15-Second Advertising Law Alert: ALJ Clarifies Evidence Needed to Support Health-Related Ad Claims

Date: May 22, 2012

Pom Wonderful won some, but lost more in a massive initial decision by the Federal Trade Commission's Chief Administrative Law Judge, released today.*

The ALJ's legal conclusions relating to two of the FTC Complaint's more aggressive assertions are of significant interest in the world beyond Pom litigation.

First, he determined that the FTC is precluded from requiring U.S. Food and Drug Administration pre-approval of health claim advertising.

Second, he concluded that there is no legal basis for the Commission to require "well-designed, well-conducted, randomized, double-blind, placebo-controlled human clinical trials" (so-called RCTs) to substantiate all health-related efficacy claims. We'll flesh out only this second conclusion here.


Among other things, the Complaint alleged that Pom deceptively claimed that its pomegranate juice and dietary supplements would treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction.

The standard of proof in such cases is that the advertiser must have possessed "competent and reliable scientific evidence" before making such claims.

There has been continuing concern among advertisers over the FTC staff's insistence -- as it did in this case -- that such evidence must contain RCTs.


The ALJ concluded that, "Neither the FTC Act nor applicable case law requires" RCTs to substantiate all health-related efficacy claims.

"The required level of substantiation is a question of fact, and the evidence in this case demonstrates that [Pom's] implied disease claims require ‘competent and reliable scientific evidence,' which does not necessarily require [RCTs], such as those required by FDA." The ALJ relied primarily on expert testimony to determine the level of testing necessary.

For more information on this and other Advertising Law matters, please contact Richard J. Leighton at +1 202.434.4220 or at leighton@khlaw.com.

* In the matter of Pom Wonderful LLC, et al., FTC Docket No. 9344 (May 17, 2012). An initial decision is subject to review by the Commission on its own or a party's motion.