WASHINGTON — The Federal Trade Commission (FTC) has upheld the May 2012 decision by an administrative law judge that POM Wonderful LLC and associated parties made false or deceptive advertising claims in the marketing of POM Wonderful 100% Pomegranate Juice and POMx dietary supplements.
The agency ruled there was inadequate scientific support for claims the products could treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction (ED). In issuing their decision by a 5 to none vote, FTC denied the defendants' appeal and rejected their argument such action by the agency would violate the First Amendment (free speech) and Fifth Amendment (due process) rights.
In its final ruling, FTC found 36 claims were deceptive or false, a marked increase from the 10 claims the agency's Chief Administrative Law Judge Michael Chappell deemed in violation. In their accompnaying Opinion, FTC argued Chappell should have ordered the defendants are required to gain pre-approval from FDA for any future disease-related claims made on any of the challenged products in the case. However, the agency's Final Order did not contain such a requirement.
In a concurring statement, FTC Commissioner Maureen Ohlhausen, who also wrote the Commission's Opinion and Final Order, said she disagreed with the majority findings of implied disease claims, as she found several of the questioned claims conveyed general effects on healthy bodies without referencing diseases or health-related conditions.
"Despite the absence of such references or of other suggestive indicators (e.g., strong medical imagery), the majority finds that these exhibits contain implied disease-related claims without extrinsic evidence that consumers viewing the exhibits would actually perceive such stronger claims and not simply perceive healthy functioning claims," she wrote. "I am concerned that, if the Commission too easily finds implied disease efficacy or establishment claims in advertisements for foods, absent extrinsic evidence, then it may tend to undermine an important balance that is struck in the regulation of food, supplement, and drug advertising under the FTC Act and other federal laws."
Ohlhausen further noted the majority decision mixed up its claims designation on several statements, ruling a claim as disease treatment statement when the claim was actually for risk reduction, and ruling a claim risk reduction that was actually a disease statement.
"Because it seems unlikely that a consumer would assume that any food or food product that lowers the risk of disease is also a viable treatment for that disease, I disagree with the majority’s conclusions that such claims are facially present in certain exhibits," she stated. "Likewise, because it seems unlikely that a consumer would assume that a treatment for existing cancer or heart disease would necessarily prevent the onset of these conditions, I disagree with the majority’s conclusion that such claims are facially present in certain other exhibits."
The commissioner further disagreed with the majority findings that POM's statements about studies being "small," "initial scientific research," "encouraging" and "promising" as establishment claims in the absence of extrinsic supporting evidence. Ditto her feelings on the ruling statements that POM spent millions on research reinforce disease-related establishment claims.
"However, the references to the money spent on research appear to be significantly related to demonstrating the amount of antioxidants in the POM products and the general effects of those antioxidants on the human body," she noted. "Therefore, we need extrinsic evidence to show that consumers would also take away the impression that the research supporting the disease claims is established and not merely preliminary."
Overall, she said there was no extrinsic evidence—e.g. facial analysis of challenged claims or copy testing evidence to demonstrate how claims may be perceived—and the practice of finding claims to be stronger than what consumers would actually perceive may levy an undue level of substantiation for those claims. She expressed concern the majority's interpretation of the POM claims blurs the "carefully drawn boundaries between different types of claims regarding the effect of food and dietary supplement products on nutrition and health" and creates inconsistency between FTC and FDA requirements by establishing a standard that mentioning "health" or "healthy" functioning" can result in a decision of implied disease claim and that mentioning scientific evidence can trigger an establishment claim ruling.
Commissioner J. Thomas Rosch also issued a concurrent statement, in which he outlined why he agreed with the majority decision and its method of finding implied claims. He noted he and his colleagues viewed the ads in the case. "There can be no dispute that the net impression of the ads is what counts in determining what impression is conveyed to consumers," he assured.
The final opinion of the Commission outlined its requirement of two randomized clinical trials (RCTs) to substantiate any future disease-related claims made by the defendants. In the Opinion, Ohlhausen noted her disagreement with this finding, saying instead she would require only one RCT for fencing-in relief, arguing, "Requiring a second RCT is not reasonably related to the violations at issue in this case because a second study would not cure any particular statistical or methodological problems. ... Moreover, although it might provide the Commission with some subjective comfort, requiring two RCTs does so at the expense of limiting consumer access to potentially useful information."