"Functional Foods" Take Heat as Industry Burns

"Functional Foods" Take Heat as Industry Burns
by Anthony Young

The United States General Accounting Office (GAO), an arm of the United States Congress, and the Center for Science in the Public Interest (CSPI), a food-oriented consumer advocacy group, issued reports mid-July questioning the safety and integrity of functional foods. The reports questioned the use of dietary supplement ingredients in conventional foods and in conventional food-form dietary supplements. However, CSPI failed to note the legal differences between foods and supplements, condemning functional foods that contain the allegedly unsafe ingredients. GAO takes a different tack; it noted the differences in requirements between foods and supplements but said consumers won't recognize the differences. In any event, it said, the law does not require that FDA pre-market review to determine that ingredients are shown to be safe or that structure function claims have evidentiary support.

CSPI identified certain ingredients as problematic, including kava kava, echinacea, ginkgo biloba, guarana, spirulina, grape seed extract, St. John's wort, gotu kola, dong quai, vitex and nettles.

CSPI also noted that it asked FDA to rule on the safety of ginseng for use in food. It did not help that an herbal medicine guru [Dr. Varro Tyler] appeared at the CSPI press conference to say that herbal medicines don't belong in drinks, snacks or cereals. [GAO mentioned three botanicals, but its report was much more philosophical and less ingredient- or product-specific than CSPI.]

Whether the GAO report and the CSPI petition will hurt category sales or whether the truism "there is no bad publicity" will work its ways won't be known for some time. Nonetheless, the subject of dietary ingredients in so-called functional foods is a subject that the dietary supplement industry needs to aggressively address. The best resolution of product integrity issues related to innovative forms of dietary supplements and foods will be written with the active involvement of those with an economic stake in the future of these product categories, and not by FDA or CSPI.

Since FDA has identified the "boundaries between dietary supplements and conventional foods" as one of its program priorities, the Agency will most likely be addressing the issue in the future [as it promised to do in its Ten Year Strategic Plan]. Some trade associations, notably the American Herbal Products Association, have stated their positions to FDA and argued for flexibility in current law definitions to permit product innovation. Other concerned parties should make their views known as well.

Of course, there is no legal product category called "functional food," nor "nutraceutical." The law says we have "foods" and "dietary supplements." When they are in conventional food form there are different legal requirements.

Dietary Supplement in Conventional Food Form:

Conventional Food:

Products labeled as dietary supplements are distinguished by the statement of identity; they quantify the amount of each dietary ingredient in the product. The law on food safety and ingredients for use in food has changed very little in the past 40 years. Any of the ingredients CSPI discusses could be Generally Recognized as Safe (GRAS) if the proper safety demonstration is made. Indeed, many companies have self-affirmed the use of ingredients such as ginseng. But a GRAS petition to FDA, even in its new accelerated form, is a costly process--starting at $50,000, which is why many companies position products as dietary supplements.

There is no direct legislative history on the point, but in DSHEA, Congress sought to enlarge dietary supplement delivery systems. FDA recognized this fact in Federal Register notices, e.g., "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. Thus, "whether a product is a dietary supplement or a conventional food will depend on how it is labeled." These guiding principles were unqualified when first set forth.

FDA made it clear that some forms of food--notably, soup--will not be allowed in supplement form. Indeed, the Agency has informally said that some other products are not appropriate as supplements (e.g., bottled water and ice cream). FDA also noted that the term "dietary supplement" in the product statement of identity "may not be enough to establish that the food is appropriately regulated as one." It is on this basis that FDA has challenged snack foods, candy bars and chipsas supplements.

The dietary supplement industry should be concerned and responsive to the fact that FDA may be in the process of formulating a policy to narrow the functional food category. When GAO reports and CSPI press conferences go unanswered, FDA is simply collecting support for this narrowing position. In DSHEA, Congress gave legal meaning to "dietary supplements." In so doing, Congress set the parameters for distinguishing dietary supplements from conventional food which, the Agency recognized, are "differences and limitations . . . [that] are created by the statute itself. FDA has no authority to modify the regulatory regime that is established by the act." 62 Fed. Reg. at 49860.

The GAO and CSPI reports are the building blocks for amendments to DSHEA. Unless this industry affirmatively polices and promotes itself to protect its franchise, DSHEA could become a historical footnote. The adage "there is no bad publicity" captures little long-term market share. As this industry now knows, prolonged bad press blunts sales and has a negative "bandwagon" effect.

Anthony L. Young is a partner with Piper Marbury Rudnick & WolfeLLP.