The decision rendered Jan. 30 in POM Wonderful v. FTC by the US Court of Appeals for the District of Columbia bolstered FTC’s position that a company must have “competent and reliable scientific evidence” to maintain that a health claim is scientifically “established.” The court upheld FTC’s assertion that because POM’s claims on its products were not based on randomized, controlled trials (RCTs) they were therefore false and misleading.
Reins tugged a bit on RCTs
But the court did not come completely around to FTC’s way of thinking. The ruling stated that one, not two, RTC was sufficient to support the kind of claims that POM was making. And the court determined that other forms of research have considerable value.
The court determined that the specificity of POM’s claims led to the call for an RCT to back those claims. POM, the court said, had “claimed a scientifically established, causal link between its products and various disease-related benefits.” This specific claim required a similarly specific kind of research backing, the court said.
The type of claims POM was making on its pomegranate beverages and dietary supplements were aggressive and were ripe for FTC review, said Ivan Wasserman, a managing partner for the Manatt law firm.
“They spent millions on advertising and millions on research. The claims they were challenged on were very strong claims on heart disease and other diseases. Claims that a product will prevent or treat a disease have historically attracted and will continue to attract the attention of the FTC,” Wasserman told NutraIngredients-USA.
Status quo for most part
“The most important thing in the ruling for FTC was a decision on whether POM’s claims were deceptive and the court agreed wholeheartedly with that,” he said. “The one thing that industry got it that FTC will be less likely to insist on 2 RCTs in future consent decrees.”
Wasserman said the landscape is thus not substantially altered. FTC's standards for supporting claims have not changed and were in fact bolstered by the court’s decision. So companies in the future must continue to be very careful to make sure claims are supported by the totality of existing claims. Wasserman also cautioned that either side may appeal the decision, either to a full sitting of the district court’s judges or to the Supreme Court, so this ruling might not be the final word.