By Riëtte van Laack -
As we anticipated, both the FTC Staff and POM Wonderful appealed the May 17, 2012 Initial Decision by the FTC’s Administrative Law Judge (ALJ). Among other things, the FTC Staff appealed the ALJ’s conclusion that substantiation of disease efficacy claims does not require well-designed, well-conducted, double-blind, randomized, controlled clinical trials (RCTs) and the ALJ’s denial of FTC Staff’s proposed remedy to require FDA approval for all future claims that any POM product is effective in the diagnosis, cure, mitigation, treatment or prevention of a disease. POM has also appealed the ALJ’s findings that POM contends were erroneous.
In general, the FTC has historically proclaimed that the standard of substantiation is “Competent and Reliable Scientific Evidence,” a standard that the FTC has stated is flexible. Although consent decrees suggested otherwise, the Agency has been unwilling to specify that, with regard to health benefit claims, this standard always requires RCTs. However, in its appeal in In Re POM Wonderful, the FTC Staff unequivocally asserts that for so-called establishment claims, i.e., claims about the amount and type of evidence about the products specific health benefit, only RCTs are sufficiently reliable to establish a causal link between the product and the reduced risk of a disease. In fact, according to the FTC Staff, it is “axiomatic that only [RCTs] can establish that a product is proven to treat, prevent or reduce the risk of a specific disease.” Although it applies a different analysis, FTC Staff also concludes that for non-establishment disease efficacy claims, i.e., claims that a product treats, prevents or reduces the risk of diseases, only RCTs will do. The FTC Staff stresses that the requirement for RCTs applies to disease efficacy claims and its statements should not be interpreted to mean that RCTs are automatically required for any health efficacy claims.
The FTC Staff also again argues that its proposed remedy requiring FDA pre-approval for future disease efficacy claims is justified in light of POM’s past conduct, the complexity of the scientific issues, the expertise of FDA to evaluate this type of claims, and the FTC’s interest in harmonizing with FDA. The FTC Staff asserts that this requirement provides a bright line and will protect the FTC from disputes of the kind it has encountered in previous litigated cases (e.g., Lane Labs, Inc. and Garden of Life, Inc.).
Now that the FTC Staff and POM have made their written arguments, the next step in the process is for the five FTC Commissioners to hear oral argument and make a final decision regarding whether to adopt, in whole or in part, or not at all, the ALJ’s Initial Decision. Oral argument before the Commission is scheduled for August 23, 2012.