Two nonprofits, the Alliance for Natural Health – USA, and TechFreedom, released a report last week alleging that the Federal Trade Commission broke free speech laws when in January 2013, it barred POM Wonderful from asserting that its pomegranate juice is "effective in the diagnosis, cure, mitigation, treatment, or prevention of any disease," including heart disease, prostate cancer, and erectile dysfunction, unless the claim is supported by two randomized, well-controlled, human clinical trials. In their report, the nonprofits estimate that the two clinical trials required by the FTC could cost up to $600 million each.

The POM order highlights the balancing act between requiring substantiation to ensure a claim is truthful and not misleading to consumers, and overly burdensome substantiation requirements that suppress otherwise truthful speech.  The nonprofits’ report criticizes the FTC’s ruling as falling into the latter category by requiring an enormously increased level of substantiation.

In the POM case, the FTC unleashed a very aggressive and somewhat unprecedented attack on POM Wonderful to stop claims it believed misled consumers about the health benefits of pomegranate juice.  Rarely before had two clinical studies been required for such claims. From POM Wonderful’s perspective, information about the health benefits of pomegranate juice was widely accepted in medical and nutritional literature that, under the FTC substantiation standard, may never reach the marketplace.  The substantiation burden was simply too high and unnecessary. The Alliance for Natural Health – USA and TechFreedom argue in their report that the FTC’s order has the effect of barring consumers from information that could be helpful to them, and that suppressing this information is a violation of free speech and the First Amendment.

In reality, there never is a one-size-fits-all answer to what level of substantiation is needed to support a claim, and finding the right balance requires expertise and careful evaluation of each situation.  Here, at least two consumer advocates think the FTC went too far.