Last month the US Federal Trade Commission brought a motion against Bayer for claims made in relation to Phillips’ Colon Health. The FTC case focuses on two sets of claims – the expressed claims (structure-function claims for dietary supplements) and alleged implied claims.
The company told us at the time that it strongly disagreed with the US FTC decision, and would defend itself “vigorously”.
The company called on the court to deny the government’s motion.
“According to the government, Bayer lacks scientific substantiation for Phillips’ Colon Health because the company has not conducted ‘randomized, placebo-controlled, and double-blind’ ‘human clinical trials’ on the “specific product,’ using the precise ‘population[s]’ and ‘methods’ chosen by the government,” stated the company.
“This is not and has never been the standard for dietary supplement claims such as those at issue. It is a brand new multi-part test the government invented for this litigation—relying on a single physician who was not even disclosed until the government moved for contempt.”
However, the court granted the government’s motion on October 23 for an order to show cause.
‘Friends of the court’
Many industry observers have warned that success for the government in this case would have wide-ranging implications, requiring structure-function claims to be substantiated by randomized clinical trials. The Council for Responsible Nutrition and the Natural Products Association filed Amicus briefs in relation to the case.
The government denied that the potential wide-reaching implications, however, stating in its response to CRN’s Amicus brief: “[T]his case is not about a change to a legal standard or an attempt by the government to re-make the dietary supplement industry.”
As such, the government also sought to dismiss both the NPA and CRN as Amicus Curiae (friends of the court), claiming that both “failed to demonstrate that [they have] or will provide the Court with any useful assistance in deciding this case” and calling on the Court to “place little, if any, weight on [NPA’s & CRN’s] brief[s].”
Implications for industry
The Court, however, had a different perspective: “Having carefully considered all submissions, the Court finds that both trade associations have a strong interest in the outcome of this case, particularly as it relates to the federal regulatory and statutory scheme governing dietary supplements. Both trade associations have submitted thorough and informative briefs, which are of assistance to the Court, particularly in considering the implications of the ultimate outcome of this dispute on the entire dietary supplement industry. As such, in an exercise of discretion, the Court hereby grants the motions for Leave to Appear Amicus Curiae that have been filed by Natural Products Association and the Council for Responsible Nutrition, respectively.”
Dr Daniel Fabricant, CEO of NPA, told NutraIngredients-USA that allowing the associations to appear as amicus curiae showed that the court had an open mind about the case.
“Laws cut both ways,” he said. “Industry wants to see appropriate enforcement, but the enforcement needs to be consistent with the law. Industry cannot operate if the rules keep changing during the game.”
So is there a possibility that the court finds Bayer in contempt of court and this doesn’t affect the industry? It depends how it’s sliced, said Dr Fabricant. “If they’re found to be in contempt on the disease claims, then that’s one thing, but if it’s on the substantiation of those claims, you’re effectively extending that to the whole industry.”