By 2010, the company had spent more than $35 million on pomegranate-related medical research, including the sponsoring more than one hundred studies at forty-four different institutions. From this research, the company made claims related to heart disease, prostate cancer, and erectile dysfunction. In a ruling in 2012 following administrative hearings, the FTC found that nineteen of POM’s advertisements and promotional materials contained implied claims that POM products treat, prevent, or reduce the risk of heart disease, prostate cancer, or erectile dysfunction.
Back in September 2010, the FTC filed a complaint against Pom Wonderful and its sister company, Roll Global, over the health claims. The FTC found no supporting clinical studies or research or trials to back up the claims. Administrative Law Judge D. Michael Chappell held a remarkably long adjudication of the dispute from May 24 to Nov. 4, 2011 with more than 2,000 exhibits. Chappell then produced a 330-page decision against the company. Pom offered at least 100 studies in the last decade on the health effects of pomegranates. However, that was not enough. The FTC found that Pom cannot claim that its juice or PomX dietary supplements treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction because it lacks competent and reasonable scientific evidence to support its claims.
The DC Circuit, in an opinion written by Judge Sri Srinivasan, found that there is “no basis for setting aside the Commission’s conclusion that many of Pom’s ads made misleading or false claims about Pom products.” The opinion is an interesting one on the level of proof needed in such claims. For example, the company insisted that studies showed that increased blood flow to the heart by groups who drank pomegranate juice saw a 50 percent greater likelihood of improved erections. However, the court found that the difference was not actually statistically significant. Notably, however, the D.C. Circuit ruled that Pom need gain only the support of one randomized, controlled, human clinical-trial study to make the claims. The FTC insisted that two such trials were needed.
The Court says that if Pom wants to make claims, it will have to pony up for more trials:
We acknowledge that RCTs may be costly, although we note that the petitioners nonetheless have been able to sponsor dozens of studies, including several RCTs. Yet if the cost of an RCT proves prohibitive, petitioners can choose to specify a lower level of substantiation for their claims. As the Commission observed, “the need for RCTs is driven by the claims [petitioners] have chosen to make.” Id. at 25. An advertiser who makes “express representations about the level of support for a particular claim” must “possess the level of proof claimed in the ad” and must convey that information to consumers in a non-misleading way. Thompson Med. Co., 791 F.2d at 194. An advertiser thus still may assert a health-related claim backed by medical evidence falling short of an RCT if it includes an effective disclaimer disclosing the limitations of the supporting research. Petitioners did not do so.
Here is the opinion: POM Decision