The United States Supreme Court denied POM Wonderful's final bid to overturn a Federal Trade Commission (FTC) decision that the company deceptively advertised its pomegranate-based products. In 2013, the FTC affirmed (and in part expanded) an administrative law judges' decision, ruling that certain ads--viewed by the FTC as claiming that POM's fruit juice could treat certain diseases--violated the FTC Act. Breaking new ground, the Commission held that certain types of ads violate the FTC Act unless supported by randomized, controlled, human clinical trials (RCTs), which are generally required for disease claims. In 2015, the U.S. Court of Appeals for the D.C. Circuit affirmed the FTC's decision. The Court noted, however, that a disease claim may not need a RCT as long as the marketer "disclos[es] the limitations of the supporting research."
The D.C. Circuit also affirmed the Commission's prospective injunction requiring POM to possess at least one RCT for disease claims. Notably, the D.C. Circuit rejected the Commission's order that required POM to possess two RCTs for certain claims. The Supreme Court's denial of POM's cert petition ends POM's attempt to overturn the D.C. Circuit and FTC decisions. In recent years, the FTC has attempted to expand this position and tried to require RCTs for ordinary "structure/function" claims in addition to disease claims. A number of companies have entered consent decrees agreeing to the RCT requirement. See FTC v. Iovate Health Sci. USA, Consent Decree at 7, No. 10-CV-587 (W.D.N.Y. July 29, 2010); United States v. Jason Pharm., Inc., Consent Decree at 3, 6, No. 12-CV-01476 (D.D.C. Sept. 17, 2012).
However, when companies do not agree to an RCT-standard for structure/function claims, they have had success in court. Most notably in United States v. Bayer, No. 07-0001 (D.N.J. 2015), the Court rejected the government's case and held that structure/function claims "do not require drug-level clinical trials" or RCTs of any kind. See also FTC v. Garden of Life Inc., 845 F. Supp. 2d 1328, 1334-35 (S.D. Fla. 2012) aff'd in part and vacated in part, 516 F. App'x 852 (11th Cir. 2013); Basic Research, LLC v. FTC, No. 2:09-cv-0779 at 26-27 (D. Utah Nov. 25, 2014).
The line between structure/function claims and disease claims is critical. The POM case serves as an important reminder for dietary supplement and food companies to not make unapproved claims that their products can
diagnose, mitigate, treat, cure, or prevent any disease. See 21 U.S.C. 343(r)(6). As demonstrated by POM, these claims must be supported by RCTs in most circumstances.
Companies that restrict their marketing to legitimate structure/function claims--like the company did in United States v. Bayer--need not meet this high standard. Structure/function claims still must be truthful and supported by competent and reliable scientific evidence, but RCTs are not required.