In a 335-page ruling dated May 17 on a complaint brought against POM by the FTC in 2010, administrative law judge Michael Chappell agreed with POM that the FTC had overstepped the mark by asking POM to seek pre-approval from the FDA before making health claims in future.
Such a requirement, said Chappell, was "unsupported by governing precedent".
He also rejected the argument that claims about food products must always be supported by randomized, double-blind placebo-controlled human clinical trials - especially if they are not being marketed as a substitute for medical treatment.
And even where products are marketed as treating, preventing or reducing the risk of disease, experts would agree that clinical studies are required, but "not necessarily double-blind, randomized, placebo-controlled clinical trials " he added.
So far, so good for POM, which has repeatedly claimed that the FTC is trying to regulate foods like drugs.
Chappell: Pomegranate juice supports prostate health, but it doesn't treat, prevent or reduce the risk of prostate cancer...
However, Chappell also concluded that while claims that pomegranate juice could "support prostate health" and "promote erectile health" could be supported; claims that it could prevent, treat or reduce the risk of prostate cancer, erectile dysfunction and heart disease were not supported by scientific evidence.
In other words, POM - despite claiming victory - had in fact lost the argument and been successfully taken to task for false advertising, said the FTC.
And this was the key takeaway from the ruling, insisted FTC consumer protection bureau chief David Vladek.
"I am pleased that Judge Chappell found that all respondents including Mr. and Mrs. Resnick violated the FTC Act by deceptively advertising that the POM products treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction and has entered an order against them.”
POM, meanwhile, has agreed to make “appropriate adjustments” to future ads.
Emord: The FTC overstepped its bounds
The battle betweem POM and the FTC has been followed closely by the food and dietary supplements industry as it addresses broader questions over free speech and the substantiation required for making claims about foods and dietary supplements (as distinct from drugs).
Food law attorney Jonathan Emord said the ruling had broad implications for the food and supplements trade.
Notably, Chappell had “correctly decided that the FTC overstepped its bounds by demanding two randomized double blind placebo controlled clinical trials as a condition precedent for the making of health benefit claims for POM products", he said.
Moreover, the FTC had "exceeded its statutory authority when it attempted to enforce the FDA’s prior restraint on health claims", he added.
Ruling establishes 'meaningful limit on FTC powers'
If Chappell's decision is upheld, he said, it "will establish a meaningful limit on the exercise of official discretion over commercial speech by agency staff who have increasingly endeavored to dumb down the information consumers may receive to a limited, state approved orthodoxy that excludes emerging science.
“The public has a right to receive information on the possible and the probable health benefits of products, not just information deemed conclusively proven by regulators; knowledge of the possible and the probable are indispensable to the exercise of informed consumer choice.”
POM: FTC tried to make food industry adhere to pharma standards… and failed
POM Wonderful chief legal officer Craig Cooper also focused on the broader ramifications of the ruling (rather than the fact that many of POM's specific claims were deemed to be unsubstantiated).
He said: "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.”
He added: “We will be able to continue to promote the health benefits of our safe, food products without having our advertisements, marketing or public relations efforts preapproved by the FDA and without having to rely on double-blind, randomized, placebo-controlled studies, the standard required for pharmaceuticals.
“We consider this not only to be a huge win for us, but for the natural food products industry."
$35m in research
If the ruling is adopted by the FTC, POM’s parent company Roll Global will be under a 20-year order that requires scientific research to back up health benefit claims.
However, “that order would not require FDA pre-approval or language that would be interpreted as the standard of double-blind, randomized, placebo-controlled studies as requested by the FTC in their complaint”, stressed POM.
Since 1996, POM Wonderful has invested more than $35m to support scientific research on its Wonderful variety pomegranate products.
Either side can appeal all or parts of the decision, notes Hyman, Phelps & McNamara attorney Riëtte van Laack in the FDA law blog:
"Both the FTC Staff which prosecuted this case and POM can seek review of this decision by the five FTC Commissioners. We expect that both parties will seek that review. We also expect that it will take many months before the FTC Commissioners rule on the appeals."
Click here for industry reaction to Chappell's ruling.
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