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OTC/supplement combos

This article was originally published in The Tan Sheet

Executive Summary

DSHEA does not prohibit marketing OTC/dietary supplement combinations, CHPA says in a Nov. 29 letter to FDA. "If Congress had intended to outlaw combinations of dietary supplements and OTC drugs, it could have done so," CHPA says. Association also notes precedents allow cosmetic/drugs to make both cosmetic and drug claims, and that an April agreement between CFSAN and CDER "effectively recognized the existence of combination products." Letter follows B.F. Ascher and Omni Nutraceuticals' responses to FDA warning letters concerning their Melagesic PM and Inholtra products, respectively (1"The Tan Sheet" Nov. 12, p. 8)...
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