FDA WILL PUBLISH SUNSCREEN TFM IN NOVEMBER OR DECEMBER

FDA WILL PUBLISH SUNSCREEN TFM IN NOVEMBER OR DECEMBER of this year, FDA Division of OTC Drug Evaluation Director William Gilbertson said at a Cosmetic, Toiletry and Fragrance Association conference April 4. Gilbertson expects the Tentative Final Monograph (TFM) to be of "equal interest among drug/cosmetic industry members," with "gravitation towards a stronger 'drug' interpretation." The document will regulate "non-beach products" such as foundation bases and lipsticks that contain sunscreens in addition to traditional sunblocks, he said. According to Gilbertson, the TFM will address the issue of high-sun protection factor sunscreens. FDA currently maintains that SPF 15 is the highest protection factor needed. Also included in the TFM will be the "drug/cosmetic issue" regarding sunscreens, Gilbertson said. The agency "recognize[s] many sunscreen products have been traditionally considered by the FDA as cosmetics," he explained. Other topics covered by the proposed monograph will be sunscreen testing procedures and UVA sunscreens. FDA referred to UVA protection claims in feedback letters to several sunscreen manufacturers and researchers, asserting that such claims are "unacceptable," and that products bearing labeling with the claims are subject to regulatory action ("The Pink Sheet" March 12, T&G-14). The TFM contains "many new labeling concepts," Gilbertson added. Schering-Plough presented its UVA testing method to FDA at an April 3 OTC feedback meeting. The company requested the meeting with FDA in order to present new data supporting the company's UVA sunscreen protection claims, which came under fire in two Feb. 22 feedback letters from the agency. In a discussion of the company's use of a "UVA protection percentage" (APP), which appears on labeling for Shade sunblock, Schering Senior VP-Scientific and Regulatory Affairs John Clayton said: "We believe the APP is a meaningful way to advise the consumer to the degree of UVA protection provided by a product, and it is a very useful subset of the SPF [sun protection factor] number." Whereas SPF reflects the sunscreen protection of the full UVB and UVA range, APP is a percentage indicating the absorbtion of UVA wavelengths "throughout the UVA range," Clayton explained. Gilbertson said the new data presented by Schering will not "necessarily" be included in the tentative final monograph record, which is now closed. "Anti-aging" claims for products containing sunscreens is another area that will be considered in the TFM, Gilbertson noted. Several manufacturers' proposals to the agency suggested that a Category I sunscreen justifies the "anti-aging" claims, he said. Manufacturers told FDA that "anti-aging" is another way of stating the agency's proposed indication, which says: "Overexposure to the sun may lead to premature aging of the skin and skin cancer. The liberal and regular use over the years of this product may help reduce the chance of premature aging of the skin and skin cancer." Sunscreens with foreign marketing experience will be addressed in the TFM, Gilbertson predicted. He pointed to the BASF petition to FDA requesting that the agency reopen the sunscreen rulemaking to include data for ethoxylated ethyl-4-aminobenzoate (PEG-25 PABA), which has never been marketed in the U.S. "This petition raises legal questions about the agency's long-standing interpretation of 'material time' and 'material extent' to mean marketing in the United States as pertains to the OTC drug review," he said. The status of octyl dimethyl aminobenzoate (Padimate O), a Category I sunscreen which has been identified as containing nitrosamine contaminants, will be determined in the TFM, according to Gilbertson. Gilbertson expects the industry will be granted a 180-day comment period due to the "many facets" and length of the document, which is currently over 400 pages.