Dietary Supplement, Food or Drug?

Dietary Supplement, Food or Drug?
by Anthony L. Young

Marketing and promotional hype aside, I hope no one is shocked to learn there is no"legal" category called nutraceutical or functional food. The Federal Food, Drugand Cosmetic Act, as amended (most relevantly by DSHEA, the Dietary Supplement Health andEducation Act of 1994) contains three categories--foods, dietary supplements and drugs.

The basic difference between foods and supplements is that supplements may only appearin conventional food form if they are not represented as conventional food. Not every foodis a supplement.

The Food and Drug Administration (FDA) has notified one company that soup may not belabeled as a dietary supplement if its soup attributes are mentioned. Similarly, FDA hasadvised companies that snacks (dry or liquid) are foods and not supplements. The lawitself states that a supplement may not be represented as a meal replacement. This meansthe claim "for those who skip breakfast" or "alternative to fast food"is a food claim. This means the key to staying in the right class is in the claims madefor the product.

In its ten year plan, FDA made identifying boundaries between dietary supplements andconventional foods a priority, i.e., to "clarify boundaries between dietarysupplements and foods by defining key terms and phrases (e.g., "intended foringestion" and "represented for use as a conventional food") and clarifyingthe forms of dietary supplements. This should be a priority. At the present time,officials in states such as California and Texas are taking a narrow view when simpleproducts like drinks can be marketed as dietary supplements. Manufacturers are confused aswell. This becomes evident when botanical ingredients that are not GRAS for food use areseen on the labels of products not labeled as dietary supplements.

While there is no direct legislative history, it is clear that Congress sought toenlarge, rather than restrict, dietary supplement delivery systems. FDA recognized thischange as follows:

The DSHEA added section 201(ff)(2) which provides that a "dietary supplement"is a product that is not represented for use as a conventional food. It also struck theprovision that excluded products that simulate conventional foods from the coverage ofsection 411 of the act (see section 3(c)(2) of DSHEA). Thus, under the act, as amended byDSHEA, a dietary supplement may be "in conventional food form." In other words,a dietary supplement may be a product with physical attributes (e.g., product size, shape,taste, packaging) that are essentially the same as a conventional food, so long as it isnot represented for use as a conventional food. [62 Fed. Reg. At 49862.] Whether a productis a dietary supplement or a conventional food will depend on how it is labeled. 62 Fed.Reg. At 49862.

The FDA went on to state that "To be a dietary supplement, a product must bear theterm 'dietary supplement' [or a modification thereof such as 'herbal supplement'] as partof its common or usual name." The Agency also noted that the term dietary supplementin the statement of identity "may not be enough to establish that the food isappropriately regulated as one."

62 Fed. Reg. at 49862: If the food is represented as a dietary supplement and is onlyintended to increase the dietary intake of specific substances (e.g., vitamins), then theproduct would likely be subject to regulation as a dietary supplement (section 201(ff)(1)of the act). It would not be subject to regulation as a dietary supplement, however, if itbears a statement that associates it with a conventional food. For example, a product inbar form that is labeled as a dietary supplement but that also bears label statements thatrepresent it as a snack food or as a substitute for a candy bar would be subject toregulation as a conventional food. Similarly, a breakfast cereal-type product couldcharacterize itself as a dietary supplement if it did not represent itself as a breakfastfood or use the term "cereal" as a statement of identity. Either of the lattertwo scenarios would represent the product as a conventional food. [Id.]

It is this last discussion which, read in its broadest form, represents a seriousmisdirection by FDA with respect to the implementation of DSHEA. Does this mean that aconventional food supplement may only be intended to increase the dietary intake ofspecific substances, and may not bear any statement that associates it with a conventionalfood?

Taken to the extreme, flavor (e.g., chocolate) could not be associated with aconventional food form supplement since a statement of flavor is "associatedwith" conventional food. Similarly, labeling the presence of particular foodingredients (e.g., whole grains) in conventional food form dietary supplements is"associated with" conventional food. Moreover, the texture (e.g., chunky) of aconventional food form dietary supplement is "associated with" food. Finally,the word "cereal" could not be used at all to describe a product, even thoughthe conventional food form of the supplement is cereal. If read literally, the Agency'sadmonition against the use of "a statement that associates [a dietary supplement]with a conventional food" (62 Fed. Reg. At 49862), would nullify Congress' intent tobroaden dietary supplement delivery systems to include conventional food forms, anexpansion which was wholly consistent with the overriding Congressional purpose of DSHEAto protect "the right of access of consumers to safe dietary supplements [as]necessary to promote wellness." Pub. L. 103-417 Sec. 2(15)(A).

Plainly, consumers purchasing conventional food supplements receive more informationabout the products they buy than consumers of conventional food. Moreover, to the extentthat dietary ingredients do not meet the strict criteria for food additives or generalrecognition of safety, products labeled as dietary supplements are plainly distinguishedfrom food and quantify the amount of such ingredient in the product. By discouragingdietary supplements in conventional food form, FDA encourages the marketing ofconventional foods containing dietary ingredients without any of the indicia of dietarysupplements.

Dietary Supplement in Conventional Food Form:

Conventional Food:

Anthony Young is a partner with Washington D.C.-based Piper Marbury Rudnick &Wolfe LLP.