Human Sports Performance

AVOIDING REGULATORY INTERVENTION

February 2011

FDA & FTC REGULATIONS
FDA: FOOD & DRUG LAW
DIETARY SUPPLEMENT LAWS

Avoidance of government regulatory intervention from the Food & Drug Administration (FDA) and/or the Federal Trade Commission (FTC) in relation to marketing Dietary Supplements requires a thorough understanding of the laws related to claims.

Under DSHEA, and under approval of the United States government, the Food & Drug Administration (FDA) has the statutory authority to:

•	Seize dietary supplements that represent a significant risk of injury or illness (or other side effects) to the public
•	Instigate criminal action against any company that markets/sells any dietary supplement that is toxic or contaminated
•	Halt the marketing/sale of a dietary supplement or raw material that has shown evidence of danger to public health
•	Halt the marketing/sale of a dietary ingredient that has not shown safety-in-humans and/or has not been submitted to the FDA for Pre-Market Notification

The FDA has authority over labels for most food products. The FTC has authority over advertising. Both the FDA and the FTC have authority over labeling.

The FDA generally has authority over labels and labeling, but when false claims are made in advertising or promotional material, the FTC will also intervene. The FTC has the capacity to levy much stronger fines and harsher penalties.

This fierce monitoring of the food & supplement industry by the FDA/FTC demonstrates the importance for all companies to comply with all requirements or risk intervention from regulatory agencies.

In many cases, despite the pleading of ignorance of the law by manufacturers and marketers, the FDA/FTC has levies fines of $250,000. to $1.5 million dollars, which must be paid.

DEFINING FDA/FTC LABELING LAWS

•	The Federal Food, Drug & Cosmetic Act defines a "label" as the "written printed or graphic material on the immediate package" and "labeling" means "all labels and other written, printed, or graphic matters upon any article or any of its containers or wrappers, or accompanying such article."
•	Labeling encompasses the label and all accompanying material on or near the package at the point of purchase.
•	The FDA/FTC requires strict enforcement of “truthful and not misleading” guidelines for all labels and marketing materials
•	All labels and accompanying material must comply with FDA requirements. If there are any issues regarding non-compliance, the FDA and/or the FTC will intervene to remedy the non-compliance.
•	TV Advertising and printed material must comply with FDA requirements (per the Code of Federal Regulations/CFR), and in this type of advertising, the FTC mandates compliance and polices the industry.
•	Website material is also subject to these guidelines when said URL appears on a label or accompanying material is considered “labeling” and is under the jurisdiction of both the FDA and the FTC. If the URL is not printed on the label or attendant literature, it is still governed by the FTC and must comply with all FTC regulations for labeling.

HOW ARE DIETARY SUPPLEMENTS DEFINED?

Dietary supplements are defined, in part, as products (other than tobacco) intended to supplement the diet that bear or contain one or more of the following dietary ingredients:

a.	A vitamin;
b.	A mineral;
c.	An herb or other botanical;
d.	An amino acid;
e.	A dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
f.	A concentrate, metabolite, constituent, extract, or a combination of any ingredient mentioned above.

Further, dietary supplements are products intended for ingestion, are not represented for use as a conventional food or as a sole item of a meal or the diet, and are labeled as dietary supplements.

The complete statutory definition is found in section 201(ff) of Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321).

NUTRITION FACTS VS SUPPLEMENT FACTS

Conventional foods are labeled with Nutrition Facts while dietary supplements are labeled with Supplement Facts.

A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet.

“Dietary Ingredients” include: vitamins, minerals, herbs/botanicals, amino acids, enzymes, organ tissues, glandulars, metabolites, extracts or concentrates.

Dietary supplements take many forms, including powders, tablets, capsules, softgels, gelcaps, and liquids. They can also be in the form of a bar, and in this case, information on the label must not represent the product as a conventional food or a sole item of a meal or diet. Regardless of the form, every supplement must be labeled as a dietary supplement.

ILLEGAL CLAIMS

IT IS ILLEGAL TO MARKET A DIETARY SUPPLEMENT AS A TREATMENT OR A CURE FOR ANY DISEASE OR MEDICAL CONDITION

Any product sold as a dietary supplement and promoted as a treatment, prevention or cure for a specific disease or condition is considered an unapproved and illegal drug.

This applies to the label as well as any accompanying material that is used to promote and market a specific product.

ILLEGAL CLAIMS INCLUDE:

•	The naming of a specific disease or class of diseases in relation to a non-drug product or dietary supplement
•	The use of scientific or lay terminology to describe the product's effect on one or more signs or symptoms recognized by health-care professionals and consumers as characteristic of a specific disease or a number of different specific diseases
•	Naming a product (product name) in relation to any disease state
•	Using citations or references that refer to disease
•	Any use of the words "disease" or "diseased"
•	Any art, such as symbols and pictures, to depict disease
•	Using any statements that the product can substitute for an approved therapy (for example, a drug).

The FTC regulates claims made in the advertising of dietary supplements, and has taken a number of strong enforcement actions against companies whose advertisements contained false and misleading information.

An example of an illegal claim is the erroneous statement that chromium is a treatment for weight loss and/or high blood cholesterol or that a thermogenic product can induce weight loss.

All labeling and marketing materials for dietary supplements must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.

RULINGS ON TESTIMONIALS

The FTC has ruled that TESTIMONIALS ARE NOT ALLOWED UNLESS THEY ARE “BACKED BY HARD CORE SCIENTIFIC EVIDENCE”

The Federal Trade Commission (FTC) has determined that all marketing material “must be truthful and substantiated by scientific evidence” and that “all who participate in selling must comply.”

Dietary supplements fall under these guidelines, including all of the following advertising formats:

•	Internet
•	Websites
•	Brochures
•	Flyers
•	Claims made on television and radio
•	Personal testimonials

Even if a testimonial represents an individual's honest opinion, it must be backed by appropriate scientific evidence, according to FTC regulations.

Richard Cleland, Assistant Director of the Federal Trade Commission’s Division of Advertising Practices, stated:

"If you are making a claim, either expressed or implied, that your product is going to cure [serious conditions], you will be required to produce the highest possible level of scientific validation, and testimonials are NOT scientific validation."

Anecdotal evidence about the individual experience of consumers is not sufficient to substantiate claims

Even if those experiences are genuine, they may be attributable to a placebo effect or factors unrelated to the supplement.

Individual experiences are not a substitute for scientific research

Ads that include testimonials should be backed by adequate substantiation that the testimonial experience represents what consumers will generally achieve when using the product, wherein said data is supplied by the manufacturer.

Vague disclaimers like "results may vary" are likely to be insufficient.

Whenever an expert or consumer endorser is used, the advertiser should disclose any material connection between the endorser and the advertiser of the product that the consumers would not reasonably expect.

LIPTON GREEN TEA BRANDED AS A “DRUG”

In 2010, the Food and Drug Administration notified Unilever Americas that claims for Lipton Green Tea 100% Natural Naturally Decaffeinated Lipton were deemed drug claims and must be amended or removed.

Lipton Green Tea 100% Natural Naturally Decaffeinated was found to be in breach of the Federal Food, Drug, and Cosmetic Act for making unsubstantiated, cholesterol-related disease reduction claims and misleading nutrition content claims.

The FDA stated that statements made on two Lipton Tea websites (www.lipton.com and www.liptont.com) established that the product was indeed a drug, per FDA guidelines.

Lipton was not the only tea product to be slammed by the FDA. A warning letter was also sent to the Dr Pepper Snapple Group when the FDA ruled that Canada Dry Sparkling Green Tea Ginger Ale was making unapproved claims.

A recent ruling regarding dietary supplements, including a green tea product, resulted in a California supplement manufacturer being ordered to pay $2.65 million dollars over alleged misleading advertisements and failure to label lead is in its products. In addition to the $2.65 million, Irwin Naturals was ordered to add labels to its products with warnings about lead.

FDA FINDS 70 FRAUDULENT WEIGHT LOSS SUPPLEMENTS

The U.S. Food and Drug Administration (FDA) has intensified its clamp-down on adulterated weight loss dietary supplement products, which have been found to contain illegal substances, including pharmaceutical/drug ingredients.

By the end of 2009, the FDA had targeted 70 fraudulent products marketed for weight loss. The companies marketing the fraudulent products were warned by the FDA that if they do not respond to recall demands, additional enforcement measures will be taken, including product seizures, injunctions and/or criminal charges.

FTC ATTACKS ARGININE CLAIMS

In 2003, the Federal Trade Commission (FTC) took action against the marketers of an arginine-containing product, called HeartBar, which claimed to protect its users against cardiovascular disease.

The resulting consent agreement prohibits unsubstantiated statements and representations related to the HeartBar Arginine product.

Unither Pharma, Inc. and United Therapeutics Corporation were charged by the Federal Trade Commission (FTC) for making deceptive claims in advertising for their HeartBar L-Arginine product.

The FTC charged that their claims were not supported by scientific evidence. The company was prohibited from repeating the deceptive claims for HeartBar and other L-Arginine products and barred them from making any unsubstantiated claims about the health benefits, performance, or efficacy of any food, medical food, or dietary supplement used in or marketed for the treatment, cure, or prevention of cardiovascular disease.

Unither Pharma, Inc. had an impressive medical advisory board of numerous physicians and researchers who backed the claims used to promote their arginine products, but the FTC was not impressed and stated that the doctors had no authority to make the claims on arginine.

HeartBar’s manufacturer, Cooke Pharma Inc, boasted the presence of Nobel laureate, Dr. Louis Ignarro, who served on their Scientific Advisory Board. Dr. Ignarro defended the science behind the HeartBar product, which was ultimately not accepted by the FTC. The FTC stated that HeartBar had a “misleading label and questionable benefits.”

Dr. Ignarro endorsed HeartBar and stated "I believe the claims of the product to have a sound basis which warrants continued investigation into determining the dose, so to speak, of HeartBar necessary to achieve the desired beneficial effects," he said.

Dr. Louis Ignarro currently works with Herbalife, promoting their Niteworks L-arginine product, and states, "Herbalife is very careful about what we say on the label."

Sources:

United States of America, Federal Trade Commission, In the Matter of Unither Pharma, Inc. and United Therapeutics Corporation, The Federal Trade Commission, having reason to believe that Unither Pharma, Inc., a corporation, and United Therapeutics Corporation, a corporation, have violated the provisions of the Federal Trade Commission Act, and it appearing to the Commission that this proceeding is in the public interest, alleges. . .

Agreement containing consent order. In the matter of Unither Pharma, Inc., and United Therapeutics Corporation, FTC File No. 022 3036.

FTC alleges Maryland companies lack support for claims that HeartBar is effective against cardiovascular diseases. FTC news release, June 12, 2003.

MONAVIE JUICES DEEMED “DRUGS” BY THE FDA

On July 6, 2007, the FDA stated, in a warning letter sent to Monavie Corporation Headquarters, that MonaVia Original, MonaVie Active, MonaVie Combo, and MonaVie Gel are “promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).”

Clearly, the FDA is not going to tolerate drug claims on dietary supplements.

CLINICAL TRIALS ARE REQUIRED

Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 343(r)(6)) requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim have substantiation that the claim is truthful and not misleading.

This guidance document is intended to describe the amount, type, and quality of evidence FDA recommends a manufacturer have to substantiate a claim under section 403(r) (6) of the Act. This guidance document is limited to issues pertaining to substantiation under section 403(r)(6) of the Act; it does not extend to substantiation issues that may exist in other sections of the Act.

When the FDA and/or FTC evaluate a claim for substantiation, an important consideration is the scientific quality of studies.

Scientific quality is based on several criteria including:

•	Study population
•	Study design and conduct
•	Data collection (e.g., assessment method)
•	Statistical analysis
•	Outcome measures
•	Human subject utilized as opposed to animal* studies
•	Expertise of the clinical examiners
•	Generally accepted scientific and statistical principles

For example, if the scientific study adequately addressed all or most of the above criteria, it is considered of high quality. Generally accepted scientific and statistical principles should be used to determine the quality of the studies used as evidence to substantiate a claim.

The "gold" standard in claim substantiations are “Human In Vivo Clinical Trials”, double-blinded when appropriate, conduced by scientific and medical professionals knowledgeable in the field.

“In Vitro” trials are not sufficient for most claims, such as “Low Glycemic” claims**.

In Vitro studies are studies that are done outside a living body. For example, such studies might examine a product's effect on isolated cells or tissues. These studies are of limited value in predicting the effect of a substance when consumed by humans.

The strongest In Vitro evidence would be based on data that have been reproduced in different laboratories, but this evidence alone would not substantiate a claim.

* According to the FDA, without data from human studies, the results of animal studies alone are not sufficient to substantiate a claim.

*, ** Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act

Office of Nutrition, Labeling, and Dietary Supplements
Center for Food Safety and Applied Nutrition
Food and Drug Administration

PEER REVIEW

The nature and quality of the written research report related to the claims for a dietary supplement are considered important.

Contrary to popular opinion, said research does not have to be published in a peer-reviewed journal or publication. The majority of research conduced by food, beverage and dietary supplement products is not published and remains in-house due to the proprietary nature of the evidence.

Although studies or evidence used to substantiate a claim do not have to be published, when appropriate, such publications do give some level of assurance that qualified experts have reviewed the research and found it to be of sufficient quality and validity to merit publication.

Moreover, the mere fact that the study was published does not necessarily mean that the research is competent and reliable evidence adequate to substantiate a particular claim.

FDA & FTC SUBSTANTIATION STANDARDS FOR CLAIMS

The FTC standard of competent and reliable scientific evidence has been defined in FTC case law as:

"Research, studies, testing, analyses, or other clinical evidence based on the expertise of professionals in the relevant area, that has 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."

If there is an existing standard for substantiation developed by a government agency or other authoritative body, the FTC can accord some deference to that standard.

Premier evidence is defined as Human In Vivo Clinical Trials conducted by government agency or other authoritative body.

ILLEGAL WEIGHT LOSS CLAIMS

Thermogenic products cannot make weight loss claims. This is because a legal, valid Thermogenic product can claim to burn fat, which is not the same as weight loss.

EXAMPLE OF AN ILLEGAL WEIGHT LOSS CLAIM

In this example of an illegal weight loss claim, a manufacturer and/or marketer states that their product, a dietary supplement, "promotes weight loss."

In this example, the dietary supplement contains various vitamins and minerals and a botanical extract.

The manufacturer has relied on a randomized controlled double-blind clinical study showing that subjects who took the botanical extract had a small but significant increase in metabolism over subjects taking a placebo over a 24 hour period.

The study did not examine the effect of the extract on subjects' weight and there is no research showing that a short term increase in metabolism will translate into any measurable weight loss.

Thus, this weight loss claim is considered illegal, and misbranded, and would likely not be considered adequately substantiated or allowed.

•	STARCH-BLOCKERS
•	CARB-BLOCKERS
•	FAT-BLOCKERS

FDA RULES ON ILLEGAL CLAIMS

The Food & Drug Administration (FDA) has sent out specific warning letters to companies making illegal claims regarding Carb-Blockers and Fat-Blockers. The FDA stated that the claims caused the products to be “Misbranded under the Federal Food, Drug, and Cosmetic Act (the Act).”

Specifically, the FDA noted that the unsubstantiated claims including those related to blocking the digestion of dietary starches, and reducing the available calories your body may otherwise convert to fat.

One specific FDA warning letter stated:

“We have reviewed these claims and have concluded that they are not supported by competent and reliable scientific evidence. Because these claims lack substantiation, they are false or misleading, and cause your products to be misbranded within the meaning of sections 403(a)(1) and 403(r)(6)(B) of the Act. [21 U.S.C. 343(a)(1), (r)(6)(B).] It is a violation of section 301 (a) of the Act to introduce or deliver for introduction into interstate commerce any food, including a dietary supplement, that is misbranded. [21 U.S.C. 331(a).] It is a violation of section 301 (k) of the Act to commit any act with respect to a food if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being misbranded. [21 U.S.C. 331(k).]

This letter is not an all-inclusive review of your web site and the products that your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.

You should take prompt action to correct any violations, including the violations identified in this letter. Failure to do so may result in enforcement action, including seizure or injunction, without further notice.”

This letter is an example of the full ability of the FDA to take action against unproven claims, and enacting “enforcement action, including seizure or injunction, without further notice.”

Another product claiming to be a starch-blocker was also notified by the FDA that their literature and website claims were not substantiated. Said claims included “allows carbohydrates to pass through the [digestive] system possibly with less caloric intake” and “successfully clinically studied to ‘neutralize’ dietary starch absorption by over 70%, with slow, steady stimulant-free weight loss” and “improvement of post-prandial glucose tolerance” and “allows you to enjoy those foods that you love without all the calories.”

The FDA responded to those claims with the following:

“We have reviewed these claims as well as the studies located on your website and have concluded that these claims are not supported by competent and reliable scientific evidence. Because these claims lack substantiation, they are false or misleading, and cause your product to be misbranded within the meaning of section 403(a)(1) of the Act. It is a violation of section 301(a) of the Act (21 U.S.C. 331(a)) to introduce or deliver for introduction into interstate commerce any food, including a dietary ingredient, that is misbranded. It is a violation of section 301(k) of the Act (21 U.S.C. 331(k)) to commit any act with respect to a food if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being misbranded.

This letter is not intended to be an all-inclusive review of the labeling, including promotional literature or your websites, for products marketed by your firm. You should take prompt action to correct any violations identified in this letter. Failure to do so may result in enforcement action, such as seizure or injunction, without further notice.

Please advise this office, in writing and within fifteen (15) working days of receipt of this letter, as to the specific steps that you have taken to correct any violations and to assure that similar violations do not occur. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be made.”

VITAMINS, GARLIC, FISH OIL, COENZYME, LYCOPENE DEEMED “DRUGS” BY THE FDA

The FDA has ruled that regular vitamins can be deemed “drugs” if the claims related to the product are illegal by FDA standards. In one example, the FDA sent a warning letter to a company that made illegal marketing claims:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site and has determined that the products "Garlic Extract 500mg 180 capsules", "A Vitamin (from fish liver oil) 25,000 IU 100 softgels", "Coenzyme Q10 30mg 120 capsules", and "Lycopene 10mg 60 softgels" are promoted for conditions that causes the product to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)(1)]. The therapeutic claims on your web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.

BEST DEFENSE

The FDA and FTC clearly have the authority and an aggressive stance against illegal claims.

The best defense against FDA/FTC actions taken against dietary supplements includes in-house legal knowledge related to regulatory compliance.

Utilizing knowledgeable legal council, well-versed in FDA/FTC regulatory guidelines, is mandatory in the prevention of government agency intervention.