With about six weeks to go before a scheduled appeals decision concerning the Federal Trade Commission in the agency’s false advertising claims complaint against POM Wonderful, the agency — and the companies it regulates — may soon have a good handle on the kinds of evidence it needs to substantiate scientific claims, according to a legal blogger.
Attorney Bethany Kennedy, blogging on the potential decision, stated that she believes that the FTC will continue to require a “at least two well-designed clinical trials or they would be deemed deceptive” regardless of whether a judge invalidates its requirement with regard to the POM Wonderful case by simply turning down trials case-by-case until it believes a company has met its standards.
The case, which is with the full FTC board, is set to be decided Jan. 18. While a judge has made it clear that POM Wonderful’s claims concerning reducing the risk of prostate cancer and heart disease — made on its web site and in advertisements — are most likely false, the case is becoming a test of the standards that the FTC requires of beverage and food companies that make “structure/function claims” about their products.
Currently, the FTC requires what it terms a “reasonable basis” for making a claim — and that is often defined as scientific substantiation, although it can be determined on a case-by-case (or claim-by-claim) basis, according to Kennedy. But in 2010 the FTC showed its hand concerning the basis for at least some of those claims, requiring a pair of companies to supply at least two “adequate and well-controlled clinical studies” that substantiate the claim, and in the POM case added that “multiple clinical trials were always required for certain health benefit claims.”
That last assertion is currently in the hands of an appellate judge, Michael Chappell, who will eventually decide if that multiple clinical trial standard is indeed the one industry must live up to.
According to Kennedy, that two trial requirement “ignores the fact that human clinical trials are not practical for all claims,” but she advises advertisers “mindful of this administration’s bias in favor of greater scientific evidence supportive of claims should strive to attain the two clinical trials in support [of the] standard whenever feasible.”