FTC Releases Health Products Compliance Guidance

Businesses making health claims about their products (e.g., foods and dietary supplements) or services (e.g., apps) should take note of new guidance that the Federal Trade Commission (FTC) released at the end of December 2022. The FTC’s Health Products Compliance Guidance replaces and updates Dietary Supplements: An Advertising Guide for Industry, issued in 1998. The new guidance (1) applies more broadly to all health-related claims, not just those related to dietary supplements; (2) builds on the FTC’s enforcement experience in this area in the last two decades; and (3) provides more detailed discussion on a variety of topics (e.g., the FTC’s “clear and conspicuous” standard and the “competent and reliable scientific evidence” standard). This alert provides a summary of the key parts of this new guidance and some takeaways for companies that are making health-related claims in their advertising.

Regulatory Framework

The FTC’s authority to prevent “unfair or deceptive acts or practices” extends to all advertising and marketing claims for health-related products. Broadly, the FTC has a mandate to ensure that 1) advertising is truthful and not misleading, and 2) advertisers have adequate substantiation for their express or implied product claims. Although advertising in this context certainly refers to more traditional forms of advertising, such as TV and internet ads, it covers all marketing techniques designed to increase consumer demand for particular products, including social media and influencer marketing, statements on labeling and packaging, and statements made during press interviews. The FTC’s enforcement authority reaches beyond the advertisers making health product claims, and includes anyone participating in the development of these ads, including ad agencies, distributors, retailers, and expert endorsers. For anyone found to be engaging in deceptive advertising, the FTC can seek to require that future advertising be truthful and substantiated, mandate certain disclosures, or require that marketers engage in corrective advertising to cure any lingering deception in the marketplace. In some cases, the FTC may seek consumer refunds, financial penalties, or bans on certain practices.

The FTC and Food and Drug Administration (FDA) share jurisdiction in the oversight of the marketing of health-related products, but there are a few key differences between their legal frameworks. While the FTC has primary responsibility for claims made in advertising, the FDA has primary responsibility for claims made in labeling (although FDA interprets “labeling” in a very broad manner which, as a matter of practical reality, encompasses product advertising as well). The FTC treats health-related claims the same as all other advertising claims, but the FDA has particular requirements for health-related claims, such as the FDA labeling law’s requirement that companies notify the FDA before making “structure/function” statements and other statements of nutritional support that appear in labeling. Unlike the FDA, the FTC has no premarket approval authority over health-related claims.

General Advertising Principles

The FTC report reiterates several generally applicable advertising principles.

  • Companies must ensure the accuracy of not only their express statements, but also the claims that they are implying or reasonably suggesting. For example, an ad for a dietary supplement that features doctors in lab coats could imply that the supplement is clinically proven to be effective.
  • Think about how the intended audience will interpret the ad. Companies are responsible for substantiating all reasonable interpretations of their ads, and they should take into account that some audiences might be more susceptible to certain claims. For example, terminally ill consumers could be more susceptible to exaggerated claims about the efficacy of cures.
  • Companies must disclose all material qualifying information. Qualifying information may include significant limitations on an advertised health benefit or significant safety concerns related to the typical use of a product. Consider an advertiser that cites a placebo-controlled study to show that a weight loss product led to greater weight loss for the treatment group than the control group. If both groups engaged in regular exercise during that study period, the ad must clearly state that regular exercise is needed to achieve similar results.
  • Qualifiers and disclosures must be clear, conspicuous, and easily understood by the average consumer. Companies should take into account, among other things, the disclosure’s size, its placement, volume and speed (if made audibly), viewability across devices and platforms and in videos, whether it is made through a hyperlink (the FTC disfavors hyperlinked disclosures), and whether it conflicts with anything else in the ad. If the take-away for a significant minority of consumers is a misleading claim from an ad, despite a qualifying disclosure, the FTC does not consider the disclosure sufficient. Abiding by these requirements can be particularly challenging when the supporting science is complex, but consumers should be able to understand the extent of scientific support and whether there is any significant contrary evidence. For example, the FTC does not think it is sufficiently clear to say that a product “may” have a claimed benefit or “helps” achieve the claimed benefit.
  • Advertisers must ensure that there is adequate support and a reasonable basis for their claims before distributing an ad that makes those claims. Many factors help determine the amount and type of advance substantiation required, such as the type of product, the type of claim, the benefits of a truthful claim versus the cost or feasibility of substantiating that claim, the consequences of a false claim, and what experts in the field believe is a reasonable amount of substantiation.

Health Claims in Advertising

Generally, claims about efficacy or safety of health-related products are more closely scrutinized and must be substantiated with “competent and reliable scientific evidence,” usually in the form of randomized, controlled human clinical testing. The FTC describes several factors it considers when assessing whether the scientific support for a claim meets the “competent and reliable scientific evidence” standard:

  • Ads must have the amount of support they claim to have. For example, if a product claims that “Scientists Now Agree!”, there must be wide scientific consensus for that claim, and the advertiser must have evidence of that consensus.
  • Randomized, controlled human clinical trials are considered the gold standard for substantiation of health benefit claims. The FTC does not require any particular number of studies to substantiate a claim, but the replication of the research in another independent, scientifically sound study will support a company’s substantiation efforts. However, relying on multiple flawed studies does not equate to relying on one scientifically sound study. Generally, the FTC also does not consider the following types of evidence to be “competent and reliable scientific evidence”: epidemiological or observational studies, animal and in vitro studies, anecdotal experiences from consumers, and public health recommendations.
  • The FTC will look to some basic principles of valid scientific research. These principles include: having a treatment and control group, randomization, double blinding, statistically significant results, clinically meaningful results, a rigorous peer review process, a clear and detailed research protocol, and submission of that protocol to an Institutional Review Board.
  • Advertisers should also consider the surrounding body of scientific evidence, in addition to the internal validity of specific studies. When the research is inconsistent, and some studies support a claim while others do not, it is important to examine the reasons behind those inconsistencies. These reasons (e.g., differences in dosage, population tested, or form of administration) can impact the type of claim that advertisers are able to substantiate and the qualifiers that they must disclose. The existence of conflicting evidence also changes the type, amount, and quality of evidence needed to substantiate a contrary claim.
  • Advertisers should ensure that the research they rely on actually supports their specific claim. They should scrutinize whether a study relied on the same or similar conditions as the product’s real-life use, and if those conditions are different, consider whether the study can be used to support the product’s claimed effect. For example, they should ask questions like whether the product in the study was administered in the same way as the advertised product, and whether the ingredients in both products are similar. Advertisers should also be careful not to exaggerate the results of a study or overstate the certainty of a claim that relies on emerging science.

Other Advertising Issues

Finally, the FTC touches on a number of additional issues, including:

  • Claims based on consumer testimonials or expert endorsements. Advertisers must be able to provide competent and reliable scientific evidence that supports the underlying claim that the product will be as effective for buyers as it was for the endorser. Testimonials should include clear and conspicuous disclosure about the typical results consumers can expect, and disclosing that “results are not typical” will not validate testimonials that advertise out-of-the-ordinary results. When using experts, advertisers must also ensure that the expert has appropriate qualifications and has tested the product, and any material connections between the endorser and the advertiser of the product must be prominently disclosed.
  • Use of the DSHEA disclaimer in advertising. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), all statements of nutritional support for dietary supplements must be accompanied by a particular disclaimer on the product label. DSHEA is separate from FTC Act requirements, and DSHEA disclaimers will not cure an otherwise deceptive ad.
  • Mischaracterizations of FDA approval. The FTC cautions advertisers against mischaracterizing FDA approval, review, and authorization (e.g., by conflating DSHEA disclosure with FDA approval).
  • Third-party literature. While the FTC does not regulate statements made in independently written books or articles, advertisers cannot deceptively use these statements in their ads, and could be responsible for claims implied by reference to this third-party literature.

Wilson Sonsini Goodrich & Rosati routinely helps companies navigate complex advertising and marketing issues, including for health-related products. For more information, please contact Georgia Ravitz, James Ravitz, Eva Yin, or Paul Gadiock in the firm’s FDA regulatory, healthcare, and consumer products practice, Maneesha Mithal or Roger Li in the firm’s privacy and cybersecurity practice, or Alyssa Worsham or Aaron Hendelman in the firm’s trademark and advertising practice.