FDA Regulatory Agenda Targets Antimicrobial Hand Washes, Sunscreen
This article was originally published in The Rose Sheet
Triclosan use in consumer hand-wash products could be addressed by FDA in a proposed rule targeted for February release. Sunscreen also is identified as a priority in the agency’s semi-annual regulatory agenda.
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While FDA’s OTC drug monograph system is an “appropriate and rational framework” for regulating cosmetic-drug products, greater transparency and more regular communication with industry are needed, according to the Personal Care Products Council’s Elizabeth Anderson, executive VP-legal and general counsel, who offered comments March 25 at a public hearing on potential improvements to the process.
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 a pair of deadlines 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 Sept. 15, 2016.
Industry has come out against a study exploring the impact of triclosan on cardiac and skeletal muscle function in animals, which they say is a “publicity campaign” and used “unrealistically large” doses of the anti-bacterial ingredient that do not represent real-world conditions. The NIH-funded study prompted investigators to call for a “dramatic reduction” in the ingredient’s use in consumer products.