substantiation matters

Guess what? When it comes to the claims you make in your advertising, substantiation matters – a lot. The FTC’s recent Final Order against POM Wonderful (POM) in which it found nearly 40 claims made by POM about its pomegranate juice products to be false and misleading based on the absence of proper substantiation, should leave no doubt that the FTC takes the issue of claim support very seriously. And the fact that most of POM’s challenged claims – claims regarding potential health benefits of the products, including that consumption could help treat, prevent, or reduce the risk of heart disease, prostate cancer, or erectile dysfunction – were not actually express claims, but rather implied claims (from both the wording and imagery of the ad), should be a reminder to us all that the entire advertisement and the overall “net impression” it conveys must be carefully considered.

A little background: In September 2010, the FTC issued an administrative complaint alleging that POM had disseminated advertising materials claiming health and disease prevention benefits from consumption of its pomegranate juice products without having a reasonable basis to make those claims. We all remember those ads, a beautifully shot bottle of POM with a broken noose around its neck and the headline “Cheat Death.” In its defense, POM argued that consumers did not take many of its ads literally, so that any perceived health claims in those ads were not material to consumers, and that when it made express health claims in ads, POM had substantiation for the claims, in the form of surveys and of studies done on animals. The FTC’s position was that all the health benefit claims made by POM – whether express or implied – were material to consumers and therefore required a “reasonable basis” of support, which POM lacked. In addition, where POM claimed to have clinical proof of the claim, the FTC argued that POM had no such proof. The FTC’s position was that for the types of health and disease prevention claims POM was making, a “reasonable basis” of support required a well-designed, well-conducted, double-blind, randomized controlled clinical trial (RCT). In fact it required two RCTs. And for the establishment claims, the FTC’s believed clinical proof also meant RCTs.

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