Addressing criticisms that FTC has attempted to impose requirements that are inconsistent with the 1994 Dietary Supplement Health and Education Act (DSHEA), a government official reiterated during an industry event that the issue in a 2015 lawsuit involving Bayer Corp. and his agency was not over the need for human clinical trials to substantiate advertising claims.
“Let’s start with the fact that the government never argued that two clinical tests were required," the FTC official, Richard Cleland, said Wednesday during The Big Natural, an event held in Las Vegas by the Natural Products Association (NPA).
Cleland had responded to an industry executive’s statement that a court determined Bayer didn’t need to conduct two double-blind, randomized controlled trials (RCTs).
Earlier in the same Q&A with Cleland, an audience member said it wasn’t the intent of DSHEA to apply the same standards to drugs and dietary supplements. Citing FTC’s own guidelines, industry lawyers have said RCTs, or human clinical trials, aren’t usually necessary to support dietary supplement advertising claims. Industry attorneys have grumbled that FTC has attempted to impose the requirement for RCTs in the Bayer litigation and other court cases involving dietary supplements.
At the time of the Bayer litigation, industry representatives expressed concern that the agency was aiming to set a precedent that would require human clinical trials before supplement marketers can tout a product’s benefits, undermining DSHEA.
Cleland reiterated the issue in Bayer was not over the need for RCTs.
“The core issue in the Bayer case, the real issue in the Bayer case, …is whether or not you had to test the exact product that you were selling," he proclaimed.
Cleland added Bayer had relied on several RCTs to substantiate its claims. Bayer’s probiotic, Phillips’ Colon Health (PCH)—and statements that the supplement helps defend against occasional constipation, diarrhea, gas and bloating—were the subject of the litigation.
In 2015, U.S. District Judge Jose Linares ruled in favor of Bayer and against the government, which argued Bayer had been in violation of a 2007 order, or consent decree, because it had failed to substantiate its claims with competent and reliable scientific evidence.
“The fundamental issue in Bayer was whether the experts in that case thought that you needed to test the exact strains—and the exact combination—that were in the Bayer product," explained Cleland, assistant director of the Division of Advertising Practices with FTC’s Bureau of Consumer Protection.
The government argued the answer was yes, but the court disagreed, Cleland acknowledged.
But Mark LeDoux, founder, chairman and CEO of Natural Alternatives International Inc., who moderated the Q&A, stepped in to highlight the reason for industry’s angst.
“I think the fundamental question here is, does DSHEA square with the FTC’s current perspective that in order to make a specific health claim, you need to conduct two double-blind, randomly controlled studies," asked LeDoux, who was recently elected by NPA’s membership as chair of its board of directors. “Is that a fair statement?"
“I’m so glad you asked that question because it’s wrong on so many levels," Cleland said, eliciting laughter from the audience.
“The question, or just the premise?" LeDoux asked.
“The premise of the question is wrong," Cleland responded.
Cleland indicated that when a company had, in his employer’s view, violated the FTC Act, the agency at one point in time imposed a requirement in its orders that such a business needed two RCTs to substantiate future advertising claims.
“We don’t do that anymore," he said.
Cleland added, “With regard to de novo cases, FTC never, ever required two RCTs to substantiate a claim.
“There’s never been a case in my almost 30 years at the FTC that turned on the issue of whether a company had one RCT or two RCTs," Cleland explained. “The issue has always been, do they have one good RCT?"
Editor’s Note: Rachel Adams reported from The Big Natural in Las Vegas.