William Rothbard – Federal Trade Commission (FTC) Suffers Setback on Controlled Clinical Trials

William Rothbard - Federal Trade Commission (FTC) Suffers Setback on Controlled Clinical Trials
William Rothbard – Federal Trade Commission (FTC) Suffers Setback on Controlled Clinical Trials

SANTA MONICA, CA – Marketing Law specialist William Rothbard is known for his keen eye regarding Federal Trade Commission actions with the potential to have a lasting effect on Ad Law. Having previously pinpointed and blogged about several FTC proceedings of legal consequence, he recently singled out the results of two cases as a notable setback to one of the Commission’s pursuits – mandating multiple Randomized Control Trials (RTCs) for health claims.

A primary objective of the Federal Trade Commission is to identify marketers that make inflated or false claims about products or services and hold them accountable. This battle reached a peak with the increased sales of dietary supplements over the Internet. Since such products do not require the same level of stringent testing as drugs do (namely, RCTs) and can enter the market without prior government approval, it is easier for supplement marketers to make extravagant claims. While the FTC has moved aggressively to address this problem, its demand for accountability soon transformed into what Rothbard refers to as a “crusade to mandate randomized controlled trials for health claims” for non-drug products. The pinnacle of this crusade may have been the FTC’s successful lawsuit against POM Wonderful, where the Commission ordered a remedy requiring at least two Randomized Trials to substantiate so-called ‘disease treatment’ claims. Last year, however, the U.S. Court of Appeals for the District of Columbia reversed this decision, ruling that a single trial was sufficient. “For other health claims,” Rothbard added, “the more flexible traditional standard of scientific evidence would still apply.”

Last year, a New Jersey federal district court overruled another attempt by the FTC to impose excessive testing requirements on supplement marketers, this time in a “contempt of court” case brought against Bayer. A 2007 consent order requires Bayer to have “competent and reliable scientific evidence” to support claims for its dietary supplement products.  The FTC claimed Bayer failed to meet this standard in advertising for its Phillips’ Colon Health (PCH) probiotic. Even though Bayer had numerous studies on the active ingredient, the FTC contended it was still in contempt for violating its order because the “competent and reliable scientific evidence” standard, in its view, required an RCT and Bayer had not done one on the product itself.

Rothbard pointed out that the court, in denying the contempt charge, found that the federal law regulating dietary supplements and the FTC’s own substantiation guidance do not require RCTs for supplement claims. Bayer could not be held in contempt for failing to do an RCT where neither the law, FTC guidelines, nor the term, “competent and reliable scientific evidence,” gave it fair warning that one was required. Despite the court’s decision, Rothbard strongly cautioned dietary supplement marketers to assume that the FTC will still expect them to conduct a Randomized Control Trial to support their claims and will hold them accountable if they don’t. “Nevertheless,” he noted, “in settlement negotiations and in court, they at least now have some fresh legal ammo with which to fire back.”

William Rothbard is a renowned business litigator and advertising and regulatory law specialist based in Los Angeles. A graduate of University of California’s Hastings College of the Law, his career spans over 35 years’ within his chosen field, including posts at the Federal Trade Commission as an Advertising Attorney and Attorney Advisor to the Chairman. This unique inside view allows him to give superior counsel to clients operating in the direct response advertising and online marketing industries. He also advises clients on trademark matters. Rothbard currently heads his own private practice where he specializes in Advertising Law, with particular focus on Federal Trade Commission and state advertising regulation.



William Rothbard – On Avoiding FTC Actions: Presentation at Affiliate Summit West: http://www.reuters.com/article/idUSnMKWS1L4qa+1e8+MKW20150713

William Rothbard – Speaks at National Ingredient Association Conference: http://www.msn.com/en-us/news/other/william-rothbard-speaks-at-national-ingredient-association-conference/ar-AAcWYUh


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William Rothbard

William Rothbard has been a business litigator and advertising law specialist for more than 30 years. He has widespread experience counseling advertisers and representing them in state and federal unfair competition and deceptive advertising proceedings. Prior to entering private practice he was an advertising enforcement attorney with the Federal Trade Commission and an attorney adviser to the FTC Chairman. A graduate of the University of Michigan and the University of California Hastings College of Law, he also served as Senior Counsel to the U.S. Senate Judiciary Committee, Subcommittee on Antitrust, Monopoly, and Business Rights.