“There are a number of grounds on which the Court could take up a case, such as if it involved a critical question of constitutional law,” Ivan Wasserman, managing director of the Washington, DC officer of the law firm Manatt, Phelps and Phillips told NutraIngredients-USA. “Or they could take up a case if there were a split in the lower courts, to break the tie, so to speak. Neither of those were true here.”
“The outcome of this case makes clear that companies like POM making serious health claims about food and nutritional supplement products must have rigorous scientific evidence to back them up. Consumers deserve no less,” said FTC chairwoman Edith Ramierez.
POM’s claims ruled to be unsupported
In declining to hear POM’s appeal, the Supreme Court has allowed to stand a lower court ruling in the case, which has dragged on for a number of years. FTC originally took POM to task over ads that it said claimed POM’s pomegranate juice and dietary supplements, with their suite of polyphenol-based antioxidants, could treat or cure diseases such as heart disease, prostate cancer and erectile dysfunction. The Wonderful Company, the holding company founded by California billionaire couple Stewart and Lynda Resnick that holds the POM Wonderful brand among others, fought back, claiming that the science behind their products supported the claims they were making. After a lengthy review, the judge in the case ruled that there were significant flaws in the studies POM was relying upon, and agreed with FTC that the ads were false or misleading in violation of the FTC Act.
There have been many twists and turns in the case, which was only made possible by the determination and deep pockets of the Resnicks, who have significant interests in California agricultural production and water rights. While FTC won the overall case, it has had over the many sub rulings in the affair to retreat from some of its early positions, including its adherence to the ‘two trial standard,’ an FTC policy requiring two randomized, placebo-controlled clinical trials to uphold every health claim. That setback came via a ruling in Washington, DC district court last year. It was this ruling that POM had unsuccessfully sought to have the Supreme Court review.
“They had to step back from the two trial standard and I believe they lost the concept that they could mandate that advertisers had to get FDA approval for claims. The district court said that was beyond FTC’s purview,” Wasserman said.
But POM is still the clear overall loser in the case even if the company might have been able to recapture a few minor positions, Wasserman said.
“Overall POM was hoping at some point a court would decide that its claims were adequately substantiated and that never happened,” Wasserman said.
Make sure the data is good
So what’s the takeaway for the dietary supplement industry? POM itself seems to have already adapted to the new landscape, with a recent national ad blitz that features the catchphrases “crazy healthy” and “packed with antioxidants.” (It should be noted that the Resnicks’ genius seems to lie principally in marketing; the couple created Fiji Water, one of the first brands to launch the bottled water category, and thereby convinced consumers to pay a price that was princely by comparison for a product they could get out of their taps for free.)
But in the main, the Supreme Court’s ‘non decision’ means that supplement marketers still need to be careful about what claims they make and what kind of substantiation they use to support those claims, Wasserman said. FTC is looking ever more closely at what kind of evidence a company has to support the advertising claims it is making, he said. With the explosion of published research showing up in journals of all types and levels of rigor, it’s no longer one size fits all when it comes to studies. Wasserman said FTC is assessing the quality of the journal and is looking at the study design and at the data itself, to make its own determination if it supports the study authors’ conclusions.
“The big sea change is that FTC no longer trusts studies. Now they almost always want to see the raw data and do their own analysis. So it’s very tricky to rely on a study to support your claims if you can’t get your hands on the raw data to see what that looks like,” Wasserman said.