FDA issues supplement beverage draft guidance

Some products now marketed as dietary supplements may actually be subject to regulation as conventional food products, or may be considered unapproved drugs, according to a new draft guidance from FDA entitled "Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods."

According to the nonbinding draft, FDA reiterates its longstanding position that beverages are conventional foods that may not be marketed as dietary supplements. “FDA considers a liquid product’s name, packaging, serving size, and recommended conditions of use, as well as other representations about the product, to be important determinants of whether the product is represented as a conventional food and may not be marketed as a dietary supplement,” the draft says. FDA also addresses in the draft guidance the use of structure-function claims for foods. By law, a conventional food can only be used for taste, aroma or nutritive value; therefore, the guidance instructs that certain structure/function claims that fall outside these areas may not be legal.

Comments are due Feb. 2, 2010.