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In its final order, the Commission stated that disease-related claims should be supported by two RCTs.
The FTC today struck down an appeal from pomegranate firm POM Wonderful in a case that found POM guilty of making unsupported, deceptive health claims for its juice and dietary supplement products. The Commission’s opinion upholds a May 2012 ruling by FTC chief administrative law judge D. Michael Chappell that ruled POM made deceptive claims. The Commission issued a final order barring POM from making any claims that a food, drug, or dietary supplement is “effective in the diagnosis, cure, mitigation, treatment, or prevention of any disease,” including heart disease, prostate cancer, and erectile dysfunctions-claims the Commission found POM Wonderful guilty of.
In its final order, the Commission stated that health claims should be supported by two randomized, well-controlled, human clinical trials:
Competent and reliable scientific evidence shall consist of at least two randomized and controlled human clinical trials (RCTs) of the Covered Product that are randomized, well controlled, based on valid end points, and conducted by persons qualified by training and experience to conduct such studies. Such studies shall also yield statistically significant results, and shall be double-blinded unless Respondents can demonstrate that blinding cannot be effectively implemented given the nature of the intervention.
This ruling opposes Judge Chappell’s opinion that while health claims should always be supported by “competent and reliable scientific evidence,” there is no requirement that substantiation must always require two randomized controlled trials (RCT). Dietary supplement industry members have also objected to a two RCT requirement. Read more here as well.
Nutritional Outlook spoke with attorney John Villafranco, partner at Kelley Drye & Warren LLP, on the FTC's stance. He said:
No question; the decision marks yet another step toward the two-study requirement. In practice, the longstanding "competent and reliable scientific evidence standard" has been dynamic and has been understood by industry to mean that advertisers should employ or retain experts to advise on the consensus among scientists for the type of studies needed to support a specific claim, to ensure that claims are based on evidence consistent with the state of science regarding the benefits of product ingredients at the time a claim is made. Today’s decision represents the FTC’s latest departure from the dynamic standard.
This will undoubtedly make it harder for supplement manufacturers who seek safe harbor by modeling practices after requirements in FTC orders. It will also likely reduce the role of scientific experts in dictating the proper way to substantiate a claim, in favor of a rigid two-study requirement.
The Commission’s opinion found POM guilty of a higher number of false claims compared to the number of false claims Judge Chappell’s ruling originally found. The Commission said POM marketers made deceptive claims in 34 advertisements and promotional materials, while Judge Chappell’s decision found POM guilty on 19 false or deceptive claims.
In a concurring statement published on January 10, 2013, however, FTC Commissioner Maureen K. Ohlhausen-who wrote the Commission’s POM opinion-disagreed with the Commission’s findings that all ads were misleading. In her statement, Ohlhausen pointed to several ads for which she said there is no extrinsic evidence to show that consumers would reasonably interpret the claims as disease claims. “We must keep in mind…that if we are too quick to find stronger claims than the ones reasonable consumers actually perceive, then we will inadvertently, but categorically, require an undue level of substantiation for those claims,” she warned in her statement.
Like Judge Chappell, however, in its final opinion the FTC Commission agreed that POM Wonderful does not need to seek FDA preapproval before making any future health claims about the products in question. "We agree with the ALJ's conclusion...that FDA preapproval is not warranted as part of the remedy in this case," the Commission stated. In his ruling, Judge Chappell called FDA claims preapproval “unnecessary overreaching.”
Finally, the Commission rejected POM’s arguments that the FTC’s original request that POM seek FDA preapproval for any future health claims violates the company’s First Amendment rights.
POM first received the FTC complaint in September 2010. POM now has the option of petitioning a review of the Commission’s opinion and final order from the U.S. Circuit Court of Appeals within 60 days.