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, Drug and Cosmetic Act, as amended (most relevantly by DSHEA, the Dietary Supplement Health and Education Act of 1994) contains three categories--foods, dietary supplements and drugs.
The basic difference between foods and supplements is that supplements may only appear in conventional food form if they are not represented as conventional food. Not every food is a supplement.
The Food and Drug Administration (FDA) has notified one company that soup may not be labeled as a dietary supplement if its soup attributes are mentioned. Similarly, FDA has advised companies that snacks (dry or liquid) are foods and not supplements. The law itself states that a supplement may not be represented as a meal replacement. This means the 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 made for the product.
In its ten year plan, FDA made identifying boundaries between dietary supplements and conventional foods a priority, i.e., to "clarify boundaries between dietary supplements and foods by defining key terms and phrases (e.g., "intended for ingestion" and "represented for use as a conventional food") and clarifying the 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 simple products like drinks can be marketed as dietary supplements. Manufacturers are confused as well. This becomes evident when botanical ingredients that are not GRAS for food use are seen on the labels of products not labeled as dietary supplements.
While there is no direct legislative history, it is clear that Congress sought to enlarge, rather than restrict, dietary supplement delivery systems. FDA recognized this change 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 the provision that excluded products that simulate conventional foods from the coverage of section 411 of the act (see section 3(c)(2) of DSHEA). Thus, under the act, as amended by DSHEA, 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 is not represented for use as a conventional food. [62 Fed. Reg. At 49862.] Whether a product is 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 the term 'dietary supplement' [or a modification thereof such as 'herbal supplement'] as part of its common or usual name." The Agency also noted that the term dietary supplement in the statement of identity "may not be enough to establish that the food is appropriately regulated as one."
62 Fed. Reg. at 49862: If the food is represented as a dietary supplement and is only intended to increase the dietary intake of specific substances (e.g., vitamins), then the product 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 it bears a statement that associates it with a conventional food. For example, a product in bar form that is labeled as a dietary supplement but that also bears label statements that represent it as a snack food or as a substitute for a candy bar would be subject to regulation as a conventional food. Similarly, a breakfast cereal-type product could characterize itself as a dietary supplement if it did not represent itself as a breakfast food or use the term "cereal" as a statement of identity. Either of the latter two scenarios would represent the product as a conventional food. [Id.]
It is this last discussion which, read in its broadest form, represents a serious misdirection by FDA with respect to the implementation of DSHEA. Does this mean that a conventional food supplement may only be intended to increase the dietary intake of specific substances, and may not bear any statement that associates it with a conventional food?
Taken to the extreme, flavor (e.g., chocolate) could not be associated with a conventional food form supplement since a statement of flavor is "associated with" conventional food. Similarly, labeling the presence of particular food ingredients (e.g., whole grains) in conventional food form dietary supplements is "associated with" conventional food. Moreover, the texture (e.g., chunky) of a conventional food form dietary supplement is "associated with" food. Finally, the word "cereal" could not be used at all to describe a product, even though the conventional food form of the supplement is cereal. If read literally, the Agency's admonition against the use of "a statement that associates [a dietary supplement] with a conventional food" (62 Fed. Reg. At 49862), would nullify Congress' intent to broaden dietary supplement delivery systems to include conventional food forms, an expansion which was wholly consistent with the overriding Congressional purpose of DSHEA to 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 information about the products they buy than consumers of conventional food. Moreover, to the extent that dietary ingredients do not meet the strict criteria for food additives or general recognition of safety, products labeled as dietary supplements are plainly distinguished from food and quantify the amount of such ingredient in the product. By discouraging dietary supplements in conventional food form, FDA encourages the marketing of conventional foods containing dietary ingredients without any of the indicia of dietary supplements.
Dietary Supplement in Conventional Food Form:
- Dietary Supplement appears in the statement of identity in bold type on the principal display panel.
- Nutrition labeling is prominently titled Supplement Facts.
- Dietary ingredients for which RDI's and DRV's have not been established must be declared by their common or usual name and their quantitative amount by weight presented.
- Dietary ingredients must be reasonably expected to be safe but need not be approved food additives, GRAS listed or GRAS self-affirmed.
- Structure/function statements must bear DSHEA disclaimer.
- "Food" attributes may not be emphasized.
- No statement differentiating this food from other conventional food.
- Nutrition labeling is titled Nutrition Facts.
- Non RDI or RDA ingredients are listed in ingredient labeling and are not quantified.
- All ingredients must be approved food additives, GRAS listed or GRAS self-affirmed.
- Structure function statements need not bear DSHEA disclaimer.
- "Food" attributes may be emphasized.
Anthony Young is a partner with Washington D.C.-based Piper Marbury Rudnick & Wolfe LLP.