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FDA SUNSCREEN RULE-MAKING PROCESS MOVING "AS EXPEDITIOUSLY AS POSSIBLE"

This article was originally published in The Tan Sheet

Executive Summary

FDA SUNSCREEN RULE-MAKING PROCESS MOVING "AS EXPEDITIOUSLY AS POSSIBLE," given the agency's limited resources, FDA Deputy Commissioner for External Affairs Carol Scheman told Sen. Joseph Lieberman (D-Conn.) in a Dec. 2 letter. Scheman said that all comments to the sunscreen tentative final monograph and available data will be "evaluated expeditiously after the record is closed so that the final rule establishing enforceable standards can be promulgated as soon as possible." In an Oct. 21 letter to FDA, Lieberman expressed his concerns regarding the manner and speed at which FDA was processing the OTC sunscreen tentative monograph published May 12 in the Federal Register ("The Tan Sheet" Nov. 29, p. 4). In her response, Scheman outlined the agency's "three-step public rulemaking process" leading to the publication of a final rule for sunscreens that has included the 1978 OTC review panel report and the May 12, 1993 TFM. Scheman pointed out that FDA has extended the period for public comment on the TFM until Feb. 7, 1994 with the exception of ultraviolet A (UVA) comments, which were due on Nov. 8 ("The Tan Sheet" Oct. 18, In Brief). Scheman also responded to Lieberman's concerns regarding UVA testing procedures. She noted that FDA is "currently evaluating" comments on the TFM and that the agency is planning to hold a workshop "in early March to publicly discuss UVA ingredients, claims and testing procedures." Regarding Sen. Lieberman's concern that sunscreen products containing ingredients that block only the shorter UVA wavelengths can continue to make potentially "false and misleading" claims, Scheman said that "such claims would only be false and misleading if it had been established that blockage of the shorter UVA wavelengths is insufficient to prevent against UVA damage." She asserted that the "most significant" portion of UVA light for causing skin damage has still not been determined and that this issue "will be addressed in the [March 1994] workshop. FDA's position on the matter, she added, will be "published subsequently in a future issue of the Federal Register." Regarding avobenzone approval, Scheman said that FDA still considers the ingredient a "new drug" and that the agency is "currently evaluating the safety and effectiveness data submitted" in a citizen petition for monograph status.

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