FDA Misclaim / Unsubstantiated Health-Claim Cases
Supplement and wellness sellers routinely cross the line from permitted structure-function claims into disease claims, or make efficacy promises without the "competent and reliable scientific evidence" the FTC standard requires. The seller's own marketing copy, captured verbatim, is the core exhibit — and the substantiation gap is provable against the published literature.
Elements & controlling authority
- Defendant made a health, efficacy, or structure-function representation
FDCA § 201(g); 21 USC § 343(r); CLRA § 1770(a)(5),(7). - Representation made in commercial speech
FTC Act § 5(a)(1); Lanham § 43(a)(1)(B). - Representation lacks competent and reliable scientific evidence, or constitutes misbranding
FTC Substantiation Policy Statement (1984); 21 USC § 352. - Materiality — affirmative health claims carry a presumption
Kwikset, 51 Cal.4th 310; In re Tobacco II, 46 Cal.4th 298 (2009). - Injury — consumer paid for unsubstantiated efficacy
Kwikset, 51 Cal.4th at 327.
The evidence you need — and what we capture
- Verbatim health claims captured from product pages and checkout flows
- Substantiation analysis against peer-reviewed literature, openFDA, and ClinicalTrials.gov
- Retraction screening so the theory never rests on withdrawn science
- Consumer-complaint corroboration from CFPB, BBB, and review platforms
Every capture is sealed at collection: SHA-256 hash-chained artifacts with RFC 3161 trusted timestamps, a methodology block, and a documented scope of audit. If the defendant changes the site tomorrow, the record of today survives.
Damages framework
UCL restitution + CLRA § 1780 statutory damages ($1,000 minimum/class member) for the purchaser class; injunctive relief against the claims themselves.
Frequently asked
When does a supplement health claim become actionable?
When it crosses from a permitted structure-function claim into a disease claim, or makes an efficacy promise without the "competent and reliable scientific evidence" the FTC standard requires — provable against the published literature.
Pre-vetted defendants in this lane are live on the marketplace. Each listing clears arbitration-posture review, a prior-litigation screen against the federal docket, and a human editorial gate before it appears. First buyer takes the defendant exclusively.
Browse 4 live FDA Misclaim / Unsubstantiated Health-Claim listings →