FTC’s New Health Claims Guidance: What You Need to Know
Feb 15, 2023 by Annie M. Ugurlayan, Assistant Director, National Advertising Division, BBB National Programs
Health-related claims remain a priority for the Federal Trade Commission (FTC), as recently made clear by the announcement of a settlement with ZyCal Bioceuticals Healthcare Company and its president James J. Scaffidi, for allegedly deceptive claims that their products grow bone and cartilage and relieve joint pain. But important new guidance on health-related claims came at the end of 2022, when the FTC issued its Health Products Compliance Guidance, updating and replacing its longstanding Dietary Supplements: An Advertising Guide for Industry issued in 1998. Although many aspects of the Dietary Supplements Guide remain in the new guidance, there are important changes that provide greater clarity to advertisers making health-related claims.
What Has Not Changed
- Competent and reliable scientific evidence (C&RSE) is required to support safety and efficacy claims. The factors remain the same: the Pfizer factors of the type of claim, the type of product, the benefits of a truthful claim, the consequences of a false claim, the cost of developing substantiation for the claim, and the level of evidence experts in the field would require.
- Claim substantiation must be relevant to the specific product and to the advertising claims.
- Qualifying information should be clearly and conspicuously disclosed (but updated guidance on clear and conspicuous disclosures is provided).
- Testimonials and endorsements, traditional use claims, and dietary supplements continue to be covered.
What Has Changed
First, the scope of the new Guidance is broader, applying to all health products, not simply dietary supplements.
Second, the Guidance refers to the rigorousness of the substantiation standard but no longer refers to its flexibility and states that randomized, controlled trials (RCTs) are generally required to support health-related claims. Epidemiologic evidence can be used to substantiate a claim in limited cases where:
- Experts in the field consider it to be an acceptable substitute for RCTs, and
- RCTs are not otherwise feasible.
Third, the Guidance adds new specific and detailed recommendations related to the reliability of studies submitted in support of health-related claims:
- Although it notes that a specific number of studies is not required, the Guidance recommends a second and independent RCT to corroborate the results of an RCT.
- Detailed criteria are outlined for reliable RCTs including a control group, randomization, double-blinding, as well as statistically significant and clinically meaningful results.
- Factors that impact the quality of a study include 1) clear and detailed research protocol; 2) submission of the research protocol to an institutional review board; 3) registration of a clinical trial in a public database; and 4) dropout rates and deviations from the study protocol.
- Post-hoc analysis of results is not allowed as it can give rise to “p-hacking” to find a positive result where one does not exist.
It also notes that advertisers should not rely on public health recommendations, such as advisories from a medical organization, as substantiation.
The Guidance expands on and clarifies prior guidance in a few other ways:
- Clear and conspicuous disclosures must be unavoidable and made visually when the claim is visual and audibly when the claim is audible. If the claim is both visual and audible, the disclosure should be both visual and audible. Hyperlinks are not sufficient because they are avoidable.
- Vague qualifiers like “preliminary,” “initial, or “pilot” to discuss the nature of the study do not convey the limitations in the study and the science generally.
- In clarifying FTC/FDA Jurisdiction, the Guidance notes that while FDA is primarily responsible for labeling claims and FTC is primarily responsible for all other advertising pursuant to their longstanding Memorandum of Understanding, the FTC is not precluded from taking action against (or obtaining orders that cover) deceptive labeling claims. The Guidance also cautions advertisers to avoid mischaracterizing the extent to which a product or claim has been reviewed, authorized, or approved by the FDA.
- The breadth, depth, and number of examples provide specific guidance for varied health products, technology, and areas of concern. Examples include bloggers, claims made in apps, ingredient claims and how to support them, and more health conditions. Notably, the examples also incorporate what makes or breaks an RCT (e.g., discussing the use of a post-hoc analysis).
- Traditional use claims extend to homeopathic medicines. Although the Dietary Supplements Guides previously referred to botanical products, the Guidance expressly refers to homeopathic medicines as traditional use products and FTC’s Homeopathic Drugs Policy Statement.
- Marketers are responsible for implied claims referring indirectly to third-party literature. The Dietary Supplements Guides referred to marketers potentially liable for claims implied by their reference either directly or indirectly to third-party literature.
Tips for Advertisers
- Be laser-focused about the quality of your evidence. The Guidance explains the elements of a reliable RCT and what to avoid. Make sure your team and any third parties with which you work are aware of this guidance to ensure your studies are reliable.
- Carefully study all the examples in the Guidance. They provide a wealth of information as to the applicability of the new guides and provide even more claim substantiation-specific guidance (e.g., what makes for a reliable ingredient study).
- Don’t overpromise your evidence and underdeliver with disclosures. Avoid qualifying language that conveys a more positive message about the state of the scientific support for a claim, and for disclosures, avoid hyperlinks and include visual and audio disclosures if the claims are visual and audible.
- Scrutinize third-party sources referenced anywhere in your advertising. As noted in one of the examples, an advertiser who indirectly links to a book touting a cancer cure, even if it is “two clicks” away from the advertiser’s website, is responsible for any implied claims that arise.