INSIDER Law
Bayer Court Victory to Stand in Probiotic Battle with FTC

Bayer Court Victory to Stand in Probiotic Battle with FTC

<p>FTC had until Tuesday, Nov. 24 to file a notice of appeal, but did not do so, a lawyer representing Bayer said.</p>

A federal court decision that was favorable to Bayer Corp. and followed closely by the dietary supplement industry will stand.

FTC had until Tuesday, Nov. 24 to file a notice of appeal, but did not do so, according to Jonathan Cohn, Bayer’s outside counsel who is a partner in Washington with Sidley Austin LLP.

Federal judge Jose Linares rejected the government’s position that Bayer had failed to substantiate its statements touting the benefits of a probiotic supplement with “competent and reliable scientific evidence." That is the standard established by FTC in a 2001 guidance and referenced in a 2007 consent decree binding Bayer.

“We are glad the government did the right thing in not appealing," Cohn said in an email Wednesday. “The district court’s decision was unassailable."

FTC spokesmen had no immediate comment.

Representatives for the dietary supplement industry expressed concerns in court filings that the government was seeking to set a dangerous precedent by requiring Bayer to conduct human clinical trials in order to back up its statements that Phillips’ Colon Health helps defend against occasional constipation, diarrhea, gas and bloating.

Bayer cited nearly 100 studies to substantiate its claims, and Linares disagreed with government lawyers that the company should be held in contempt for violating the consent decree.

“As two other courts have held, competent and reliable scientific evidence does not require drug-level clinical trials, and the Government cannot try to reinvent this standard through expert testimony," the judge wrote in his decision.

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