California juice and supplement maker POM Wonderful has entered a new stage in its product claims battle with the Federal Trade Commission (FTC) with a May 24 hearing in Washington, DC. POM’s troubles with FTC date back to September 2010, when the regulatory body filed a complaint asserting the company had made disease claims on its juice and supplement products, including reduction of the risk of heart disease, prostate cancer and erectile dysfunction.
The case harkens back to similar complaints filed against Nestle and Dannon last year over disease claims of similar scope. FTC resolved that, were the defendants to make the same claims in the future, they would require two double-blind, placebo-controlled, human clinical trials performed on the finished product, as well as FDA pre-market approval of claims.
FTC was unable to reach a settlement agreement with Los Angeles-based POM after the complaint was filed, and the case has entered the trial stage. POM’s management—including California agricultural barons Lynda and Stewart Resnick—deny FTC’s case on the grounds that POM has sufficient scientific evidence to back every claim.
The company’s legal brief boasts $35 million in scientific research to bolster its claims, including “more than 90 scientific investigations with over 65 studies on POM products, including 17 clinical trials.” As such, POM’s attorneys have appealed to the First Amendment in their defense, asserting that POM’s product claims are substantiated free speech.
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If you’re going to drop $35 million on research, though, make sure you get what you pay for.
According to Bloomberg, following yesterday’s initial hearing, FTC attorney Heather Hippsley argued that POM’s science lacked teeth. Studies the company cited often lacked control group comparisons, showed statistically immaterial changes in medical conditions, and measured the wrong biomarkers, she said.
Furthermore, Hippsley pointed to company documents showing management’s knowledge of the studies’ weaknesses. That $35 million worth of studies is not enough to impress FTC and FDA really speaks to the emergence of two double-blind, placebo-controlled, human clinical trials as the gold standard for finished product claims, specifically those that take a step beyond structure/function.
Some in the industry have called the POM case a travesty, and tyrannical on the part of FTC. Food law attorney John Emord, for example, recently told NutraIngredients-USA.com that “the FTC richly deserves to lose,” and that “it has exceeded the limits of its statutory authority.”
But FTC’s request seems reasonable enough: If you’re going to make drug claims on your products, do what a drug company does. Otherwise get a smart attorney to help you draw within the lines.
The trial is expected to last through at least the next four months. The Resnicks and the rest of POM look to be in for a long, well-funded fight.
“I can’t tell you what’s going to happen but I want a front-row seat,” said Risa Schulman, PhD, president of Tap-Root Consultancy and former director of research at POM Wonderful. “I know the people at POM, they’re very savvy and they don’t back down easily. It’s going to be a fun one to watch.”