Last Friday, the U.S. Department of Justice (DOJ), with assistance from the FTC, filed a motion of contempt against Bayer Corp., alleging that the company violated a 2007 court order by making unsubstantiated structure/function claims about its Phillips’ Colon Health probiotic product.
In 2007, a court order involving Bayer’s One-A-Day multivitamin and a $3.2 million civil penalty banned the company from making future unsubstantiated product claims. The Phillips’ Colon Health product is marketed to support immune and digestive health and to “defend” against occasional constipation, diarrhea, gas, and bloating. According to the DOJ, Bayer lacks “competent and reliable scientific evidence” to back up these claims. Bayer, however, says it believes its claims are adequately substantiated.
Members of the dietary supplements industry are speaking out, stating that the FTC has gone too far by enacting a substantiation bar for dietary supplements akin to the level of substantiation required for drugs.
“We are disappointed and dismayed by the motion filed by the Justice Department on behalf of the Federal Trade Commission (FTC) to require multiple drug-like randomized controlled trials (RCTs) for a dietary supplement product that has been substantiated as safe and beneficial,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC), to the press. “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.”
While dietary supplements must meet a standard of “competent and reliable scientific evidence” in order to make a structure/function claim (which is not a disease claim), “structure/function claims have never been held solely to the multiple RCT standard that the FTC now seeks to impose through this enforcement activity,” Mister said. By law, “competent and reliable” scientific evidence for supplements can include a “variety of rigorous and robust scientific studies,” he noted. “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,” Mister said.
The Consumer Healthcare Products Association (CHPA; Washington, DC) expressed similar objections. “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,” said president and CEO Scott Melville in a press statement. “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 supported through a variety of rigorous and robust scientific studies, not simply randomized clinical trials,” Melville concluded.
Is the FTC going too far in its substantiation requirements for supplements—or, as Mister put it, “over-reaching its authority”? As I wrote this past June regarding another FTC deceptive-advertising case over the BrainStrong DHA omega-3 dietary supplement, opinions are sometimes even split among FTC Commissioners on just how high that bar should be. In the case of the BrainStrong supplement, one Commissioner noted that unduly high substantiation requirements could dissuade companies from investing in quality research, stop companies from innovating, and, ultimately, make consumers worse off.
Are companies like Bayer and BrainStrong—those who make efforts to invest in quality research—the ones the FTC should be targeting? One could argue, as Mister does, that the agency’s efforts would be better spent pursuing companies that actually do break the law by making “outrageous, unsubstantiated” claims, such as those that can treat or cure disease.
“It is a truly sad day when government chooses to reprimand the responsible industry meeting legal requirements,” he said.
But John E. Villafranco, a partner in the advertising and marketing practice at Kelley Drye & Warren LLP in Washington, DC, has a different take on the implications of the Bayer case.
“There may be a silver lining to this cloud," he says. "In its motion against Bayer, the FTC relied on the opinion of an expert to argue that the 'competent and reliable scientific evidence' standard from Bayer's prior order requires randomized, double-blind, placebo-controlled clinical testing for the specific claims at issue. That is really nothing new."
What is new, he says, is that the FTC may actually be applying the "competent and reliable scientific evidence" standard more thoughtfully than it has in the past. "More importantly, the FTC’s position, as argued in its motion, is more measured than it has been in previous cases, where the FTC asserted broadly that the law requires RCTs for any health-related claim," he says. "It appears that the FTC has reconsidered what the 'competent and reliable scientific evidence' standard means and concluded that it does not mean randomized, double-blind, placebo-controlled trials in every instance where a health benefit claim is made. And that is a good thing.”
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