Two non-profit organisations, the Alliance for Natural Health - USA, and TechFreedom, recently released a report alleging that the Federal Trade Commission (FTC) 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 be supported by two randomised, well-controlled, human clinical trials. In their report, the non-profits 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 that a claim is truthful and not misleading to consumers, and overly burdensome substantiation requirements that suppress otherwise truthful speech. The non profits' report criticises the FTC's ruling for falling into the latter category by requiring a significantly increased level of substantiation.

In this case, they argue, the FTC unleashed an aggressive and unprecedented attack on POM Wonderful to stop claims that it believed misled consumers about the health benefits of pomegranate juice. Rarely before have 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 is simply too high and unnecessary. The Alliance for Natural Health – USA and TechFreedom argue that the FTC's order has the effect of barring consumers from potentially helpful information, and that suppressing this information is a violation of free speech and the First Amendment.

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

For further information on this topic please contact Caroline Klocko at Reed Smith by telephone (+1 202 414 9200), fax (+1 202 414 9299) or email ( ).

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