In a much anticipated opinion, the Court of Appeals for the District of Columbia upheld the vast majority of a Federal Trade Commission order enjoining pomegranate juice maker POM Wonderful from advertising that its products treat or reduce the risk of certain diseases without a reasonable basis to substantiate the claims, including evidence from randomized controlled trials RCTs).
However, the appellate court modified the FTC’s determination that such substantiation for POM’s disease claims would require evidence from two RCTs, holding that the agency’s justification for requiring two supporting RCTs was “inadequate.” Rather, the appellate court ruled that one RCT would be sufficient to substantiate POM’s disease claims.
The court left the door open for FTC to require two RCTs under some circumstances, but rejected a categorical requirement of two RCTs for all disease claims, and importantly, did not impose an RCT burden on non-disease claims.
In September 2010, the FTC filed a complaint against POM, its founders and its then current CEO, alleging 43 of POM’s print, newsletter, website, press releases, media interviews and Internet advertisements contained false, misleading and unsubstantiated representations in violation of federal law. Specifically, the FTC alleged the ads represented – without a reasonable basis – that consumption of POM Juice, POMx Pills and POMx Liquid products treats, prevents or reduces the risk of heart disease, prostate cancer, or erectile dysfunction.
In May 2012, an Administrative Law Judge (ALJ) agreed with the FTC, finding that 19 of the 43 challenged ads implied that POM’s products treat, prevent or reduce the risk of heart disease, prostate cancer or erectile dysfunction and that POM lacked adequate competent and reliable scientific evidence to support the implied claims. On appeal, the full Commission upheld the ALJ’s general finding that POM’s advertisements were false, misleading and unsubstantiated, but strengthened the substantiation burden for POM’s disease claims by requiring two well-controlled, randomized studies that yielded statistically significant results and, unless ineffective to implement, were double-blinded. POM was barred from making any disease-related claims without this substantiation. Both POM and the FTC appealed this decision.
On appeal, the US Court of Appeals for the District of Columbia Circuit generally upheld the decision of the full Commission, noting the broad discretion given to the FTC in its area of expertise. It also found that the First Amendment does not protect misleading commercial speech.
The Court of Appeals, however, struck down the FTC’s blanket requirement of two RCTs to substantiate disease claims. The Court of Appeals noted that commercial speech restrictions require that the asserted government interest be substantial and that the restriction be related to advancing the interest, while being no more extensive than necessary to serve that interest. While the Court of Appeals acknowledged that requiring RCT substantiation is an appropriate remedy for past deceptive conduct, it concluded that categorically requiring two RCTs to substantiate disease-related claims is not a narrowly tailored requirement.
While the Court of Appeals acknowledged that having a larger number of scientific studies demonstrates stronger evidence, it emphasized the considerable cost associated with the FTC’s categorical two-RCT requirement. Not only is such research expensive, the court noted, but also the public suffers when shielded from the results of a single reliable study, merely because it was only conducted once. Furthermore, the Court acknowledged that a “wealth of medical research and evidence apart from RCTs” – such as observational studies – can reinforce a single RCT and that other federal agencies recognize that a well-conducted and controlled clinical trial supported by a body of evidence from observational and mechanistic studies can provide sufficient evidence to establish a substance/disease relationship.
Ultimately, the Court of Appeals found the two-RCT requirement not only inconsistent with past precedent, but also unnecessary given the general requirement that health-related claims be supported by competent and reliable scientific evidence that is sufficient to substantiate that the representation is true. In the court’s view, this overarching standard provided sufficient protection against misleading advertisements without the need for a more specific, bright-line rule.
This may not be the final word on the matter. It remains to be seen whether either party will seek United States Supreme Court review or whether different courts will have the opportunity to weigh in on the dispute in other related cases. Companies making disease claims, whether those claims are express or implied, should stay tuned for further developments, and for potential impacts this dispute may have on the broader food and supplement industry.