UVB-Only Sunscreen Monograph Opposed By Senators, Consumer Groups
This article was originally published in The Tan Sheet
Executive Summary
The publication of a sunscreen monograph that only addresses UVB radiation protection "could result in sunscreen labeling that unintentionally misinforms consumers about the level and type of protection that sunscreen products provide and how best to use them," Sens. Jack Reed (D-R.I.) and Christopher Dodd (D-Conn.) state in a March 30 letter to FDA. Reed was the sponsor of the final sunscreen monograph deadline provision of the FDA Modernization Act that requires the monograph be published by May 19.
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The publication of a sunscreen monograph that only addresses UVB radiation protection "could result in sunscreen labeling that unintentionally misinforms consumers about the level and type of protection that sunscreen products provide and how best to use them," Sens. Jack Reed (D-R.I.) and Christopher Dodd (D-Conn.) state in a March 30 letter to FDA. Reed was the sponsor of the final sunscreen monograph deadline provision of the FDA Modernization Act that requires the monograph be published by May 19. The senators note that since publication of the proposed final monograph in May 1993 and the 1993-1994 comment period, "the proposed final monograph has not been comprehensively reviewed to incorporate new insights or information that could be of significant value to the monograph." Recognizing FDA is developing separate procedures for validating UVA testing methodologies, the senators state: "We would encourage you to continue your efforts to foster extensive public discussion among interested parties as you address these issues (see related story, p. 8). "Meanwhile, we would also urge you to continue working toward a comprehensive sunscreen monograph that provides accurate and complete information about the full dangers of sun exposure and the benefits of sunscreen use." The National Consumers League also takes issue with FDA's plan to bring out only the UVB portion of the final monograph. In an April 14 letter to FDA, NCL says "final labeling rules must contain clear and consistent messages about SPF levels, UVA protection and water resistance." While FDA's goal is to provide "accurate information in a simple format...the consequences of the new labeling will be to cast doubt on the need for higher SPF sunscreens while increasing public concerns that a very safe, topical product may be irritating," NCL maintains. Furthermore, NCL says it was not Congress' intention in requiring a timeframe on the monograph "that FDA rush to meet a deadline if the result could be misleading." NCL's letter is also signed by the American Academy of Dermatology, the National Women's Health Network, the Society for the Advancement of Women's Health Research and Public Voice for Food and Health Policy. |