On the recordSeptember 22, 2005
I thank Senator Bennett and Senator Kohl for their efforts as floor managers of H.R. 2744, the Agriculture appropriations bill, and for their willingness to include in that legislation an amendment that I offered along with Senators Harkin, Reed, Carper, Biden, and Lieberman. Our amendment, No. 1818, expresses the sense of the Congress that the Food and Drug Administration, FDA, should act within 1 year to issue comprehensive labeling guidelines for over-the-counter, OTC, sunscreen products--a so-called ``final monograph.'' The FDA began work to develop such a monograph in 1978. In 2002, after 24 years, the agency issued a final monograph. Unfortunately, the final sunscreen monograph failed to address one of the most critical aspects of sunscreens--how to measure protection against UVA rays, which are responsible for causing skin cancer. Because the final monograph failed to address this key issue, the FDA stayed it until a comprehensive monograph could be issued in order to avoid consumer confusion and the need for unnecessary product relabeling. That stay was issued nearly 4 years ago, and the FDA has yet to issue a comprehensive final monograph. Sunscreen manufacturers need clear guidance on product labeling in order to provide consumers with crucial information about the protective benefits of sunscreen products. Studies have shown that skin cancer rates continue to rise, especially in younger adults and women.…
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