FDA Extends Sunscreen Monograph Implementation Date To December 2002
This article was originally published in The Rose Sheet
Executive Summary
FDA will delay the effective date of the OTC sunscreen final monograph a year-and-a-half, following a request from the Cosmetic, Toiletry and Fragrance Association, the agency says in an Oct. 1 letter to the trade group.
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Hawaiian Tropic
FDA's final sunscreen monograph December 2002 effective date should be further extended because it does not allow industry enough time to comply, the sunscreen manufacturer says in a July 6 letter to the agency. Because the introduction cycle of a sun care product "is quite long," usually beginning two or three years before the product launch, the financial burden to adjust production "will be incredible," Hawaiian Tropic says. The effective date was postponed a year-and-a-half to provide a "comprehensive monograph" with both UVA and UVB methodologies included (1"The Rose Sheet" Oct. 11, 1999, p. 3)