In a 345-page Initial Decision by the Chief Administrative Law Judge, the FTC's complaint against POM Wonderful LLC (POM) and its principals was upheld to the extent that the company had claimed that its products 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. Perhaps more importantly, however, the ALJ rejected FTC's position that POM was required to have double-blind randomized placebo controlled studies before it could make the claims. The decision is a fascinating analysis of advertising law and the rules applicable to substantiating health claims.
In the decision, the ALJ ruled that while claims that a product treats prevents or reduces the risk of a disease must be supported by competent and reliable evidence, including clinical studies, these studies need not necessarily be double-blind randomized placebo controlled clinical trials.
According to the decision: "As a matter of law, [n]othing in the Federal Trade Commission Act...requires placebo-controlled double blind studies."
"...the appropriate level of substantiation for claims that a product treats, prevents or reduces the risk of a disease is competent and reliable scientific evidence. ...[W]here such claims are 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...[and] competent and reliable scientific evidence must include clinical studies...that are adequate to show that the product did treat, prevent or reduce the risk of disease.
The POM Wonderful decision runs counter to the FTC's settlement requirements imposed in the Nestle and Iovate 2010 cases as well as other recent FTC settlements. There, the FTC mandated that making certain health claims required at least two adequate and well controlled randomized double blind human clinical studies, and that making certain disease or illness claims had to first be pre-approved by the Food and Drug Administration.
The ALJ also rejected the FTC's attempt to require the company to get prior FDA approval before making any disease claim declaring that "would constitute overreaching". Here too, the ALJ's decision is contrary to that set forth in more recent FTC settlements requiring such advance approval.
The ALJ also ruled that the clinical evidence presented by POM was sufficient to show that consuming the product promoted erectile health, which is different from being a treatment for the medical condition of treating erectile dysfunction. Similarly, although the evidence showed that the product was of value in reducing arterial plaque or improving blood flow, and such claims could be made, the impression of the advertising was found to be that the product would treat, prevent or reduce the risk of prostate cancer or heart disease, and the evidence was insufficient to support those claims.
The ALJ ruled that "The standard applied to new drugs should not be applied to nutrients as long as the product is not claimed to be a substitute for conventional drug therapies or medical care and shown to be safe".
TAKE AWAY: The ALJ's Initial Decision is likely not the end of the road with respect to this hotly-contested matter. However, the fact that the Chief Administrative Law Judge presiding over FTC matters rejected the FTC's positions regarding the level of substantiation required and pre-approval certain claims by FDA should give the FTC pause in insisting on such standards in future proceedings.