FDA Supplement Labeling: Rules for Online Sellers
Dietary supplements sold in the United States are regulated for labeling and claims under FDA rules and DSHEA. Online supplement listings are a frequent target for FDA warning letters, usually because of the claims they make and missing mandatory disclosures. Disease and "FDA approved" claims are a leading cause of FDA warning letters, which can lead to product seizure, import refusal, and listing removal.
Claims that reclassify a product as a drug
FDA labeling rules govern the claims, disclosures, and ingredient information for cosmetics, dietary supplements, and food sold in the United States. The fastest way to draw a warning letter is a disease or treatment claim — wording such as "cures," "treats cancer," "prevents disease," or "lowers blood pressure" reclassifies the product as an unapproved drug.
Also avoid stating a product is "FDA approved." Cosmetics and dietary supplements are not approved by the FDA, so that wording is false. Use permitted structure/function language instead — for example, "supports joint health" rather than "treats arthritis."
Required disclosures for supplements
Dietary supplements that make structure/function claims must carry the DSHEA disclaimer: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
Listings should also reference a Supplement Facts panel (serving size, servings per container, nutrients, and ingredients per 21 CFR 101.36). Use permitted structure/function language such as "supports immune health" rather than disease claims, and never state the supplement is "FDA approved."
Frequently Asked Questions
Can I say my product is FDA approved?
No. The FDA does not approve cosmetics or dietary supplements, so an "FDA approved" claim on those products is false and a common trigger for enforcement.
What kinds of claims trigger FDA warning letters?
Disease and treatment claims — such as cures, treats, or prevents a named condition — are the leading cause. They reclassify the product as an unapproved new drug.
What are structure/function claims and are they allowed?
Structure/function claims describe how an ingredient affects normal body structure or function — for example, "supports joint health" or "helps maintain healthy skin." They are permitted for supplements and cosmetics provided they do not imply diagnosis, treatment, or prevention of disease and, for supplements, are accompanied by the DSHEA disclaimer.
What is the DSHEA disclaimer and when do I need it?
It is the statement that the FDA has not evaluated your claims and the product is not intended to diagnose, treat, cure, or prevent disease. It is required whenever a supplement makes a structure/function claim.
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