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Will one randomized controlled trial (RCT) become the new standard for any company making disease-related claims?
In a ruling announced late last week, the U.S. Court of Appeals for the District of Columbia Circuit maintained the FTC’s decision that POM Wonderful made unsubstantiated disease claims while marketing its pomegranate products. Although the court did not echo the FTC’s call for requiring two randomized controlled trials (RCTs) prior to health claims, the ruling did mandate one RCT for future claims made by POM Wonderful LLC (Los Angeles, CA), with the possibility of requiring two if warranted by further incidents.
In light of this ruling, it’s worth considering whether the FTC might be able to mandate one RCT for other companies making disease-related claims in the future. Does the court’s decision raise the bar for companies making similar claims, or does it give marketing departments a reason to feel relieved?
“I think it’s a little bit of both,” says Steve Mister, president and CEO, the Council for Responsible Nutrition (Washington, DC). “I think on the one hand, companies are breathing a sigh of relief that the court did not accept this two RCT standard as an across-the-board requirement for all disease claims. That’s a good thing. But I do think that this is a cautionary tale for the industry because of some of the things that the court does require.”
The legal battle between POM Wonderful and the FTC began in 2010 after the FTC filed a complaint that POM did not have adequate evidence to support the claims that its pomegranate products had the potential to reduce the risk of heart disease, prostate cancer, and/or erectile dysfunction. The FTC eventually ordered the company to cease making claims of treating, curing, or preventing any disease unless the claim was supported by two RCTs.
However, the recent court ruling scales back what the FTC had originally proposed by only mandating one RCT in the POM case. According to Mister, the court felt that requiring two RCT’s would be detrimental because it “might end up preventing consumers from getting health information that they would like to know about.” With a higher standard required to make health claims, companies may be discouraged from researching new ingredients or sharing study results, thereby depriving consumers of useful information.
Mister also cautions against reading this circuit court decision as binding on the entire country, or trying to extrapolate the specific facts of this case to other companies or other health claims.
John Villafranco, partner, Kelly Drye & Warren LLP (Washington, DC), reads the court’s ruling as “entirely consistent with what the FTC has been doing with disease claims” in recent years. If anything, he thinks the ruling may “force [the FTC] to think more broadly than they have been about what is acceptable substantiation.”
“I think [FTC] staff has been quick in recent matters to criticize any evidence that isn’t an RCT, and this decision recognizes the value of other evidence and even cites FTC and FDA statements that support use of non-RCT evidence,” says Villafranco. He believes the FTC may still be requiring two RCTs for certain claims, such as weight loss, but also accepts observational studies in other cases.
Although mandatory RCTs may well be the most obvious discussion point in this ruling, perhaps the greater lesson for companies is simply to ensure all health claims have some basis in study results. Mister advises all companies to carefully construct their studies and ensure that the results exactly match any claimed health benefits.
Nutritional Outlook magazine
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