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Congress demands final sunscreen monograph

This article was originally published in The Rose Sheet

Executive Summary

Rep. Nita Lowey, D-N.Y., reintroduces the "Skin Cancer Prevention, Education, and Consumer Right-To-Know Act." H.R. 2088 would bring into force FDA's proposed rule amending the final sunscreen monograph - notwithstanding "any other provision of law" - 180 days after the bill's enactment. FDA's draft rule includes formulation, testing and labeling requirements to ensure consumers are protected against ultraviolet A as well as ultraviolet B radiation. Publication of the final sunscreen monograph, issued in 1999, has been repeatedly stayed due to industry pressure; in its December 2007 comments to the agency, industry groups opposed FDA's proposed 4-star rating system for UVA protection, which consumers could wrongly interpret to signify a product's overall effectiveness (1"The Rose Sheet" Jan. 14, 2008, p. 3). Meanwhile Ciba Corporation, whose Tinosorb M and Tinosorb S broad-spectrum sunscreen actives are marketed overseas - as well as companies interested in formulating with the ingredients - have been pressuring FDA to complete its "stagnant" review of UV filters, which would give U.S. consumers the same protection options enjoyed by the rest of the world (2"The Rose Sheet" Dec. 8, 2008, p. 4). More than 1 mil. new cases of skin cancer are diagnosed in the U.S. each year, H.R. 2088 notes. Bill has been referred to the Energy and Commerce Committee

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