On November 26, 2014, the President signed into law the Sunscreen Innovation Act (Pub. L. No. 113-195). The Act is primarily intended expedite FDA procedures for approving new sunscreen active ingredients and ingredient blends for use in nonprescription sunscreen products under the Federal Food Drug and Cosmetics Act, and address the current backlog of sunscreen ingredient applications pending at FDA. The last over-the-counter (OTC) sunscreen ingredient to be approved by FDA was in 1999. Since that time, eight new sunscreen applications have been filed and are still awaiting review.
Importantly, the Act also sets forth a new framework for FDA to expedite similar approval processes for nonprescription drugs other than sunscreen active ingredients under FDA’s existing time-and-extent application (TEA) process. Sunscreens and other OTC drug products that are currently marketed will not be affected by the provisions of the Act.
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