Glossary
FDA disclaimer
Updated:
The FDA disclaimer is the 2-sentence statement 21 CFR 101.93 requires next to any structure/function claim on a dietary supplement: that FDA has not evaluated the statement, and that the product is not meant to address any health condition. It must appear verbatim, in a box or set off, on the same panel as the claim.
When a dietary supplement label makes a structure/function claim, 21 CFR 101.93(c) requires a disclaimer in two sentences. The first: This statement has not been evaluated by the Food and Drug Administration. The second disclaims any intent for the product to diagnose, cure or prevent any disease, or to act on one in any other way (21 CFR 101.93(c)). When a label carries more than one claim, the plural form, These statements have not been evaluated, is used.
The wording may not be modified. FDA's labeling guide requires the disclaimer to be placed adjacent to the claim or linked to it by a symbol, set off in a box or by other typographic means, and printed in type no smaller than the claim (FDA Labeling Guide ch. VI). An asterisk after each claim pointing to a single disclaimer on the same panel is the common layout.
The disclaimer does not license any claim. It accompanies a lawful structure/function statement; it does not convert a drug claim into a permitted one.
Hemp products use the disclaimer by convention even though FDA holds that CBD does not qualify as a dietary supplement ingredient (FDA). Retailers print it on product pages, packaging and marketing copy wherever a structure/function statement appears.
Sources
- 21 CFR 101.93, Certain types of statements for dietary supplements Cornell Legal Information Institute (accessed 2026-10-13)
- Dietary Supplement Labeling Guide: Chapter VI. Claims U.S. Food and Drug Administration (accessed 2026-10-13)
- FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) U.S. Food and Drug Administration (accessed 2026-10-13)