SPECIAL FOCUS: D.C. Circuit Limits FTC’s Ability to Require Two Randomized Clinical Trials to Substantiate Disease Claims in Long-Awaited POM Decision
On January 30, 2015, the U.S. Court of Appeals for the District of Columbia Circuit issued its long-awaited opinion in the POM case.1 In a press release, the Federal Trade Commission (FTC or the Commission) Chairwoman Edith Ramirez touts the decision as a “victory for consumers. It is in keeping with established law that advertisers who market products for serious health conditions must have rigorous science to back up those claims.” While the court’s ruling that POM’s advertising claims were unsubstantiated was certainly a victory for the FTC, of even greater significance was the court’s rejection of the FTC’s position that such claims had to be supported by at least two randomized clinical trials (RCTs).
Since 2010, the FTC has been requiring in many of its Consent Orders involving dietary supplements and weight-loss products that advertisers agree in the future to support such claims with at least two RCTs. However, in the POM decision, the D.C. Circuit rejected the across-the-board two-RCT substantiation requirement for all future disease-related claims by POM because the Commission failed to meet its burden of showing a “reasonable fit” between the remedy and the government interest at issue, which the U.S. Supreme Court required in Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n.2 The D.C. Circuit held that while two RCTs would certainly be more reliable scientific evidence than one, the Commission has failed to justify that the increased scientific certainty afforded by this requirement outweighs the consequences.
The FTC had argued that the two-RCT requirement was justified given POM’s demonstrated propensity to make deceptive claims regarding health and diseases. However, the D.C. Circuit held that the two-RCT requirement was unduly burdensome to address this government interest. Importantly, the D.C. Circuit recognized that the FTC’s two-RCT requirement imposes increased costs and resources to design and conduct an RCT and observed that “[i]f there is a categorical bar against claims about the disease-related benefits of a food product or dietary supplement in the absence of two RCTs, consumers may be denied useful, truthful information about products with a demonstrated capacity to treat or prevent serious disease. That would subvert rather than promote the objectives of the commercial speech doctrine.” Furthermore, the D.C. Circuit noted that the two-RCT requirement was overly restrictive because it prohibited POM from making any disease-related claim, regardless of how compelling the study and other medical research, absent the completion of two RCTs. Finally, the D.C. Circuit stated that not only is the requirement of two RCTs arbitrary, but it also contradicts prior policy statements by the Commission, which provide that “[i]n most situations, the quality of studies will be more important than quantity.”3
Overall, the POM decision was still a victory for the Commission because the Order against POM was deemed valid insofar as the court accepted the requirement that disease claims must be substantiated with at least one RCT. Additionally, the D.C. Circuit did not foreclose the possibility of imposing a two-RCT requirement going forward. Instead, the D.C. Circuit carefully left open the possibility that a narrowly crafted two-RCT requirement, likely limited to a particular disease, could survive First Amendment scrutiny if the FTC could offer an appropriate justification. As the decision explains, the two-RCT requirement in the POM Order “fails Central Hudson scrutiny insofar as it categorically requires two RCTs for all disease-related claims. That is not at all to say that the Commission would be barred from imposing a two-RCT-substantiation requirement in any circumstances. Rather, the Commission has failed in this case adequately to justify an across-the-board two-RCT requirement for all disease claims by petitioners.”4
Why it matters: The clear message of the D.C. Circuit decision is that the two-RCT requirement cannot be imposed as a blanket across-the-board requirement to all disease-related claims, but rather that the level of substantiation required will have to be considered on a more case-specific basis. While this decision may have some impact on how the FTC crafts its orders in the future, it is not likely to significantly alter the FTC’s recent enforcement policy. The FTC has always insisted that its policy is to require a level of substantiation that experts in the field deem is necessary, and accordingly, marketers should not assume from this decision that one RCT will always be enough. It seems clear from this decision and FTC enforcement history that for disease-related claims, one RCT will continue to be the minimum level required, but whether one study will be sufficient will depend on a variety of factors including the nature of the claim, how robust the one RCT is, how compelling the results are and whether there are other studies that contradict the results. Marketers can expect the FTC to continue to heavily scrutinize their testing and to remain vigilant in its enforcement of health and weight-loss claims.
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1See POM Wonderful, LLC v. the Federal Trade Commission, No. 13-1060 (D.C. Cir. Jan. 30, 2015).
2Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n, 447 U.S. 557, 566 (1980).
3POM at p. 39. citing U.S. Fed. Trade Comm’n, Dietary Supplements: An Advertising Guide for Industry 10 (Apr. 2001), available at http://www.business.ftc.gov/documents/bus09-dietary-supplements-advertising-guide-industry.
4POM at p. 45 (internal citations omitted).