Dealing with DSHEA – Understanding the Regulations Which Govern the Supplement Industry

Every now and then the FDA still pulls it’s storm-trooper act, complete with black jumpsuits, helmets with plexi-glass face plates and bullet proof vests. With machine guns at the ready, they’ve been known to bust into corporate offices and have the whole place, from warehouse clerks to secretaries to corporate executives spread-eagled against the wall.

If it weren’t for the fact that this actually happened to one of my clients recently, I’d pass it off as another urban legend. You’d think that the FDA would have better things to do than shake down a company selling a homeopathic weight control patch.

On the other hand, the FDA has a very important job. Protecting the consumer from dangerous drugs, contaminated foods, untested cosmetics or misleading statements that might cause people to self medicate with a nutrient when medical treatment is actually called for.

The purpose of this article is to give you a better idea of how the Dietary Supplement Health Education Act (DSHEA) governs the nutritional supplement industry and the ways in which it influences what can be sold as a dietary supplement, and also how those same supplements can be marketed.

Prior to 1994 the Food and Drug Administration had broad control over the dietary supplement industry. That’s because the provisions for dietary supplements were undifferentiated from the laws which governed foods, drugs and cosmetics. These laws, which were enacted as the Food Drug and Cosmetic Act in 1958 were never intended to deal with the broad class of compounds which today constitute the bulk of the items sold as dietary supplements.

In 1994 bowing to intense pressure from the public as well as from proactive members of congress, including Senator Orrin Hatch of Utah, the Dietary Supplement Health Education Act was signed into law by President Clinton.

DSHEA, sometimes referred to as the Hatch Proxmire Amendment made sweeping changes to the way in which supplements were evaluated prior to distribution to retail channels.

Rather than being subject to the intensive pre-marketing approval process required of new food ingredients or for new uses of old food ingredients, the new law provided for a different set of safety requirements for dietary supplements.

Essentially, the provisions detailed in DSHEA define dietary supplements and dietary ingredients, establish a new framework for assuring safety, outline guidelines for literature displayed where supplements are sold, specify the types of statements and claims which can be made about products and/or individual ingredients, provide a detailed template for labeling and ingredient disclosure of dietary supplements, and grant the FDA the authority to establish good manufacturing process (GMP) for dietary supplements. The law also requires the formation of an executive level Commission on Dietary Supplement Labels and an Office Dietary Supplements within the National Institutes of Health.

Dietary Supplements According to DSHEA

Based on DSHEA, the definition of a dietary supplement is actually fairly narrow. To wit; dietary supplements include vitamins, minerals, herbs and similar nutritional substances, fish oils, psyllium, enzymes, glandulars, and mixtures of these.

Specifically, a dietary supplement:

• Is a product, (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients; a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extracts of combinations of these ingredients.
• Is intended for ingestion in pill, capsule, tablet, or liquid form.
• Is not represented for use as a conventional food or as the sole item of a meal or diet.
• Is labeled as a “dietary supplement”.
• Includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval certification or license (unless the Secretary of Health and Human Services waives this provision)

Repercussions of these requirements as they pertain to bodybuilders.

Perhaps the most critical provision above relates to the second clause. I spoke with Dr. Robert Moore, the director of the Office of Special Nutritionals (which is the department within the FDA which governs dietary supplements) to get him to clarify this clause.

When questioned about ingestion methods of supplements his response was “dietary supplements are to be consumed as or like food” This specifically excludes methods of delivery which intentionally bypass the gastrointestinal tract.

This means that both transdermal and transmucosal delivery systems are expressly prohibited. A fact which he verified by stating that both of these compound delivery methodologies are “drug delivery systems” and that the constituent components delivered via these methods are certainly not intended to supplement the diet.

In other words, both the prohormone transdermal gels, and even more specifically the cyclodextrin/prohormone complexes (not to mention the topical/injectible prohormone mixtures) based upon their marketing materials which specifically describe the fact that by delivering the nutrient compounds directly into the bloodstream they increase absorption which is compromised by the digestive tract and the first pass through the liver.

Just so there was no confusion, I also asked Dr. Moore if either of the above examples would be eligible to be marketed as a homeopathic drug. Again, his response was negative. Homeopathic drugs are covered under their own unique section of the FD&C Regulations. Critically, the only ingredients which are approved to be marketed as homeopathic drugs must be listed in Clarke’s Materia Medica of Homeopathic Compounds which is the basis for the United States Homeopathic Pharmacopoeia.

Additionally, the US Homeopathic Pharmacopoeia specifies acceptable delivery methodologies. For example, sublingual absorption is allowed, so is topical delivery, however, unless the compounds which act as carriers are also listed in the USHP the compound will not be eligible to be a homeopathic drug.

So if compounds like the cyclodextrin prohormones aren’t homeopathic drugs, and based upon their method of nutrient delivery, aren’t dietary supplements either, what are they?

Well, according to Dr. Moore they’re unapproved new drugs.

That’s because DSHEA amends the adulteration provision of the FD&C Act as follows:

Under DSHEA, a dietary supplement is adulterated if it or one of its ingredients presents a “significant or unreasonable risk of illness or injury” when used as directed on the label, or when used under normal conditions if no directions for use are stated on the label. Further, a dietary supplement is considered to be adulterated when it contains a new dietary ingredient (any dietary ingredient which was not sold as dietary supplement prior to 1994) for which there is inadequate information to provide reasonable assurance that the ingredient will not present a significant or unreasonable risk of illness or injury.

A product may also be considered adulterated if the Secretary of the Department of Health and Human Services determines that it poses an imminent hazard to public safety. However, like any other foods, it is a manufacturers responsibility to ensure that its products are safe and properly labeled prior to marketing.

This means that the marketers and manufacturers of these compounds can be prosecuted for selling unapproved new drugs as spelled out in the Code of Federal Regulations.

Further, according to Dr. Moore, even the conventional prohormones pose some problems. That’s because according to DSHEA, a compound which has not been sold as a dietary supplement prior to 1994 must have pre-market approval as a new dietary ingredient prior to marketing and sale.

To Dr. Moore’s knowledge none of the prohormones have had NDI applications filed. Additionally, Dr. Moore suggested to me that it was likely that none of the prohormones would have been issued an NDI because there was insufficient data to support the safety of these compounds for regular human consumption.

In other words, someone didn’t do their homework. Of course, the repercussions to the bodybuilding nutrition industry could be significant.

Not only are the sales of prohormones a significant portion of the revenues of numerous bodybuilding supplement marketers, they also represent a significant source of advertising revenue for any number of magazines published for and about the sport of bodybuilding.

What about literature and product claims?

DSHEA of course has specific provisions for the marketing statements that are acceptable for dietary supplements. A basic summary of these regulations follows:

Literature

Supplement stores are allowed to make available “third-party” literature to help inform consumers about any health related benefits of dietary supplements. These can include articles, book chapters, scientific abstracts and articles, audio and video tapes, web content, etc.

The provisions stipulate that the information must not be false or misleading; must be displayed with other similar materials to present a balanced view; must be displayed separate from supplements and may not have other information attached (product promotional information for example).

This means, for example that a supplement retailer can’t hang a favorable study on Coenzyme Q10 and heart disease on a shelf adjacent to CoQ10 products.

Similarly, a web site like Mesomorphosis can have page after page of articles detailing the benefits of supplements so long as the information is fairly presented and there are not direct hyperlinks within the page or along the borders connecting such a page with specific products.

Advertising and Labeling

The regulations for advertising (which is controlled not by the FDA, but by the FTC) and the provisions for what constitutes adequate substantiation for claims are beyond the scope of this review, however there are certain basic criteria which pertain to all advertising of dietary supplements. They are as follows:

The FTC’s truth in advertising law as it relates to supplements can be distilled to two distinct propositions;

• Advertising must be truthful and not misleading.

AND

• Before dissemination of an advertisement advertisers must have adequate substantiation for all objective product claims.

A deceptive advertisement is one the contains an omission or misrepresentation that is likely to mislead consumers acting reasonably under the circumstances to their detriment. The FTC’s substantiation standard is flexible and dependent upon numerous factors. Typically, the FTC evaluates claims relating to the safety and efficacy of foods, dietary supplements and drugs based upon a standard of the presence or absence of competent and reliable scientific evidence.

There are three distinct types of claim that an advertiser may make, providing of course that those claims meet with the two above criteria.

Nutrient Content Claims

This type of claim is exactly what it sounds like. A claim that a product in fact has a given amount of a specific nutrient. The claim would of course be substantiated by the nutrient content claim being met by the contents of the product. Such a claim is more common in foods that dietary supplements. An example would be a commercial dairy milk product with added vitamin E claiming that the product was high in vitamin E.

Disease Claims

The second claim is a disease claim. Only 5 disease claims have been approved by the FDA for dietary supplements. These include calcium and osteoporosis, folate and neural tube defects, oat bran and cholesterol, oat bran and colorectal cancer, psyllium husk and colorectal cancer.

Companies can also make claims regarding nutrient deficiency diseases providing they also detail the relative occurrence of such a disease within the general population. One such association would be vitamin C and scurvy. As you can imagine these claims are not terribly common because in the US where occurrence of these types of diseases is almost non-existent, the benefit to the consumer is commensurately low.

Any company which intends to make a claim relating to a specific disease other than those listed above must first request permission from the FDA.

Structure/Function Claims

The third kind of claim is a structure/function claim. These are the most varied and also the most common. Unfortunately, they also happen to be the claims that are the most frequently misused.

A structure function claim details the effects of a specific nutrient or combination of nutrients on the structure or function of the human body. Marketers of dietary supplements can also make statements about the “well being” achieved by the use of a specific ingredient.

To use these claims, manufacturers are required to have adequate substantiation based upon the nature of the claim being made. For example, if a company refers to a scientific study or a number of studies demonstration that a certain ingredient can promote improved cognitive function, they must in fact, have possession of the aforementioned studies. Further, those studies must truly be representative of the claim. A study on rats, for example would not be adequate substantiation for a claim like the one above.

It goes without saying that statements must also be truthful and not misleading, as I mentioned previously. Additionally, product labeling or advertising (which is considered to be an extension of product labeling) which contains any statements of nutritional support or structure function claims must bear the following disclaimer:

“These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”

If you see advertising or labeling that has a structure function claim but is lacking this FDA disclaimer, which is altogether far too common, it’s likely that the company will eventually get into trouble. Most of the time, this is more a sin of omission than intentional negligence. Particularly since these disclaimers are now so common that they hardly present a significant detraction from a consumer standpoint.

There are of course further regulations detailing labeling regulations, manufacturing practices, third party literature and others. Beyond this, the regulations diverge slightly for cosmetics, prescription and OTC pharmaceuticals, and homeopathic drugs.

We will cover this these topics in detail in a greater installment. Also in a forthcoming installment, I’ll detail the type of penalties levied against supplement companies for violations of the various regulations I’ve just detailed.

One note in closing…if the advertising you are reading seems hyperbolic or you can’t find a reference on medline that seems to correspond to the claims about a product, it’s a good chance that the research doesn’t exist, the claims are bogus and your money could be better spent.

References

Code of Federal Regulations, 21 101.36, 4/4/99

Dr. Robert Moore, Director Food and Drug Administration Office of Special Nutritionals, Personal Communication

Dietary Supplement Health Education Act, Final Rules, 9/21/98