In this short video, FDA compliance attorney Lisa Capote covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa Capote, an FDA compliance attorney. Today’s topic is dietary supplement labeling basics — because getting your label right is absolutely foundational to selling supplements legally in the United States.
Every dietary supplement label must include specific elements under FDA regulations at 21 CFR Part 101.
First, the statement of identity. The principal display panel must clearly identify the product as a “dietary supplement” or more specifically — for example, “Vitamin C Dietary Supplement” or “Herbal Supplement.”
Second, the net quantity of contents — the amount of product in the container — must appear on the principal display panel in both metric and U.S. customary units.
Third, the Supplement Facts panel. This is the nutritional information panel specific to dietary supplements, listing serving size, servings per container, dietary ingredients, amounts, and percent daily values where applicable.
Fourth, the ingredient list — the “Other Ingredients” section that lists any non-dietary ingredients like binders, fillers, excipients, and coatings in descending order of predominance.
Fifth, the name and place of business of the manufacturer, packer, or distributor.
Sixth, any applicable claims — and if structure/function claims are made, the required disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Missing or incorrect labeling elements make a dietary supplement misbranded under the FD&C Act. Before your label goes to print, have it reviewed by a regulatory attorney. We can help. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.