On December 20, 2022, the Federal Trade Commission (“FTC”) announced its issuance of Health Products Compliance Guidance, which updates and replaces its previous 1998 guidance, Dietary Supplements: An Advertising Guide for Industry.  While the FTC notes that the basic content of the guide is largely left unchanged, this guidance expands the scope of the previous guidance beyond dietary supplements to broadly include claims made about all health-related products, such as foods, over-the-counter drugs, devices, health apps, and diagnostic tests.  This updated guidance emphasizes “key compliance points” drawn from the numerous enforcement actions brought by the FTC since 1998, and discusses associated examples related to topics such as claim interpretation, substantiation, and other advertising issues.

Identifying Claims and Interpreting Advertisement Meaning

The updated guidance first discusses how claims are identified and interpreted, including the difference between express and implied claims.  The updated guidance emphasizes that the phrasing and context of an advertisement may imply that the product is beneficial to the treatment of a disease, which in turn would require that the advertiser be able to substantiate the implied claim with competent and reliable scientific evidence, even if the advertisement contains no express reference to the disease.

In addition, the updated guidance provides examples of when advertisers are expected to disclose qualifying information, such as when a product is targeted to a small percentage of the population or contains potentially serious risks.  When the qualifying information is necessary to avoid deception, the updated guidance contains a discussion of what constitutes a clear and conspicuous disclosure of that qualifying information.  Specifically, the guidance states that a disclosure is required to be provided in the same manner as the claim (i.e., if the claim is made visually, the disclosure is required to be made visually).  A visual claim should stand out, and based on its size, contract, location, and length of time is appears, must be easily noticed, read, and understood.  An audible disclosure should be at a volume, speed, and cadence so as to be easily heard and understood.  On social media, the guidance states a disclosure should be “unavoidable,” which the FTC clarifies does not include hyperlinks.  The qualifying information should not include vague qualifying terms, such as that a product “may” have benefits or “helps” achieve a benefit.

Substantiating Claims

The updated guidance next lays out a number of factors used to determine the amount and type of substantiation that is required to constitute competent and reliable scientific evidence, such as the type of product and claim, the benefits of a truthful claim, the cost/feasibility of developing substantiation, the consequences of a false claim, and the amount of substantiation that experts in a field believe is reasonable.  The updated guidance states that the amount, type, or strength of support of evidence for the claim must be accurate (e.g., an advertisement should not suggest scientists have reached a consensus if that is not accurate).

The updated guidance emphasizes the use of randomized, controlled human clinical trials (“RCTs”), underscoring that RCTs are “the most reliable form of evidence and are generally the type of substantiation that experts would require for health benefit claims.”  According to the guidance, no specific number of RCTs is required to meet the standard for competent and reliable scientific evidence; the quality of the research is more important than the quantity.  The guidance also states that research should yield statistically significant results and be clinically meaningful.  In addition, statistically significant results that are a result of post hoc analysis may draw suspicion of data mining or “p-hacking.” On the other hand, the updated guidance suggests that epidemiological or observational studies are only acceptable in limited circumstances, namely where 1) experts in the field consider them to be an acceptable substitute; and 2) RCTs are not otherwise feasible.  Similarly, animal and in vitro studies, anecdotal evidence about individual experiences of consumers, and public health recommendations are described as insufficient to substantiate health claims. 

Other Advertising Issues

Lastly, the updated guidance discusses other common issues in health-related advertisements, including consumer testimonials and expert endorsements, claims based on alternative medicine, and claims about FDA approval.  Reinforcing the Endorsement Guides, the updated guidance emphasizes that advertisements portraying dramatic results cannot be cured by stating “results not typical”—rather, they must contain a clear disclosure about what a typical consumer can expect in the depicted circumstances.  Expert endorsers must have appropriate qualifications; according to an example in the updated guidance, an expert should not be referred to as a doctor in an advertisement if the expert is not licensed and does not practice in a field relevant to the product and claim.  The updated guidance emphasizes that there is no exception to the substantiation standard for traditional use/homeopathic products—while claims can be made about traditional use, these products also must be substantiated with competent and reliable scientific evidence.

The updated guidance is intended to serve only as business guidance and does not have the force or effect of law.