Bayer’s Court Battle with FTC: Implications for the Dietary Supplement Industry
A recent United States District Court (New Jersey) decision has scored a small but significant win in a battle between Bayer and the federal government. As was described in the Court’s opinion, Bayer was the defense in a case brought by the Federal Trade Commission (FTC), although Bayer was the ultimate victor in the courtroom battle. This case illustrates that the government can be found to be unconvincing in its arguments against a manufacturer, if the manufacturer has had the foresight to prepare adequate supporting evidence of a claim. However, other supplement manufacturers must take the findings of this case with caution; the circumstances were specific and related to previous enforcement actions against the company.
In order to fully evaluate the findings of the case, some background of the interaction between Bayer and FTC is necessary. In 2007, Bayer entered into a Consent Decree (CD) with the United States government stemming from an alleged violation of the 1991 FTC administrative order (entered into by Miles, Inc., a predecessor to Bayer) that required a cease and desist on certain advertising practices stemming from the One-A-Day WeightSmart brand of vitamin and mineral supplements (the claims revolved around metabolism enhancement and weight control). Part of the decree prevented the manufacturer from making any representation of the benefits, performance, or efficacy of any dietary supplement it markets or sells unless the manufacturer possesses and relies upon competent and reliable scientific evidence to substantiate a claim at the time a claim is made.
In 2008, Bayer began an advertising campaign to market Phillips Colon Health (PCH), a probiotic dietary supplement product. Bayer notified the Food and Drug Administration (FDA) for each claim that was made for the PCH product (i.e., “to promote overall digestive health” and “helps defend against occasional constipation, diarrhea, gas and bloating); the label contained the FDA disclaimer “This product is not intended to diagnose, treat, cure or prevent any disease.” In 2011, the FTC began investigating Bayer to ensure that the manufacturer had adequate evidence to substantiate the information that was used in advertising for PCH. Bayer supplied documents to FTC in 2011 and 2012 as evidence to support the advertising campaign associated with PCH. Apparently, those documents were not adequate to persuade the FTC that Bayer was complying with the