The House of Representatives has passed the Sunscreen Innovation Act reforming how FDA approves sunscreen ingredients through its Time-and-Extent ("TEA") process. The Senate approved the bill in September 2014, and President Obama is expected to sign the bill, which is designed to speed up approvals for sunscreen products stalled in the U.S. regulatory pipeline. Since 2002, sunscreen makers have filed eight new applications that are still awaiting review, and the last FDA sunscreen ingredient approval was in the 1990s. Many of these pending sunscreen ingredients have been used in other countries for decades, and the bill would streamline review of applications for those ingredients that have been used safely for at least five years in another country. If signed, the new law would require FDA to conclude its review of the eight pending ingredients by the end of 2015. It also calls for FDA to issue regulations for "timely and efficient" review of TEA applications within 18 months of the law's enactment. Under the new law, FDA will also have to report to Congress regularly on efforts to reduce the backlog of applications.
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