By Riëtte van Laack –
On May 21, 2012, the FTC posted the 345-page Administrative Law Judge’s ("ALJ’s") Initial Decision in In the Matter of POM Wonderful LLC et al. ("POM") (FTC Docket No. 9344). The ALJ upheld the FTC’s Complaint insofar as the FTC asserted that POM made deceptive claims in some (but not all) advertisements that its products (100% juice and POMs supplements) would treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction because these claims were not supported by sufficient competent and reliable evidence.
However, the ALJ’s Order is a stunning rejection of the FTC’s theory that POM was legally required to have double-blind, randomized placebo-controlled clinical trials to make the claims that the FTC attacked. The ALJ’s order would merely bar POM from making certain claims unless POM possesses competent and reliable scientific evidence to support the claim. As clarified in the Initial Decision, however, this standard is not defined as double-blind, randomized, placebo-controlled clinical studies. In fact, according to the ALJ:
[for health benefit] claims . . . made in connection with a food, or food-derived product that is safe, and that is not being offered as a substitute for medical treatment, double-blind, randomized, placebo-controlled clinical trials, such as those required by the Food and Drug Administration, are not required. However, . . . claims that a food or food-derived product treats, prevents or reduces the risk of a disease, . . . competent and reliable evidence must include clinical studies, although not necessarily double-blind, randomized, placebo-controlled clinical trials, that are adequate to show that the product did treat, prevent, or reduce the risk of disease.
The ALJ also rejected the Commission’s attempt to require POM to get prior FDA approval for certain claims. The ALJ held that the FTC’s proposed requirement that POM would be prohibited from making any disease claim in the future unless the claim had been approved or authorized by FDA “would constitute overreaching.”
Both the FTC Staff which prosecuted this case and POM can seek review of this decision by the five FTC Commissioners. We expect that both parties will seek that review. We also expect that it will take many months before the FTC Commissioners rule on the appeals.