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SUNSCREEN PRODUCT PERFDRMANCE STANDARDS RATHER THAN SPECIFIC PRDTOCOLSO$

Executive Summary

SUNSCREEN PRODUCT PERFDRMANCE STANDARDS RATHER THAN SPECIFIC PRDTOCOLSO$ should be adopted by FDA to substantiate efficacy studies, the Proprietary Assn. (P-A) and the Cosmetic, Toiletry and Fragrance Assn. (CTFA) stated in a July 17 letter to FDA OTC Div. Director William Gilbertson. "The most appropriate manner to address the question of efficacy substantiation is to adopt a performance standard, and to make available a guideline that outlines a currently acceptable method of evaluating products to determine if they meet the performance standard," the two associations commented. The P-A/CTFA letter was written in response to an April letter from Gilbertson requesting comments on sunscreen testing procedures and standards. Gilbertson said the standards, developed by the OTC Topical Analgesics Panel seven years ago, might need to be revised to account for advances in testing procedures and methodology ("The Pink Sheet" April 29, T&G-2). The two associations stated that "mandating specific test protocols, that must be followed to substantiate efficacy, is not in the best interest of consumers." They asserted: "Such actions tend to stifle scientific and technological investigation into these areas, as those affected by such rules are often unwilling to support additional research, knowing that any changes proposed would have to go through a lengthy notice and comment rulemaking procedure before being accepted. Additionally, during this period, other advances would be likely, causing the whole process to be repeated again and again." P-A and CTFA noted that the performance standard that has been defined and generally agreed to by the scientific and medical communities as the sun protection factor (SPF) is defined as: "The UV energy required to produce a minimal erythema dose (MED) on protected skin divided by the UV energy required to produce an MED on unprotected skin." The associations said "consumers understand this concept as the SPF indicating how many times longer they can stay in the sun without burning than they normally would." In response to specific questions posed by FDA, P-A and CTFA noted that the majority of sunscreen mfrs. and testing laboratories use the methods proposed by the OTC sunscreen panel for determining SPF values of products marketed in the U.S. "We are aware that other methods and modifications are being used or are under discussion, principally outside the U.S.," the associations stated. In further comments, P-A and CTFA noted that nonclinical tests are being used "solely for screening proposed new formulations." With regard to evaluation of SPF, they said tests are normally conducted only on the original formulation and there is no justification for individual batch testing.

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