On December 20th, 2022, the Federal Trade Commission published new guidance regarding claims about the benefits and safety of health-related products: Health Products Compliance Guidance. This guidance replaces the Commission’s previous guidance, Dietary Supplements: An Advertising Guide for Industry, issued in 1998. The new guidance expands the scope to include other health-related products, such as foods, over-the-counter drugs, and devices.
The new guidance first addresses how claims are identified and interpreted. This section discusses the difference between express and implied claims and when to qualify claims. It also discusses how “clear and conspicuous” the qualifying disclosures should be.
For example, the guidance adds examples of what qualifying terms are appropriate. In doing so, the FTC explains that words like “‘promising,’ ‘preliminary,’ ’initial,’ or ‘pilot’” are likely viewed by consumers as “positive product attributes, rather than as substantial disclaimers about the state of the science behind a claim.”
Another example discussed where disclosures may be necessary for interactions with medications. The guidance discussed a botanical sleep aid supplement marketed for “when life’s stresses get you down or you are just too anxious to fall asleep.” The product doesn’t present safety risks when used alone, but if the active compounds use the same metabolic pathway as common prescription medications for anxiety and depression and interfere with the efficacy of those medications, a disclosure may be needed.
The FTC also adds details concerning whether disclosures are considered clear and conspicuous, including that “if the claim requiring a disclosure is made both visually and audibly, the disclosure should be made both visually and audibly.”
In discussing how claims may be substantiated, the FTC emphasizes that the amount and type of substantiation required depends on a litany of factors, including the type of claim and the amount of substantiation that experts in the field believe is reasonable. Indeed, ads referring to a specific level of support, such as referring to a product that has a “clinically tested ingredient” for improving blood flow and increasing endurance, implies that the ingredient was tested and “that the test results prove a benefit for blood flow and endurance.”
In addition, the FTC expands its description of the appropriate use of randomized controlled clinical trials (RCTs) and explains that generally, “substantiation of health-related benefits will need to be in the form of randomized, controlled human clinical testing to meet the competent and reliable scientific standard” and that “numerous flawed and inadequate studies are unlikely to add up to competent and reliable scientific evidence sufficient to substantiate a claim.” The agency adds that public health recommendations are not “equivalent to a finding that there is a causal link between the recommended course of action and the health benefit.”
The guidance then provides significant detail that expands upon how the quality and totality of evidence should be evaluated in light of its relevance to the specific product and claim. For example, and as the FTC notes in its announcement, the guidance specifically warns against statistical “p-hacking,” where one positive result is pulled from a study that fails to show a treatment effect. The agency still notes that some results that are statistically significant may be “too small to provide real consequences for consumer health.”
Finally, the FTC addresses several other substantiation issues, such as claims based on
- Consumer testimonials and expert endorsements
- The history of a product’s traditional use
- Use of the DSHEA disclaimer
- Mischaracterizations of FDA approval
- Citations to third-party literature
Venable’s team is available to answer any questions that you may have about the FTC’s new Health Products Compliance Guidance and will be providing further insights on this important development in the near future. Please feel free to contact us at any time.