FDA review of non-U.S. cosmetics agents under material time/extent proposal requested.
This article was originally published in The Rose Sheet
Executive Summary
FDA REVIEW OF NON-U.S. COSMETICS AGENTS UNDER MATERIAL TIME/EXTENT proposal requested by Paris-based L'Oreal SA in comments submitted to FDA Jan. 16. Responding to the agency's proposal to consider foreign "conditions of use" (including ingredients, indications and dosage forms) for products that have been marketed "for a material time" and "to a material extent" as part of the U.S. OTC monograph system, L'Oreal points out that the proposal "excludes specific reference to a wide range of personal care products which are regulated as cosmetics outside of the U.S. but would be subject to U.S. drug regulations since [they] fall within an existing OTC monograph category." FDA published the advanced notice of proposed rulemaking with suggested criteria defining the terms "material time" and "material extent" in the Oct. 3 Federal Register.