Health advertising claims
Health claims for drugs must be supported by substantial evidence and must not misstate FDA approval status. The FTC requires adequate substantiation for health claims, and the FDA can act against false or misleading drug claims.
Not legal or medical advice.
This page is for informational purposes only. Always verify the current official source or consult a qualified professional before making compliance, prescribing, purchasing, or clinical decisions. Read full disclaimer.
Who this applies to
Promotional claims for drugs, compounded products, and related wellness products
Definitions
- Substantial evidence
- Adequate and well-controlled investigations for the claims being made.
- Express vs. implied claim
- An express claim is stated directly; an implied claim is suggested by images, context, or wording.
Decision flow
- Is the product marketed as a drug (prevents, treats, cures, mitigates disease)?
- If yes, is there an approved application or an applicable exemption?
- Are claims substantiated?
- Does the claim correctly distinguish approval, compounding, and investigational status?
Examples
- • A social post saying 'This peptide is FDA approved' when only a different brand-name product is approved is misleading.
- • Calling a compounded product 'the same as Ozempic' omits that compounded drugs are not FDA approved.
Common mistakes / limitations
- ✗ This page does not cover all FTC advertising requirements.
- ✗ It does not apply to lawful off-label discussion by prescribers.
What can change this answer
Rules can change through new legislation, FDA final guidance, declaratory orders, court decisions, or updated bulk-drug-substance lists. Check the latest controlling sources and the update feed for this rule.
Controlling law and sources
- FDA Warning Letter to Xcel Research LLC
U.S. Food and Drug Administration, CDER Office of Compliance · Warning letter · 694608