The U.S. Food and Drug Administration (FDA) today published two final guidances for industry to help dietary supplement and beverage manufacturers determine whether a liquid food product is properly classified as a dietary supplement or as a beverage, and to remind the industry of legal requirements regarding the substances that may be added to either type of product. Together, the two guidances finalize a previously published draft guidance, and take into account public comments submitted on that draft.

One of the guidances — Distinguishing Liquid Dietary Supplements from Beverages — describes the factors that characterize liquid products that are dietary supplements and those that characterize beverages that are conventional foods. Such factors include product claims, names, packaging, serving size, recommended daily intake, conditions of use, and product composition, as well as statements or graphic representations in labeling and advertising.

The second guidance — Industry Guidance on Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements — reminds the industry of requirements in the Federal Food, Drug, and Cosmetic Act that apply to substances added to both conventional foods, such as beverages, and to dietary supplements. These statutory requirements are intended to assure the safety for consumers of both types of products.

FDA is issuing these guidances to clarify legal requirements in the face of growth in the marketplace of beverages and liquid dietary supplements that contain novel substances such as botanical extracts or other botanical ingredients.

For additional information, see the following documents:


Author(s): Staff