On January 30, the D.C. Circuit Court of Appeals held in POM Wonderful, LLC, et al. v. Federal Trade Commission that the FTC did not have an adequate basis to require POM Wonderful, LLC to conduct a minimum of two successful “randomized and controlled human clinical trials” before making advertising claims regarding product efficacy and disease prevention.
POM represented that medical studies show that its products may prevent heart disease, prostate cancer and erectile dysfunction. Issues flagged by the FTC included deficient studies, small sample sizes, insignificant results and failing to adequately disclose the existence of a contrary body of evidence.
Ultimately, the FTC ordered POM to possess “competent and reliable scientific evidence” for claims regarding general health benefits. For claims regarding effect on serious health conditions and diseases, the FTC ordered POM to possess at least two (2) RCTs with statistically significant results.
The FTC aggressively promotes a two (2) RCT standard in conjunction with health-related claims. However, such requirements are often in conjunction with settlements and some question whether the imposition of a two (2) RCT requirement across the board is too broad brush.
POM petitioned the D.C. Circuit Court for review of the FTC’s order, arguing that requiring RCTs for disease-related claims “ordinarily amounts to an outright prohibition on such claims,” due the cost of an RCT. While the D.C. Circuit sustained the FTC’s conclusion that POM’s advertisements contained deceptive claims, and that the company selectively relied on studies as proving its claims while downplaying negative studies, it reversed the two (2) RCT requirement on constitutional grounds that it was not a “reasonable fit” with the government interest being advanced.
In doing so, the Court stated that under the present standard, “consumers may be denied useful, truthful information about products with a demonstrated capacity to treat or prevent serious disease.” For example, there may be situations where one well-designed RCT, along with other supporting non-RCT evidence, could adequately substantiate a claim.
The D.C. Circuit panel modified the FTC’s order to require only one RCT before making future disease-related claims. In doing so, the Court rejected the across-the-board two (2) RCT substantiation requirement for all future disease-related claims.
So, what effect does this ruling have on the FTC’s ability to promote the two (2) RCT standard?
Perhaps most importantly, the POM decision was limited to disease claims. Since 2010, the FTC has strictly required in many of its settlements involving dietary supplements and weight-loss products that advertisers agree to support future claims with at least two (2) RCTs that are based upon the entire body of the evidence.
The D.C. Circuit also made clear that FTC efforts to regulate advertising are subject to First Amendment limitations. Before the FTC can impose restrictions on future advertising, it must demonstrate that the restrictions are narrowly tailored to accomplish the government’s interest in preventing deceptive advertising.
While the ruling signals that the two (2) RCT requirement cannot be imposed as a blanket requirement to all disease-related claims, the FTC will almost certainly continue to require two (2) RCTs on a case-by-case basis.
It is safe to assume that the POM ruling may impact future FTC orders. However, it may not be wise to believe that the ruling will significantly impact enforcement policy. The number of studies required will continue to depend upon a variety of factors.
Contact an advertising law attorney to discuss critical compliance principles, how to avoid becoming an easy target and what this ruling means to your business.
Information conveyed in this article is provided for informational purposes only and does not constitute, nor should it be relied upon, as legal advice. No person should act or rely on any information in this article without seeking the advice of an attorney.
