German pharmaceutical company Bayer has a profitable side-line in multi-vitamins and probiotics. Both vitamins and probiotics are frequently the subject of debate, with advocates on both sides over the question of whether they actually work and whether the typical healthy person needs to take them.
The Bayer case centered on probiotics. Probiotics are cultures of live microorganisms (most often lactic acid bacteria.) Probiotics can, in theory, confer a health benefit. There are some studies which support the consumption of live microorganisms in the human body and others that have not found any significant biochemical changes to have taken place.
The U.S. Federal Trade Commission (FTC) attempted to bring a case against Bayer for not following the guidelines about “evidence-based medicine.” The case was based on a complaint from a consumer who lives in California.
The charge was about a product called Phillips’ Colon Health, designed to protect against constipation and diarrhea. The FTC said Bayer did not conduct human clinical trials to substantiate its claims about the product and on this basis, U.S. consumers were being sold a product for which there was no direct evidence. To support the case, the FTC provided Loren Laine, M.D., a professor of digestive diseases from the Yale School of Medicine, as its expert witness.
Bayer responded, according to The Insider, and argued it had ample evidence to back up its product claims with “competent and reliable scientific evidence.” Bayer also maintained that trials were not required under the 1994 Dietary Supplement Health and Education Act (DSHEA).
The Bayer argument convinced federal judge Jose Linares (New Jersey), who has dismissed the FTC case, according to the Natural Products website. The judge, who made the decision on September 24, has yet to publish his rationale (this is expected on October 8, 2015).
With the case was against Bayer, the FTC was intending to set a precedent, based on a ruling in its favor, which would require human clinical trials to have been held and published before supplement marketers can market a product’s benefits.
Commenting on the outcome of the case, Jonathan Cohn, partner at Sidley Austin LLP, told Digital Journal: “Too often, the FTC attempts to regulate by litigation and force companies to enter into settlements through threats of litigation. This case shows that the Government may not attempt to apply new standards to the industry through contempt and threats of contempt. The FTC must follow the law, like every other agency. The FTC may not attempt to hold a company in contempt on the basis of a novel and unlawful legal standard.”
The Sidley legal team for Bayer includes Mark D. Hopson, Jonathan F. Cohn, Benjamin Mundel and Blair Greenwald.
