On December 20, 2022, the Federal Trade Commission ("FTC") issued a guidance document to update and replace the FTC’s 1998 brochure entitled Dietary Supplements: An Advertising Guide for Industry. The new publication, Health Products Compliance Guidance, ("New Guidance") draws on the issues raised in the more than 200 cases involving false or misleading advertising claims relating to dietary supplements and other health-related products that the FTC has settled or adjudicated since the release of its 1998 document. While many of the legal fundamentals remain unchanged from the 1998 version, as the title of the New Guidance suggests, it is meant to apply more broadly to all health-related products and claims, including food, over-the-counter drugs, homeopathic products, health equipment, diagnostic tests, and health-related apps – not just dietary supplements. Additionally, the New Guidance reflects updates from other FTC guidance documents, such as the FTC’s guidelines on endorsements and testimonials and a 2016 enforcement policy statement on homeopathic drugs.
In an accompanying document to the New Guidance, the FTC describes it as “what may be one of the most important documents you’ll read in 2022.” As the New Guidance will undoubtedly affect marketers of health-related products, below is a snapshot of the New Guidance’s key provisions and most notable updates:
- “Clear and conspicuous disclosure” standard: The New Guidance underscores that when the disclosure of qualifying information is necessary to prevent an ad from being deceptive, advertisers should present the information clearly and conspicuously, so that it is difficult to miss (i.e., easily noticeable) and easily understandable by ordinary consumers. The New Guidance also clarifies that the type of disclosure should match the type of claim; e.g., if a claim is made only visually or audibly, the disclosure should at least appear in the same way – but a simultaneous visual and audible disclosure is more likely to be clear and conspicuous. Notably, with regard to disclosures in digital media (e.g., social media, the internet or interactive media), the New Guidance appears to differ from the FTC’s guidance in its 2013 .com Disclosures: How to Make Effective Disclosures in Digital Advertising, in which the FTC states that where it is not possible to make a disclosure in a space-constrained ad, “it may, under some circumstances, be acceptable to make the disclosure clearly and conspicuously on the page to which the ad links.” The New Guidance, however, unequivocally states that the “disclosure should be unavoidable; disclosures made through hyperlinks are avoidable.” As such, for health-related claims, disclosures made through hyperlinks are considered inadequate. The New Guidance also states that the “ultimate test” of whether a disclosure is effective is the net impression that consumers take from an ad with the disclosure. If a significant minority of consumers accept a misleading claim from an ad despite a disclosure, the disclosure is insufficient.
- Randomized, controlled human clinical testing is essential to meet “competent and reliable scientific evidence” standard: The New Guidance reiterates the FTC’s requirement that claims about the health benefits of health-related products must meet the basic substantiation standard of “competent and reliable scientific evidence.” The FTC has defined this standard as “tests, analyses, research, or studies that: (i) have been conducted and evaluated in an objective manner by experts in the relevant disease, condition, or function to which the representation relates; and (ii) are generally accepted in the profession to yield accurate and reliable results.” In one of the most significant changes to the FTC’s guidance, the New Guidance expands this general rule to state that substantiation of health-related benefits will need to be in the form of Randomized, Controlled human clinical Trials (RCTs) in order to meet the competent and reliable scientific evidence standard. While the New Guidance does not specify a specific number of RCTs required to meet the standard, replication of research in an independently-conducted study adds to the weight of the evidence. Ultimately, however, the quality of the research – not the quantity – determines sufficiency. The FTC also noted that it will accept high-quality epidemiologic evidence to substantiate a claim in those limited cases where: (i) it is considered an acceptable substitute for RCTs by experts in the field; and (ii) RCTs are not otherwise feasible. The New Guidance also states that animal and in vitro studies “may provide useful supporting or background information” but cannot substantiate health-related claims without confirmation by RCTs in humans.
- Prohibition against “p-hacking”: As it relates to post hoc analysis of data (i.e., analysis that departs from the original study protocol, such as looking at various smaller subgroups of the study population), the FTC specifically cautions against “p-hacking” or data mining in an attempt to find some positive result to report from a study that otherwise failed to show any treatment effect. For that reason, post hoc analysis that departs from the originally stated study protocol may identify areas for future exploration, but does not generally provide reliable evidence to substantiate a claim.
- Consumer testimonials or expert endorsements: The New Guidance advises that advertisers should not make claims through consumer testimonials or expert endorsements that would be deceptive or could not be substantiated if the advertiser made them directly. Specifically, (i) the advertiser must have competent and reliable scientific evidence that the product will be as effective for buyers as it was for the endorser; (ii) testimonials should include clear and conspicuous disclosures about the typical results consumers can expect (i.e., disclosing “results are not typical” will not cure deception); and (iii) when using experts, advertisers must ensure the individual has appropriate qualifications and has tested the product, as well as prominently disclose any material connections between the endorser and the advertiser.
- Inadequacy of vague qualifying terms: Per the New Guidance, vague qualifying terms such as that the product “may” have the claimed benefit or “helps” achieve the claimed benefit, are inadequate. Similarly, the FTC explains that modifiers such as “promising,” “preliminary,” “initial,” or “pilot” are likely to be interpreted by consumers as positive product attributes, rather than as substantial disclaimers about the state of the science behind a claim, particularly when the study is positively touted in the ad. Thus, consumers may interpret an ad to mean that a product will prevent or reduce the risk of a disease, even if the ad includes language indicating that the science supporting the effect is limited in some way.
While the New Guidance does not have the force or effect of law, it illustrates that health-related claims remain a key area of focus for the FTC and should serve as an alarm bell to marketers operating in the health-related space – particularly those who previously fell outside the ambit of the FTC’s 1998 guidance. In order to reduce the risk of becoming the target of a future FTC enforcement action, all health-related marketers should take heed to carefully evaluate their health-related advertising claims and substantiation practices to ensure they are scientifically sound, clinically significant, and relevant to the specific product and advertising claim, as well as evaluate the sufficiency of their disclaimers, to determine what changes may be needed to align with the FTC’s latest guidance. Stay tuned for our Association of National Advertisers (ANA) webinar on this topic on February 14th at 1 pm ET, where we will dive deeper into the key takeaways from the New Guidance.