Nimble Marketing Law Library A maintained reference for founders

FDA — DSHEA Structure-Function Claims & Disclaimer

21 USC §343(r)(6)
warn Effective date pending

The Dietary Supplement Health and Education Act (DSHEA) permits supplements to make "structure-function" claims — describing how an ingredient affects the body's structure or function ("supports immune function"). When a piece of content makes such a claim, the DSHEA disclaimer must appear in the same content piece. What it means for you: structure-function language is allowed, but pair it with the DSHEA disclaimer. The flagging engine treats a structure-function claim with no disclaimer present as a violation (companion-rule logic). This is a reference summary, not legal advice — confirm with counsel.

Suggested disclosure language

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.

Jurisdiction
United States (Federal) (federal)
Citation
21 USC §343(r)(6)
Severity
warn
Corpus version
v1-929074c7ba3b

Applies to (categories)

Supplements

Applies to (channels)

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Confirm with counsel Reference summary only — not legal advice. Confirm applicability and any required disclosure language with counsel.