Supplement marketing claims are regulated on two separate tracks. The FDA requires a notification within 30 days of first marketing a supplement that carries a structure/function claim, plus a standard label disclaimer. The FTC separately requires competent and reliable scientific evidence for any health claim in advertising, which its 2022 guidance says generally means randomized, controlled human clinical testing.
What does the FDA require for a structure/function claim?
A structure/function claim describes the role a nutrient or dietary ingredient plays in the structure or function of the human body, and the FDA requires a notification for each one. The Dietary Supplement Health and Education Act of 1994 (DSHEA) allows these statements on supplement labeling.
The company marketing the product must notify the FDA no later than 30 days after first marketing the supplement with the claim. The notification includes the claim text, the supplement name with its brand name, and the signature of a responsible individual who can certify the information.
The label must also carry the disclaimer that the statement has not been evaluated by the Food and Drug Administration and that the product is not intended to diagnose, treat, cure, or prevent any disease. The FDA states that its response to a notification, or the absence of one, is not a statement about whether the product meets other legal requirements. A notification is a filing, not an approval.
What evidence does the FTC require behind a supplement claim?
The FTC requires competent and reliable scientific evidence for every health-related claim in supplement advertising, whatever the label disclaimer says. On December 20, 2022, the FTC issued its Health Products Compliance Guidance, which replaced its 1998 guide, Dietary Supplements: An Advertising Guide for Industry.
The 2022 guidance says that, as a general matter, substantiation needs to be randomized, controlled human clinical testing. It states that anecdotal evidence, including surveys of consumer experiences, is never sufficient, and that products sold on traditional use have no exemption from the standard.
The guidance also states that DSHEA has no effect on the FTC Act, and it cautions advertisers against using DSHEA disclaimers to imply that the FDA approved a claim. A supplement can satisfy FDA labeling rules and still fail FTC substantiation, because the two agencies share jurisdiction over supplement marketing.
How do the FDA and FTC requirements compare?
The FDA governs what a supplement label may say and requires a filing, while the FTC governs whether advertising claims are truthful and substantiated. The table shows which rule applies to each type of claim.
| Rule | Regulator | What it requires | Where it applies |
|---|---|---|---|
| Structure/function notification (FD&C Act section 403(r)(6)) | FDA | Notification within 30 days of first marketing, plus the label disclaimer | Supplement labeling |
| Health Products Compliance Guidance (December 2022) | FTC | Competent and reliable scientific evidence, generally randomized, controlled human trials | Health claims in advertising |
| Endorsement Guides, 16 CFR Part 255 (revised 2023) | FTC | Disclosure of material connections to the brand | Influencers, affiliates, testimonials |
| Consumer Reviews Rule, 16 CFR Part 465 (effective October 21, 2024) | FTC | Bans fake reviews, review suppression, and undisclosed insider reviews | Reviews and testimonials |
What do the Endorsement Guides and Reviews Rule change?
Influencers and reviewers with a material connection to a supplement brand must disclose it, and advertisers can face liability when disclosures are missing. The FTC revised its Endorsement Guides in 2023 for the first time since 2009, and a material connection must be disclosed when a significant minority of the audience would not expect it. A free product sent to a creator counts as a material connection.
The Consumer Reviews Rule, 16 CFR Part 465, took effect on October 21, 2024. It prohibits fake reviews, including AI-generated ones, buying reviews, undisclosed insider reviews, and suppressing negative reviews.
For a supplement brand, that means a seeding program needs a disclosure requirement in the creator brief, and a product page cannot hide negative reviews. The substantiation standard also applies to claims creators make in sponsored posts, so the brief should list only claims the brand can support with human clinical evidence.
How can a supplement team check a claim before it goes live?
A supplement team can check a claim in four steps before publishing it: classify it, match it to evidence, file the notification, and brief every endorser.
- Classify the claim. A statement about maintaining a body structure or function can be a structure/function claim. A statement that the product treats or prevents a disease is a disease claim, which a supplement may not make.
- Match the claim to human clinical evidence. Keep the randomized, controlled human trial that supports the exact claim on file, since the FTC treats anecdotes and consumer surveys as insufficient.
- File the FDA notification and place the disclaimer. Submit the notification within 30 days of first marketing, with the supplement and brand name and the claim text.
- Brief endorsers and monitor reviews. Give creators the approved claims, require disclosure of free product, and leave negative reviews visible.
Each step produces a document, and together those documents form the claims file a company can produce if a regulator asks. A claim that fails after launch becomes a reputation problem, which the supplement crisis recovery guide covers.
Where should supplement claim review sit in a launch plan?
Claim review belongs before media outreach and creator seeding, because every pitch, post and product page repeats the claim. Brands planning a release can apply the checklist above to the PR guide for launching supplements, and teams working on ingredient messaging can use it with the functional nutrition and supplement PR guide and the plant-based supplement PR strategies.
The through-line is that every supplement claim needs a classification, an evidence file and a disclosure plan before a campaign starts. Teams that want that review built into media relations and content can see how a supplements marketing and PR agency structures it, and the Supplements AI Visibility Index 2026 shows how supplement brands appear in AI answers.
