Written and maintained by CASRAI Editorial Board
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Short answer. The FTC Endorsement Guides (16 CFR Part 255) say that an endorsement must reflect the honest opinion or experience of the endorser, that the advertiser is liable for misleading or unsubstantiated statements made through endorsements, and that a connection that might materially affect the weight or credibility of an endorsement must be disclosed. For health products, the FTC’s Health Products Compliance Guidance adds that a truthful testimonial is not enough if the claim it carries is deceptive. This page is general regulatory information, not legal or medical advice.
Who searches this: publishers, clinic or lab staff and supply-side marketers who need to check a health-product page before it goes live. After reading, you should be able to run the layered checklist below. For wording examples of a disclosure, see affiliate links disclosure example; this page does not repeat them.
Definition and scope: what counts as an endorsement
Under 16 CFR 255.0(b), an endorsement is any advertising, marketing or promotional message for a product that consumers are likely to believe reflects the opinions of someone other than the advertiser. A review, a testimonial, a staff recommendation or a post by a creator can each qualify. The FTC’s topic page states that the Guides are not regulations, but that if advertisers do not follow them the FTC may decide to investigate. The current revision was published at 88 FR 48102 (July 26, 2023).
Claims first, disclosure second
The order matters for health products. The FTC’s Health Products Compliance Guidance (section III.C.1) states that advertisers should not make claims through consumer testimonials or expert endorsements that would be deceptive, and that it is not enough that a testimonial represents the honest opinion or experience of an endorser. Three related points:
- Consumer endorsements themselves are not competent and reliable scientific evidence (16 CFR 255.2(a)).
- Testimonials that report results more dramatic than users can generally expect are likely to be deceptive, and a “results not typical” disclaimer does not cure that (Health Products Compliance Guidance, III.C.1).
- A disclosure should not be contradicted or mitigated by, or inconsistent with, anything else in the ad (Health Products Compliance Guidance).
In practice, this means a disclosure label cannot repair an unsupported claim. Check the claim first, then the connection.
Material connections and affiliate links
Under 16 CFR 255.5(a), a material connection is one that might materially affect the weight or credibility of the endorsement; it is disclosed when a significant minority of the audience would not expect it. The Health Products Compliance Guidance asks advertisers to clearly and conspicuously disclose any material connection between the endorser and the advertiser. The FTC’s “What People Are Asking” page (June 29, 2023) adds practical points:
- Disclose the relationship to the retailer clearly and conspicuously on your site.
- Consumers might not understand that “affiliate link” means the person placing the link is getting paid; a “paid link” label right next to an affiliate link should be an adequate disclosure.
- A disclosure is more likely to be seen if it is very close to, or part of, the endorsement; a disclosure in the comments to a post is easily avoidable.
- Tagging a brand is an endorsement, but it is not a disclosure.
For how this plays out when a publisher links to a medical supplier, see medical supply affiliate programs.
Expert and organizational endorsements
Where an advertisement represents, expressly or by implication, that the endorser is an expert, 16 CFR 255.3 applies, and the Health Products Compliance Guidance says the endorser must have appropriate qualifications to be represented as an expert. Section 255.4 covers organizations: the endorsement must be reached by a process sufficient to ensure it reflects the judgment of the organization. For clinic or lab staff, this separates a named clinician’s own expert opinion from a statement attributed to a department or society. Payments tied to referrals raise a separate question; see fee splitting in medical practice.
Who is liable
| Party | What the sources say | Source |
|---|---|---|
| Advertiser | Subject to liability for misleading or unsubstantiated statements made through endorsements | 16 CFR 255.1(d) |
| Endorser | May be liable for statements made in the course of their endorsements | 16 CFR 255.1(e) |
| Company with a network of promoters | Ultimately responsible for what others do on its behalf; needs reasonable programs to train and monitor members of its network | FTC, What People Are Asking |
Checklist before publishing a health-product endorsement
This checklist is an editorial aid built from the sources listed below; it is not a legal safe harbor. Each line maps to a cited statement.
- Is it an endorsement? Would consumers likely believe the message reflects someone other than the advertiser (255.0(b))?
- Is the claim itself supported? A consumer testimonial is not scientific evidence (255.2(a)); results beyond what users can generally expect are likely deceptive (Health Products Compliance Guidance, III.C.1).
- Is the endorser’s opinion honest? Endorsements must reflect honest opinions, findings, beliefs or experience (255.1(a)).
- Is an expert claim backed by qualifications? (255.3; Health Products Compliance Guidance, III.C.1.)
- Is there a material connection? If yes, is the disclosure clear, conspicuous, close to the endorsement and not contradicted elsewhere (255.5; Health Products Compliance Guidance; FTC Q&A)?
- Who monitors the promoters? A company that uses a network needs reasonable programs to train and monitor it (FTC Q&A).
When a supplier or network supplies the claims, a reasonable set of questions to ask follows from the same sources: what substantiates each health claim, what qualifies each named expert, and how the network is trained and monitored. For a parallel enforcement record on unsupported advertising claims, see AI washing enforcement by the SEC and FTC.
Common misunderstandings
- “A disclosure fixes the claim.” It does not; the Health Products Compliance Guidance treats claim substantiation and disclosure as separate duties.
- “Results not typical” protects the page. The guidance says such disclaimers do not cure testimonials that are likely to be deceptive.
- “Tagging the brand discloses the relationship.” The FTC says tagging is an endorsement, not a disclosure.
- “Only the advertiser is responsible.” Endorsers may also be liable under 255.1(e).
- “The Guides are a statute.” They are not regulations, though the FTC may investigate when they are not followed.
FAQ
Do the FTC Endorsement Guides apply to health products?
Yes. 16 CFR Part 255 applies to endorsements of products generally, and the FTC’s Health Products Compliance Guidance applies the same principles to health-related claims, including testimonials and expert endorsements.
What is an FTC affiliate disclosure for health products?
It is a clear and conspicuous statement of a material connection, such as being paid for a link. The FTC says a “paid link” label right next to an affiliate link should be adequate. Placement should be close to the endorsement.
Is there a medical affiliate disclosure template?
The FTC does not publish a mandatory template in its endorsement guidance. Wording and placement examples are on the affiliate links disclosure example page.
Can a disclosure make a health claim acceptable?
No. A disclosure should not be contradicted or mitigated by anything else in the ad, and a truthful testimonial can still carry a deceptive claim.
Sources
- eCFR, 16 CFR Part 255, Guides Concerning the Use of Endorsements and Testimonials in Advertising: https://www.ecfr.gov/current/title-16/part-255 (checked 2026-11-01).
- FTC, Health Products Compliance Guidance: https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance (checked 2026-11-01).
- FTC, FTC’s Endorsement Guides: What People Are Asking (June 29, 2023): https://www.ftc.gov/business-guidance/resources/ftcs-endorsement-guides-what-people-are-asking (checked 2026-11-01).
- FTC, Advertisement Endorsements topic page: https://www.ftc.gov/news-events/topics/truth-advertising/advertisement-endorsements (checked 2026-11-01).
