In a ruling that seems to put pomegranate juice on comparable footing with pharmaceutical drugs, the Federal Trade Commission in a final decision issued January 16 will require juice maker POM Wonderful to conduct extensive clinical trials before it can make any claims about the health benefits of its products.
The five FTC commissioners largely upheld the May 21 decision by Administrative Law Judge Michael Chappell that POM did not have adequate support to back up advertisements that its products could treat, prevent, or reduce the risk of heart disease, prostate cancer and erectile dysfunction. But the commissioners went further, ordering POM not to run any ads touting the health benefits of the juice unless they're are backed by at least two randomized and controlled human clinical trials.
However, in a minor win for POM, the commissioners did not endorse a request by FTC staff that POM be required to obtain pre-approval from the Food and Drug Administration for any health claims.
POM in a statement vowed to appeal the decision in federal court. "With this ruling, the FTC is taking the unprecedented step of holding food companies like POM Wonderful to the same standards as pharmaceuticals. Their new legal standard would require food companies to conduct double-blind, placebo-controlled studies in order to talk about potential health benefits of fruits and vegetables," the company stated.
In Chappell's initial decision overruled by the commission today, the administrative law judge ruled such studies were not necessary when "the safety of the product is known; the product creates no material risk of harm; and the product is not being advocated as an alternative to following medical advice." Chappell also noted that unlike drugs, foods aren't generally patentable, which makes it difficult for any food maker to foot the bill – in the range of $600 million – for such double-blind trials.
But the commission in a 53- page opinion penned by Commissioner Maureen Ohlhausen disagreed. "The expert evidence was clear that [randomized and controlled studies] are necessary for adequate substantiation of [POM's] representations," Ohlhausen wrote.
However, the commission took steps to rein in the applicability of the order, writing "we limit our findings to the specific disease treatment and prevention claims that are before us….we address only the level of substantiation needed to support the claims that are at issue in this case and do not address hypothetical claims."
POM, a private company owned by the Stewart and Lynda Resnick Revocable Trust, sold nearly $250 million worth of the pomegranate juice products at issue between 2002 and 2010.
The FTC's problem was not with the product itself, but rather POM's advertising campaign, which included claims such as such as "SUPER HEALTH POWERS!.… Backed by $25 million in medical research. Proven to fight for cardiovascular, prostate and erectile health" and "Ace your EKG….A glass a day can reduce plaque by up to 30%! Trust us, your cardiologist will be amazed."
The commissioners found that POM violated Sections 5a and 12 of the FTC Act by making false and misleading claims, and rejected the company's arguments that the agency's actions would violate their First Amendment rights, or their Fifth Amendment right to due process.
The commissioners also rejected POM's arguments that its "ads simply report study results in a qualified manner with words such as 'preliminary,' 'promising,' 'encouraging,' or 'hopeful.'" Instead, the FTC found that "When an ad represents that tens of millions of dollars have been spent on medical research, it tends to reinforce the impression that the research supporting product claims is established and not merely preliminary."
POM was represented by the Roll Law Group; Covington & Burling; and Greenberg Glusker Fields Claman & Machtinger.
The fight between FTC and POM became public in 2010, when the agency was investigating POM's ads. When this newspaper learned of it through a court filing, POM sued to block The National Law Journal from revealing what agency was doing the investigating. D.C. Superior Court Judge Judith Bartnoff granted POM's request, but POM subsequently asked the judge to rescind her order.
With the investigation public, POM struck the first blow and sued the FTC in the U.S. District Court for the District of Columbia, alleging the agency was unlawfully creating a new standard for the evaluation of deceptive practices and false advertising. In October, Judge Richard Roberts declined to delve into the merits of the dispute because the FTC administrative proceedings were ongoing and provided the proper forum to challenge the agency's rules.
This article originally appeared in The National Law Journal.
