The three judges panel determined that FTC’s requirement that food and supplement companies provide two valid RCTs to be able to make claims was too strict, and went on record as saying that the need for two trials could mean that consumers are “denied useful, truthful information about products with a demonstrated capacity to treat or prevent serious disease”.
“[W]e hold that the Commission’s order is valid to the extent it requires disease claims to be substantiated by at least one RCT,” stated the decision. “But it fails Central Hudson scrutiny insofar as it categorically requires two RCTs for all disease-related claims. That is not at all to say that the Commission would be barred from imposing a two-RCT-substantiation requirement in any circumstances.”
Steve Mister, President and CEO of the Council for Responsible Nutrition, which supported POM’s case as an amicus curiae, told us that the decision was a clear indication that the court was not going to defer to FTC.
“It’s a fencing in of the FTC,” said Mister.
Mister added that there three key pieces of advice for the industry from the decision:
“1. Spending a lot of money on trials doesn’t guarantee you can make claims that will be supported;
2. You have to be careful how you construct your study; and
3. The court makes a big distinction between efficacy and establishment claims: Establishment claims are those which use language like ‘clinically proven’ and you are subjecting yourself to a higher standard, so you’d better be able to back them up.”
‘Competent and reliable’
Commenting on verdict, Alexander Schauss, PhD, Senior Research Director and CEO, Natural and Medicinal Products Research, AIBMR Life Sciences, told us: “In my opinion this means the quality of a single randomized, double-blind, placebo-controlled study, considered the ‘gold standard’, must meet the FTC's definition that it is ‘competent and reliable’, which will become the grounds for debate. They should also be designed mindful of the FDA's regulations for making health claims.
“If one competent and reliable study is needed to substantiate a claim, it would be wise for a company to insure that such as study meets all elements of the ‘competent and reliable’ guidelines of the FTC, with particular attention to the characteristics of the population studied, sample size and power, to support a claim based on the study.”
Daniel Fabricant, PhD, CEO of the Natural Products Association, said that he wasn’t surprised by the court’s decisions, and he expected the split in the earlier verdict to be upheld. “It is refreshing to see that the one RCT was upheld for substantiation.”
Dr Fabricant cautioned against companies believing at this stage that one RCT is sufficient to substantiate their claims. The decision came from an appeals court in the District of Columbia and it's dispositive to the whole county.
“I think the Bayer case is a bigger arbiter of this. We’ve seen other recent consent decrees from FTC with two RCTs, so I think this is multi-pronged. The FTC vs POM verdict certainly helps coming from a judicial perspective but it’s not as final as legislation.”
So what next? There are a few options still open to both parties, explained CRN's Mister: Both parties could accept the decision, or there could be an attempt to elevate the case from a three judge panel to the full court (en banc), or there could be an attempt to try to appeal up to the Supreme Court. "I've had no indication of any further action at this stage," said Mister.