FTC’s Substantiation Bar: Bayer Corp. (September 2014)

The September 12, 2014, motion for order of contempt for Bayer says the company's health claims for its Phillips’ Colon Health probiotic product violate an existing 2007 FTC

for Bayer's One-A-Day WeightSmart vitamin. That 2007 consent order stipulated that the company can no longer make weight loss or disease claims in the future unless “competent and reliable scientific evidence substantiates the representation.” In the 2007 consent order, “competent and reliable scientific evidence” is defined as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”

Although the FTC does not specify how many trials would be needed, in its 2014 motion for order of contempt, the FTC, upon consulting a board-certified gastroenterologist, indicated it would require randomized, placebo-controlled human clinical trials. Additionally, because the product comprises three specific probiotic strains (Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, and Bifidobacterium longum MM-2), the FTC says that studies must be performed on the same combination of those exact bacterial strains. Probiotic manufacturers should take note of this FTC statement: “[O]ne cannot ‘extrapolate’ (or generalize) the health effects of one bacterial strain to another strain of the same species of bacteria..."

Finally, FTC specifies that clinical trial subjects should represent the product’s target consumer. Because the product is not a drug, clinical studies should target a healthy population (people without constipation, diarrhea, and/or gas and bloating). The focus would be on preventing those symptoms from occurring in healthy people in the first place. The motion reads that if Bayer wants to make implicit treatment or cure claims, then “all of the study participants would have the symptoms being assessed at the time of enrollment.”

According to the FTC, the bottom line is that Bayer doesn't have the substantiation the agency requires. "[N]one of Bayer’s purported substantiation contains all of the required elements to be deemed competent and reliable scientific evidence," it says, because some studies (1) aren’t human studies, (2) aren’t randomized, double-blinded, or place-controlled, or (3) studies were done in the wrong population, according to the FTC.

FTC Requirement: Randomized, double-blind, placebo-controlled human RCTs (but doesn't specify number of studies)

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Jennifer Grebow
Editor-in-Chief
Nutritional Outlook magazine jennifer.grebow@ubm.com

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