In POM Wonderful Trial, Court Rules One Human Clinical Trial Sufficient

A Jan. 30, 2015 ruling by a federal appeals court in Washington could ease the burden on dietary supplement marketers to make disease-related claims.

A three-judge panel rejected FTC’s assertion that two randomized, controlled human clinical trials were needed before POM Wonderful could claim a relationship between consumption of its products and the treatment or prevention of a disease.

“I think the case is significant because it specifically sends a message to FTC [that] the across-the-board requirement for two RCTs (randomized controlled trials) is not going to fly in the courts," said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), in a phone interview.

Linda Goldstein, a partner with the law firm Manatt, Phelps & Phillips, LLP, said she anticipates companies will resist future attempts by FTC to require two controlled studies as part of a consent decree in order to substantiate their claims. Since 2010, FTC has required two trials in nearly all weight loss and dietary supplement orders, said Goldstein, chair of the firm’s advertising, marketing & media division, in a phone interview.

The court, however, affirmed an FTC decision that held Pom falsely advertised its products by stating they could reduce, treat or prevent the risk of heart disease, prostate cancer and erectile dysfunction.

In a statement, FTC chairwoman Edith Ramirez touted the ruling as “a victory for consumers," which is consistent with the requirement that advertisers back up their claims with “rigorous science."

Pom said it was grateful the court reduced the requirement on conducting multiple trials.

“Consumers know that pomegranate juice is inherently healthy, and POM Wonderful has always communicated with consumers in a transparent, honest manner, delivering valuable information about the potential health benefits of our products," the company said in a statement.

Mister highlighted the court’s statement that an outright ban against disease-related claims without two RCTs may deny consumers “useful, truthful information about products with a demonstrated capacity to treat or prevent serious disease."

But the case also illustrated companies cannot continue to promote claims if a study fails to show support for such statements. The court noted Pom repeatedly promoted the results of a limited study related to heart disease without referencing contrary findings in larger studies that were conducted later. The company said it has conducted $35 million-worth of peer-reviewed scientific research concerning pomegranates and pomegranate juice.

“Just because you spend a lot of money doing this kind of research doesn’t assure you are going to be able to use it," Mister said. “Companies need to know doing this kind of research is a gamble."

The ruling by the U.S. Court of Appeals for the District of Columbia Circuit could have persuasive authority in other places, such as in New Jersey federal court, where Bayer Corp. is fighting FTC.

In that case, FTC has accused the German conglomerate of failing to substantiate its claims that a probiotic supplement can defend against gas, bloating, constipation and diarrhea. Bayer—and the dietary supplement industry—contend the government is seeking to hold the company to a drug standard.