Monday was a curious day to be a nutrition industry writer. The long-awaited decision on the prolonged lawsuit between the Federal Trade Commission and POM Wonderful saw first light early Monday morning in a POM press release that heralded victory for the pomegranate company. “The FTC’s Administrative Law Judge [ALJ] has upheld POM Wonderful's right to share valuable, scientifically-validated information about the health benefits of its safe food with consumers,” the statement read, implying that the company had gotten off scot-free.
But, according to an FTC statement released later that day, and according to the published decision itself, the ALJ upheld FTC’s allegation that POM had made unsubstantiated disease claims in advertising for its juice and supplement products.
But the results of the ALJ weren’t entirely in FTC’s favor either. In the decision’s summary, the judge pointed out that though POM failed to prove certain of its claims, the science required to prove those claims would not necessarily need to be double-blind, randomized, placebo-controlled clinical trials—FTC’s gold standard for substantiation.
“For claims that a food or food-derived product treats, prevents or reduces the risk of a disease,” the decision reads, “experts in the relevant fields would agree that competent and reliable scientific evidence must include clinical studies, although not necessarily double-blind, randomized, placebo-controlled clinical trials.”
Sounds like a major setback for the agency, which has been leveraging that gold standard for the past few years in consent orders with major food and supplement manufacturers sued by FTC for use of disease claims. The decision suggests that implied disease claims on products may be substantiated without gold standard science in cases where the product is especially safe and the advertising does not suggest that one forego medical treatment.
Don't jump to conclusions... yet
But it’s important to put this decision in perspective and realize that the ALJ’s ruling is small compared to the weight FTC has put on its gold standard. This case is far from over, said Ivan Wasserman, attorney at Manatt, Phelps & Phillips, who noted that this is “an ALJ initial decision without much precedential value.”
“Whether this will change the FTC staff's opinion on what constitutes reliable scientific evidence to support a disease claim seems unlikely,” Wasserman said. A possible course of action would be for either party to appeal the decision to the Commission itself, which could then overturn the decision and prompt POM to appeal to the Federal Courts.
Let’s not go overboard and say that now’s the time for manufacturers to start making disease claims on their products.
“I think companies should continue to proceed with extreme caution when making any sort of disease prevention or treatment claims, both from the FDA and FTC perspective,” Wasserman said. “In theory, you could have randomized, double-blind, placebo-controlled studies on your product, and the FDA could still take action against you for being an unapproved new drug.”