Advertising Claim Substantiation Requirements for Health Products

April 13, 2026

Inside the Ad Law Tool Kit: Advertising Claim Substantiation

Todd Harrison, Claudia Lewis Venable LLP + Follow Contact LinkedIn Facebook X Send Embed

Advertising Claims Substantiation

Objective advertising claims must be supported by prior substantiation. These claims—whether express or implied—generally concern measurable or otherwise verifiable attributes of a dietary supplement, food, device, or cosmetic. When an advertisement includes such claims, marketers must have a “reasonable basis” for them. As a general guideline, a reasonable basis means possessing the level and type of substantiation that experts in the relevant field would consider adequate to support the claim. Extra caution is required for health-related claims, including structure/function claims, or other assertions that consumers cannot readily assess for themselves (such as statements that a product “supports normal cholesterol levels”) which must be supported by competent and reliable scientific evidence. The amount and type of evidence needed will depend on the nature of the claim and what experts in the field would deem appropriate. This is a flexible standard and does not necessarily require a product-specific clinical study

If you are making health claims to sell your product or service, you should ask yourself the following important questions:

Understanding the Claim

• Is the claim a health claim, a structure/function claim, or a general wellness claim—and are you applying the correct substantiation standard for that category?
• Does your claim imply disease treatment, cure, or prevention, even if you did not intend it to?
• Does your claim suggest a level of scientific certainty (e.g., “clinically proven,” “scientifically tested”) that exceeds the strength of the evidence you have?

Evaluating Your Substantiation

• Does your ad contain numerical or comparative claims (e.g., “20% fewer calories than the leading brand”)?
• Does your ad contain express statements about the type or amount of support you have (e.g., “studies prove,” “two out of three doctors recommend”)? If so, do you actually possess that level of support?
• Are you relying on studies of your product to substantiate your claims?
• If relying on studies of other products, do those products contain the same ingredients, in the same quantity and with the same quality, as your product?
• Do your studies reflect the population for which the product is intended (e.g., age, health status, route of administration, dosage)?
• Are your study designs adequate for the type of claim being made? For example, is a randomized, double-blind, placebo-controlled study required, or will other competent and reliable scientific evidence suffice?
• Have you evaluated the totality of the evidence? Are there studies contradicting the ones you rely on?
• Do your conclusions align with what experts in the relevant field would consider appropriate?
• Assessing Consumer Interpretation
• Have you conducted consumer perception testing to confirm that the claim is not misleading and aligns with how a reasonable consumer would interpret it?

• Could the overall context of the ad—visuals, testimonials, graphics—create unintended implied claims that require additional substantiation?
  Reviewing Marketing Channels and Messaging

• Have you reviewed social media content, including influencer partnerships, for compliance with substantiation requirements?

• Are influencers or affiliates making unapproved or unsubstantiated claims attributable to your brand?

• Are disclosures and disclaimers clear, prominent, and consistent with FTC and FDA expectations?

• Is your claim consistent across all platforms—labels, websites, e-commerce pages, videos, email marketing, testimonials, and influencer content?

Ongoing Compliance and Risk Management

• Do you have a process for ongoing monitoring of new scientific research, regulatory developments, or competitor challenges that may affect your substantiation?
• Have you evaluated whether making the claim aligns with your overall risk tolerance and regulatory strategy? To learn more about advertising claims substantiation, download the 14th edition of our Advertising Law Tool Kit. For more insights into advertising law, bookmark our All About Advertising Law blog and subscribe to our monthly newsletter.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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