Newark, NJ-A U.S. District judge in Newark, NJ, decided not to hold Bayer Corp in contempt for supposedly violating a 2007 consent decree about how it markets dietary supplements.
In September 2014, the Federal Trade Commission (FTC) filed a motion against Bayer for allegedly making illegal health claims about its Phillips Colon Health probiotic. FTC claimed that Bayer hadn't done any specific randomized, double-blind, placebo-controlled trials to prove that its product supports digestive health. Specifically, Bayer implied the supplement would help those with constipation, diarrhea, and gas and bloating.
FTC had its eye on Bayer because of a 2007 permanent injunction issued against Bayer for its marketing of WeightSmart One-A-Day vitamins. According to court papers, "The 2007 Order requires Bayer to have competent and reliable scientific evidence to substantiate any representation it makes about the benefits, performance, or efficacy of any dietary supplement it markets or sells."
In a September 2014 briefing, the plaintiffs stated, "Because of Bayer’s widespread, unsubstantiated efficacy claims in violation of this Court’s 2007 Order, consumers should be compensated for their loss."
Meanwhile, Bayer made the case that the substantiation that FTC sought went beyond Congress's intent for how dietary supplements should be regulated under Dietary Supplement Health and Education Act (DSHEA). Under this law, Bayer presented evidence that its claims were properly substantiated.
Judge Jose Linares agreed, dismissing FTC's case.
Jonathan Cohn, counsel for Bayer and partner at Sidley Austin LLP, stated, "Too often, the FTC attempts to regulate by litigation and force companies to enter into settlements through threats of litigation. This case shows that the Government may not attempt to apply new standards to the industry through contempt and threats of contempt. The FTC must follow the law, like every other agency. The FTC may not attempt to hold a company in contempt on the basis of a novel and unlawful legal standard."
NPA filed two Amicus briefs in support of Bayer back in October 2014 with the belief that FTC's actions were contrary to DSHEA.
“We are happy with the decision of the court and it appears our Amici were considered heavily in the decision as only NPA’s comments were repeated verbatim in the opinion,” said Daniel Fabricant Ph.D., CEO and executive director of the Natural Products Association, in a press statement. “Still, this case is evidence that the FTC is willing to try and expand their authority through enforcement decisions, even with a bad case which they had from the start, and this remains one of the biggest, if not the biggest concern for the industry. As we said throughout the court proceedings, NPA felt the FTC would have set a dangerous precedent had the overbearing standards it was seeking become affirmed.”
Published in WholeFoods Magazine, November 2015 (online 9/28/15, updated 9/29/15, updated 9/30/15)