A HEADACHE FOR BAYER

United States Seeks Civil Contempt Against Bayer Corporation for Failure to Substantiate Promotional Claims for Phillips' Colon Health

The Department of Justice announced last week that it filed a motion to show cause why Bayer Corporation should not be held in civil contempt for violating a court order in the U.S. District Court for the District of New Jersey. The court order, entered in 2007 in United States v. Bayer Corporation, prohibits Bayer from making unsubstantiated claims for any dietary supplement it promotes or sells. The government alleges in today's motion that Bayer promotes one of its products, Phillips' Colon Health, using claims about the product's purported benefits without having evidence to substantiate those claims.

The court order prohibits Bayer from making any claim about the performance or efficacy of any dietary supplement, multivitamin or weight-control product unless, at the time Bayer makes the claim, the company possesses "competent and reliable scientific evidence" to support the claim. In its motion, the United States alleges that Bayer expressly claims Phillips' Colon Health can "defend against" occasional constipation, diarrhea, and gas and bloating, and impliedly claims that Phillips' Colon Health prevents, treats and cures constipation, diarrhea, and gas and bloating, even though the company lacks competent and reliable scientific evidence for those claims.

"Bayer is required to abide by a longstanding court order to back up claims it makes about the products it sells," said Assistant Attorney General Stuart F. Delery for the department's Civil Division. "The Department of Justice will not tolerate companies that seek to gain an unfair advantage over their competitors by promoting to consumers unsubstantiated claims about the health benefits of their products."

In its motion, the United States describes Bayer's multimillion dollar nationwide marketing campaign for Phillips' Colon Health, which includes print advertisements and television commercials featuring "The Colon Lady," in addition to claims on the product's packaging. The motion further alleges that consumers have paid hundreds of millions of dollars for Phillips' Colon Health, even though Bayer lacks the evidence to support the claims of the purported benefits of this product.

The Consumer Protection Branch of the Civil Division and the U.S. Attorney's Office for the District of New Jersey filed the motion for contempt with the assistance of the Federal Trade Commission (FTC). The matter is filed as United States v. Bayer Corporation, No. 07-0001, in the District of New Jersey.

In 2007, the United States filed a civil complaint against Bayer alleging that Bayer marketed its One-A-Day WeightSmart multivitamin and dietary supplement with unsubstantiated claims that, among other things, One-A-Day WeightSmart helped prevent some of the weight gain associated with a decline in metabolism in users over the age of 30. The complaint alleged that those unsubstantiated claims violated an order issued in 1991 by the FTC against Bayer's predecessor, Miles Inc., that required all claims about the benefits of One-A-Day brand vitamins to be substantiated by competent and reliable scientific evidence.

In order to resolve the complaint's allegations, in 2007, Bayer agreed to pay a $3.2 million civil penalty and agreed that it would not make unsubstantiated representations regarding the benefits, performance, efficacy, safety or side effects of any dietary supplement, multivitamin or weight-control product. In 2007, the U.S. District Court for the District of New Jersey entered an order resolving the complaint's allegations and prohibiting Bayer from making unsubstantiated claims about its products.

Assistant Attorney General Delery commended the efforts of the FTC to investigate Bayer's compliance with the 2007 court order and for referring this latest matter for enforcement. This case is being handled by the Civil Division's Consumer Protection Branch.