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Comments to FDA on Sunscreen Products

In February, the Food and Drug Administration (FDA) proposed a rule that would strengthen regulations for sunscreen products. We submitted comments explaining how FDA can improve its analysis of the rule’s impacts.

FDA’s proposed rule would bar the use of two sunscreen ingredients and require further safety testing for twelve others. The rule would also require all sunscreens with an advertised sun protection factor of 15 or greater to offer broad-spectrum protection against both UVA and UVB rays.

We encourage the agency to make a few clarifications in its assessment of the rule’s likely costs and benefits. FDA’s breakeven analysis estimates the number of cases of skin cancer the rule would need to prevent for its benefits to equal its costs, but the agency does not indicate whether it believes the rule is indeed likely to prevent that many cases. We urge FDA to make such a determination. Our comments also ask the agency to better explain how it developed its estimate of the dollar value of an avoided case of skin cancer.