A recent Initial Decision by Chief Administrative Law Judge D. Michael Chappell presents yet another mixed result for the Federal Trade Commission’s ongoing efforts to set more stringent substantiation levels for health claims. The Initial Decision rejected the substantiation standard proffered by Complaint Counsel for the FTC, but still ruled that POM Wonderful made deceptive health claims regarding its “POM Wonderful 100% Pomegranate Juice” and POMx supplements. The Judge found that the advertisements in question contained implied claims that the POM products would treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction, but that there was insufficient competent and reliable scientific evidence to support those claims.
The parties agreed that substantiation of such claims required “competent and reliable scientific evidence,” but they disagreed on what that means. The FTC sought to require double-blind, randomized, placebo-controlled clinical trials (RCTs) to substantiate POM’s claims. The Judge rejected this requirement, stating that RCTs were neither a legal requirement mandated by the FTC Act nor case law, nor appropriate in this case. Applying the so-called “Pfizer factors” to determine the appropriate level of substantiation, the judge’s analysis focused on the sixth factor: “the amount of substantiation experts in the field would agree is reasonable.” He found that the weight of the expert testimony did not require RCTs where the product is a safe, food-derived product that is not being offered as a substitute for medical treatment. However, the Judge still concluded that “experts in the field” would agree that clinical trials were required, just not RCTs, because the claims were disease-related rather than general and highly qualified health claims. After reviewing POM’s substantiation, the Judge held that it failed to meet the “competent and reliable scientific evidence” standard.
The FTC also sought to prohibit POM from making any disease claim in the future unless the Food and Drug Administration pre-approved any such claim. The Judge rejected this requirement, stating
"no previous decision by the Commission or any court has required FDA pre-approval as the required level of substantiation for disease claims, including for purposes of a cease and desist order.”
Rather, the competent and reliable evidence standard is “established precedent,  reasonably related to the violations found to exist, and  sufficiently clear and precise to guide Respondents’ future advertising practices.” As such, any FDA pre-approval requirement “would constitute unnecessary overreaching.”
As we have noted in previous posts (see here and here), the FTC’s efforts to require stronger substantiation for health claims have met some resistance by courts. There may yet be further developments in this case as the Judge’s Initial Decision is subject to review by the full Federal Trade Commission on its own motion, or by motion of any party.