Judge: Health Claims About Pomegranate Juice Not So ‘Wonderful’
NEW YORK, May 30, 2012 /PRNewswire/ — A judge’s ruling that POM Wonderful lacked the science to back up bold claims about its pomegranate products–including that its juice could fight heart disease, cancer and even erectile dysfunction–points to the risks of aggressively marketing so-called functional foods. It might also lead to a showdown over whether the FTC can force marketers to get “gold-standard” scientific evidence before they run such ads, said LeClairRyan attorney and 17-year FTC veteran Thomas A. Cohn.
“Over the past couple of years, the newly aggressive FTC has tried to redefine ‘competent and reliable scientific evidence’ for certain serious health claims to mean something quite specific–namely, randomized, double-blind clinical studies involving human subjects,” said Cohn, a New York-based partner in the national law firm. “While this is part and parcel of the Food & Drug Administration’s strict pre-approval process for certain drugs, it represents quite a departure in the arena of supplements and functional foods. The POM Wonderful case is significant because the judge found there was no precedent for the FTC’s imposition of these more-stringent substantiation standards.”
In the May 21 ruling, the FTC administrative law judge found that POM Wonderful LLC and affiliated respondents had made false and unsubstantiated advertising claims by asserting that the brand’s pomegranate juice and pills could treat, prevent or reduce the risk of heart disease, prostate cancer and erectile dysfunction. “The judge found that POM did not have competent and reliable scientific evidence that drinking a serving of POM juice daily, or taking a similar dose of POMx pill or liquid, could achieve these effects,” Cohn said.
But the judge also noted that the existing substantiation requirement for disease-fighting claims does not require carefully controlled clinical trials along the lines of FDA drug pre-approval. “Rather, the ruling was that POM’s evidence must meet standards generally accepted in the relevant scientific field, and that this evidence must be weighed in light of the entire body of ‘relevant and reliable’ scientific evidence,” Cohn said. “That might sound demanding, but it is a far cry from clinical trials.”
And yet in the past two years the FTC has reached nearly 20 settlements in which it has persuaded marketers of supplements and functional foods to conform to this higher standard–particularly when it comes to weight-loss and disease-fighting claims, Cohn said. In various business education publications, the agency has also warned marketers of the need to comply with stringent, FDA-derived protocols. “Significantly, the judge said this was without any precedent, and that new standards could only be established through adjudication or rulemaking,” Cohn noted. “The judge simply included in his order the usual definition of competent and reliable scientific evidence from most past FTC orders. The FTC, in other words, had overstepped its authority by trying to impose another agency’s requirements.”
Now it is up to the full commission to review the administrative law judge’s decision, which it can do on its own or at any party’s request. If the full commission’s decision is contested, the matter would go to a federal appeals court. All told, the POM case creates a host of broader questions, Cohn noted. “Will the respondents fight the rulings against them? Will FTC staff push for an FDA pre-approval requirement, which it has inserted into many recent settlements but has never successfully litigated?” he asked. “If FTC loses this point on appeal to federal court, that might even nullify this requirement in those past settlements.”
An FTC victory, on the other hand, could force marketers of functional foods to dial back their disease-fighting claims in the absence of data from clinical trials. “Such studies are so astronomically expensive that only the biggest companies can afford them,” Cohn said. “This is significant in an industry full of small startups.”
In the meantime, those who market the likes of coconut oil and goji berries should take care to avoid making unsubstantiated claims, Cohn advised. “A just-the-facts approach is critical. If you are marketing cherry soda and your product actually contains real cherries, it might be OK to put ‘Contains antioxidants’ on the label,” he said. “But if you add another gram of vitamin K to your cereal, you should think twice about trumpeting that it ‘fights cancer’ or ‘boosts immunity.’ “
Marketers should also avoid messaging that might cause FTC experts to believe certain health benefits were being implied, if not explicitly claimed. “The exact wording of the ad is not the whole story,” Cohn said. “When it comes to implied claims, judges usually defer to the FTC’s expert witnesses. Subtle suggestions, in other words, also carry risk.”
Founded in 1988, LeClairRyan provides business counsel and client representation in corporate law and high-stakes litigation. With offices in California, Connecticut, Massachusetts, Michigan, New Jersey, New York, Pennsylvania, Virginia and Washington, D.C., the firm has approximately 350 attorneys representing a wide variety of clients throughout the nation. For more information about LeClairRyan, visit www.leclairryan.com.
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Thomas A. Cohn