ALJ Says Some Implied Health Claims in POM Wonderful Ads Not Substantiated

An administrative law judge (ALJ) has upheld some of the Federal Trade
Commission’s (FTC’s) allegations that POM Wonderful violated federal law
by making deceptive claims in some advertisements that the company’s
pomegranate juice and related products treat, prevent, or reduce the risk of
heart disease, prostate cancer and erectile dysfunction. In re: POM Wonderful
LLC, No. 9344 (FTC, decided May 17, 2012). The ALJ’s initial decision is
deemed the decision of the FTC 30 days after it is served on the parties, unless
appealed or placed on FTC’s docket on its own motion.

According to the ALJ, some, but not all, of POM’s ads could be interpreted as containing an “implied claim” that the company’s products treat, prevent or reduce the risk of some diseases and that “these effects were clinically proven.” The ALJ also determined that (i) “the appropriate level of substantiation for claims that a product treats, prevents, or reduces the risk of a disease is competent and reliable scientific evidence”; (ii) if such claims are made in connection with a food or food-derived product “that is not being offered as a substitute for medical treatment, double-blind, randomized, placebo-controlled clinical trials, such as those required by Food and Drug Administration [FDA], are not required”; and (iii) for claims that a food or food-derived product treats, prevents or reduces the risk of disease, “competent and reliable scientific evidence must include clinical studies, although not necessarily double-blind, randomized, placebo-controlled clinical trials, that are adequate to show that the product did treat, prevent, or reduce the risk of disease.”

On these bases, the ALJ concluded that POM’s substantiation was inadequate to support the implied claims in some of its ads, and thus they were false or misleading under federal law. “The evidence further shows that such health-related efficacy claims are material to consumers,” said the ALJ. While the ALJ’s cease and desist order is designed to prevent POM from engaging in deceptive advertising practices in the future, it does not include FTC’s “proposed provision prohibiting Respondents from making any disease claim in the future, unless the claim has received prior approval from the Food and Drug Administration in accordance with Food and Drug Administration statutes and regulations.”

POM Wonderful has responded to the decision by mounting an “aggressive” ad campaign in the national media including selected quotations; POM contends that the company has the “right to share valuable, scientifically validated information about the health benefits of its safe food with consumers.” Among the quotations is “Competent and reliable scientific evidence supports the conclusion that the consumption of pomegranate juice and pomegranate extract supports prostate health, including by prolonging PSA doubling time in men with rising PSA after primary treatment for prostate cancer.” Omitted is an ALJ caveat that follows the statement: “However, the greater weight of the persuasive expert testimony shows that the evidence relied upon by the respondents is not adequate to substantiate claims that POM products treat, prevent or reduce the risk of prostate cancer or that they are clinically proven to do so.”

In a statement, the company’s chief legal officer reportedly said, “Through its
lawsuit against POM, the FTC tried to create a new, stricter industry standard,
similar to that required for pharmaceuticals, for marketing the health benefits
inherent in safe food and natural food-based products. They failed.” The
company also hailed the ALJ’s rejection of FTC’s request that POM receive
pre-approval for its health claims. In this regard, the ALJ stated, “Neither FDA
pre-approval, nor FDA standards for obtaining such approval, constitutes the
required level of substantiation under the FTC Act or applicable case law.” A
company spokesperson called this “a huge win for us [and] for the natural
food products industry.”

According to a news source, POM has sponsored at least 100 studies on the health effects of pomegranate juice over the past decade, devoting more than $35 million to the research. New York University Nutrition Professor Marion Nestle commented on those aspects of the ruling dealing with conflicting research by noting, “It is not difficult to design research studies to give sponsors the answers they want and to make sure they are conducted well. POM is getting the best research that money can buy.” She also indicated, “Health claims are about marketing, not health. Let’s hope the FTC can make the decision stick.” See POM Wonderful News Release and FTC News Release, May 21, 2012; Law.com, May 22, 2012; Courthouse News Service and FoodPolitics.com, May 23, 2012; The New York Times, May 25, 2012.