Industry Groups Seek Meeting With FDA On Antibacterial Ingredient Studies
This article was originally published in The Rose Sheet
The Personal Care Products Council and American Cleaning Institute say industry is undertaking studies on benzethonium and benzalkonium chloride in consumer antimicrobial wash products, but seek input from FDA on study designs and an extended timeframe for their completion. The agency’s commitment to publish a final monograph regarding triclosan use by September 2016, per a late 2013 consent decree, should not have bearing on the GRASE status of other antibacterial ingredients or industry’s efforts to provide data supporting their safe and efficacious use, the groups say.
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FDA’s rule “clarifies the mission” for manufacturers of consumer antibacterial soaps, which have a year to demonstrate that they are safe and effective or risk losing the entire OTC drug category.
FDA’s final rule “clarifies the mission” for manufacturers of consumer antibacterial soaps, which have a year to demonstrate that benzalkonium chloride, benzethonium chloride and chloroxylenol are safe and effective or risk losing the entire OTC drug category. The rule bars firms from marketing consumer antiseptic wash products containing triclosan, triclocarban and 17 other lesser-used active ingredients.
In comments to FDA, the Personal Care Products Council and American Cleaning Institute challenge agency cost projections and question the need for clinical study data to back the efficacy of antibacterial hand-wash products, as called for in a proposed rule issued by the agency in December 2013. Groups say manufacturers require guidance and request an extension of the deadline for data submissions, current set for December 2014.