December 4, 2009
FDA recently sent letters to some firms informing them that, after reviewing the packaging and labeling of their products, the Agency had determined that the products are not “dietary supplements,” a term defined by law, but are instead conventional beverages. As a result, the products were improperly labeled and did not provide consumers with important nutrition information.
FDA determined that the products, all liquids, do not meet the statutory definition of a dietary supplement in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 321(ff)) and instead were beverages that are considered conventional foods, and as a result they must meet the regulatory requirements that apply to conventional foods. FDA also issued a draft guidance to prevent the incorrect marketing of these beverages as dietary supplements in the future. FDA’s Draft Guidance [published in the Federal Register December 4, 2009 http://edocket.access.gpo.gov/2009/E9-28926.htm] identifies factors that can be used by manufacturers and distributors of dietary supplements to identify liquid products that are excluded from being dietary supplements because they are represented as conventional foods. The guidance informs firms that 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The Draft Guidance also reminds manufacturers and distributors about the requirements of the Act regarding the marketing of beverages and other conventional foods containing novel ingredients and informs them of FDA’s concerns about the use/misuse of food ingredients in conventional beverages and the use of claims for some foods with novel ingredients that misbrand such products or otherwise violate the Act.
FDA’s Draft Guidance also reminds manufacturers and distributors of beverages and other conventional foods, particularly those that contain novel ingredients, about the legal requirements regarding ingredients and labeling. The Agency is concerned about the growth in the marketplace of beverages that contain novel ingredients, such as added botanical ingredients or their extracts which have not previously been used as food ingredients. FDA notes that some of the novel ingredients that are being added to conventional foods may cause the food to be considered adulterated, because they are unapproved food additives. Such ingredients must be used in accordance with an approved food additive regulation or they must be generally recognized as safe (GRAS) by qualified experts for their intended use. FDA will consider enforcement action regarding any unapproved food additives. In addition, some ingredients being added to conventional foods, although present in the food supply for many years, are now being used at levels in excess of their traditional use levels or in new foods that raise questions regarding whether the levels and new uses are safe.