Here's The 'Rub' On Antiseptic Washes: FDA Wants Additional Safety, Efficacy Data
This article was originally published in The Tan Sheet
FDA says in a proposed rule that it currently does not intend to remove any products containing alcohol or benzalkonium from the market, but asks firms that want to continue marketing the products to submit additional GRAS/GRAE data on the ingredients.
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The Personal Care Products Council and American Cleaning Institute say industry needs FDA input on study designs and more time to study benzethonium and benzalkonium chloride in consumer antimicrobial wash products. FDA’s commitment under a 2013 consent decree to publish a monograph for triclosan use by September 2016 should not influence the GRASE status of other ingredients, the groups say.
A Nov. 21 consent decree sets multiple deadlines over a five-year period to make FDA finalize its OTC topical antimicrobial drug products monograph with respect to triclosan. Under one deadline of note to triclosan product makers, the agency must publish a tentative final monograph for consumer antiseptic hand wash products by Dec. 16, with a final monograph due by Sept. 15, 2016.
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