Food and dietary supplement manufacturers can take some comfort—at least for now—that the Federal Trade Commission’s (FTC) recent consent decrees that impose on respondents draconian standards for advertising claims will not become the norm for future companies that run afoul of FTC advertising law. In an opinion issued on May 17, 2012, an administrative law judge (ALJ) concluded that the Agency’s requirement for pre-approval of disease claims and randomized, placebo-controlled human clinical trials (RCTs) to substantiate health-related claims for foods and food products, such as dietary supplements, has no support in FTC law.
In a 335-page opinion, and after review of a voluminous hearing record, the ALJ found that while some of POM’s advertisements for its POM Juice and supplement products contained claims that were not substantiated by “competent and reliable scientific evidence” (CARSE) and therefore were false or misleading under the FTC Act, FTC’s interpretation of CARSE—requiring RCTs for all health-related claims—was flawed. Instead, the judge adopted a more flexible approach to the amount of substantiation required to constitute CARSE, reflecting the traditional approach taken by FTC and supported by relevant case law—an approach that, until recently, stood on solid ground.
Recent consent decrees with Iovate Health Systems, Inc. (July 14, 2010), Nestlé HealthCare Nutrition (July 14, 2010), and The Dannon Company, Inc. (Dec. 15, 2010) had foreshadowed a new standard for claim substantiation, including a three-tiered approach with increasing evidentiary requirements. Under the new standard, FTC required of respondents preapproval from FDA for disease claims (i.e., “reduces risk of heart disease”), at least two adequate and well-controlled clinical studies for specific health claims (i.e., “reduces children’s sick day absences”) and a modified version of the traditional CARSE standard for other health claims (i.e., “keep your kids healthy”). The POM decision, which may be appealed by complaint counsel to the full Commission, did not address directly the new approach, but in a footnote dismisses the decrees as not constituting legal precedent.
The POM opinion leaves open the possibility that one or more RCTs under certain circumstances would be required to substantiate food or supplement claims. The opinion makes clear, however, that the amount of substantiation should be determined by the court based on evidence at trial—namely, expert testimony. In the case of POM, the judge determined, after a review of expert testimony, that RCTs were not required because the safety of the product was known, the product did not create any material risk of harm, and the products were not advertised as replacing medical treatment.
Given the uncertainty of the status of the POM opinion, companies cannot ignore the heightened requirements set forth in the recent decrees, which were unanimously approved by FTC Commissioners. Heightened substantiation requirements continue to apply to explicit and implied disease claims that, when viewed in the context of the entire advertisement, draw a connection between product health benefits and disease treatment or prevention. Expert opinion also continues to play a vital role in determining the appropriate amount of substantiation for such claims.