Dealing with DSHEA: Understanding the Regulations Which Govern the
Supplement Industry
by Oliver Starr
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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 (which now would also include online shops like
Peakhealth.net, PlanetRx.com, and of course BeyondMuscle.com)
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.
Please send us your feedback on
this article.
Oliver W. Starr,
CEO, Supplement Facts, Inc.
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
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