Bayer did not violate the terms of a 2007 consent order with the Federal Trade Commission, according to a New Jersey federal court judge who rejected the agency’s contention that the company disseminated unsubstantiated claims for its Philips Colon Health.

The dispute began with a 1991 administrative order issued by the FTC to Bayer’s predecessor in interest to cease and desist certain advertising practices with respect to One-A-Day brand vitamins and mineral supplements. According to the agency, Bayer violated the terms of that order with claims about enhanced metabolism and the prevention of weight gain.

To settle the disagreement, Bayer agreed in 2007 to pay a $3.2 million civil penalty and be subject to a consent decree that prohibited the company from making misrepresentations that any of its products:

“increases metabolism; enhances metabolism through its … content; helps prevent some of the weight gain associated with a decline in metabolism in users over age 30; helps users control their weight by enhancing their metabolism; makes a material contribution to any program or system that promotes weight maintenance; can or will cure, treat, or prevent any disease; or have any effect on the structure or function of the human body.”

Further, Bayer was enjoined from making any representation, express or implied, about the benefits, performance, or efficacy of any dietary supplement it markets or sells unless, at the time the representation is made, the company “possess and relies upon competent and reliable scientific evidence that substantiates the representation.”

Importantly, the 2007 consent order defined “competent and reliable scientific evidence” as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”

The FTC alleged that Bayer violated the terms of the consent order with a 2008 advertising campaign to promote Philips Colon Health, a dietary supplement containing a proprietary blend of three specific strains of bacteria. Claims included: “To Promote Overall Digestive Health” and “Helps Defend Against Occasional Constipation, Diarrhea, Gas and Bloating.” The government filed a motion for an order to show cause as to why Bayer should not be held in civil contempt and U.S. District Court Judge Jose L. Linares held a seven-day hearing on the issue.

He then sided with Bayer.

The FTC told the court that “competent and reliable scientific evidence” required randomized, placebo-controlled, and double-blind human clinical trials using the specific product for which the claims are made. The trials must be conducted in the population at which the claims are directed and appropriate statistical methods must be used to assess and validate the outcome.

But Judge Linares noted that such trials were not required under the Dietary Supplement Health & Education Act (DSHEA), by the FTC guidance on advertising for dietary supplements, or even under the consent order itself.

“The Consent Decree does not mention randomized controlled clinical trials of any kind, let alone say they were required,” the court wrote. “In the seven years after entering the Consent Decree, the Government never told Bayer or anyone else in the industry that drug-level clinical trials … were required. Indeed, counsel for the Government conceded in closing argument that ‘you have to go outside the four corners of the consent decree’ in order to find support for the Government’s standard.”

In consent decrees with other companies, the FTC included a requirement for randomized, placebo-controlled, and double-blind human clinical trials, demonstrating that the agency knows how to require such studies when it wants, the judge added.

The FTC’s expert did not distinguish between study requirements for drugs and dietary supplements, the court said, and he testified that he was not familiar with DSHEA or regulatory guidance covering dietary supplements. Nor was the government’s expert from the field of probiotics. Bayer’s experts, on the other hand, were familiar with the regulatory regime for dietary supplements, were experts in the area of probiotics, and testified that a “vast majority” of their colleagues would disagree that the testing proposed by the FTC was necessary in their field.

“The government 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,” Judge Linares said.

The court also found that the FTC failed to present clear and convincing evidence that Bayer made implied disease claims, noting that the claims made for Philips Colon Health “are ubiquitous in the industry.” If such claims were truly 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 Food and Drug Administration,” the court wrote.

In addition, “every one of Bayer’s labels and advertisements contain the FDA disclaimer that [Philips Colon Health] is ‘not intended to diagnose, treat, cure or prevent any disease,’ and a Government witness conceded that, with this disclaimer, Bayer ‘disclaim[ed]’ any disease claim,” the court said.

Bayer possessed and relied upon sufficient evidence to support its claims, the court concluded, and it refuted the government’s argument that the company needed to print and record the studies it relied upon as the consent decree did not require physical copies. The absence of physical records did not give rise to an inference that Bayer did not possess and rely upon competent and reliable scientific evidence, Judge Linares explained, particularly as the company provided almost 100 studies in support of its claims when the FTC filed its motion for contempt.

To read the opinion in U.S. v. Bayer Corp., click here.

Why it matters: The decision reiterates that the FTC may not create additional requirements outside the lines of an existing consent order, particularly when the mandate goes beyond existing federal law and regulations. The judge cited two other decisions from federal courts in Florida and Utah, where courts held that competent and reliable scientific evidence did not require drug-level clinical trials and that the government could not reinvent the standard through expert testimony.