On December 4, 2009, The Food and Drug Administration (FDA) released a draft guidance document titled "Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods" (the "Draft Guidance"). The Draft Guidance appears to be FDA's shot-across-the-bow directed at both dietary supplements that look like conventional beverages, and at conventional (functional) beverages that contain ingredients that may not be Generally Recognized as Safe (GRAS) at all or in the amounts used in the product.
It is important to note that this is a draft document and industry has an opportunity to shape the final version before it is released. FDA has requested that comments on the Draft Guidance be submitted by February 2, 2010.
If it looks like a duck ...
The key issue in the first part of the Draft Guidance is the meaning of one word: represented. The Dietary Supplement Health and Education Act of 1994 (DSHEA) provides that a dietary supplement "may not be represented for use as a conventional food." Sounds straightforward, right? Wrong. The problem is that it is unclear what exactly our representatives (pun intended) in Congress intended that provision to prohibit when they passed DSHEA in 1994.
In the Draft Guidance, FDA takes the position that "beverages" are conventional foods, and that the following are "important determinants" of whether a liquid dietary supplement is "represented for use as a conventional food":
- If it is packaged in bottles or cans similar to those in which conventional beverages like soda, bottled water, fruit juice, or iced tea are sold;
- If the serving, packaging, or recommended daily intake suggest that it should be consumed in an amount that provides a significant part of the average fluids a person drinks in a day (1.2 liters); or
- If a product or brand name uses conventional food terms like "beverage," "drink," "water," or "juice."
Nothing in DSHEA expressly states that a dietary supplement in liquid form or otherwise, cannot look like a conventional food, be consumed in relatively large quantities, or use specific terms like "drink." Nevertheless, that is how FDA appears to be interpreting the "represented for use as conventional food" provision, and it undoubtedly has manufactures of legitimate dietary supplements with one or more of these "determinants" very concerned. What is likely adding to their concern is the absence of a list of "determinants" that go the other way. In other words, if a company is selling a dietary supplement in a 16-ounce can, what factors, if any, would FDA consider as mitigating against a determination that the product is represented for use as a conventional food?
Or a functional food ...
The second part of the Draft Guidance is, in a way, the opposite of the first — it concerns liquid products marketed as conventional foods that may more appropriately be marketed as dietary supplements because of the ingredients in the product. Unlike dietary supplements, all ingredients used in conventional beverages generally must either be approved as food additives or be generally recognized as safe (GRAS) for the intended use in the product. If an ingredient in a food is neither, it causes the food to be "adulterated," and cannot be legally sold in the US.
In the Draft Guidance, FDA expresses its "concern" that beverage companies are adding "novel" ingredients that may not be GRAS for their intended use in the product or may not be used in accordance with a food additive approval. FDA further expresses its concern about the safety of new beverages "and other conventional foods" that use ingredients at much higher amounts than they have been traditionally used.
FDA has requested that comments on the Draft Guidance be submitted by February 2, 2010. Even when finalized, a guidance document is not law, and it is not binding on the agency or public. Nevertheless, it does represent the agency's thinking and is likely to drive enforcement decisions. Therefore, it is important to make your views known.
Ivan J. Wasserman is a partner at Mannatt Phelps and Phillips law firm. Manatt is a national law firm with range of specialized capabilities typically found only in boutique firms. Its practice in the nutraceutical industry includes FDA and FTC compliance, trademarks and patents, and litigation. www.manatt.com, 202.585.6529.