FDA Requests Additional CTFA Test Results For Final Sunscreen Monograph
This article was originally published in The Rose Sheet
Executive Summary
FDA has asked the Cosmetic, Toiletry and Fragrance Association to submit data from a number of UVA testing methodologies before the agency completes its final sunscreen monograph before the end of May. Multiple in vitro tests may be included.
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FDA Extends Sunscreen Monograph Implementation Date To December 2002
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UVA sunscreens
FDA reiterates outstanding questions on the critical wavelength method, or modified Diffey, in a July 16 letter to the Cosmetic, Toiletry and Fragrance Association. The letter is a formal response to CTFA's April 1996 proposal that the method be accepted as a test for UVA protection. In its response, FDA asks technical questions related to the use of instruments and area to be tested in the critical wavelength proposal, as well as the minimal erythemal dose of 1 J/cm2 measurement. The agency also repeats its request for additional UVA testing data. The queries are a restatement of those raised with CTFA during a Jan. 27 "feedback" meeting (1"The Rose Sheet" Feb. 1, p. 8)