FDA Provides Final Guidance on Beverages and Dietary Supplements

When is a dietary supplement really a beverage?  The FDA provides final Guidance.

On January 13, FDA announced the availability of two guidance documents concerning beverages and liquid dietary supplements: “Distinguishing Liquid Dietary Supplements from Beverages” and “Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements.”  

FDA considers several factors to determine the status of a substance as a dietary supplement or a drink.  The list includes labeling and advertising, product name, product packaging, serving size and recommended daily intake, directions for use, marketing practices and composition.  For each of these areas, the guidance provides examples.

FDA appears to consider use of the term “refresh” or “rehydrate” as indicating a beverage. Such terms are said to represent the product for use as a beverage offering taste, refreshment, and thirst-quenching ability.  Also classified as beverages, are products that use conventional food names such as “beverage,” “drink,” “water,” or “soda”.  Beverages are regulated under conventional food law rather than dietary supplement requirements.