FTC Stretched Standards In Enforcement Against Bayer Probiotic Claim

Judge Jose Linares states in his opinion that FTC’s requirement for “competent and reliable scientific evidence” to substantiate ad claims for consumer health care products aligns with FDA’s regulation of supplement claims under DSHEA, and Bayer complied with both agencies’ regs.

The Federal Trade Commission abandoned its own standards in arguing that without clinical trials to back Phillips’ Colon Health probiotic claims, Bayer AG violated an earlier settlement on substantiating dietary supplement claims, a federal judge says.

The ruling in US District Court for the District of New Jersey perhaps is the strongest yet against FTC’s policy of asking for randomized, controlled trials to substantiate claims that FDA considers to be structure/function claims, allowed without clinical trials as evidence.

FTC’s standard of “competent and reliable scientific evidence” to substantiate consumer health care product claims “does not require drug-level clinical trials, and [FTC] cannot try to reinvent this standard through expert testimony,” Judge Jose Linares states in his opinion unsealed on Oct. 1.

The lead counsel for Bayer in the litigation, Jonathan Cohn, a partner at Sidley Austin LLP in Washington, says Linares’ opinion adds to separate rulings against FTC’s attempts to require RCTs from other firms for standard supplement claims (Also see "Regulatory News In Brief" - Pink Sheet, 22 Apr, 2013.).

“The way we see it, they now have three strikes and … strike three was written with comprehensive, persuasive language,” Cohn said in an interview.

“Judge Linares is completely thorough and analytical in discussing the FTC’s misguided application. So it’s not just strike three, it’s strike three with a 100 mile-an-hour fastball,” he added.

In his opinion, Linares said FTC’s regulation on substantiation for ad claims aligns with FDA’s standard for supplement claims under the Dietary Supplement Health & Education Act, but FTC’s enforcement against Bayer conflicts with its and FDA’s regulations.

Bayers’ claims for Phillips’ Colon Health, he said, not only are compliant with FTC and FDA regulations, but also with Bayer’s 2007 consent decree with FTC that resolved allegations the firm made unsubstantiated claims for its WeightSmart line of One-A-Day vitamins.

On Sept. 24 the judge issued an order denying the Department of Justice’s motion to find Bayer in contempt of the decree, which required the firm to substantiate all supplement product claims with competent and reliable scientific evidence.

The judge intended to unseal his opinion on Oct. 8 to allow time to ensure that a third party’s confidential information submitted in the case would not be disclosed. He agreed to unseal the document early at the request of Bayer and FTC.

Linares notes that for supplements, DSHEA says “the only substantiation requirement is that claims must be ‘truthful and not misleading,’” while not specifying substantiation necessary to render a claim compliant with the standard.

“As long as the supplement is not marketed as a drug … it is not regulated like a drug,” the judge said.

FTC and DoJ have “not pointed to any instance when it has asserted that these claims are disease claims. If these claims were disease claims, then many of the most popular probiotic supplements on the market would be in violation of the law, and subject to seizure by the FDA,” he added.

FTC “cannot enter into a consent decree using the general competent and reliable scientific evidence standard and then subsequently require RCTs through the expert testimony it produces in a contempt action,” Linares added in his 38-page opinion critical of the evidence FTC presented and of the agency’s premise for filing a motion to find Bayer in contempt of the 2007 decree.

The decree “does not mention randomized controlled clinical trials of any kind, let alone say they are required,” the judge says.

FTC “cannot seek contempt on the basis of a lone expert who proposes a standard that was not disclosed to industry until the day the government filed its contempt motion,” he adds.

DoJ had requested millions in damages and penalties of $25,000 per day until Bayer complied with the 2007 order by ceasing the contested Phillips’ Colon Health claims. However, Linares denied the motion in its entirety, rejecting each of DoJ’s claims and awarding no damages (Also see "Decision On Bayer Probiotic Claim Could Weaken FTC Argument For Clinical Trials" - Pink Sheet, 28 Sep, 2015.).

While Bayer HealthCare LLC’s Consumer Care Division in Whippany, N.J., prevailed in defense of using claims that Phillips’ Colon Health helps prevent occasional constipation, diarrhea, gas and bloating, courts have rejected arguments that other firms targeted in FTC enforcement have made against needing clinical trial substantiation for more extraordinary claims (Also see "RCT Spells Requirement For Lipidryl, Shrinking Beauty Weight Loss Claims" - Pink Sheet, 5 Jan, 2015.).

FTC also is arguing to RCTs as substantiation for OTC homeopathic claims. The agency conducted a workshop on Sept. 21 as part of its ongoing review of claims made for the products (Also see "FTC Homeopathic Advertising Review Spurs Broader Disclaimer Suggestion, Opens New Stage For RCT Debate" - Pink Sheet, 22 Sep, 2015.).

Unqualified Expert, Unnecessary Demand

The testimony and conclusions of FTC’s expert were rejected by researchers who, Bayer’s attorneys, like the judge, said were more qualified to make recommendations on substantiating probiotic claims.

“Their expert, who knows nothing about probiotics and admits he’s not a probiotics expert, was trying to conjure theories of why you have to have randomized, controlled trials on the precise strains of bacteria in Phillips’ Colon Health. Those arguments weren’t availing, obviously,” Cohn said.

Judge Linares notes the FTC’s expert did not rely on FTC’s guidance for claims substantiation, was not familiar with DSHEA and “admitted he was ‘not paying attention to the law or regulations about the difference between dietary supplements and drugs’.”

The expert’s testimony, the judge says, was “inconsistent with the agency’s own guidance.”

He also was dismissive of FTC’s argument that Bayer, or any firm marketing nutritional products making structure/function claims actually keep on file, as paper or digital documents, copies of substantiating studies, including those in the public domain.

FTC “asserts that the Court should infer that Bayer did not possess or rely upon any such studies because Bayer did not print out, copy, or otherwise record all of those studies,” Linares says.

However, “Bayer’s only obligation was to possess and rely upon competent and reliable scientific evidence,” and “no inference should be drawn from the lack of physical records, because the recordkeeping provision of the Consent Decree did not require Bayer to print out documents in the public domain,” he adds.

Cohn referred to FTC’s contention that Bayer produce the files as a “Hail Mary argument.”

“It was a scattershot approach. But they never abandoned the novel legal theory that dietary supplements must abide by the gold standard for” substantiating disease claims, he said.

After Bayer agreed to a consent decree in 2007 concerning WeightSmart claims, FTC might have anticipated another settlement on the contempt complaint, Cohn said.

But Bayer’s defense could mark a turning point for the agency and nutritional product marketers.

FTC “just didn’t expect this case to go as far as it does. They instead hope and depend on companies signing onto consent decrees to avoid litigation and the government carries a pretty heavy sledgehammer that they can use to threaten companies into signing onto those consent decrees,” Cohn said.

“That’s probably why they assumed why we would not fight this one, but they were wrong because they were so far out of their league and so far out on a tenuous limb. We had to chop off that limb.”

Supplement Claims Remain Targets

While a crucial win for Bayer, though, Linare’s opinion still will not impede FTC from requiring RCTs of other nutritional product marketers. Moreover, Bayer’s evidence supporting Phillips’ Colon Health claims sets a high bar for other firms to back their claims.

Other attorneys familiar with FTC enforcement on supplement ad claims said Bayer’s evidence could represent a minimum for competent and reliable evidence to substantiate structure/function claims to the agency’s satisfaction. And other firms FTC targets likely will make claims for which they have no credible substantiation.

Additionally, Linares’ decision does not address complaints alleging violation of state consumer fraud. Court rulings that products are not making disease claims would have little impact when plaintiffs prove false advertising.