The Federal Trade Commission (FTC) has issued its Health Products Compliance Guidance (the Health Products Guidance), updating and replacing the Dietary Supplements: An Advertising Guide for Industry from 1998. Israeli companies who market any type of health-related product in the US must familiarize themselves with the details of this new Guidance.
While the 1998 Dietary Supplements guidance focused on dietary supplements, the new Health Products Guidance, issued in late December, applies to express and implied claims made in the marketing of any health-related product, including, but not necessarily limited to, “foods, over-the-counter (OTC) drugs, homeopathic products, health equipment, diagnostic tests, and health-related apps.”
The Health Products Guidance “draws on” issues raised in more than 200 FTC cases since 1998 involving false or misleading claims about the benefits or safety of health-related products and reinforces that FTC continues to scrutinize advertising of this category. Notable highlights from the Guidance are summarized below.
Breadth of advertising subject to FTC’s Health Products Guidance
While the 1998 Guide was applied widely as a best practice, FTC’s scope of coverage under the new Guidance clearly indicates it intends to reach broadly across advertising mediums, reflecting the complex realities of today’s marketplace.
The Guidance defines “advertising” as encompassing “a wide variety of marketing techniques” and provides numerous examples of activities that would qualify as advertising. These include not just the traditional TV, radio, print, and Internet ads referenced in the initial 1998 Guide but also an expansive array of more modern advertising statements or depictions appearing in a broad array of formats: on packaging and labeling, in promotional materials, in social medial and influencer marketing, in press releases, in press interviews, in other media appearances, at trade shows, at conferences, at seminars, and made “indirectly through healthcare practitioners or other intermediaries.”
Substantiation of health-related claims (efficacy and safety)
Marketers must have a “reasonable basis” for their claims before disseminating them, and advertisements referring to a specific level of support must possess at least that level of support. While the “reasonable basis” may vary depending on the claim and context of the ad, the Guidance explains that several factors determine the appropriate amount and type of substantiation required including: the type of product, the type of claim, the benefits of a truthful claim and feasibility of developing substantiation, the consequences of a false claim, and the amount of substantiation experts in the field believe to be reasonable. The Guidance reiterates that for claims about the efficacy or safety of health-related products, the factors identified above make up FTC’s “competent and reliable scientific evidence” standard.
Further, the FTC has more specifically defined the “competent and reliable scientific evidence” standard as “tests, analyses, research, or studies that (1) have been conducted and evaluated in an objective manner by experts in the relevant disease, condition, or function to which the representation relates; and (2) are generally accepted in the profession to yield accurate and reliable results.” To meet the standard, research must be “sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true.”
Importantly, the Guidance further reiterates that “as a general matter” for health-related benefit claims, randomized controlled human clinical testing (RCT) is required to meet the competent and reliable scientific substantiation standard. RCTs are considered by FTC to be “the most reliable form of evidence” and the Guidance notes that they are typically required by experts to substantiate health benefit claims. Although the FTC does not require a specific number of RCT’s to adequately substantiate a health-related claim and deems the quality of the research to be more important than the quantity, it explains that “the replication of research in an independently-conducted study adds to the weight of the evidence.”
As to other types of non-RCT substantiation, additional scientific studies (ie, epidemiological observational, animal/in-vitro) may be helpful as part of the totality of the evidence, but do not in and of themselves prove causation. The Guidance notes that in some cases RCT testing may be infeasible, including notably in the nutrition context where it can take extended time to determine the causal relationship between nutrients and development of a disease.
Importantly, FTC acknowledges that in “limited cases where: 1) it is considered an acceptable substitute for RCTs by experts in the field; and 2) RCTs aren’t otherwise feasible,” the FTC will accept high-quality epidemiological evidence to substantiate a health-related claim. Further, according to the Guidance, certain evidence – standing alone – is not sufficient to substantiate claims about the effects of a health product. This includes “anecdotal evidence about the individual experiences of consumers” (such as consumer surveys), healthcare practitioner observations about the effect of a health product on patients, and public health recommendations and advisories from a medical organization.
In addition, FTC reiterates that the approval of dietary supplements under a foreign monograph also does not constitute sufficient substantiation; instead, the advertiser must examine the underlying research and any evidence that may contradict the monograph.
Claims based on consumer testimonials, expert endorsements
The Guidance emphasizes that advertisers must have appropriate scientific evidence to support express and implied claims that a product is effective and will work for buyers, whether the claims are made directly or through consumer testimonials or expert endorsements. Thus, advertisers should not make claims through consumer testimonials or expert endorsements that would be deceptive or couldn’t be substantiated if the advertiser made them directly.
As to testimonials, attempts to disclaim results with statements like “results not typical” are not sufficient to cure deception. Instead, “testimonials should be accompanied by a clear and conspicuous disclosure of the results a typical consumer can actually expect.” For endorsements, the Guidance cautions that advertisers should “clearly and conspicuously disclose any material connection between the endorser and the advertiser.”
Claims premised on traditional use
For health-related claims based on traditional use, such as homeopathic medicines and other alternative products that have a history of use as traditional medicine in the U.S., the FTC requires advertisers to meet the same competent and reliable scientific evidence standard as with other products. At the same time, the FTC explains that an advertisement may describe the traditional or historic use of a product if it carefully qualifies the claim to avoid any misleading implications about the product’s efficacy or health benefits.
Disclosure of qualifying information
An ad may be misleading if it fails to disclose qualifying information that is material in the context of the claims or customary use of the product. For health-related claims, this includes disclosure of significant limitations on advertised health benefits and significant safety risks. When qualifying information is necessary to prevent deception, the disclosure must be clear and conspicuous, and should meet the following criteria:
- The disclosure should stand out (based on size, contrast, location, length of time shown, and other characteristics), and be easily noticed, read, and understood.
- The disclosure should appear in “at least” the same medium as the claim is made (for example, an ad that is made visually should at least provide a visual disclosure), and a simultaneous visual and audible disclosure is “more likely to be clear and conspicuous.”
- Vague qualifiers stating that a product “may” have a claimed benefit or “helps” to achieve a claimed benefit, are inadequate to qualify the claimed benefit. Similarly, using terms such as “promising,” “preliminary,” “initial,” or “pilot” tend to imply positive attributes rather than functioning as disclaimers about the state of the science.
- To be clear and conspicuous, the disclosure should not be contradicted, mitigated by, or inconsistent with, anything else in the ad.
- In social media, the internet, or other interactive media forms, the disclosure should be “unavoidable” meaning it may not be made through hyperlinks.
The “ultimate test” of a disclosure is consumers’ net impression of the ad with the disclosure. If a “significant minority of consumers” are misled by the ad, despite the disclosure, then the disclosure is not sufficient. If it is not possible to make an effective disclosure, the claim should either be modified so that a disclosure is not necessary, or the claim should be removed. For ads targeting a specific audience, the effectiveness of the disclosure is judged from the perspective of members of that audience group.
Interplay between FTC and FDA regulation of health-related claims
As with the prior dietary supplements Advertising Guide, the Guidance also discusses the FTC and Food and Drug Administration’s (FDA) shared jurisdiction over the marketing of health-related products, including dietary supplements, foods, drugs, and devices. It emphasizes that the agencies work closely together to ensure that enforcement efforts are consistent, and notes that both agencies have authority to take action against marketers making deceptive labeling claims.
The Guidance highlights the following distinctions between FDA and FTC requirements for marketers to keep in mind:
- Unlike the FDA, the FTC does not distinguish between types of health-related products or claims. Thus, the FTC’s approach to advertising of health-related products is the same whether the claim is a structure/function or drug claim or whether the product is a food, supplement, or drug.
- The Dietary Supplement Health and Education Act of 1994 (DSHEA) requiring a two-part disclaimer on dietary supplement product labels stating that the product has not been evaluated by FDA and is not intended to diagnose, treat, cure, or prevent any disease, “has no effect on the FTC Act.” Thus, the DSHEA disclaimer is not required in other forms of advertising. The FTC makes clear that inclusion of a DSHEA disclaimer also will not cure otherwise deceptive ad.
- Unlike the FDA, the FTC does not pre-approve health claims. However, the FTC presumes that health claims that meet FDA’s “significant scientific agreement” standard are substantiated. Advertisers should be careful not to mischaracterize the extent of FDA approval, review, or authorization of a claim or product, including the science supporting a particular claim. For example, “compliance with the DSHEA notification and disclaimer provisions doesn’t constitute FDA authorization, and advertisers shouldn’t imply that the FDA has specifically approved any claim on that basis.”
- Unlike the FDA, the FTC does not require notification for structure/function claims. The FTC only requires that the marketer have prior substantiation that the claims are truthful and not misleading.
The new Health Products Compliance Guidance affects a broader swathe of products than its predecessor and provides additional clarification on substantiation expectations. To learn more about the implications of this more expansive guidance, please contact either of the authors or your usual DLA Piper contact.