(CN) – Current research does not support linking Pom Wonderful pomegranate juice to certain health benefits, like diminished erectile dysfunction, the D.C. Circuit ruled.
In a September 2010 complaint, the Federal Trade Commission (FTC) took issue with reliance by Pom Wonderful and its sister company, Roll Global, on “clinical studies, research and or/trials” that purportedly proved the health benefits it touted for consumers of their products.
While the FTC claimed that no such evidence exists, Pom countered that the FTC’s advertising standards were unfair and contradicted well-established advertising rules.
A hearing of the FTC complaint by Administrative Law Judge D. Michael Chappell stretched from May 24 to Nov. 4, 2011, and included more than 2,000 exhibits, including testimony from diet and heart health expert Dr. Dean Ornish.
Most of Chappell’s 330-page decision examined the scientific evidence on which Pom claims to have relied when making the disputed health claims, as well as the proper standard for making such claims.
Pom argued that it had to rely only on competent and reliable scientific evidence because it never claimed that consuming its products could substitute for drugs or other therapy to treat disease.
The Delaware company, which is headquartered in Los Angeles, has sponsored at least 100 studies in the last decade on the health effects of pomegranates, invested more than $35 million in such research.
But an FTC judge ruled in 2012 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 D.C. Circuit upheld the ruling Friday.
“The FTC Act proscribes – and the First Amendment does not protect – deceptive and misleading advertisements. Here, we see no basis for setting aside the Commission’s conclusion that many of Pom’s ads made misleading or false claims about Pom products,” Judge Sri Srinivasan wrote for a three-judge panel.
Pom’s ads touted the results of the studies it sponsored, but did not reveal the studies’ limitations or share the total results, which showed some factors were not improved by drinking pomegranate juice.
For example, Pom pointed to studies showing that increased blood flow to the heart by groups who drank pomegranate juice saw a 50 percent greater likelihood of improved erections. But the study, while showing some association between pomegranate juice consumption and improved erections, was not actually statistically significant, the court found.
“We conclude that the commission’s findings of deception are supported by substantial evidence in the record; and we would reach the same conclusion even if we were to exercise de novo review, at least with respect to the nineteen ads determined misleading by the administrative law judge and held by the commission to form a sufficient basis for its liability determination and remedial order,” Srinivasan said.
The court ruled that Pom need gain only the support of one randomized, controlled, human clinical-trial study – not two, as the FTC ruled – before Pom again may claim a causal relationship between consumption of pomegranate juice and prevention of any disease.
“Requiring additional RCTs [randomized clinical trial] without adequate justification exacts considerable costs, and not just in terms of the substantial resources often necessary to design and conduct a properly randomized and controlled human clinical trial,” the 45-page opinion states. “If there is a categorical bar against claims about the disease-related benefits of a food product or dietary supplement in the absence of two RCTs, consumers may be denied useful, truthful information about products with a demonstrated capacity to treat or prevent serious disease.”
FTC Chairwoman Edith Ramirez called the court’s decision a “victory for consumers.”
“It is in keeping with established law that advertisers who market products for serious health conditions must have rigorous science to back up those claims,” Ramirez said in a statement.
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