On December 20, 2022, amidst a flurry of end-of-year activity on Capitol Hill, the Federal Trade Commission’s (FTC) Bureau of Consumer Protection issued a major update of its over two-decades-old guidance titled “Dietary Supplements: An Advertising Guide for Industry” (1998 Guidance). As the FTC itself explains, this new guidance, titled “Health Products Compliance Guidance” (2022 Guidance), “merits your careful attention” if you are “looking for advice on substantiating your company’s advertising claims,” as it contains several major changes and is intended to replace the 1998 Guidance. Since 1998, the FTC has brought more than 200 challenges to false or deceptive advertising, and according to the commission, the 2022 Guidance incorporates the “lessons of those cases.”
A brief note about the FTC’s authority to oversee the advertising of these products: Under the FTC Act (15 U.S.C. §§ 41-58), the FTC is charged with preventing “unfair or deceptive acts or practices,” which includes ensuring that advertising is “truthful and not misleading” and is supported by “adequate substantiation.” When it comes to the health-related products at issue in the 2022 Guidance, the FTC shares jurisdiction over marketing practices with the Federal Food and Drug Administration (FDA)—the FDA oversees the “labeling” (i.e., packaging, product inserts and point-of-sale promotional materials) while the FTC oversees advertising in all forms, including claims appearing on labeling.
Among the major changes are:
2022 Guidance: More Than Just ‘Dietary Supplements’
Significantly, the new guidance makes clear that it is meant to apply to more than “dietary supplements,” which were the singular focus of the 1998 Guidance. The title change is intended to convey clearly that the 2022 Guidance applies to all health-related products, not just dietary supplements. Examples of products now covered include foods, over-the-counter drugs, homeopathic products, health-related apps and devices, and other health-related products.
‘Clear and Conspicuous’ Standard
The FTC has long required that any disclosure that is necessary to prevent certain advertising from being deceptive be presented in a way that is clear and conspicuous enabling consumers to easily understand and notice such disclosure. The 2022 Guidance provides more specific information, with several new examples, on how the FTC interprets this “clear and conspicuous” standard in the context of health-related claims. For instance, if a claim in an advertisement is “made both visually and audibly,” the disclosure of requisite qualifying information should also be both in a visual and audible format. Also, the FTC warns of using “vague qualifying terms”, such as “helps,” “may,” “promising,” “preliminary,” “initial” or “pilot”—to qualify or modify a claim about a health benefit (e.g., prevention or reduction of the risk of a disease), because consumers are “likely to interpret” these modifiers as “product attributes, rather than substantial disclaimers about the state of the science behind a claim.”
‘Competent and Reliable Scientific Evidence’ Standard
When assessing whether advertisers have adequate support for their health-related product claims, the FTC applies a “rigorous” standard of “competent and reliable scientific evidence.” Although this has long been the standard, the 2022 Guidance makes clear that “as a general matter,” the substantiation the FTC believes is adequate “will need to be in the form of randomized, controlled human clinical testing.” The FTC lays out examples of the “limited cases” in which “high-quality epidemiologic evidence” may be used (i.e., when experts agree that it is appropriate and when controlled trials are not feasible). Other types of evidence, including animal and in vitro studies, anecdotal evidence, and public health recommendations, are generally not sufficient alone to meet the competent and reliable scientific evidence standard.
As noted in the 2022 Guidance, the FTC assesses not only the amount and type of evidence but also the quality of the evidence supporting a health-related claim. The 2022 Guidance reiterates the basic principles that are widely accepted amongst the scientific community (including the need for a human clinical study to have a control group, use appropriate randomization or careful matching criteria, be double-blinded, and yield statistically significant results) and further cautions against post hoc analysis of data that amounts to cherry-picking data in an effort to produce a positive result despite a negative finding (aka p-hacking). The FTC also urges advertisers to ensure that any studies relied upon are considered in the context of the wider body of scientific evidence in the field, again, in an effort to avoid distorting the support for a particular conclusion.
Like its predecessor, the 2022 Guidance is just that—guidance provided by the FTC staff—and is not itself legally enforceable. Complying with the guidance does not “provide a safe harbor from potential liability, nor does noncompliance automatically result in liability for companies.” However, much of the guidance and updated examples are based on various enforcement actions taken by the FTC over the years and provide a critical glimpse into the FTC’s current thinking and priorities going forward. While some of the positions taken by the FTC staff in the 2022 Guidance may be subject to challenge, any company making a health-related claim should carefully review this document and update its advertising compliance practices where appropriate to avoid inviting unnecessary scrutiny from the FTC.