored in the view that it has the potential to transform the fortunes of our economy and society," she said.

The prime minister was delivering the keynote address at the launch of the National Nutraceutical Industry, at the Hope Zoo in St Andrew, on March 5.

The global nutraceutical industry is considered one of the fastest growing sectors worldwide. It is projected that by 2018, the sector will be worth US$600 billion with the opening of the Asian markets.

Simpson Miller pointed out that with the recent thrust to develop the local nutraceutical sector, the possible economic benefits for Jamaica are tremendous.

"Thousands of new jobs can be created through mass cultivation and employment in labs and processing plants. There is the potential for increased revenue from greater earning power of new workers and there will be more foreign exchange through greater exports and the development of medical tourism," she noted.

Citing Jamaica's rich tradition in folk medicine and its abundance of plants with proven medicinal properties, Simpson Miller said there is no reason why the country cannot attract significant investments in this area.

Declaring that the country is "sitting on a gold mine", she informed that of the 160 plants declared as having medicinal properties worldwide, there are over 80 that are endemic to Jamaica.

Simpson Miller said with this in mind, her Administration will be moving in a serious way to develop the local nutraceutical industry, noting that this will form an integral part of a national strategic approach for ensuring economic growth, development and job creation.

She pointed out that the National Commission on Science and Technology has been charged with the mandate to regularise and develop a sustainable nutraceutical industry in Jamaica.

"Today's launch heralds the start of a system to encourage, regulate and monitor production locations, processes and products to ensure that they meet national and international standards," the prime minister said.

Simpson Miller emphasised that moving forward, Jamaica must attract and engage large investors to maximise the wealth potential of the industry, adding that the National Nutraceutical Industry, through a board, will facilitate, nurture, monitor, assist, and empower businesses, large and small, in realising the tremendous potential of the sector.

"We want to move from the production of samples to large-scale operations," she said.

In the meantime, the prime minister hailed the work of local scientists, such as Dr Henry Lowe, Dr Manley West and Dr Albert Lockhart, for their pioneering role in the nutraceutical business and their enormous contributions to Jamaica.

She also commended Professor Errol Morrison, the University of Technology, and the University of West Indies for invaluable scientific research.

Simpson Miller further called for more Jamaicans to invest and participate in the growing sector.

She said the Government is working to include all stakeholders, and informed that a memorandum of understanding will be signed with the Jamaica 4-H Clubs to involve some 8,500 youth in the sector.

"The partnership in its initial stage will focus on the establishment of greenhouses and gardens and strengthening 4-H programmes within some institutions," the prime minister explained.  Link to original article.

vitamin awareness outpaces consumer usage, according to one survey

January 22, 2015

By Michael Crane

Despite high awareness among consumers of the importance of omega-3s and vitamin D as part of a healthy lifestyle, a new survey suggests a majority of consumers polled are not actually getting enough of these key supplements in their diets.

The international survey, commissioned by the Global Nutrition and Health Alliance (GNHA; New York), found that 81% of Americans recognize the importance of omega-3s to their health, but only 45% regularly take an omega-3 supplement. When it comes to vitamin D, awareness of its health benefits is even higher at 89%, with 62% of Americans taking Vitamin D supplements.

Although this discrepancy between awareness and usage might seem alarming, Suzanne Steinbaum, MD, cardiologist at Lenox Hill Hospital (New York) and cofounder of GNHA, reads the survey results as “absolutely” a sign of progress.

“I think it’s a great sign,” says Steinbaum. “What we’re starting to see is that people are starting to show awareness.” Although this is the first time this survey has been conducted, Steinbaum believes vitamin awareness has grown significantly in the last decade. Actual usage still lags behind, but Steinbaum sees a growth in awareness as a “first step” toward more consumers adding omega-3 and vitamin D supplements to their diets.

The survey was conducted by online questionnaire in December 2014, with just over 1000 consumers each from the United States, Germany, and the United Kingdom participating. In terms of both awareness and usage, American consumers outpaced their overseas counterparts. That difference was especially clear in omega-3 usage, with 45% of Americans supplementing their diet with the nutrient, compared to 29% of Britons and 24% of Germans taking omega-3 supplements.

“I think in America we have a little bit of an advantage,” says Steinbaum. She attributes the higher vitamin awareness in the U.S. to a widespread acceptance of supplementation that is lacking in many other countries.

To keep both awareness and vitamin usage on the rise, Steinbaum advises everyone from practitioners to manufacturers to educators to spread the message that vitamin D and omega-3s are a crucial part of a healthy diet. As awareness continues to rise, Steinbaum hopes to see usage following closely behind.  Link to original article.

vitamins high priority for americans in 2015, survey says

January 16, 2015

By Michael Crane

Among the many New Year’s resolutions for 2015, taking vitamins ranks as the fifth most popular healthy habit that Americans are committed to, according to a new survey conducted by Harris Poll on behalf of the Council for Responsible Nutrition (CRN; Washington, DC). The survey asked more than 2000 U.S. adults to select the health and wellness habits they are committing to in 2015, with “taking vitamins” listed as a priority by 47% of people.

Although CRN conducts its extensive Consumer Survey on Dietary Supplements every August, this is the first time CRN has commissioned a smaller, snapshot survey through Harris Poll. From December 8-10, 2014, 2021 adults aged 18 and older responded to the online panel on healthy habits in 2015.

“We decided to do a series of these quick polls because we thought that it would be interesting to do some that are timed to specific times of the year or timed to specific events,” says Judy Blatman, senior vice president, communications. “We’re planning to do a few more of them this coming year.”

Ranked even more popular than “taking vitamins” in the poll were “drinking enough water” (72%), “eating healthy/healthier in general” (66%), “getting more physically active” (62%), and “getting more sleep” (49%). However, with a 47% vote, vitamins came before priorities such as having a healthy breakfast every day, spending more in-person time with family and friends, and staying calm in traffic.

“I wouldn’t say [the results] were surprising because we know that so many people take vitamins in this country; they’re such a mainstream category. But certainly, they were encouraging results,” says Blatman.

Taking into account age, sex, race/ethnicity, education, region, and household income of survey participants, Harris Poll weighted the date where necessary to match it with demographics of the general population. No estimates of theoretical sampling error could be calculated because the sample was based on voluntary participation in an online panel.

Blatman says one of the most striking observations from this poll, as well as from CRN’s larger annual survey, is how people taking dietary supplements are also more likely to engage in other healthy habits.

“It’s really the constellation of healthy habits that people are engaging in,” says Blatman. “They’re not just looking at one thing; they’re recognizing that there are a lot of different things that they need to do, and we feel very good about the fact that they recognize that taking vitamins or other supplements is one of those important things when it comes toward your health.”  Link to original article.

celebrating dshea with caution

November 5, 2014

By Jennifer Grebow

October 25th marked the 20th year since President Clinton signed the Dietary Supplement Health and Education Act (DSHEA) into law. DSHEA defined the category of dietary supplements in the United States and, by so doing, gave consumers free market access to the health benefits that supplements provide. But even as today’s industry stakeholders pay tribute to the two decades of DSHEA’s governance, those celebrations are shadowed by strong suspicions that some—namely, the FTC, through recent regulatory actions—are treading on the law as written.

According to industry leaders, the latest indication of FTC overstepping was when the FTC filed a legal motion for order of contempt against Bayer Corp. this fall, calling the company’s Phillips’ Colon Health probiotic structure/function claims unsupported. Bayer says the product “defend[s] against occasional constipation, diarrhea, gas, and bloating. When taken on a daily basis, it can help replenish the good bacteria in your colon and support digestive health and immune health.”

According to the FTC and its own gastroenterology expert, Bayer would need randomized, placebo-controlled human clinical trials (RCTs) to substantiate such claims. But industry leaders argue that RCTs are required for drug treatment claims, not supplement structure/function claims, and that both law (DSHEA) and formal FDA and FTC guidance specifically state that dietary supplements are not to be regulated as drugs.

While structure/function claims must be supported by “competent and reliable scientific evidence,” RCTs are not required. There are a number of reasons for this, relating to the fact that supplement studies—studies proving that a product shores up general good health over time rather than curing an acute disease—are more complicated than the typical single-API drug study. Supplement studies are also complicated by such factors as subjects’ overall nutrient intake and the fact that performing studies in healthy populations requires a very long (and expensive) trial. As such, supplement firms are allowed to refer to a number of study types to support structure/function claims, including, explains the Council for Responsible Nutrition (CRN; Washington, DC), randomized clinical studies on a specific population whose results are extrapolated to the general population, epidemiological evidence, in vitro studies, animal studies, and observational studies. FTC guidance even makes clear that there is “no fixed formula for the number or type of studies required,” CRN points out, and FDA does not require that studies must be done on the finished product being sold.

Industry leaders say the Bayer case is just the latest example of FTC overstepping DSHEA’s authority, as it has in consent orders past. And the slope towards unofficially rewriting supplement regulations, they say, is slippery. As the Natural Products Association (NPA; Washington, DC) said, if the Bayer case is allowed to stand, “the distinction between dietary supplements and drugs will effectively evaporate.”

This is why CRN and NPA are now objecting legally in the Bayer case. In October, both associations filed amicus briefs (“friend of the court” insights that challenge the FTC’s legal actions in the Bayer case) “to try to inform the judge as to what we believe the correct standard is, because we believe the FTC is using the wrong standard in this case,” says Steve Mister, CRN’s president and CEO. Because, he points out, Bayer is not making drug claims that would require RCTs. “In this case, you’re not talking about treating an acute symptom. The product is not suggesting that when you have gas, you go out and buy the product and it cures the gas in 30 minutes. That’s not what the product says. In this case, what we see is a straight structure/function claim: defends against occasional gas, bloating, constipation, and diarrhea. Those are recognized for years in both the FTC guidance and the FDA guidance on structure/function.”

At this stage in the legal game for Bayer, there is still a chance that the court could take these associations’ objections into consideration. “We’re waiting to hear now whether the FTC would oppose that,” Mister says. If it does, “then we’d have to go have a hearing with the judge to argue why we have the right to intervene in this case and become an amicus in the case.”

If the dietary supplements industry aims to celebrate another 20 years of DSHEA, then it needs to defend the law. “I think everything about this case is a wake-up call to the industry that we need to pursue this,” says Mister. Link to original article.