FTC and POM Wonderful battle over pomegranate health claims
The FTC takes aim at the makers of POM Wonderful, a brand of pomegranate juice that it says has been touted with "false and unsubstantiated claims that their products will prevent or treat heart disease, prostate cancer, and erectile dysfunction." POM Wonderful says the FTC overstepped its bounds.
FTC and POM Wonderful battle over pomegranate health claims
"SUPER HEALTH POWERS!"
“NEW RESEARCH OFFERS FURTHER PROOF OF THE HEART-HEALTHY BENEFITS OF POM WONDERFUL JUICE. 30% DECREASE IN ARTERIAL PLAQUE … 17% IMPROVED BLOOD FLOW … PROMOTES HEALTHY BLOOD VESSELS … ”
This morning, the Federal Trade Commission took aim at the makers of POM Wonderful, a brand of pomegranate juice that it says has been touted with "false and unsubstantiated claims that their products will prevent or treat heart disease, prostate cancer, and erectile dysfunction."
[Update] In a statement this afternoon, POM Wonderful said the FTC has overstepped its bounds and vowed to fight back.
Hype over the supposed health benefits of particular foods and ingredients is nothing new, though it has mushroomed in the nearly 20 years since the government relaxed rules governing food supplements - a period that coincided with the growth of the Web, which has turned out to be the ideal medium for disguising advertising hype as "news."
Still, truth-in-advertising laws never disappeared, and the FTC has been trying hard lately to remind marketers that there needs to be substantial evidence behind their claims.
“Any consumer who sees POM Wonderful products as a silver bullet against disease has been misled,” David Vladeck, director of the FTC’s Bureau of Consumer Protection, said in a statement. “When a company touts scientific research in its advertising, the research must squarely support the claims made. Contrary to POM Wonderful’s advertising, the available scientific information does not prove that POM Juice or POMx effectively treats or prevents these illnesses.”
The FTC complaint alleges that POM Wonderful’s heart disease claims are false and unsubstantiated because many of the scientific studies conducted by POM Wonderful did not show heart disease benefit from use of its products. It alleges that the prostate cancer claims are false and unsubstantiated because, among other reasons, the study POM Wonderful relied on was neither “blinded” nor controlled. Finally, it alleges that the erectile dysfunction claims are false and unsubstantiated because the study on which the company relied did not show that POM Juice was any more effective than a placebo.
The complaint sets forth a proposed order that would prevent future law violations by POM Wonderful. In part, the proposed order would require that future claims that any pomegranate-based product cures, prevents, treats, or reduces the risk of any disease not be misleading and comply with Food and Drug Administration regulations for the claim. Although FDA approval of health claims generally is not required for compliance with the FTC Act, the proposed order would require FDA pre-approval before POM Wonderful makes future claims that certain products prevent or treat serious diseases, in order to provide clearer guidance for the company, facilitate POM Wonderful’s compliance with the proposed order, and make it easier to enforce. The complaint also proposes to prohibit the respondents from making any other health claim about any food, drug, or dietary supplement without competent and reliable scientific evidence.
In a related case, Mark Dreher, POM Wonderful’s former head of scientific and regulatory affairs and expert endorser, has agreed to a settlement that bars him from making any disease treatment or prevention claims in advertising for a POM Wonderful product unless the claim is not misleading and comports with FDA requirements for the claim. The settlement also prohibits Dreher from making other health claims for a food, drug, or dietary supplement for human use without competent and reliable scientific evidence to support the claim. The settlement contains a cooperation clause and reporting provisions to assist the FTC in monitoring compliance with the order.
POM Wonderful's website, here, contains descriptions of the studies it cites and links to more information.
[Update] Via email Monday afternoon, POM Wonderful's Rob Six offered this response to the FTC:
POM Wonderful fundamentally disagrees with the FTC and believes that the commission’s allegations against POM are completely unwarranted.
Pomegranates are food – highly nutritious produce, designed by nature itself. Because POM products may in fact offer the promise of better health, we believe it is important to share the research results as they become available. This is especially true since our products do not carry the risks associated with pharmaceutical drugs. It’s a shame that the government is unable to understand this fundamental distinction, and instead is wasting taxpayer resources to persecute the pomegranate.
We do not make claims that our products act as drugs. What we do, rather, is communicate, through advertising, the promising science relating to pomegranates. Consumers and their health providers have a right to know about this research and its results.
We stand behind the vast body of scientific research documenting the healthy properties of Wonderful variety pomegranate. Our research is unprecedented among food and beverage companies, and we take pride in having initiated a program of modern scientific research to investigate the health benefits of this ancient and revered fruit.
For more than a decade, we have provided over $34 million to support scientific research on pomegranates, working with top researchers, including a Nobel Laureate, at leading universities around the globe. To date, more than 55 studies on POM products, including 19 clinical trials, have been published in peer reviewed journals. The results have been encouraging and many additional studies are in progress.
POM believes very strongly in its first amendment rights to communicate the promising results of our extensive scientific research program on pomegranates. We believe the commission is acting beyond its jurisdiction, exceeding its authority, and creating a new regulatory scheme that attempts to treat our juice as a drug, which it is not. The FTC is violating POM’s constitutional rights to share useful and important information with the public, and therefore we have initiated a separate lawsuit to preserve these rights.