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This article was originally published in The Tan Sheet

Executive Summary

SUNSCREEN TFM COMMENT PERIOD FOR NON-UVA ISSUES TO BE EXTENDED 90 DAYS, FDA's OTC Monograph Review Staff Director William Gilbertson told the Society of Cosmetic Chemists" annual sunscreen symposium in Orlando, Fla. on Oct. 2. A notice announcing the new deadline for comments on the sunscreen tentative final monograph will be published in the Federal Register "within the next couple of weeks," Gilbertson said. Comments on UVA issues will continue to be due by the current Nov. 8 deadline, according to FDA. Gilbertson explained that the agency is planning to hold a workshop on UVA testing, protection, ingredients and labeling in the spring of 1994 and needs comments on those issues by the earlier date to prepare for the session. The comment period extension grants half the extra time that had been requested by the Cosmetic, Toiletry and Fragrance Association in an Aug. 27 letter to the agency ("The Tan Sheet" Sept. 6, p. 8). Gilbertson said that "the agency agrees" with CTFA's argument that many of the issues raised in the TFM are "vast and of a complex nature" and that more time is needed for industry to prepare comments, but maintained that a 180-day extension is "too long." Noting that the agency is one-third of the way through its sunscreen products review, Gilbertson predicted a final rule would be released in 1996. FDA is planning a series of workshops regarding amendments to the TFM in areas including testing, Gilbertson said. The TFM "has been a long time coming," he noted, and "the science keeps moving on." Due to recent advances in science, Gilbertson predicted "several" amendments to the TFM's requirements on labeling and testing. "I cannot see us coming out with a final rule with the testing that is there without making changes in it to make it more consistent and up-to-date," he said, adding: "We probably would have to repropose that part of the document as a tentative final [monograph] prior to the release of the final rule." Asked if the labeling terms "chemical-free" and "PABA-free" will be permitted in the final rule, Gilbertson said it would depend on the comments received. The SPF 30 limit is another aspect of the TFM that may change in the final rule. Gilbertson said that the limit could be "changed or raised" or that sunscreen products with higher values may be marketed only under a prescription in the future. The TFM raised the maximum value to SPF 30 from SPF 15, noting that "OTC sunscreen drug products with SPF values higher than 15 are beneficial to consumers." SPF 15 had been proposed as an upper limit by FDA's topical analgesic panel in a 1978 panel report. FDA continues to consider the issue of using foreign marketing experience data in petitions for monograph status, Gilbertson said. "We are trying to develop a policy now that will allow products to be considered for market in the U.S. . . . based upon marketing experience in Europe or other countries," he remarked. In addition to sunscreens, the new policy would apply to other product categories such as antiplaque products and phytomedicines, Gilbertson indicated.





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