By Charles Toutant, From New Jersey Law Journal

Bayer is being held to a “novel and erroneous” legal standard in civil contempt proceedings by the federal government over the marketing of its Phillips’ Colon Health product, the company said in court papers.

The U.S. Department of Justice, on behalf of the Federal Trade Commission, has accused Bayer of violating a 2007 consent order barring unsubstantiated claims about its dietary supplements. But Bayer said in court documents filed Oct. 3 that the government is wrongly penalizing it for failure to conduct randomized, placebo-controlled and double-blind human clinical trials of Phillips’ Colon Health.

The consent order requires only that marketing claims for Bayer supplements be supported by “competent and reliable scientific evidence,” which may include animal testing, in vitro testing or extrapolation from other research, the company said.

Bayer made the assertions in response to an order to show cause filed by the Justice Department on Sept. 12 in federal court in Newark. The government said Bayer’s promotion of Phillips’ Colon Health made claims about the product’s purported benefits without having evidence to support those claims. The government said Bayer should be found in contempt because its claims that Phillips’ Colon Health can “defend against” occasional constipation, diarrhea, gas and bloating implies that the product can treat those conditions, even though the company lacks competent and reliable scientific evidence to back up those claims.

The government claimed the marketing of Phillips’ Colon Health violated a 2007 agreement in a dispute over Bayer’s One-A-Day WeightSmart. In that case, the government filed a civil complaint accusing Bayer of making unsubstantiated claims that One-A-Day WeightSmart helped prevent weight gain associated with declining metabolism in persons over the age of 30. Bayer also paid a $3.2 million civil penalty in connection with that case.

The government’s 2007 complaint against Bayer, in turn, alleged that the company’s unsubstantiated claims about One-A-Day WeightSmart violated a 1991 order issued by the FTC against Bayer’s predecessor, Miles Inc., requiring all claims about the benefits of One-A-Day vitamins to be substantiated by competent and reliable scientific evidence.

In its answer to the government’s motion concerning Phillips’ Colon Health, the company said other FTC consent decrees with supplement makers have specifically required randomized, controlled clinical trials but no such requirement was made in the 2007 Bayer consent decree.

Bayer also asserted that the government’s contempt action violates the Dietary Supplement Health and Education Act of 1994, which says that dietary supplements are not drugs. Under that act, dietary supplements are not subject to the stringent clinical-trial standard applicable to drugs, and manufacturers’ statements about them need only be “truthful and not misleading,” Bayer said.

The government’s contempt action also violates the First Amendment by subjecting Bayer to heightened scrutiny even though the manufacturer’s statements about the product are not false or misleading, the company said.

What’s more, Bayer cannot be held in contempt of the consent decree because it “substantially complies” with the order and any violation was “inadvertent,” the company said. And principles of equity prohibit a finding of contempt because the action targets only Bayer even though “no one in the industry meets the government’s novel standard,” the company said.

Bayer said in a statement that the company “strongly disagrees with the FTC’s motion against the company for claims made in support of Phillips’ Colon Health. The government’s motion is based on an erroneous standard—one that the government advances in this litigation but has never articulated previously to Bayer or anyone else in the dietary supplement industry. The government asserts that Bayer lacks scientific substantiation for PCH because the company has not conducted ‘randomized, placebo-controlled, and double-blind’ ‘human clinical trials’ on the ‘specific product,’ using the precise ‘population[s]’ and ‘methods’ chosen by the government. This is not and has never been the standard for dietary supplement claims such as those at issue.

“Claims about Phillips’ Colon Health are fully substantiated by numerous clinical, animal and genetic studies, among other things, and satisfy all applicable legal standards,” the statement said.

Bayer is represented in the case by lawyers from Sidley Austin in Washington, D.C., and Coughlin Duffy in Morristown, N.J. A spokeswoman for the Justice Department, Nicole Navas, said the department would file a response to Bayer’s filing but did not have any comment.

IMAGE: Phillips’ Colon Health, manufactured by Bayer

For more on this story go to: http://www.njlawjournal.com/id=1202672480891/Bayer-Says-FTC-Applied-Artificial-Standard-in-Contempt-Case#ixzz3FSSHKsIU