POM Wonderful and FTC Appeal Initial Decision
As we previously reported, in September 27, 2010, the Federal Trade Commission (“FTC“) filed a complaint against POM Wonderful LLC (“POM“) for allegedly making unsubstantiated claims, which were also false or misleading in violation of Sections 5(a) and 12 of the Federal Trade Commission Act (“FTC Act“). In its Complaint, the FTC alleged that POMs claims that its products prevent, reduce the risk of, or treat heart disease, high blood pressure, prostate cancer, and erectile dysfunction (“ED”) were not supported by competent and reliable evidence. Additionally, the Complaint contained a proposed cease and desist order that would require, among other things, U.S. Food and Drug Administration (“FDA“) approval of certain disease claims for POMs products.
On May 17, 2012, an FTC Administrative Law Judge (“ALJ”) held in an Initial Decision that POMs claims that its products could treat, prevent, or reduce the risk of heart disease, prostate cancer, and ED were deceptive because these claims were not supported by sufficient competent and reliable evidence. However, the Decision rejected the FTCs theory that POM was required to have double-blind, randomized placebo-controlled clinical trials (RCTs) to make the claims that the FTC attacked. The Decision clarified that the standard for substantiation is competent and reliable scientific evidence. The ALJ also held that the FTCs proposed requirement that POM be prohibited from making any disease claim in the future unless the claim had been pre-approved by FDA “would constitute unnecessary overreaching.”
Both POM and the FTC appealed the Initial Decision to the FTC Commissioners. POM appealed all portions of the Decision relating to the finding of liability. The FTC appealed the ALJs conclusion arguing that (1) all advertisements challenged in the Complaint violated the FTC Act, (2) the substantiation of disease efficacy claims should require well-designed, well-conducted RCTs, and (3) the ALJ erred in not adopting the proposed remedy to require FDA approval for all future claims that any POM product is effective in the diagnosis, cure, mitigation, treatment or prevention of diseases. The appeal briefs for POM and the FTC can be read here and here respectively.
If the ALJs Initial Decision is upheld, it will establish that the FTC exceeded its authority by requiring RCTs and FDA preapproval to substantiate food and dietary supplement claims. Marketers of food and dietary supplements will therefore be able to continue to promote health benefits that are supported by competent and reliable scientific evidence, without conducting RCTs and obtaining FDA preapproval.
Nevertheless, in the past two years, the FTC has reached numerous settlements in which it has persuaded marketers of food and dietary supplements to conform to a new standard for substantiation requiring RCTs, particularly with respect to weight-loss and disease-fighting claims. Recently published consent orders include those against Nestle USA, Iovate Health Sciences, Inc., and The Dannon Company, Inc., in which the FTC prohibits future claims by the companies unless the claims are supported by two well-controlled RCTs. Please see our previous report for more information regarding these agreements.
In a recent trend, Courts have disagreed with the FTCs attempts to redefine and enforce a heightened level of substantiation for health related claims. As we previously reported, the Garden of Life (“GOL”) decision is one example. In FTC v. Garden of Life, the FTC sought to modify a previous consent decree by changing the definition of “competent and reliable scientific evidence” to require “two adequate and well-controlled human clinical studies for all absolute or comparative claims” and FDA approval for disease claims. In rejecting the FTCs position, the Court stated that competent and reliable evidence does not mean “uncontroverted proof.”
The next step in the process is for the five FTC Commissioners to hear oral argument and make a final decision regarding whether to adopt, in whole or in part, or not at all, the ALJs Initial Decision. Oral argument before the Commission is scheduled for August 23, 2012. Fuerst Ittleman will continue to monitor the development of the POM case. For more information about food and dietary supplement claims or to have Fuerst Ittleman complete a label and website review of your products, please contact us at (305) 350-5690 or firstname.lastname@example.org.
This entry was posted on Thursday, July 19th, 2012 at 2:41 pm and is filed under FDA.
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