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FTC Requests Drug Claim Support For Bayer Probiotic Supplement

This article was originally published in The Tan Sheet

Executive Summary

On behalf of the FTC, DoJ alleges Bayer violated a 2007 settlement to substantiate supplement claims and asks a court to require the firm to provide two RCTs for dietary supplement claims for Phillips’ Colon Health. Trade groups rally behind the firm, arguing the requirement is unfair and illegal.

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Decision On Bayer Probiotic Claim Could Weaken FTC Argument For Clinical Trials

FTC attempts through litigation, rather than rulemaking to establish RCTs as the standard for supplement claims, industry stakeholders say. The decision shows FTC “may not attempt to apply new standards … through contempt and threats of contempt,” says Jonathan Cohn, lead counsel for Bayer in the litigation.

Decision On Bayer Probiotic Claim Could Weaken FTC Argument For Clinical Trials

FTC attempts through litigation, rather than rulemaking to establish RCTs as the standard for supplement claims, industry stakeholders say. The decision shows FTC “may not attempt to apply new standards … through contempt and threats of contempt,” says Jonathan Cohn, lead counsel for Bayer in the litigation.

‘Distressing’ Substantiation Trends Tighten FTC Supplement Claim Enforcement

FTC tightens requirements for claims substantiation due to fraud in studies and peer reviews, but its changes are not “monumental,” says Division of Advertising Practice official Richard Cleland. FTC likely will ask more supplement or nutritional product firms to conduct RCTs to support marketing claims, he adds.

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