Editorial: POM Wonderful

In the midst of the well-publicized legal fight between POM Wonderful (Los Angeles) and the FTC, there appears to be some good news-for the larger dietary supplements industry, at least.

In May, the FTC’s chief administrative law judge (ALJ) D. Michael Chappell ruled that POM Wonderful did in fact engage in deceptive advertising, making unsubstantiated health claims for its pomegranate juices and supplements. Judge Chappell’s decision was a response to an initial complaint the FTC filed against POM in 2010.

Either side may still appeal the ALJ decision, but as it stands now, Judge Chappell’s cease-and-desist order bars POM from making misleading claims for the next 20 years. And while none of this sounds particularly pleasant, there does appear to be a bright spot in the ALJ’s judgment.

Despite finding that POM did not adequately substantiate certain claims, Judge Chappell’s ruling at the same time rejected efforts by the FTC in its complaint to require that POM obtain FDA preapproval for future claims. In his ruling, Judge Chappell wrote that such preapproval “would constitute unnecessary overreaching.”

Even more significantly for industry, Judge Chappell also clearly stated that while “competent and reliable scientific evidence” is always needed to support claims, there is no universal rule that such evidence must take the form of two randomized controlled trials (RCTs).

These two requirements-the FDA claims preapproval and a demand for two RCTs-have been stipulations in other recent FTC consent orders that companies such as Nestlé and Iovate Health Sciences did end up signing. These agreed-to consent order stipulations had some in the dietary supplements industry wondering whether the FTC-under some kind of new, unofficial rule-now requires two RCTs to substantiate any health claims, and moreover, whether the FTC has the power to enforce this standard de facto.

Turns out, it doesn’t.

Rather, wrote Judge Chappell, “[I]n examining the totality of the evidence, basic science and ‘pilot’ studies, not just RCTs, can be relied upon as competent and reliable evidence.” Moreover, he wrote, “basic science” could include in vitro, in vivo animal, and preclinical studies.

POM positively called this aspect of the ALJ judgment a “win” for the industry. “While we are still analyzing the ruling, it is clear that we will be able to continue to promote the health benefits of our safe, food products without having our advertisements, marketing, or public relations efforts preapproved by the FDA and without having to rely on double-blind, randomized, placebo-controlled studies, the standard required for pharmaceuticals,” said POM’s chief legal officer Craig Cooper. “We consider this not only to be a huge win for us, but for the natural food products industry.”

Others in the industry would agree. Commenting on the significance of this portion of the ALJ ruling to the dietary supplements industry, Steve Mister, president and CEO of trade association the Council for Responsible Nutrition (Washington, DC), stated: “Subject to whatever appeals happen going forward, at least at this point [what this ruling says is that] the administrative law judge is not going to allow the FTC to impose this across-the-board standard for two randomized clinical trials, period. And that’s a good thing for the industry.”

He continued, “We’ve been talking for some time about the need for a flexible approach to the review of evidence, and that you have to look at the totality of the evidence and that for certain nutrients it’s impossible or at least impractical to do these kinds of RCTs, particularly when you’re trying to study prevention as opposed to treatment…[And in his ruling,] the judge talks about the impracticality of requiring an RCT in every case.”

He concludes, “Assuming this decision stays in place and is not overturned, I think this decision gives us a lot of clarity as to what the appropriate standard of review is at the FTC. It says that we will not be subject to the two-RCT standard in every single case. It gives the industry a pretty good idea of what kind of standard the FTC can impose.”