On January 30, the D.C. Circuit largely affirmed the Federal Trade Commission’s ruling that POM Wonderful LLC made false and misleading advertising claims that its pomegranate juice products were effective in treating or preventing diseases. POM’s ads, the court held, claimed that its products could help fight heart disease, prostate cancer, and erectile dysfunction, yet POM lacked adequate substantiation to support those claims. The court also agreed with the FTC that POM’s ads misleadingly failed to disclose evidence that contradicted those claims.

However, the D.C. Circuit modified the FTC’s remedial order. While the FTC had required that any future disease claims by POM be supported by at least two randomized, well-controlled human clinical trials—known as “RCTs”—the D.C. Circuit held that a single RCT could be sufficient.

In reaching that conclusion, the court found that the FTC failed to meet its burden of showing a “reasonable fit” between its legitimate interest in preventing deceptive claims and its chosen remedy of requiring two RCTs. Thus, the court explained, the FTC’s remedy ran afoul of the First Amendment test for commercial speech restrictions under the Supreme Court’s decision in Central Hudson Gas & Electric Corp. v. Public Service Commission. The court observed, “a categorical bar against claims about the disease-related benefits of a food product or dietary supplement in the absence of two RCTs” would risk depriving consumers of “truthful information about products with a demonstrated capacity to treat or prevent serious disease.” 

The court made clear, however, that it was not precluding the FTC from imposing a two-RCT requirement in all cases. Rather, the court simply found that the FTC had failed to justify that requirement in this particular instance. The court observed that the two-RCT requirement should generally be imposed “only in narrow circumstances based on particularized concerns.” 

TIP: Advertisers are responsible for having adequate substantiation that provides a reasonable basis for their claims. The D.C. Circuit’s decision in POM Wonderful indicates that disease claims for foods and dietary supplements may be supported by one RCT, provided there is additional corroborating evidence and the results of that RCT are not contradicted by other scientific evidence.