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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.

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Marketing In Brief

ModiFace launches forecasting tool: Toronto-based virtual makeover firm introduces ShadeCast, a makeup sampling and forecasting tool based on behavioral tracking. ShadeCast is used in conjunction with iPhone application MakeUp, which allows consumers to virtually try on makeup in hundreds of shades from brands including Revlon, Cover Girl, Lancome and Clinique. ShadeCast offers 1,000 cosmetic shades from 40 brands and assigns a ShadeScore "to approximately position the [app's] hottest and most sampled color." ModiFace exec Nikkie Gatto likens the app to radio music playlists, helping consumers "looking to capture the current look, but also provide vital market intelligence to our retail channel partners," she says in Nov. 3 release. "The value of data to demonstrate the aggregate behavior will help the industry predict the latest trends and help cosmetic manufacturers better understand the color and products which most resonate with online and iPhone virtual makeover users," the company says

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