By Anthony L. Young, Contributing Editor
In June 2001, FDA issued warning letters to three companies marketing beverages with herbal ingredients, stating that Echinacea, Ginkgo biloba, eleuthero, bilberry extract and lutein may not be GRAS for use in conventional foods, and that the products may be adulterated. FDA also found that the products were misbranded by unauthorized nutrient-content claimse.g., with Echinacea, added pure organic Ginkgo, lutein is added, etc. Finally, the warning letters pointed out that structure/function claims are very limited for conventional foods, but not dietary supplements.
Fast-forward to Dec. 4, 2009, and FDAs draft guidance for industry, titled Factors that distinguish liquid dietary supplements from beverages, considerations regarding novel ingredients, and labeling for beverages and other conventional foods. As Yogi Berra said, Its déjà vu, all over again. And FDA followed up with a Jan. 13, 2010, warning letter to Innovative Beverage Holdings, Inc., with respect to its product Drank. Bottom line: Your product contains an unapproved food additive, melatonin, that is not GRAS in foods.
Some companies have introduced liquids with exotic ingredients as dietary supplements instead of as functional foods. Under the law, this can be done, so long as the product is not represented as a conventional food. After all, FDA has stated that dietary supplements may be similar to conventional foods in composition and form. Whether a product is a dietary supplement or a conventional food, however, will depend on how it is represented (Federal Register, Sept. 23, 1997; Vol. 62:49826, 49837).
But a dietary supplement resembling a conventional food may not be represented for use as a conventional food. Dannons Actimel was considered by FDA, in an Aug. 1999 courtesy letter, to be a food beverage based on claims that it was a delicious fermented milk drink and a wholesome fast food.
Even in this restricted environment, the number of 8- to 16-oz. liquid dietary supplements has grown rapidly, and are now found in cold cases nationwide.
In its new draft guidance, FDA states that, even when the label of a liquid product characterizes it as a dietary supplement, factors such as their packaging, the volume in which they are intended to be consumed, their product or brand name, and statements about the product in labeling or advertising can cause them to be deemed foods.
FDA has now stated that it considers a liquid products name, packaging, serving size and recommended conditions of use, as well as other aspects, to be important determinants of whether the product is a conventional food and may not be marketed as a dietary supplement.
Anthony L. Young, Esq., is a partner with Kleinfeld, Kaplan and Becker LLP, Washington, D.C.
Want to learn more about the regulatory issues surrounding functional beverages and liquid dietary supplements? Join Anthony L. Young, Esq., and Marc Ullman, Esq., for the session "Is FDA Spoiling the Liquid Supplement and Conventional Beverage Segment?" at 9 a.m. on April 28, 2010, at SupplySide East. Find more details at SupplySideShow.com.