- The U.S. Department of Justice and the Federal Trade Commission (FTC) had alleged that Bayer made false claims about Philip's Colon Health, an OTC product.
- The judge has decided in favor of Bayer in the suit. The decision was informed by the Dietary Supplementary Health and Education Act, which stipulates that supplements are not subject to the same strict guidelines as drugs in terms of marketing and sales.
- In a 2007 consent decree, Bayer paid a $3.2 million civil penalty to settle a case involving unsubstantiated claims about its Once-a-Day line of vitamins.
The feds alleged that Bayer's claims about Phillip's Colon Health were unsubstantiated. In fact, the claims, which addressed prevention of constipation, diarrhea, gas, and bloating, were supported by close to 100 studies detailing the digestive benefits of the three probiotic bacteria in the product.
The prosecutors attempted to make the case that the lack of a sufficent number randomized, placebo-controlled clinical trials rendered Bayer's advertising false and misleading. However, the rules are not the same for supplements as they are for FDA-approved drugs. Supplements are regulated under a different set of regulations.
According to information from the FDA's web site: "FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA)."
In the final analysis, the judge found that Bayer had provided enough documentation and evidence to support its claims within the framework of the guidelines for dietary supplements. As might be expected, Bayer was pleased with the outcome of this case.