identity crisis over: dietary supplements can be "dietary supplements"

March 9, 2016

By Katie Bond of Kelley Drye & Warren LLP

In its dietary supplement labeling guide, first issued in April 2005, FDA advised that it wouldnot consider the term, “dietary supplement,” alone, to be an appropriately descriptive “statement of identity.” FDA, however, has now reversed course. Revised guidance released last week now provides as follows:

Can the term “dietary supplement” by itself be considered the statement of identity?

Yes. This term describes the basic nature of a dietary supplement and therefore is an “appropriately descriptive term” that can be used as the product’s statement of identity. The statement of identity for a dietary supplement may therefore consist simply of the term “dietary supplement.”

The revised guidance also adds the following: “Dietary supplement” may be included as “part of a longer statement of identity (e.g., ‘cod liver oil liquid dietary supplement’).” Click here to view the original article.

dietary supplement legal update

April 15, 2016

By Porzio Bromberg & Newman PC

Since passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement industry has grown to more than $35 billion in annual sales. This robust growth of the industry reflects not only increased interest in these products among consumers, but also significant advancements in nutrition and wellness science and new legal and regulatory challenges to appropriately monitor this marketplace. There have been several recent developments on the legal and regulatory issues challenging the dietary supplement industry, both on the federal and state level.

Editors Richard J. Oparil and Kevin M. Bell

Voluntary GMO Labeling Bill Fails In Senate; Vermont GMO Law Challenge Pending

The Senate failed to pass legislation that would have created national, voluntary standards for labeling GMOs and precluded bar states from requiring GMO labels. The bill, S. 2609, failed on a 48 to 49 procedural vote. The House passed a bill last year, H.R. 1599, that would block state GMO-labeling requirements and set up a federal GMO-free certification program. Vermont's GMO law, scheduled to take effect on July 1, requires farmers and food manufacturers who sell their products in Vermont to label foods that have ingredients enhanced by genetic engineering (GE). Act 120 requires certain products with GE ingredients to include a label warning consumers that the products are or may be "produced with genetic engineering." Manufacturers are also precluded from using "natural" or similar words to describe these products. The Grocery Manufacturers Association and three other groups sued Vermont in federal court to strike down Act 120. In April 2015, the U.S. District Court granted in part and denied in part Vermont's motion to dismiss and denied the plaintiffs' motion for preliminary In This Issue Voluntary GMO Labeling Bill Fails In Senate; Vermont GMO Law Challenge Pending Senator McCaskill Requests DOJ Records Of Enforcement Actions After Attorney General Lynch Warns On Supplements Senator Heinrich Asks FDA To Increase Enforcement FTC Reaches Settlement With Four Companies Falsely Promoting Their Personal Care Products as "All Natural" or "100% Natural." Fifth is Charged in Commission Complaint California Supreme Court Holds "Organic" Unfair Competition Claim Is Not Preempted By Federal Law. FDA Sued Over Legality Of Action On GE Salmon FDA Issues Revised Guidance Concerning Dietary Supplements Labeling Comments Requested on Label Statements FDA Sends Warning Letters On Acacia Rigidula Groups Seek FDA's Revocation Of Perchlorate As A Food Additive Pom Wonderful Loses False Advertising Case Against CocaCola Chobani Yogurt Labelling Case On Appeal To Ninth Circuit New Jersey Supplement Company Owner Pleads Guilty Pure Green Coffee Companies Enter Into Consent Order 5-Hour Energy Wins Trademark Infringement Case California Proposes Changes to Prop. 65 Regulations injunction. The association appealed the decision to the U.S. Court of Appeals for the Second Circuit. It argued that the Act 120 is unconstitutional under the First Amendment and that it was error to deny the preliminary injunction to stop the law from taking effect. The Second Circuit held oral argument in the case on October 8. A decision is expected before July.

Senator McCaskill Requests DOJ Records Of Enforcement Actions After Attorney General Lynch Warns On Supplements

On March 29, 2016 Senator Claire McCaskill, ranking minority member of the Committee on Aging, sent a letter to U.S. Attorney General Loretta Lynch requesting a comprehensive list of enforcement actions taken by the Department of Justice (DOJ) related to the dietary supplement industry. The letter, a copy of which is available here, seeks disclosure of cases referred to DOJ by the FDA, FTC or other agencies, including the reason for the referral, the names of the parties, the dates of referral, the status of the referrals and the dates any were resolved. Senator McCaskill has asked DOJ to respond by April 12, 2016. In recent months, DOJ has become more active in dietary supplement cases. Last Fall, DOJ brought more than 100 civil and criminal cases targeting marketers and manufacturers of dietary supplements, including USPlabs and its executives. In a March 8th video, Attorney General Lynch issued a warning about the use of dietary supplements. She said that "every day millions of Americans are ingesting substances whose safety and efficacy are not guaranteed. Some of these supplements are simply a waste of money, promising results they can't deliver or advertising ingredients that they don't contain, and too often these supplements don't just abuse consumer trust, they also endanger public health." She went on to say that some products contain harmful ingredients and others falsely claim to cure illness. Attorney General Lynch advised supplement users to visit the FDA, FTC, Department of Defense and U.S. Anti-Doping Agency websites to help make informed choices. She also recommended that consumers consult with their doctor before using a dietary supplement. The video is available here. Editors Kevin M. Bell 202.517.6325 kmbell@pbnlaw.com Richard J. Oparil 202.517.6323 rjoparil@pbnlaw.com

Senator Heinrich Asks FDA To Increase Enforcement

Senator Martin Heinrich sent a letter to the new FDA Commissioner, Dr. Robert Califf, requesting increased enforcement in the dietary supplement market and the removal of bad actors causing trouble for the reputable supplement industry. The Senator wrote: "I respectfully ask that you take steps to raise the visibility and enforcement of dietary supplement safety and compliance measures available to the FDA." He went on to ask the FDA to use "existing legal authorities to prevent criminals from marketing and manufacturing products that masquerade as dietary supplements. By selling adulterated products under the guise of dietary supplements, these bad actors erode consumer trust in legitimate products and tarnish the credibility of reputable industry members. Consumers deserve to have confidence that their dietary supplements contain legal ingredients properly disclosed on the label."

FTC Reaches Settlement With Four Companies Falsely Promoting Their Personal Care Products as "All Natural" or "100% Natural." Fifth is Charged in Commission Complaint.

Four companies that market skin care products, shampoos, and sunscreens online have agreed to settle claims by the Federal Trade Commission (FTC) that they falsely claimed that their products are "all natural" or "100% natural," despite the fact that they contain synthetic ingredients, including Dimethicone and Phenoxyethanol. The FTC also brought an administrative claim against a fifth personal care company. Under the proposed settlements, the four companies are barred from making similar misrepresentations in the future and must have competent and reliable evidence to substantiate any ingredient-related, environmental, or health claims. In announcing the settlement, Jessica Rich, Director of the FTC's Bureau of Consumer Protection said: "'All natural' or '100 percent natural' means just that -- no artificial ingredients or chemicals." "Companies should take a lesson from these cases." More information about the FTC's announcement is available at here.

California Supreme Court Holds "Organic" Unfair Competition Claim Is Not Preempted By Federal Law

In December 2015, the California Supreme Court ruled that federal law did not preempt a state law unfair competition claim brought against a company that was mislabeling conventionally grown herbs as organic. In Quesada v. Herb Thyme Farms, Inc., the defendant operated multiple herb farms in California. While one of the farms used organic methods and was certified as such, the company also operated conventional farms. During processing, distributing and marketing, the products were mixed together but nevertheless sold with a "fresh organic" label. The class action plaintiff sued for unfair competition and false advertising. The defendant argued that the case was preempted under the federal Organic Foods Production Act of 1990. Both the trial and intermediate appellate courts agreed, but the California Supreme Court reversed. The Court found that the complaint alleged defendant engaged in fraud by intentionally labeling conventionally grown herbs as organic. The purpose of the Organic Foods Acts was to create a standard for what production methods qualify as organic to prevent fraud. The Court held that nothing in the Act indicates that Congress intended that the enforcement mechanisms it provided would be exclusive. Thus, the state law claim was not preempted.

FDA Sued Over Legality Of Action On GE Salmon

On November 19, 2015, FDA gave its first approval for a genetically engineered animal intended for food, AquAdvantage Salmon, an Atlantic salmon that reaches market size more quickly than non-GE farm-raised salmon. The FDA regulates GE animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act, because the recombinant DNA (rDNA) construct introduced into the animal meets the definition of a drug. The rDNA introduces a trait that makes the AquAdvantage Salmon grow faster. FDA found the GE salmon met the regulatory requirements for approval, including that the fish is safe to eat. FDA also determined that the AquAdvantage Salmon is as nutritious as food from other non-GE Atlantic salmon and that there are no biologically relevant differences between AquAdvantage Salmon and other farm-raised Atlantic salmon. The FDA imposed strict conditions to contain the fish and prevent their escape and establishment in the environment. The AquAdvantage Salmon may be raised only in land-based, contained hatchery tanks in two specific facilities in Canada and Panama. There must be physical barriers in the tanks and in the plumbing that carries water out of the facilities to prevent the escape of eggs and fish. The AquAdvantage Salmon are reproductively sterile so that even in the highly unlikely event of an escape, they would be unable to interbreed or establish populations in the wild. The approval does not allow AquAdvantage Salmon to be bred or raised in the United States. On March 30, 2016, 11 groups sued FDA in U.S. District Court for the Northern District of California, alleging that the AquAdvantage decision is illegal because FDA has no jurisdiction to regulate GE animals under the new animal drug provisions of the Food, Drug and Cosmetic Act, failed to fully considering or disclose the alleged environmental and other risks of this decision, and did not follow proper administrative procedures. The case - titled Institute For Fisheries Resources v. Burwell, et al., No. 3:16-cv-1574 - asks the Court to vacate the decision, require FDA to withdraw its assertion of jurisdiction over GE animals, and enjoin FDA from taking further action on the GE salmon application or any other application for commercialization of a genetically engineered food animal until Congress provides explicit statutory authority governing regulation of such products.

FDA Issues Revised Guidance Concerning Dietary Supplements Labeling

On March 7, 2016, the FDA announced revised guidance for industry titled "A Dietary Supplement Labeling Guide: Chapter II. Identity Statement." The revised guidance clarifies that the term "dietary supplement" may be used as the entire statement of identity for a product without other identifying or descriptive terms. In a 2005 guidance - titled "A Dietary Supplement Guide" - the FDA indicated the term "dietary supplement," by itself, could not be considered a statement of identity. The negative response was contrary to the Food, Drug, and Cosmetic Act §§ 201(ff)(2)(C) and 403(s)(2)(B), as well as 21 C.F.R. § 101.3(g), which explicitly requires dietary supplements to be identified by the term "dietary supplement" as a part of the statement of identity, with only some flexibility. A dietary supplement that fails to comply with the requirements of section 403 of the Act may be considered misbranded. Under section 301(a), violations are subject to penalties, including monetary fines and imprisonment. Thus, the revised and clarified guidance is important.

Comments Requested on Label Statements

FDA has invited comments on the information collection provisions of the regulation requiring the manufacturer, packer, or distributor of a dietary supplement to notify the FDA that it is marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in the Federal Food, Drug, and Cosmetic Act. The notice also invites comment on a new electronic form that allows manufacturers, packers, and distributors of dietary supplements to notify the FDA via FDA's Unified Registration and Listing System (FURLS). Comments are due by May 10, 2016. See comments.

FDA Sends Warning Letters On Acacia Rigidula

FDA sent warning letters to five marketers of dietary supplements containing the botanical Acacia rigidula (A. rigidula), advising them this is a new dietary ingredient (NDI) for which there is insufficient data showing the ingredient is "reasonably expected to be safe." FDA said it considers these supplements adulterated and told the recipients to immediately cease distribution of the supplements. FDA has said A. rigidula was not marketed in the United States before October 1994, is not an approved food additive and is not generally recognized as safe for foods. FDA also wrote that "the new dietary ingredient notification requirement applies to all dietary supplements that contain new dietary ingredients that have not been present in the food supply as articles used for food in a form in which the food has not been chemically altered." However, it further said an NDI notification for A. rigidula likely would not be approved: "we know of no evidence that would establish that your product is not adulterated."

Organizations Seek FDA's Revocation Of Perchlorate As A Food Additive

A group of organizations, including the Natural Resources Defense Council, has asked the U.S. Court of Appeals Ninth Circuit to order FDA to decide their administrative petition to revoke FDA's approval of perchlorate as a food additive. Perchlorate, used in food packaging, is alleged to be an endocrine-disrupting chemical that interferes with the thyroid gland. The groups petitioned the FDA in 2014 requesting that FDA rescind its approval of perchlorate as a food additive. Under the law, FDA had 180 days to issue an order granting or denying the petition. FDA did not meet the June 29, 2015 deadline and, on March 31, 2016, the groups filed a petition for mandamus with the U.S. Court of Appeals for the Ninth Circuit for an order compelling the FDA to act.

Pom Wonderful Loses False Advertising Case Against Coca-Cola

Pom Wonderful lost a case it brought against Coca-Cola in 2008 under the Lanham Act, a federal trademark statute under which competitors can sue each other for false advertising. Pom accused Coca-Cola of deceiving consumers into believing that a Minute Maid beverage contained mostly blueberry and pomegranate juices; in fact, it contained very little of each. The U.S. Supreme Court had previously ruled that the Federal Food, Drug and Cosmetic Act and the Lanham Act complement each other in the federal regulation of misleading food and beverage labels. "Competitors, in their own interest, may bring Lanham Act claims like Pom's that challenge food and beverage labels that are regulated by the FDCA." On remand to the lower court for trial, Pom sought damages of $78 million from Coca-Cola. However, the jury ruled that Pom had not proved Coca-Cola's labeling was misleading. The product, "Enhanced Pomegranate Blueberry Flavored 100% Juice Blend", contained just 0.5 percent of the named juices. Coca-Cola argued that the label stated merely that the product was "flavored" with pomegranate and blueberry juices.

Chobani Yogurt Labeling Case On Appeal To Ninth Circuit

In May 2012, a suit was filed on behalf of a putative class of people who had purchased Chobani Greek yogurt, alleging that the products were labeled "all natural" but in fact contained artificial ingredients, flavorings, coloring and chemical preservatives. Further, the labels referred to evaporated cane juice and did not disclose that this is another term for sugar. The District Court dismissed the case, finding that the complaint did not sufficiently allege the plaintiffs were deceived by the term evaporated cane juice. On appeal to the Ninth Circuit, plaintiffs' argued that they had been seeking out yogurt without added sugar. They were misled into buying the Chobani products because the labels did not refer to "sugar" or "syrup." Chobani countered that the labels were accurate under federal regulations because they disclosed the presence of "evaporated cane juice" and the use of "sugar" would be incorrect. The appeal was argued in March 2015 and a decision is pending.

New Jersey Supplement Company Owner Pleads Guilty

The owner of New Jersey dietary supplement companies pleaded guilty in connection with the sale of methamphetamine precursor chemicals, a separate scheme to defraud purchasers of dietary supplements and money laundering. The defendant, David Romeo, admitted that he was a principal of Global Nutrients, Stella Labs and Nutraceuticals. Starting at least as early as 2003, Romeo directed his employees to use cheaper substitutes in place of the dietary ingredients that had actually been ordered by customers, most of whom were other companies engaged in production of dietary supplements. Romeo admitted that, as part of the scheme, his businesses sold a weight-loss ingredient called "hoodia." Stella Labs and Nutraceuticals represented to consumers that they were selling hoodia that had been sourced from a rare South African plant, Hoodia gordonii. However, the substance being sold was actually manufactured at a facility in China. As part of his plea agreement, Romeo agreed to forfeit more than $1.2 million. Sentencing is scheduled for May 18, 2016.

Pure Green Coffee Companies Enter Into Consent Order

On March 28, 2016, a Middle District of Florida federal judge approved a consent order in FTC v. NPB Advertising, Inc., et al., enjoining Pure Green Coffee manufacturers and promoters from making unsubstantiated weight loss claims. The defendants are enjoined from making any representations that a dietary supplement, food or drug causes weight loss unless the representation is not misleading and is supported by competent and reliable scientific evidence. They had promoted the product saying it could help consumers lose as much as 17 pounds in 12 weeks. They are also barred from misrepresenting a website or publication is an objective news report. They had created deceptive online sites to promote Pure Green Coffee featuring mastheads of actual or apparent news organizations and advertised the product with an unreliable clinical trial.

5-Hour Energy Wins Trademark Infringement Case

A New York district court awarded the manufacturer of 5-Hour Energy drink a judgment of $20 million plus attorneys' fees against companies that allegedly made and sold millions of counterfeit bottles of the energy supplement. In granting summary judgment, the court found that the defendants willfully infringed the 5-Hour Energy trademark. The court also found that the defendants showed a reckless disregard for public health and tried to cover up the counterfeiting. California Proposes Changes to Prop. 65 Regulations California's Office of Environmental Health Hazard Assessment (OEHHA), which administers Prop. 65, has provided notice of changes to the regulation. Public comments are due by April 18, 2016. A copy of the proposed changes is available here.

natureal dietary supplement recalled for unapproved drugs

November 11, 2015

By Linda Larsen

Inaffit, LLC is voluntarily recalling all lots of Natureal light green and dark green capsules after FDA testing discovered it contains sibutramine. That is an appetite suppressant that was withdrawn from the U.S. in October 2010. The drug substantially increases blood pressure and/or heart rate in some patients and may present a significant risk for patients who have a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. That makes this supplement an unapproved new drug. It may interact with other medications a consumer is taking in life-threatening ways.

The recalled product is used as a weight loss dietary supplement. It is packaged in clear bottles with light green and dark green capsules. The codes on the product are Manufactured 3/12/2015 Expiration Date 3/11/2017. They were distributed from the Natureal office in Palmetto Bay, Florida and nationwide to consumers over the internet.

If you purchased this product, do not consume it. Throw it away or return it to the place of purchase for a refund. Infant has switched to a FDA Registered Facility to make their supplements and changed the Natural packaging to a clear bottle with clear capsules.

If you took this product and have experienced adverse reactions, report it to the FDA. The MedWatch Adverse Event Reporting program is at FDA.gov. Link to original article.

death by dietary supplement

November 4, 2015

By Henry I. Miller and Gilbert Ross

Former NBA star and TV reality show participant Lamar Odom was found unresponsive at a Nevada brothel last month. Although he has emerged from the coma, he was very close to becoming yet another statistic in the body count racked up by “herbal supplements.” According to a 911 call that was made when he first became ill, Odom reportedly took up to 10 tablets of “herbal Viagra,” along with other substances.

A recent study published in the New England Journal of Medicine, “ER Visits for Adverse Events Related to Dietary Supplements,” continues the decades-long drumbeat of alarms about the risks of “dietary-nutritional supplements.” The researchers from the CDC and the FDA analyzed representative surveillance data from 63 hospital Emergency Rooms over a 10-year period (2004-2013), and their statistical analysis projected about 23,000 ER visits annually resulting from ingestion of supplements, about one-tenth of which led to hospitalization.

According to the authors, “Such visits commonly involve cardiovascular manifestations from weight-loss or energy products among young adults and swallowing problems, often associated with micronutrients, among older adults.” But because of irresponsible, two-decade-old legislation, the answer to the critical question, “How many Americans are killed each year due to ingestion of so-called dietary-nutritional supplements?” cannot be answered.

The culprit is the Dietary Supplements Health and Education Act of 1994 (DSHEA). Congress virtually exempted supplements from oversight under DSHEA, which bars federal authorities from requiring evidence that herbal remedies are safe or effective, or even that the dosage information on the label is correct. Since 1994, these products have not been subject to the same regulatory requirements as prescription drugs—or in fact to any meaningful regulation at all.

Although the law prohibits supplements from being marketed for the treatment or prevention of disease, this restriction is widely ignored, as any viewer of TV ads can attest. The marketers of these products evade the mandate simply by playing word games: Instead of claiming that a product treats, controls or cures a condition (which would subject it to onerous regulation as a “drug”), they simply substitute the term “supports,” as in “supports the immune system or supports heart (or brain or prostate) health.” If they add a pro forma disclaimer — “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease”–it seems they can get away with anything. Including murder.

The estimated number of supplement products increased from 4,000 in 1994 to more than 55,000 in 2012 (the most recent year for which data are publicly available). Approximately half of all adults in the United States report having used at least one dietary supplement in the past month. In 2007, out-of-pocket expenditures for herbal or complementary nutritional products reached $14.8 billion, one third of the out-of-pocket expenditures for prescription drugs. And sales are certainly much higher today.

Many herbal supplements are complex, highly variable and impure. Similar to the 19th century snake-oil preparations that were dangerous but had little if any effectiveness, many are toxic, carcinogenic or otherwise unsafe. (And many that do have some “efficacy” do so only because they are laced with “real” drugs, of unknown dose or purity.) Link to original article.

FDA Stays final guidance on indS for foods and dietary supplement studies

November 3, 2015

By Devon Winkles

On October 30, 2015, the U.S. Food and Drug Administration announced that it was staying portions of its controversial Final Guidance relating to the types of studies that require compliance with Investigational New Drug procedures. The stay serves to encourage scientific research into the relationship between diet and health while FDA considers numerous comments questioning the novel application of IND rules to foods, dietary supplements, and cosmetics. The stay is effective immediately.

Specifically, the FDA has stayed parts of the subsection on conventional foods (VI.D.2), and all of the subsection on studies intended to support health claims (VI.D.3), with one exception: the stay of the health claim subsection does not apply to clinical studies that include:

children under one year of age;
people with altered immune systems; or
people with serious or life-threatening medical conditions.

As a result of the stay, researchers and sponsors of studies to determine whether a conventional food or dietary supplement may reduce the risk of a disease and that are intended to support a new or expanded health claim do not need to obtain an IND, unless the study population includes members of these sensitive groups. In addition, researchers and sponsors of studies of non-nutritional effects of conventional foods on the structure or function of the body do not need to obtain an IND while the stay is in effect. Importantly, however, the stay does not affect investigations of conventional foods or dietary supplements studied for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Foods and dietary supplements used for those purposes are considered drugs under FDA rules.

Historically, FDA had required Investigational New Drug Applications to be filed prior to clinical research on unapproved “new drugs” primarily to enable pharmaceutical companies to develop the scientific evidence necessary to support FDA approval and commercialization of new drug products. But in September 2013, the Final Guidance broadly expanded the scope of studies subject to the IND requirements, targeting clinical research involving articles of food, dietary supplements, and cosmetics to IND requirements, even though those products are not “drugs” under the Food, Drug, and Cosmetic Act when they are not intended to diagnose, cure, mitigate, treat, or prevent a disease. In response to multiple comments asking for a further opportunity to comment on subsections VI.C (relating to cosmetics) and VI.D (relating to foods), FDA reopened the comment period as to those subsections.

During the comment period, FDA received comments from trade organizations, individual companies, scientific associations, public interest organizations, and individuals discussing the effect of FDA’s expansion of the IND process. Many of these commenters expressed concern over FDA’s statutory ability to expand the IND rules to foods, dietary supplements, and cosmetics, and also over the practical implications of imposing IND requirements on such a broad range of studies. Commenters suggested that the new policy would discourage important health research and shift clinical research outside of the United States. Moreover, the comments questioned whether the new restrictions were justified, considering that the products are subject to existing safety standards, have often been proven safe through years – if not centuries or millenia – of safe consumption, and generally pose less risk than unapproved new drugs.

FDA has said that, during the period of stay, it is taking time to further consider these comments. We will continue to monitor developments on this issue. 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 states

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.

structure function claims win in bayer vs the ftc case

October 27, 2015

By Jennifer Grebow

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.

Background

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.

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

October 27, 2015

By Jennifer Grebow

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.

an overview of the european food supplements legislation as part of a realistic integrated approach to food safety.

October 23, 2015

By Giovanni Moschetta

EXPO MILANO 2015gives a‘global portrait’ of Food in the World: Food as ‘nutritional tales’ and also as a ‘pleasure’. But the main objective of EXPO is to foster research and development and innovation in how to think about, and regulate, food in all its aspects today and for the future.

European citizens need to have access to safe and wholesome food of the highest standard. A series of food incidents in late 1990s draw attention to the need to establish general principles and requirements, specific and technical rules concerning food and feed law at Union level. Accordingly, the European Commission (‘Commission’) developed an integrated approach of food safety ‘from farm to table’, primarily set out in its White Paper on Food Safety.39 It covers all sectors of the food chain, including feed production, primary production, food processing, storage, transport and retail sale. But the approach of the Commission needs to have a complementary link with the supplement legislation, as we suggest with the ‘overview’, that we consider as an important part of the European food safety policy.

The EU General Food Regulation40 from 2002 is considered as the foundation of food and feed law. Its set up an overarching and coherent framework

for the development of food and feed legislation and to this end it lays down general principles, requirements and procedures that underpin decision making in matters of food and feed safety, covering all stages of food and feed production and distribution. It also has set up an independent Agency responsible for scientific advice and support, the European Food Safety Agency (EFSA). Moreover, it creates the main procedures and tools for the management of emergencies and crises as well as the Rapid Alert System for Food and Feed (RASFF).

Food supplements are an important part of the make up of many foods eaten by Europeans. So the Commission, at the end of the Nineties, proposed to the EU legislator, the Council, to adopt a Directive on the approximation of the laws of the Member States in relation to food supplements.

Vitamins and minerals may be added to foods voluntarily by food manufacturers, or must be added as nutritional substances as provided for by specific Community law. They may also be added for technological purposes as additives, colourings, flavourings, preservatives or other uses including authorised oenological practices and processes provided for by relevant EU law.

The objective of the harmonised rules of Directive 2002/46/EC 41 on food supplements is to protect consumers against potential health risks from those products. With respect to the safety of food supplements, Annex I of the Directive lays down a harmonised list of vitamins and minerals that may added for nutritional purposes as food supplements. Annex II contains a list of permitted sources (vitamin and mineral substances) from which those vitamins and minerals may be manufactured.42

Directive 2006/37/EC43 has amended Annex II to Directive 2002/46/EC. The changes have been made after the full consultation of the European Food Safety Authority44 (EFSA) to evaluate the food safety aspects. Thus the amendments follow on from thorough scientific evaluations. In addition the risks identified by EFSA have been subjected to the risk management process in the Commission and the Member States via the Standing Committee on Food Chain and Animal Health. The evaluation of health and safety is and on-going process based on the European system for the management of food health and safety which includes thorough science and rigorous risk management. For this reason and considering the ‘nature’ of exclusive competence of the EU in relation to food safety, the Commission has continued to legislate with ‘ad hoc’ Regulations.

Commission Regulation (EC) No 1925/200645 on the addition of vitamins and minerals and of certain other substances to foods represents a ‘milestone’ of the EU legislation for this kind of supplements.

The Commission stated that: ‘Since the objective of this Regulation, namely to ensure the effective functioning of the internal market as regards the addition of vitamins and minerals and certain other substances to foods whilst providing a high level of consumers protection, cannot be sufficiently achieved by the Member States, and can therefore be better achieved at [EU] level, the [EU] may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty’.

The Regulation is based on the assumption that there is a wide range of nutrients and other ingredients that my be used in food manufacturing, including trace elements, amino acids, essential fatty acid, fibre, various plants and herbal extracts.

Beside food safety another important consideration for EU food law is the free movement of goods. The addition of additives to specific food (as opposed to the authorisation of the use of particular additives) is regulated in Member States on the basis of differing national rules that can impede the free movement of these products, and can create unequal conditions of competition and thus have a direct impact on the functioning of the internal market. For this to be avoided Community rules harmonising national provisions relating to the addition of vitamins and minerals and of certain other substances to foods were needed.

This Regulation46 aims to regulate the addition of vitamins and minerals to foods and the use of certain other substances or ingredients containing substances other than vitamins or minerals that are added to foods or used in the manufacture of foods under conditions that result in the ingestion of amounts greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers. In the absence of specific rules regarding prohibition or restriction of use of substances or ingredients containing substances other than vitamins or minerals under this Regulation or under other specific EU provisions, relevant national rules may apply without prejudice to the provision of the Treaty.

The Commission underlines that: ‘an adequate and varied diet can, under normal circumstances, provide all necessary nutrients for normal development and maintenance of a healthy life in quantities such as those established and recommended by generally acceptable scientific data’, and ‘…however, surveys show that this ideal situation is being achieved neither for all vitamins and minerals nor by all groups of the population across the Community. Foods to which vitamins and minerals have been added appear to make an appreciable contribution to the intake of these nutrients and as such may be considered to make a positive contribution to overall intakes’.47

But the main purpose of the Commission is to regulate manufacture and to protect consumers. In fact, food to which vitamins and minerals are added are in most cases promoted by manufacturers and may be perceived by consumers as products having a nutritional, physiological or other health advantages over similar or other products without such nutrients added. This may induce consumer choices that may be otherwise undesirable.

To counter these potentially undesirable effects, the Commission considered it appropriate to impose some restrictions on the products to which vitamins and minerals can be added, in addition to those that would be result naturally from technologically considerations or become necessary for safety reasons when maximum limits of vitamins and minerals in such products are set. 48

Commission Regulation (EC) No 1925/2006 sets out: rules on requirements, conditions, restrictions and EU Scrutiny for the addition of vitamins and minerals; purity criteria; labelling; substances restricted and restricted; EU Register; free movement of goods; notification procedure; safety measures.

The rules on food supplements are one element in an ever more complex body of laws being set by the EU to ensure a high level of food safety and a single market in which foodstuffs can move freely between different Member States.

The irony is that just as the EU is on the cusp of completing the project to harmonise EU food law in a way that allows the free movement of foodstuffs, the average consumer seems to be demanding local food and to know the origin of all foods.

To view all formatting for this article (eg, tables, footnotes), please access the original here. Link to original article here.

a hard pill to swallow: the deleterious side effects of dietary supplements

October 22, 2015

By Manali Begur

Packaged in colorful little bottles plastered with claims of “scientifically proven” benefits, dietary supplements are flying off the shelves and into the stomachs of health-conscious Americans. Replacing their dubious predecessors of magic weight loss pills and miraculous appetite suppressants, dietary supplements like vitamins and mineral pills have been welcomed as a more scientific and trustworthy “fast food” approach to health.

A stop at the local Vitamin Shoppe in my hometown revealed that now, there truly is a pill for everything from muscle building to memory improvement. For college students, the idea of taking a pill to achieve a healthier lifestyle seems appealing, especially when our schedule gets chaotic and eating right is not a priority. A study published last week in the New England Journal of Medicine, however, uncovers how millennials’ supplement obsession is impacting health.

Citing data from 63 emergency departments in the US, the probe revealed that more than 23,000 ER visits were due to dietary supplement usage — 28 percent of which involved adults 20 to 34 years old. Most of the visits were more specifically attributed to “herbal or complementary nutritional products” for dieting and energy. Of the many severe side effects reported, chest pain, high heart rate and irregular heartbeat were the most common for college-aged patients.

Yet, once you look at the Food and Drug Administration’s supplement approval processes, these findings are hardly surprising. Supplement companies do not have to ensure that their products are effective or even safe. The FDA monitors the dietary supplement market by the sole means of recall — only if the supplements are proven to be unsafe, after they are already on the shelves, can they be regulated and removed.

Though there might be a small minority of college students that use vitamins and mineral supplements, energy-boosting pills are definitely popular on campus. The long list of energy supplements, caffeine pills, guarana, ginseng, Vitamin B12 and Coenzyme Q10parallels their popularity. A study from Northwestern University found that of caffeine supplement abuse cases, the average age of patients was 21. Dietary supplements are increasingly becoming an issue on college campuses –– students turn to them in desperate times as “study aids,” but there are a few natural and much safer alternatives for students finding themselves in a bind:

Think Coffee Over Caffeine

Now this might seem obvious, but it is far easier to abuse caffeine, which is technically a drug, if you take a pill versus waiting in line at TroGro. Also, caffeine pills are highly concentrated. Magnum 357 Caffeine tablets have 200 milligrams of caffeine in each pill, which is at the tail end of the safe range of caffeine consumption per day. Take two or three, and depending on your body weight, you could overdose on caffeine.

Eat Your Vitamins, Don’t Take Them

Your body is built to absorb vitamins and minerals from food, not chemically synthesized pills. Though not all the evidence is in yet on the effectiveness of dietary supplements, marginally overdosing on Vitamin A and Retinol has been proven to cause a multitude of negative side effects.

Ask A Doctor

If you feel the need to take a vitamin or mineral supplement to make up for deficiencies in your diet for example, talk to a doctor first. Make use of your student health fees and stop by Engemann to get a second opinion and ensure that the brand of supplements you want to take is effective and safe.

Dietary supplements can complement a balanced diet, but till the effects of nutrition pills are truly understood, it might be best to err on the side of caution, and stick to safer alternatives. Link to original article.

4 ways to determine if your nutritional supplement is healthy for you

October 19, 2015

By Suzee Skwiot

They may seem like “easy fixes,” but multivitamins, dietary supplements and energy-boosting pills may not be the safe cures they promise to be. A new federal study, completed by the Centers for Disease Control and Prevention in association with the Food and Drug Administration and published in the New England Journal of Medicine, reports that supplements were the reasons behind approximately 23,000 emergency room visits each year.

The complications with the supplements show that the popular pills can have seriously adverse effects. Photo credit: Shutterstock

From heart problems—which include irregular heartbeat and chest pain—to choking on pills or even accidental ingesting of pills by children, the complications with the supplements show that the popular pills can have seriously adverse effects.

Weight loss and energy pills—the most common supplements taken—were behind the majority of the visits. By studying the emergency visits throughout a 10-year period of time, researchers investigated the ones where dietary supplements were involved. Patients reported severe allergic reactions, nausea, vomiting and heart troubles, from having taken supplements. But as one doctor notes, the statistics may not even scratch the surface.

“This is just a sampling of emergency rooms around the country,” says Mark Moyad, MD, MPh, author of The Supplement Handbook. “Patients who have side-effects from supplements don’t always think of emergency rooms. They think of urgent care or their primary care doctors. If [this study] is not capturing all of the urgent cares and minute clinics and visits to the internists or primary care doctors, that number is much higher.”

In fact, as the study notes, the 23,000 patients who visited the emergency room are just one-tenth of one percent of the number of people who use supplements. But as Moyad points out, it could be much higher.

“This has been a long time coming and I think the real number are a lot larger than this,” Moyad adds.

So if you’re considering adding a supplement to your diet, follow Moyad’s top recommendations for supplement care:

1. Read the Ingredient List

“When you look at a lot of products on sale today, they have a list of ingredients,” says Moyad. In reality, your supplement should not have a blend of ingredients. “If you go to a health foods store and buy melatonin, for example, you’re buying melatonin,” Moyad continues. “But when you go to a CVS or a Walgreens, a lot of the products say ‘melatonin’ on the front, but have a mixture of ingredients companies have put together to create a proprietary or unique blend. The problem with those blends is that they’ve never been tested on human beings.”

2. Read the Studies

With your doctor—or individually—look up the actual study that proves a specific supplement should be used. “By doing a little bit of homework and looking up the paper, you can reward the research that went throuth the study,” Moyad says. “The supplement industry is a $35 billion business and there are are many fly-by-night companies, so looking up the facts and specific ingredients used in a study, you can get the best products.”

3. Get Verified

“Don’t be shy to look on the supplement’s website, call the company or look on the bottle for some kind of label,” Moyad adds. “Look for items that have the NSF stamp. It’s a third-party control system—used by the NFL—that audits supplement companies and it means that your product has gone through some scrutiny.”

4. Set a Higher Standard

“This should up the threshold of what people should require of their supplements,” Moyad says. “Instead of getting information, people are being clinical trials of one and they’re signing up to be a clinical project.” That means speaking to a doctor, confirming that a supplement will deliver on its promises and not buying pills simply thanks to their celebrity endorsements. “Take an extra effort,” he adds. “Supplements can really change your life if they’re done correctly.” Link to original article.

the latest study about antioxidants is terrifying. scientists think t hey may boost cancel cells to spread faster.

October 16, 2015

By Ariana Eunjung Cha

Since the term "antioxidants" made the leap from the realm of biochemistry labs and into the public consciousness in the 1990s, Americans have come to believe that more is better when it comes to consuming the substance that comes in things like acai berries, green tea and leafy veggies.

A provocative new study published Wednesday in the journal Nature raises important questions about that assumption.

Antioxidants — which include vitamins C and E and beta-carotene, and are contained in thousands of foods — are thought to protect cells from damage by acting as defenders against something called "free radicals" which the body produces as a part of metabolism or that can enter through the environment.

That's all great for normal cells. But what researchers at the University of Texas Southwestern Medical Center found is that antioxidants can work their magic on cancerous cells, too — turbo-charging the process by which they grow and spread.

Researcher Sean Morrison and his colleagues conducted experiments on mice that had been transplanted with skin cancer cells (melanoma) from human patients. They gave nothing to one group. To the other they gave doses of N-acetylcysteine (NAC) which is a common antioxidant that's used in nutritional and bodybuilding supplements and has been used as a treatment for patients with HIV/AIDS and in some children with certain genetic disorders.

The results were alarming: Those in the second group had markedly higher levels of cancer cells in their blood, grew more tumors and the tumors were larger and more widespread than in the first.

"What we're starting to learn is that there can be bad cells from cancer that appear to benefit more from antioxidants than normal cells," he said in an interview.

Green tea is among the many food products being touted as being rich in antioxidants. (iStock)

Morrison, director of the Children’s Medical Center Research Institute at UT Southwestern, explained that it has to do with something called oxidative stress.

Scientists have known for a while now that cancer metastasis — especially when it involves spreading a great distance to another part of the body — is a very inefficient process and that many cells die along the way. This is likely due to oxidative stress, which is an inability by the body to counteract the harmful effect of free radicals. When antioxidants supplements are given, the paper hypothesizes, they may give new life to those cancerous cells that are on the edge of dying.

Morrison said that previous studies have shown that the progression of metastasis of human melanoma cells in mice is predictive of their metastasis in humans, which raises concerns about the use of dietary antioxidants by patients with cancer.

Moreover, melanoma may not be the only type of cancer to be affected this way.

A similar study conducted at Vanderbilt University and published in PLoS One in 2012 involving mice with prostate cancer also showed that antioxidants appeared to increase the proliferation of cells in the pre-cancerous lesions. And another one in rodents with lung cancer published in Science Translational Medicine in 2014 found that normal doses of vitamin E and smaller doses of acetylcysteine, an antioxidant supplement, appeared to lead to a three-fold increase in the number of tumors and caused them to be more aggressive. As a result, the mice given antioxidants died twice as fast the ones in the control group. The reaction appeared be dose dependent with larger doses leading to a more severe reaction.

Morrison said that further study needs to be done to confirm the findings and that cancer patients should still consume antioxidants as part of a healthy diet.

But, he added, "personally, from the results we've seen, I would avoid supplementing my diet with large amounts of antioxidants if I had cancer."

Over the past 20 years, numerous studies were launched to ascertain the effect of antioxidants on other conditions ranging from heart disease to memory loss. Early results have mostly been mixed, but that hasn't stopped food companies from hyping their disease-fighting abilities. Link to original article.

dietary supplements send more than 23,000 people to the er each year

October 15, 2015

By Ariana Eunjung Cha

Multivitamins, diet pills and energy boosters may not be the harmless substances you think they are.

In the first study of its kind, published Wednesday in the New England Journal of Medicine, researchers estimated that 23,000 people end up in the emergency room each year suffering from heart palpitations, chest pain, choking or other problems after ingesting dietary supplements. Most of those patients were young adults, children or the elderly.

While that number is a small fraction — just 5 percent — of the number of ER visits involving pharmaceuticals, the issue is a cause for concern because the market for herbal and complementary nutritional products remains largely unregulated. Surveys have shown that about half of U.S. adults used at least one dietary supplement in the past month and that there were more than 55,000 products on the market as of 2012. Out-of-pocket expenditures on these products is estimated to be about a third of what people spend on prescription drugs.

In recent years, U.S. health officials have ramped up efforts to warn consumers about the potential dangers of these substances after several highly publicized cases of deaths of otherwise healthy individuals who took supplements. Last year, two people — Logan Stiner, an 18-year-old high school senior in Ohio, and 24-year-old James Wade Sweatt of Georgia, who was newly married and a recent college graduate — died of overdoses from powdered caffeine.

On Tuesday, former Los Angeles Lakers basketball star Lamar Odom collapsed after taking "herbal Viagra" pills called Reload that the FDA had previously issued warnings about. The FDA had said the supplement "contains [a] hidden drug ingredient" that could cause severe reactions. Odom remains on life support, according to news reports.

The study, which was conducted by a team from the Centers for Disease Control and Prevention and the Food and Drug Administration, tracked ER admissions at 63 hospitals throughout the United States from 2004 to 2013. Of the estimated annual 23,000 ER visits, 2,000 resulted in hospitalizations.

Andrew I. Geller, the study's lead author and a medical officer at the CDC, said in an interview that it was impossible to pinpoint exactly what the patients took other than the broad categories from the data collected as physicians sometimes didn't write down brand names and even if they did companies tend to change ingredients frequently.

More than a quarter of the ER visits documented in the study involved young adults between the age of 20 and 34 years. "With the younger adults one of our central findings was weight loss or energy products were the most commonly implicated dietary supplements and the fact is found many with cardiac symptoms — which are effects we might see with caffeine," Geller said.

A second group frequently seen in emergency rooms was children who got into supplements like multivitamins they weren't supposed to touch. Older adults were less commonly involved, but when they were it usually had to do with choking.

The Council for Responsible Nutrition, a trade group for the dietary supplement industry, said that the results of the study reinforce that that the products are safe.

"To put this projected number of 23,000 annual emergency room (ER) visits into context, we estimate that far less than one tenth of one percent of dietary supplement users experience an emergency room visit annually," Duffy MacKay, senior vice president for scientific and regulatory affairs for the group, said in a statement.

MacKay said the percentage is even smaller if you exclude products like eye drops, ear drops, and other products that the organization says were "inaccurately included."

The CRN said that companies have already been responding to some of the concerns raised in the study such as the choking issue and are offering options such as liquids, gummies, melts or effervescent powders instead of pills.

There were an estimated 55,000 supplement products on the market in 2012. (Bigstock)

The CDC's Geller said that patients taking supplements or considering taking them should keep these precautions in mind:

Young adults taking products to lose weight or increase energy should keep in mind that some of these products can have effects on their heart, and they should not take these products in excess. If you have a heart condition, talk to your doctor before starting a weight loss or energy supplement.
Older adults should be mindful of possible choking or other swallowing problems from taking supplements. They should avoid taking several pills at once, avoid extra large pills or capsules, and swallow supplements with plenty of water or other fluid. Tell your physician you are having difficulty swallowing pills and ask him/her or your pharmacist for other options or if you can cut the supplement in half.
Patients should always tell their doctors if they are taking dietary supplements, and which ones.
All medicines and dietary supplements should be stored up, away, and out of sight of young children.

He said doctors should be careful to:

Ask patients about dietary supplement use.
Consider the possibility of adverse effects from supplements (e.g., chest pain or palpitations in young adults).
Encourage patients keep supplements up, away, and out of sight of children.

supplements send thousands of americans to emergency room every year, study finds

October 15, 2015

By Maggie Fox

Weight-loss, bodybuilding and energy supplements send thousands of teens and young adults to emergency rooms each year — more than prescription stimulants, government researchers reported Tuesday.

They calculate that 23,000 people have to go to the ER every year after something goes wrong with a supplement or vitamin pill. While many of the cases involve children who mistakenly took a supplement or older adults choking on big pills, many involved young adults looking to lose weight or stay awake, Dr. Andrew Geller of the Centers for Disease Control and Prevention and colleagues found.

"More than one quarter (28 percent) of emergency department visits for supplement-related adverse events in our study involved young adults between the ages of 20 and 34 years," they wrote in their report, which was published in the New England Journal of Medicine.

"Weight-loss or energy products caused more than half these visits, commonly for cardiac symptoms," they added. These included rapid heartbeat, chest pain and heart palpitations.

"Weight-loss or energy products were implicated in 71.8 percent of all emergency department visits for supplement-related adverse events involving palpitations, chest pain, or tachycardia (rapid heartbeat)," the report adds.

These symptoms can be caused by stimulants. Supplements are not supposed to contain active drug products and are almost always marketed as being made from "natural", herbal or otherwise benign ingredients.

But the Food and Drug Administration has been warning consumers that many so-called natural supplements in fact do contain prescription drugs that are not marked on their labels.

"Unlike over-the-counter or prescription medications, there are no requirements to identify adverse effects on dietary-supplement packaging," the researchers added.

While this study did not look at what people actually took, it shows even vitamins, mineral and other products found online and on drug store, grocery store and health food store shelves can cause trouble.

"Notably, cardiac symptoms were documented more frequently in emergency department visits for adverse events associated with weight loss (43 percent) and energy products (46 percent) than for prescription stimulants," the researchers wrote.

If anything, their findings are probably an underestimate, the researchers noted. Emergency room staff rarely ask people about supplements or vitamins - unless someone is very obviously choking on one.

"This is only a limited look at the risk," said Curtis Haas, director of pharmacy for the University of Rochester Medical Center, who was not involved in the study.

"I think it should be a concern. As you know there is limited regulatory authority over these products," Haas told NBC News. "These are not benign products."

The Dietary Supplement Health and Education Act (DSHEA), passed in 1994, specifically exempts vitamins and supplements from FDA's pre-marketing scrutiny, although the agency can warn against products found to be dangerous.

Yet the products are extremely popular. According to the National Center for Health Statistics, more than half of Americans took some sort of dietary supplements in 2003-2006, 40 percent of them multivitamins.

"In 2007, out-of-pocket expenditures for herbal or complementary nutritional products reached $14.8 billion, one third of the out-of-pocket expenditures for prescription drugs," Geller's team wrote.

The CDC and FDA team used a national database covering 63 hospitals over 10 years, from 2004 to 2013.

"Cases were defined as emergency department visits for problems that the treating clinician explicitly attributed to the use of dietary supplements," they wrote. The estimate excludes any long-term effects of the products and excluded deaths because the records are not precise or consistent.

Lyndsay Meyer, a spokeswoman for the FDA, says weight loss, body building and sexual enhancement products are the three types of so-called supplements that are most likely to contain unlisted, and potentially dangerous, prescription drug ingredients.

One recent warning: Fat Zero, a product whose label says it contains bee pollen, green tea and lotus seed. But the FDA found it also contains sibutramine, a prescription diet drug that was so dangerous it's been pulled off the U.S. market for causing heart problems.

The FDA's also cautioned about sales of bulk caffeine. Caffeine in large doses can kill, and in smaller doses can cause heart symptoms such as rapid heartbeat.

Meyer noted that the agency issues warnings about some type of adulterated supplement or herbal product almost daily. The report helps the agency decide just how often such products cause bad side-effects in people who take them.

"We would love it if people would report these adverse events to us," she told NBC News. "We are unable to test and identify all products marketed as dietary supplements."

The FDA has a website that lists the known adulterated supplements.

People can report adverse reactions here. The FDA has created, through the Safety Reporting Portal (SRP), a convenient secure, and efficient method for letting FDA know when industry or consumers finds a problem with a dietary supplement.

"The results of this study reinforce that dietary supplements are safe products, particularly when put into context with the number of people — over 150 million Americans — who take dietary supplements every year," said Duff MacKay of the Council for Responsible Nutrition, the trade association for the supplement industry. Link to original article.

dietary supplements riskier than most realize

October 15, 2015

By Conny Hooper

Every year, dietary supplements are responsible for roughly 23,000 emergency room visits, according to a new study by the U.S. Food and Drug Administration and the U.S. Centers for Disease Control. Many of these visits are due to complications related to taking the dietary supplements, which include herbal supplements, complimentary nutritional supplements, supplemental vitamins, and supplemental minerals.

Annually, Americans spend billions of dollars on dietary supplements, making it a lucrative market for manufacturers to enter. A recent study concluded that nearly half of adults were taking at least one dietary supplement in the past month. Many people don’t realize that adverse effects are possible with these supplements and are caught unaware when they have a bad reaction.

The study conducted by the CDC and FDA used emergency department data from 63 locations around the nation taken between 2004 and 2013.Roughly 20 percent of the emergency room visits involved children who had accidentally ingested a supplement while their caretakers weren’t paying attention. Older adults commonly reported issues with swallowing when taking supplementary vitamins and minerals.

Many of the emergency room visits involved young adults between the ages of 24 and 30. Most of these young adults arrived at the emergency rooms complaining of heart palpitations, increased heart rate, and/or chest pain after taking energy supplements or weight loss products. The study found that 72 percent of adverse events involving cardiovascular issues were linked to energy products and weight loss products. The study was recently published in the New England Journal of Medicine.

It is important for people to remember that dietary supplements do not undergo the same rigorous testing that prescription drugs and over-the-counter drugs undergo before being released to market. It is against the law to market a supplement for the treatment of a medical condition or disease in the United States, but many people decide to take them for a particular ailment after researching them on the internet.

The agencies want doctors to play a greater role in advising consumers on which dietary supplements are likely to help them and which they should avoid to prevent these adverse events. Doctors should regularly ask patients about their supplement use and provide them with interaction information if they are taking other medications while they are taking the supplements. More action may be able to reduce the number of adverse incidents sending supplement takers to the hospitals.

dietary supplement use sends thousands to the er each year

October 14, 2015

By Mary Brophy Marcus

Bad reactions to dietary supplements are sending tens of thousands of Americans to the ER every year, a new study shows.

More than 23,000 visits to emergency rooms occur annually due to complications from taking dietary supplements such as herbal or complementary nutritional products, vitamins, and minerals, according to scientists from the U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration who coauthored the study. About 2,154 of the visits resulted in hospitalizations, the scientists reported.

"People may not realize dietary supplements can cause adverse effects but each year thousands of people are treated in emergency departments because of adverse events related to these supplements," Dr. Andrew Geller, lead author of the study and medical officer in CDC's Division of Healthcare Quality Promotion, told CBS News.

The research, published in The New England Journal of Medicine, used surveillance data collected from 63 emergency departments across the country between 2004 and 2013.

The ER visits commonly involved young adults between ages 20 and 34 who'd taken weight loss or energy products. The most common symptoms were chest pain, palpitations, and elevated heart rate.

In many other cases, unsupervised children ingested supplements.

"More than 20 percent of emergency room visits were young children getting into supplements meant for somebody else," Geller said.

In the United States, supplements can't be marketed for the treatment or prevention of diseases -- they don't get scrutinized and approved by the FDA like prescription drugs -- but many people take them to address a range of symptoms or to boost general health.

About half of adults used at least one dietary supplement in the past month, and people spend billions on herbal or complementary nutritional products every year, according to the researchers.

Two years ago, when Chris Herrera was fifteen, he lost 56 pounds while taking a green tea extract billed as a fat burner. His mom, Lourdes Gonzalez approved.

"His pants size went down dramatically. He probably decided to take more on his own without letting me know," she told CBS News.

But then his eyes turned yellow and medical tests showed his liver was failing. Doctors blamed the green tea extract.

"Having to hear the doctor tell me every day that Christopher had a 50 percent chance of dying and not making it, it was hurtful, hoping every day he'd get better soon," she said. Fortunately, her son recovered.

In the study, weight loss or energy products caused 72 percent of supplement-related adverse events involving cardiovascular issues including chest pain, tachycardia, and heart palpitations.

Swallowing problems, often associated with vitamins and minerals, were more likely to occur among older adults aged 65 and over.

Sometimes misconceptions about supplements exist. Dr. Andrew Greenberg, director of the Obesity and Metabolism Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Boston, told CBS News, "If your doctor tells you to take two pills, you take two pills, but if you go to a nutrition store you may think if two pills is good, then six must be great. In the supplement world, more is not necessarily good."

Greenberg said, "Show your doctor what you want to take and discuss it with them because it's very hard for a lay person to understand what the ingredients are within a supplement."

Geller offers this advice for people who take supplements:

Young adults taking products to lose weight or increase energy should keep in mind that some of these products can have effects on their heart, and shouldn't be taken in excess or without consulting with their doctors.

If you have a heart condition, talk to your doctor before you start taking a weight loss or energy supplement.

Older adults should be mindful of choking and swallowing problems when it comes to supplements. Avoid taking more than one pill at a time, avoid extra large capsules, and swallow products with plenty of fluids. Pills or pill fragments can get lodged in the windpipe or esophagus and can lead to complications.

If you're having pill-swallowing problems, talk with your pharmacist or doctor about other options, or if the supplements can be cut in half.

All medicines and dietary supplements should be stored up, away, and out of sight from young children.

Tell your doctor if you're taking any supplements and which ones.

Geller says doctors can play a role in supplement safety by asking patients about their use and considering the possibility of adverse effects. "Some dietary supplements may have benefits, but there are risks which are not the same among any two dietary supplements."

He added that adverse effects from medications are typically seen in older adults in emergency rooms, making these results were somewhat surprising. "It is notable that for dietary supplements, we're talking about young adults and young children. When you think about it, we don't traditionally think of young adults as a vulnerable group, so that was somewhat striking about this," he said. Link to original article.

sec charges musclepharm with string of violations

September 10, 2015

By Steve Myers

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.

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.

akttive fat burner recalled for unapproved drugs

July 24, 2015

By Carla Gillespie

Life & More, L.L.C. of Miami is voluntarily recalling 783 bottles of Akttive High Performance Fat Burner Gold that were found to contain undeclared, unapproved drugs. Consumers who have purchased this product with the lot #000185004400, UPC 859189005005, and Expiration 12/17 should not use it as serious health problems could occur if they do.

The US Food and Drug Administration (FDA) tested the product and found that it contained Sibutramine, desmethylsibutramine, and Phenolphthalein. According to the FDA, “Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not approved for marketing in the United States.”

Consumers should consult their physicians before taking dietary supplements. The undeclared drugs in these products can cause adverse reactions such as increased blood pressure and/or pulse rate. For patients with a history of coronary artery disease, they can cause congestive heart failure or stroke.

These drugs can also interact with other medications to produce life threatening conditions. At the time of the recall, no injuries had been reported.

The product was sold online to consumers and shipped to distributors in the following states: NV, FL, NY, AZ, MA, NJ, CA, MD, TX, VA and MI. Link to original article.

legal, regulatory forum covers spectrum of supplement issues

July 2, 2015

By Steve Myers

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.

sports supplements link to male eating disorders?

August 7, 2015

By Steve Myers

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.

smart lipo capsules recalled for undeclared, unapproved drugs

June 6, 2015

By Carla Gillespie

Smart Lipo capsules are being recalled because they contain unapproved drugs that are not declared on the label. Consumers who have purchased this product should not use it as the unapproved drugs pose a significant health risk.

The 800 and 900 mg capsules of Smart Lipo contain sibutramine, desmethylsibutramine, and phenolphthalein. Sibutramine, an appetite suppressant, was withdrawn from the market in 2010 after it was found to cause significant health risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein, a laxative, was withdrawn from the market due to concerns that it may cause gastrointestinal disturbances, irregular heartbeat, and cancer.

These undeclared ingredients pose risk on their own but mat also cause a life-threatening interaction with other medications.

The recalled product was marketed as a dietary supplement and was sold in bottles of 30 capsules with the following expiration dates: 800mg capsules – 9/15/2017, 900mg capsules – 7/30/2017, 950mg capsules – 7/30/2017 and 7/30/2018. Smart Lipo was sold in stores, Centro Naturista in Richardson, TX, SmartLipo365 in Arlington, TX, as well as through online sales. L ink to original article.

bee pollen recalled for undeclared drugs

November 21, 2014

By Fred Pritzker

REFA Enterprises, LLC is voluntarily recalling Forever Beautiful Bee Pollen and Forever Beautiful Infinity because they contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein, discovered through FDA analysis.

Sibutramine is an appetite suppressant that was removed from the U.S. market in October 2010 because of increased risk of seizures, heart attacks, arrhythmia, and strokes. Phenolphthalein is an ingredient that was used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for use in this country. These undeclared ingredients make the products unapproved new drugs. The products can interact in life-threatening ways with other medications and can be dangerous on their own. Sibutramine can increase blood pressure, and phenolphthalein could cause irregular heartbeat, cancer, and serious GI disturbances. No illnesses or adverse events have been reported.

Forever Beautiful Bee Pollen is packaged in bottles of 60 capsules and distributed via the internet to consumers nationwide from July 7, 2014 to November 3, 2014. The UPC number is 6333090804632. Forever Beautiful Infinity is packaged in bottles of 60 capfuls and was also distributed via the internet from July 7, 2014 to November 3, 2014. The UPC number for that product is 633090804649.

REFA Enterprises is notifying customers by mail and is arranging for return of all recalled products. If you have purchased these products, stop using them and return them.

Contact a doctor if you have experienced any problems that may be related to using these products. You can report adverse reactions to the FDA’s MedWatch Adverse Event Reporting program. Link to original article.

regeneslim recalled for dmaa

August 8, 2014

By Carla Gillespie

Regeneca Worldwide a division of VivaCeuticals Inc. of Las Vegas has issued a nationwide recall of RegenESlimappetite control dietary supplement because it contains 1,3-dimethylamylamine (DMAA) an unapproved drug that can pose serious health risks. Although no illnesses have been reported in connection with this product, the U.S. Food and Drug Aministration (FDA) has received more than 86 reports of illnesses and death associated with supplements containing DMAA.

Consumers who have purchased this product should not use it. DMAA is a stimulant that can narrow blood vessels and arteries, causing a rise in blood pressure or other cardiovascular problems such as shortness of breath, tightening in the chest, irregular heartbeat and heart attack. It can also cause problems with the nervous system. It may be especially dangerous when used in combination with caffeine

The recalled product are from the lot # EX0616R15814 and lot #11414RE5516 packaged in 3 ½” by 3” green and white sachets that contain 2 capsules, with the name RegeneSlim displayed prominently on the front of the sachet. RegeneSlim is purchased by and distributed through a direct sales force within the United States and Puerto Rico, and through online sales, for both personal consumption and retail sales.

The recall was issued after an FDA analysis of the product confirmed the presence of DMAA. The company continues their investigation as to the cause of the problem. Link to original article.

fda's final guidance distinguishes liquid dietary supplements from beverages

February 5, 2014

By Latham & Watkins LLP

Two new FDA guidance documents can assist both conventional beverage and liquid dietary supplement manufacturers to avoid costly mischaracterization and enforcement action.

The US Food and Drug Administration (FDA or Agency) has raised concerns regarding the increase in the marketing of liquid products with a variety of ingredients and intended uses, some of which are marketed as dietary supplements and others as conventional foods. To assist members of the dietary supplement and beverage industries in distinguishing between these two product categories and complying with the regulatory requirements applicable to each, FDA issued draft guidance in 2009 and, most recently, in January 2014 issued two final guidance documents. These documents, entitled, “Distinguishing Liquid Dietary Supplements from Beverages”1 and “Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements,”2 together update the Agency’s December 2009 draft guidance entitled, “Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods.”3 The final guidance documents are consistent with the 2009 Draft Guidance, but provide greater detail with respect to distinguishing dietary supplements and beverages. Thus, they are valuable resources for beverage and liquid dietary supplement companies navigating the often muddy food and dietary supplement regulations.

Distinguishing Liquid Dietary Supplements From Beverages

FDA stated in the 2009 Draft Guidance that it intended to assist the dietary supplement and beverage industries in determining whether a liquid product could be labeled and marketed as a dietary supplement. Similarly, the 2014 Liquid Supplement Guidance aims to assist in classifying a liquid product as a beverage or dietary supplement. The distinction between beverages (which are foods) and dietary supplements is critical, as their labeling, advertising, manufacturing, and composition requirements and restrictions differ. Notably, dietary supplements are subject to distinct good manufacturing practice regulations, ingredient compliance requirements, and labeling requirements, just to name a few differences. Thus, misclassification of a liquid product can expose a company to risk of significant enforcement action. In the 2009 Draft Guidance, FDA very briefly listed factors, such a as liquid product’s name, packaging, serving size, and recommended conditions of use, as important determinants of whether the product is represented as a conventional food and thus may not be marketed as a dietary supplement.4 However, the 2009 Draft Guidance does not provide significant detail regarding the application of these factors in making such a determination.

The 2014 Liquid Supplement Guidance provides a more in-depth analysis of these factors, including specific examples of situations in which a liquid product will or will not be deemed to be appropriately marketed as a dietary supplement, as follows. Characteristics suggesting that a product is a conventional food that cannot be marketed as a dietary supplement:

• Labeling, advertising, and marketing that bears (i) statements that indicate that the product is intended to “refresh,” “rehydrate,” or “quench thirst,” or (ii) graphics representative of a conventional food.

• Product or brand names that use terms that are generally associated with conventional foods, such as “beverage,” “drink,” “water,” “soda” and so forth.

• Product packaging characteristics that are similar to packaging for common beverages.

• Serving size and recommended daily intake amounting to a significant part of average daily drinking fluid intake. Notably, however, powdered premix products and liquid concentrates are not necessarily conventional foods.

• Marketing practices such as comparing the product to a beverage, use of metatags resulting in the product’s appearance in the results of an electronic search for beverages, or payment of fees for the product to be displayed in the beverage section of retail stores.

• Composition where the product is essentially a copy of a common beverage with a dietary ingredient added. In other words, the addition of an ingredient that falls within the definition of a “dietary ingredient” will not necessarily convert a beverage to a dietary supplement.

• Other representations in publicly-available documents, such as SEC or trademark filings indicative of a conventional food.

FDA notes that it intends to consider all relevant factors in context when making a determination that a product is represented as a conventional food rather than a dietary supplement. To that end, the analysis requires a fact-specific, case-by-case determination, and apparently no one factor will be dispositive. As noted above, significant differences exist in the regulatory requirements for conventional food beverages and those for liquid dietary supplements. The 2009 Draft Guidance provided some detail on nutrient labeling requirements for conventional foods and on when health or structure/function claims could result in a conventional food being mislabeled or deemed an unapproved drug. In the 2014 Liquid Supplement Guidance, FDA addresses labeling claims for both conventional foods and dietary supplements. In conjunction with the statute, regulations and other FDA guidance, the 2014 Liquid Supplement Guidance can assist both conventional beverage and liquid dietary supplement manufacturers avoid labeling omissions or claims that could result in a determination of mislabeling.

Application of Food Additive Regulations to Beverages and Liquid Supplements

In addition to elaborating on the factors that FDA uses to distinguish between a dietary supplement and conventional food, the 2014 Liquid Supplement Guidance — together with the 2014 Substances Added to Food Guidance — clarifies the regulatory requirements applicable to substances added to both conventional foods and dietary supplements. With respect to conventional foods, FDA expresses concer that novel ingredients, such botanical ingredients or extracts, added to beverages or conventional foods might cause the food to be adulterated because they have not undergone food additive premarket approval and are not deemed generally recognized as safe (GRAS). In addition, non-novel additives to conventional foods may be added to foods in excess of the levels traditionally found in the food supply, which may make them unapproved additives. The 2009 Draft Guidance provided a brief overview of the regulatory framework applicable to the substances added to conventional foods, but did not explicitly address the application of this regulatory scheme to substances in dietary supplements. Both of the 2014 guidance documents clarify that ingredients and other substances in dietary supplements that do not meet the definition of a “dietary ingredient” under the Federal Food, Drug, and Cosmetic Act (e.g., fillers, excipients and binders that do not qualify as dietary ingredients) must meet the same standards as substances added to conventional foods. That is, these ingredients and substances must comply with the food additive regulatory framework or be deemed GRAS for their intended use. This clarification does not represent a new interpretation of the requirements applicable to the substances in dietary supplements. However, the new guidance documents explicitly set forth FDA’s view on this matter.

Next Steps

While the topics addressed in FDA’s 2014 Guidance Documents are not novel, the new guidance documents provide manufacturers and other members of the industry with additional clarity on FDA’s interpretation of its laws and regulations, and thus some insight into FDA’s potential enforcement theories and priorities. To that end, dietary supplement and beverage manufacturers would be well-served to review the guidance and assess the potential impact on their products, operations and businesses. Although FDA deems these newly issued guidance documents as final, the Agency will accept comments at any time. Thus, members of industry could take advantage of the opportunity to raise any concerns regarding FDA’s interpretations in the guidance through the public comment process. Click here to view the original article.

mega slim dietary supplement recalled for dmaa

January 31, 2014

By Linda Larsen

YoungYou International is recalling Mega Slim Herbal Appetite Management, a dietary supplement, because it contains DMAA. DMAA, also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, is dangerous to your health. It can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, tightening in the chest, or heart attack. The chemical is an unapproved dietary ingredient.

Mega Slim Herbal Appetite Management is packaged in white bottles with 30 white capsules. The lots include the bar code 736211614094 and an expiration date of June 2014. The product was only sold through the YoungYou web site.

If you purchased this product, do not take it. Return it to the company for a refund. The company is only issuing refunds to customers who return more than 50% of the unused product within 30 days of publication of this advisory, dated January 30, 2014.

This is a Level 1 recall, in which there is a “reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death”. If you have experienced any adverse reactions while taking this product, report it to the FDA MedWatch Adverse Reporting program. Link to original article.

dsc hold dietary supplement briefing

May 31, 2013

By Debra S. Dunne, Laurie A. Henry, and Madeleine M. McDonough of Shook Hardy & Bacon LLP

The Congressional Dietary Supplement Caucus (DSC) recently held its 17th educational briefing, “Sports Health and Fitness: The Role of Dietary Supplements,” for Capitol Hill staff. The event, held in cooperation with five trade associations representing the dietary supplement industry—the American Herbal Products Association, Consumer Healthcare Products Association, Council for Responsible Nutrition, Natural Products Association , and United Natural Products Alliance—featured NFL wide receiver Larry Fitzgerald Jr. of the Arizona Cardinals and Ed Wyszumiala, general manager of NSF International’sDietary Supplement Certification Programs.

The briefing was one of several that DSC and the supplement industry trade associations hold throughout the year “to provide educational opportunities to ensure that newly elected members of Congress have accurate information about dietary supplements and their role in good health.”

According to the trade groups, key messages included “the significant role dietary supplements play in supporting the nutritional needs of active individuals and athletes, and the importance of good manufacturing practices, product certification and testing programs to help ensure safe dietarysupplements for athletes and consumers.” See American Herbal Products Association News Release, May 13, 2013. Click here to view the original article.

nutraceutical company wins $3.3 million from protein powder supplier

October 31, 2013

By Debra S. Dunne, Laurie A. Henry, and Madeleine M. McDonough of Shook Hardy & Bacon LLP

A federal jury in Florida has reportedly awarded California-based nutraceutical company Natrol, Inc. nearly $3.3 million for breach of contract and warranty, finding that Nature’s Products Inc. (NPI) of Sunrise, Florida, supplied Natrol with protein powder products, labeled and advertised as gluten- and wheat-free, leading to a Food and Drug Administration recall order because the products contained gluten and wheat, potential allergens for some consumers. Nature’s Prods. Inc. v. Natrol, Inc., No. 11-62409 (U.S. Dist. Ct., S.D. Fla., jury verdict rendered October 24, 2013). While Natrol will have to pay the supplier some $750,000 in unpaid invoices, its counsel stated that the nutraceutical company would seek attorney’s fees and the costs of litigation under the contract.

The recalled products, a dozen varieties of protein powder supplements, were manufactured by NPI and sold to Natrol from June 2010 through September 2011. According to Natrol’s counsel, “The jury got it right. NPI refused to honor its pre-manufacturing indemnification agreement with Natrol and then sued Natrol for invoices, requiring Natrol’s counterclaim for the full amount of the damages NPI caused Natrol to incur.” See Sacher, Zelman Press Release, October 25, 2013; South Florida Business Journal, October 26, 2013. Click here to view the original article.

creafuse powder recalled because it contains dmaa

September 13, 2013

By News Desk

Ge Pharma, LLC is recalling Creafuse Powder because it contains 1,3 dimethylamylamine (DMAA), which is used as a stimulant, pre-workout, and weight loss ingredients. The FDA warns that DMAA is potentially dangerous to your health because it can elevate blood pressure and lead to heart disease. It is not a dietary ingredient and is not compliant with the Dietary Supplement Health and Education Act.

The recalled products are Creafuse Powder Grape Lot #GE4568 and Creafuse Powder Fruit Punch #GE4570, packaged in white, 600 gram containers with expiration date of 2/2015. The products were distributed nationwide and sold via telephone and email. There have been no reports of adverse reactions to date.

If you purchased this product, discontinue use immediately. Contact your health care professional if you experience any adverse side effects. If you do experience problems, contact the FDA through their MedWatch Adverse Event Reporting Program. Link to original article.

beta recalls supplements with potentially dangerous ingredient

June 23, 2013

By Carla Gillespie

Beta Labs LTD is recalling the dietary supplements Oxyphen XR, Phentalene, Phen FX, and Red Vipers Lot because they contain the potentially dangerous ingredient 1,3 dimethylamylamine (“DMAA”). The Products contain DMAA. Ingesting DMAA can elevate blood pressure and lead to cardiovascular problems. Consumers who have purchased these products should not use them.

The UPC codes and lot numbers for the recalled products are as follows: Oxyphen XR, UPC 70541 59974, Lot #s 200910 and 200911; Phentalene UPC 70541 59982, Lot # 58800512; Phen FX UPC 29882 55980, Lot # 1205129; and Red Vipers UPC 29882 55981, Lot # 1205128. The products were all sold in capsule form. The recalled products were sold nationwide.

The U.S. Food and Drug Administration (FDA) has warned consumers that DMAA is potentially dangerous to health. It can elevate blood pressure and could cause heart attack, shortness of breath, tightening of the chest and other cardiovascular problems. The FDA has received 86 reports of illnesses and death associated with supplements containing DMAA as of April 11, 2013, according to the agency.

At this point, there have been no reports of adverse events associated with the products under recall. No other products distributed by Beta are included in the recall.

Consumers with questions can contact Beta at accounting@betalabs.net or by calling 1- 877-283-1742, Monday – Friday, 10 a.m. – 5 p.m. CST. Adverse reactions or quality problems experienced in association with the use of these product(s) may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax. The form and instructions for the form may be found at http://www.fda.gov/Medwatch/getforms.htm Link to original article.

healthy people co. expands voluntary recall

February 22, 2012

By Linda Larsen

The February 2, 2012 recall of dietary products by Healthy People Co. is being expanded. The brand names of the recalled products are listed below. This update recalls all listed products regardless of their lot number. The products were sold on or before October 25, 2011 and were distributed nationwide.

The products may contain Sibutramine and Tadalafil, which are FDA-approved drugs. The presence of those drugs in these products makes the products unapproved new drugs. Sibutramine has been withdrawn from the U.S. market because people taking it had an increased risk of heart attack and stroke. For more information about the drugs and their inclusion in these products, please see the previous recall.

Product details:

MINCE BELLE (Dietary Supplement)
- 30 capsules
- UPC Number 7503013203305
EVERLAX (Dietary Supplement)
- 30 capsules
- UPC Number 7503013203046
EVER SLIM (Dietary Supplement)
- 30 capsules
- UPC Number 7503013203053
EVER SLIM Shake Mix (Dietary Supplement)
- Strawberry
- 17.6 ounce
- UPC Number 7503013203084
EVER SLIM Shake Mix (Dietary Supplement)
- Chocolate
- 17.6 ounce
- UPC Number 7503013203077
ACAI-MAN MANGOSTEEN Herbal Drink (Dietary Supplement)
- 16.6 ounce
- UPC Number 7503013203015
PERFECT MEN (Dietary Supplement)
- 10 capsules
- UPC Number 7503013203190

The company says that, “Although there is no evidence suggesting that other lot numbers contain these substances, today Healthy People Co. announced an expanded recall of the company’s dietary supplements sold under the brand names described herein, to include all lot numbers sold on or before October 25, 2011.”

If you have purchased any of these products with any lot numbers on or before October 25, 2011, return to the store at 13105 Ramona Blvd., Ste F, in Irwindale, California 91706 for a full refund or replacement. For questions or instructions about the return process, you can call 1-626-939-4132 from 9:00 am to 5:00 pm PST from Monday through Friday.

If you have taken any of these products and experienced adverse effects, contact the FDA’s MedWatch Adverse Event Reporting Program. Link to original article.

dietary supplements: fds should take further actions to improve oversight and consumer understanding

March 2, 2009

GAO (Government Accountability Office)

Dietary supplements and foods with added dietary ingredients, such as vitamins and herbs, constitute multibillion dollar industries. Past reports on the Food and Drug Administration's (FDA) regulation of these products raised concerns about product safety and the availability of reliable information. Since then, FDA published draft guidance on requirements for reporting adverse events--which are harmful effects or illnesses--and Current Good Manufacturing Practice regulations for dietary supplements. GAO was asked to examine FDA's (1) actions to respond to the new serious adverse event reporting requirements, (2) ability to identify and act on concerns about the safety of dietary supplements, (3) ability to identify and act on concerns about the safety of foods with added dietary ingredients, and (4) actions to ensure that consumers have useful information about the safety and efficacy of supplements.

FDA has made several changes in response to the new serious adverse event reporting requirements and has subsequently received an increased number of reports. For example, FDA has modified its data system, issued draft guidance, and conducted outreach to industry. Since mandatory reporting went into effect on December 22, 2007, FDA has seen a threefold increase in the number of all adverse event reports received by the agency compared with the previous year. For example, from January through October 2008, FDA received 948 adverse event reports--596 of which were mandatory reports submitted by industry--compared with 298 received over the same time period in 2007. Although FDA has received a greater number of reports since the requirements went into effect, underreporting remains a concern, and the agency has further actions planned to facilitate adverse event reporting. FDA has taken some steps to identify and act upon safety concerns related to dietary supplements; however, several factors limit the agency's ability to detect concerns and remove products from the market. For example, FDA has limited information on the number and location of dietary supplement firms, the types of products currently available in the marketplace, and information about moderate and mild adverse events reported to industry. Additionally, FDA dedicates relatively few resources to oversight activities, such as providing guidance to industry regarding notification requirements for products containing new dietary ingredients. Also, once FDA has identified a safety concern, the agency's ability to remove a product from the market is hindered by a lack of mandatory recall authority and the difficult process of demonstrating significant or unreasonable risk for specific ingredients. Although FDA has taken some actions when foods contain unsafe dietary ingredients, certain factors may allow potentially unsafe products to reach consumers. FDA may not know when a company has made an unsupported or incorrect determination about whether an added dietary ingredient in a product is generally recognized as safe until after the product becomes available to consumers because companies are not required to notify FDA of their self-determinations. In addition, the boundary between dietary supplements and conventional foods containing dietary ingredients is not always clear, and some food products could be marketed as dietary supplements to circumvent the safety standard required for food additives. FDA has taken limited steps to educate consumers about dietary supplements, and studies and experts indicate that consumer understanding is lacking. While FDA has conducted some outreach, these initiatives have reached a relatively small proportion of dietary supplement consumers. Additionally, surveys and experts indicate that consumers are not well-informed about the safety and efficacy of dietary supplements and have difficulty interpreting labels on these products. Without a clear understanding of the safety, efficacy, and labeling of dietary supplements, consumers may be exposed to greater health risks associated with the uninformed use of these products. Click here to view the original article.

Click here to view the full report.

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