POM Wonderful Falsely Advertised, But Won’t Need Premarket Approval

* Updated

POM Wonderful LLC (Los Angeles, CA) made deceptive claims in ads for pomegranate juice products and supplements and violated federal law, according to a decision released Monday by an FTC administrative law judge.

Responding to a complaint filed by the FTC in 2010, Judge D. Michael Chappell ruled that POM Wonderful and its founders, Stewart Resnick and Lynda Resnick, “failed to meet the level of substantiation required” for implied disease claims made about POM Wonderful products and a potential to treat, prevent, or reduce the risk of heart disease, prostate cancer, and/or erectile dysfunction.

The 335-page order can be downloaded here.

The judge’s ruling bars POM Wonderful and parent company Roll Global LLC from making any further representations about “health benefits, performance, or efficacy” for food, drug, or dietary supplement products unless such representation is backed by competent and reliable evidence.

For five years, the two companies are now required to maintain and make available to the FTC all packaging, labeling, advertisements, promotional materials, and scientific materials backing up any representations made of products.

But Judge Denies Other FTC Requests
Despite finding that POM did make unsubstantiated claims, Judge Chappell’s ruling at the same time rejected efforts by the FTC to require that POM obtain FDA preapproval for future advertising claims. In his ruling, Judge Chappell ruled that FDA claims preapproval “would constitute unnecessary overreaching.”

Additionally, Judge Chappell denied FTC efforts to require that future claims have adequate substantiation specifically in the form of two randomized controlled trials (RCT).

These FTC requirements-FDA claims preapproval and claims substantiation comprising two randomized controlled trials-have been stipulations in other recent FTC consent orders signed with companies such as Nestléand Iovate Health Sciences. These consent order stipulations have led some in the dietary supplements industry to wonder whether two randomized controlled trials is unofficially a new substantiation standard being enforced by the FTC.

Representatives from POM stated that this outcome of the ALJ judgment is a “win” for the dietary supplements 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 Wonderful chief legal officer Craig Cooper. “We consider this not only to be a huge win for us, but for the natural food products industry.”

Both the FTC and POM now have the option of appealing the ALJ ruling.

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.”

More on this case will be covered in the June issue of Nutritional Outlook.