What Makes a Food a Dietary Supplement in the Eyes of the U.S. FDA?

The U.S. Food and Drug Administration (FDA) regulates food and dietary supplement labels. There are strict FDA guidelines regarding what are considered appropriate statements for each category, and companies often have difficulty determining what type of claims may be made for their products.

FDA acceptable labeling claims are often dependent upon whether your product is classified as a “conventional food” or as a “dietary supplement.” FDA’s Federal Food, Drug, and Cosmetic Act (FFDCA) defines “food” as “articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article” (FD&C Act Sec. 201(f)). According to the FDA, “Conventional foods” are those that are consumed for taste, aroma, and nutritive value. The FDA’s FFDCA defines “dietary supplement” as a product “intended to supplement the diet and contains one or more of the following: a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract or combination of any the aforementioned; is intended for ingestion as a tablet, capsule, powder, softgel, gelcap, or liquid form, or if not intended for ingestion in such a form, is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet” (FD&C Act Sec. 201(ff)). Sometimes the distinction between the two classifications is not clear. It is important to understand the distinct FDA labeling regulations.

Dietary supplements are sometimes marketed in forms that resemble conventional foods and beverages. FDA recently issued draft guidance regarding dietary supplements that resemble conventional beverages. FDA guidance document states “liquid products that suggest through their serving size, packaging, or recommended daily intake that they are intended to be consumed in amounts that provide all or a significant part of the entire daily drinking fluid intake of an average person in the U.S., are represented as beverages.”

In addition, the name of a product can represent the product as a conventional food in the eyes of the FDA. Product or brand names that use conventional food terms such as “beverage,” “drink,” “water,” ‘juice,” or similar terms represent the product as a conventional food. In sum, 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.”

If you have question regarding FDA compliant labeling for your particular product, Registrar Corp’s team of experts can assist you. Simply contact Registrar Corp 24/7 via Live Help or call Registrar Corp’s U.S. Office at: +1-757-224-0177.

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