WASHINGTON — The Department of Justice announced Friday that it filed a motion to hold Bayer in civil contempt for violating a court order in the U.S. District Court for the District of New Jersey. The court order, entered in 2007 in United States v. Bayer, prohibits Bayer from making unsubstantiated claims for any dietary supplement it promotes or sells. According to the DOJ complaint, Bayer has made claims in support of its probiotic Phillips' Colon Health that are unsubstantiated because there are no clinical trials in support of those claims.
The motion did not sit well with the industry.
“Without commenting on the specifics of this case, we are extremely concerned about the growing federal drift away from the longstanding legal standards for substantiating dietary supplement claims,” stated Scott Melville, president and CEO for the Consumer Healthcare Products Association. “Specifically, we are alarmed about the increasingly rigid application of the principle of ‘competent and reliable scientific evidence’ and the undue emphasis on multiple controlled clinical trials for such non-pharmaceutical products. We continue to believe that the public interest is best served when dietary supplement structure/function claims are supportable through a variety of rigorous and robust scientific studies, not simply randomized clinical trials.”
“We are disappointed and dismayed by the motion filed by the Justice Department on behalf of the Federal Trade Commission to require multiple drug-like randomized controlled trials for a dietary supplement product that has been substantiated as safe and beneficial," commented Steve Mister, president and CEO for the Council for Responsible Nutrition. "This action by the agency is an assault on the principle of evidence-based nutrition, and is inconsistent with the current requirements under the law, which we are poised to defend with force for our industry," he said.
CRN explained that under the law, dietary supplements are held to a high standard of ‘competent and reliable scientific evidence.’ In order to make a structure/function claim, which is not a disease claim, a company must have legitimate and reputable scientific literature in support of its claim. However, the ‘competent and reliable scientific evidence’ standard in the law has long recognized that a variety of rigorous and robust scientific studies can fulfill that requirement.
Structure/function claims have never been held solely to the multiple RCT standard that the FTC now seeks to impose through this enforcement activity. Requiring these claims to be supported by multiple RCTs, without regard for other credible methods of analysis, would hold dietary supplements to unreasonable, inflexible and pharmaceutical-like standards, which contradicts how dietary supplements are defined and regulated under the law.
"It is a truly sad day when government chooses to reprimand the responsible industry meeting legal requirements," Mister said. "The FTC’s mandate to protect consumers would be better served by using the FTC’s limited resources to target rogue companies who break the law by making outrageous, unsubstantiated claims to treat or cure serious disease, rather than over-reaching its authority, and making unreasonable and unlawful demands on those companies who play by the rules.”