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The FTC’s recent opinion in the POM Wonderful pomegranate case reveals more about the agency’s view on health-benefit claims.
The FTC this January struck down an appeal from pomegranate marketer POM Wonderful in a case that found POM guilty of making unsupported, deceptive health claims. POM had appealed FTC chief administrative law judge (ALJ) D. Michael Chappell’s ruling back in May 2012 that POM made deceptive claims for its juice and dietary supplement products. The FTC Commission’s opinion, In the matter of POM Wonderful LLC1, details its January decision.
In contrast to previous FTC settlements involving health-benefit claims for food products, the 53-page January opinion provides detailed insight into the Commission’s position on health-benefit claims for conventional food and beverage companies contemplating novel health-centered marketing strategies. There is a lot the dietary supplement industry can take away from this case.
This case goes back to ALJ Chappell’s May 2012 decision in an administrative complaint filed by the FTC. In the FTC complaint, the FTC charged POM Wonderful with making false and unsubstantiated claims for its pomegranate juice and POMx supplements. The agency said POM had claimed its products will prevent or treat heart disease, prostate cancer, and erectile dysfunction.
In his decision, the ALJ determined that 19 of the 43 challenged advertisements and promotional materials of concern to the FTC staff contained implied claims that POM Products will treat, prevent, or reduce the risk of heart disease, prostate cancer, or erectile dysfunction. The ALJ ruled that these claims were false or misleading and material to consumers’ purchasing decisions.
However, importantly, ALJ Chappell decided that POM Wonderful should not be required to obtain FDA preapproval prior to making similar claims in future advertising-something the FTC had requested.
The ALJ also determined that in the case of a “safe food” that is not advertised as a substitute for medical treatment, competent and reliable scientific evidence should include clinical studies. Crucially, however, he said that those clinical studies do not necessarily need to be double-blind, randomized, placebo-controlled clinical trials (RCTs).
The ALJ’s ruling that RCTs may not be required to substantiate POM’s claims was considered a blow to the FTC staff. The agency had argued that POM’s claims should be substantiated by two RCTs. Both parties, POM and the FTC, appealed the ALJ’s decision, and this is what led to the FTC Commission’s review of the case de novo and its decision this January.
The FTC Commission’s January opinion2 largely upheld and expanded the scope of the ALJ’s May 2012 decision, ruling that 36 of POM’s 43 ads made efficacy claims and were false and misleading.
However, and very importantly, the Commission rejected of the ALJ’s position regarding the requisite substantiation for POM’s claims. The Commission instead agreed with the FTC staff that POM isrequired to present two RCTs to substantiate claims regarding heart disease, prostate cancer, and erectile dysfunction. The Commission also ruled that claims that a product can treat, prevent, or reduce the risk of these ailments are “serious disease claims.”3
While most of the remaining Commission rulings were unsurprising,4 some of the Commission’s discussion of POM’s actions sheds more light on how FTC scrutinizes health-benefit claims. Insights include how the Commission determines the net impression of an ad and when the Commission deems it appropriate to pursue individual liability for company officers. Below are just a few of the key points:
Regulators are increasingly scrutinizing campaigns marketing the relationship between diet and disease. The POM Wonderful case is just one of many recent examples of regulatory action.
POM reinforces the importance of ensuring that all health-benefit claims are carefully constructed to reflect the underlying science. Companies interested in minimizing the risk profile for a product line should take a conservative approach to describing the science supporting health-benefit claims in advertisements.
For example, in the absence of clear evidence establishing a causal relationship between a substance and a disease, companies should avoid touting the amount of money spent on research and should avoid coupling such claims with medical symbols, such as a caduceus. In addition, when developing marketing campaigns, companies may also want to consider whether the claims would involve a “serious disease” and refrain from making claims related to serious diseases unless such claims are supported by RCTs.
Taken together, these steps can help a company sustain the scrutiny of the FTC and avoid both company and individual liability for potential deceptive claims.