Supplement/OTC Combos Have Precedents In Other Categories, Firms State
This article was originally published in The Tan Sheet
Executive Summary
Prior sale of combination products such as drug/ devices or drug/biologics set a precedent for selling dietary supplement/OTC combination products, B.F. Ascher and Omni Nutraceuticals maintain in separate letters sent to FDA Nov. 6
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OTC/supplement combos
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)...