Does the FDA Regulate Supplement Labels? An Expert's Guide to Dietary Supplements

The Food and Drug Administration (FDA) has regulations in place that require dietary supplement labels to include the product name and a statement that it is a dietary supplement or an equivalent term that replaces “dietary” with the name or type of dietary ingredient in the product. The Division of Dietary Supplement Programs (HFS-8) Office of Nutritional Products, Labeling and Dietary Supplements is part of the Center for Food Safety and Applied Nutrition at the FDA. The FDA provides guidance documents, which are not legally enforceable responsibilities. Instead, they describe the agency's current ideas on a topic and should be considered as recommendations only, unless specific regulatory or legal requirements are cited.

The use of the word “should” in agency guidelines means that something is suggested or recommended, but it's not mandatory. An information panel on the supplement is required if you make a statement about the nutrient content. You can use these statements if, and only if, you include the specific amount of the nutrient. These statements are considered nutrient content statements and are not exempt from including a disclosure statement when necessary. If a similar dietary supplement is normally expected to contain a nutrient and your dietary supplement is specially processed, altered, formulated or reformulated to reduce the amount of the nutrient in the food, eliminate the nutrient from the food, or not include the nutrient, then you are allowed to make a free or low statement, as appropriate.

Sugar content claims are subject to nutrient content reporting requirements. The nutrients subject to the claim must have a recognized antioxidant activity. In addition, the level of each nutrient covered by the statement must be sufficient to qualify for statements high in 21 CFR 101.54 (b), good source statements in 21 CFR 101.54 (c), or more statements in 21 CFR 101.54 (e). For example, for a product to be considered a product that is high in vitamin C in antioxidants, it must contain 20 percent or more of the Recommended Daily Intake (RDI) for vitamin C. That is, it must meet the high level defined in §101.54 (b).

For a product to qualify as a good source of antioxidants (vitamin C), it states that it must contain between 10 and 19 percent of the RDI for vitamin C.You can file a beta-carotene claim when the level of vitamin A present in the form of beta-carotene is sufficient to meet the requirements. For example, it can be said to be a good source of antioxidant beta-carotene when 10% or more of the RDI for vitamin A is present in the form of beta-carotene. You can use the term high potency on the labels of your dietary supplements to describe the individual vitamins or minerals that are present in 100 percent or more of the RDI per reference amount commonly consumed. However, when you use the term high potency to describe the individual vitamins or minerals in your product that contain other nutrients or dietary ingredients, you must clearly identify which vitamin or mineral you describe with the term high potency. It is a statement that draws the consumer's attention to one or more nutrients (other than the nutrient subject of the statement) in a dietary supplement (e.g., sugar content claims). The FDA regulates dietary supplements under a different set of regulations than those that cover conventional foods and medications. You should indicate any dietary ingredient for which there is no Recommended Daily Intake (RDI) and also provide quantitative information about its amount in an information panel on your supplement label.

A statement about nutrient content characterizes, expressly or implicitly, the level of a nutrient in a dietary supplement. It is a statement about the content of nutrients that characterizes the level of one or more antioxidant nutrients present in a dietary supplement. Please note that you must meet any dietary supplement requirements that may be published after this guidebook. The FDA receives many questions about labeling dietary supplements. A low-calorie claim cannot be made in dietary supplements, except when it is an equivalent amount of a dietary supplement that resembles and replaces another labeled dietary supplement (e.g., what's new in dietary supplements). The reference food must be clearly identified, its quantity must be identified and information on its actual amount of dietary ingredient must be stated both on its own label and on that of its reference food.

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