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Marketing and claims

Can a company just say a product 'supports' or 'boosts' something without proof?

Plain English first, then the primary source. Education, not legal advice.

Interpretation

In short: advertising claims need competent and reliable evidence before they are made, and testimonials do not supply it.

Plain English

Under the FTC Act, advertising claims must be truthful, cannot be deceptive or unfair, and advertisers must have a reasonable basis, meaning competent and reliable evidence, to support their claims before they are made. This substantiation requirement applies regardless of whether the claim is express or reasonably implied.

The FTC's Endorsement Guides separately address testimonials and influencer content, requiring that endorsements reflect the honest views of the endorser and that any material connections, such as payment or free product, be clearly disclosed.

These requirements apply on top of, not instead of, FDA rules about drug and device claims, so a marketing claim can violate FTC substantiation rules, FDA intended-use rules, or both at once.

Why it matters

  • Marketing teams for RUO products need to satisfy both FTC evidentiary standards and FDA intended-use rules, which is a common gap in compliance programs that only think about one agency.

Where the answer becomes fact-specific

The Foundation does not manufacture legal conclusions. These points change the analysis and may require qualified regulatory counsel.

  • What counts as adequate substantiation depends on the specific claim made and the type of product; health-related claims generally require a higher level of scientific evidence.

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