On December 20, 2022, the Federal Trade Commission (“FTC”) released guidance to update and replace the FTC’s 1998 booklet titled Dietary supplements: an advertising guide for the industry. The new publication, Healthcare Product Compliance Guide, (“New Guidance”) draws on issues raised in the more than 200 cases involving false or misleading advertising claims related to dietary supplements and other health products that the FTC has resolved or adjudicated since the publication of its 1998 filing. Although many of the fundamentals remain unchanged from the 1998 version, as the title of the new guidance suggests, is intended to apply more broadly to all health-related products and claims, including foods, over-the-counter medicines, homeopathic products, healthcare equipment, tests diagnostics and health-related apps, not just dietary supplements. In addition, the new guidance reflects updates to other FTC guidance documents, such as the FTC’s guidelines on approvals and testimonials and a 2016 enforcement policy statement on homeopathic medicines.
In a companion document to the New Guidance, the FTC describes it as “what could be one of the most important documents you’ll read in 2022.” As the New Guidance will undoubtedly affect sellers of health-related products, below is a snapshot of the key provisions of the New Guidance and the most important updates:
- Standard “Clear and clearly visible information”:
The new guidance emphasizes that when disclosure of qualifying information is necessary to prevent an ad from being misleading, advertisers should present the information in a clear and prominent manner, in a way that is hard to miss (i.e. easily perceived) and easily understood by ordinary consumers.
The new guidance also clarifies that the type of disclosure must match the type of complaint; for example, if a statement is made only visually or audibly, the disclosure should at least appear the same, but a simultaneous visual and auditory disclosure is more likely to be clear and prominent.
Specifically, with respect to disclosures in digital media (for example, 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 disclosures effective in digital advertising, in which the FTC states that where a disclosure cannot be made in a space-constrained ad, “it may, in some circumstances, be acceptable to make the disclosure clearly and prominently displayed on the page to which the ad links “. The new
The guidance, however, states unequivocally that “disclosure should be inevitable; disclosures made via hyperlinks are avoidable. Therefore, for health-related claims, disclosures made via hyperlinks are considered inappropriate. The new guidance also states that the “ultimate test” of a disclosure’s effectiveness is the net impression consumers get of 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 trials in humans are essential to meet the standard of “competent and reliable scientific evidence”:
The new guidance reiterates the FTC’s requirement that claims about the health benefits of health-related products must meet the basic standard of “competent and reliable scientific evidence.” The FTC has defined this standard as “tests, analyses, research or studies which: (i) were conducted and objectively evaluated by experts in the relevant disease, condition or function to which the representation relates; and (ii) are generally accepted in the profession to produce 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 for health-related benefits will need to be in the form of randomized controlled human clinical trials (RCTs) in order to meet the standard of evidence. competent and reliable scientist. While the new guidance does not specify a specific number of RCTs needed to meet the standard, replication of the 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 epidemiological evidence to substantiate a claim in those limited cases where: (i) it is considered an acceptable substitute for RCT by industry experts; and (ii) RCTs are not otherwise feasible.
The new guidance also states that animal and in vitro studies “can provide useful supporting or background information” but cannot substantiate health claims without confirmation from RCTs in humans.
- Prohibition of “p-hacking”:
Regarding post-hoc data analysis (that is, analysis that deviates from the original study protocol, such as looking at various smaller subsets of the study population), the FTC specifically warns 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 this reason, post-hoc analysis that deviates from the originally stated study protocol may identify areas for future exploration, but generally does not provide reliable evidence to support a claim.
- Consumer testimonials or expert endorsements:
The new guidance advises advertisers not to make claims through consumer testimonials or expert endorsements that would be deceptive or could not be substantiated if the advertiser made them themselves. In particular, (i) the advertiser must have competent and reliable scientific evidence that the product will be as effective for buyers as it was for the promoter; (ii) testimonials should include clear and obvious disclosures about typical results consumers can expect (e.g., disclosing “non-typical results” will not resolve the deception); and (iii) when using experts, advertisers must ensure that the individual is appropriately qualified and has tested the product, and prominently disclose any material links between the advertiser and the advertiser.
- Inadequacy of vague qualifying terms:
According to the New Guidance, vague qualifying terms such as that the product “may” have the claimed benefit or “help” to 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 attributes of the product, rather than substantial disclaimers about the state of the science at the time. basis of a claim, particularly when the study is advertised positively in the ad. Thus, consumers may interpret an ad to mean that a product prevents or reduces the risk of a disease, even if the ad includes language that indicates that the science supporting the effect is somewhat limited.
Key points
While the new guidance does not have the force or effect of law, it does illustrate that health-related claims remain a key area of concern for the FTC and should serve as a wake-up call for health care marketers, in particular particularly for those who previously fell outside the scope of the 1998 FTC guidance. In order to reduce the risk of becoming the target of future FTC enforcement action, all health-related marketers should be careful to evaluate carefully their health-related advertising claims and testing practices to ensure they are scientifically sound, clinically meaningful, and relevant to the specific product and advertising claim, and evaluate the sufficiency of their disclaimers, to determine what changes may be necessary to align with the latest FTC guidelines. Stay tuned for our Association of National Advertisers (ANA) webinar on this topic on February 14 at 1 PM ET, where we’ll delve into the highlights of the new guide.
Customer Notice 2023-014