On November 26, 2014, President Barack Obama signed into law S. 2141, the “Sunscreen Innovation Act,” which modifies the Food and Drug Administration’s (FDA) process for the review and approval of over-the-counter (OTC) sunscreen ingredients. The legislation was initially introduced by Sen. Jack Reid (D-RI) on March 13, 2014. The bill was then passed by the Senate on September 17, 2014 and by the House of Representatives on November 13, 2014 before being signed into law. The legislation has at least some industry support, as L’Oréal USA — a major marketer of sunscreen products — issued a statement in support of the legislation, noting that it will “provide American consumers greater access and choice when it comes to the latest and most effective sunscreen products available.”
The Sunscreen Innovation Act amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of OTC sunscreen active ingredients. Under the law, any person can submit a request to the FDA to determine whether an OTC sunscreen active ingredient (i.e., ingredients not previously evaluated under the OTC Sunscreen Monograph) or combination of ingredients is safe and effective.
The law requires the FDA’s Center for Drug Evaluation and Research to complete a review of a filed request and determine the safety and efficacy of the sunscreen active ingredient or combination of ingredients within 300 days for new requests, or a shorter timeframe for requests pending before enactment of the law. Ingredients that are found to be safe and effective by the FDA can be used to formulate OTC sunscreen products.
The law also permits sponsors of eligible non-sunscreen OTC drug applications to request that the FDA provide a framework for review of their application similar to the review process established for sunscreen active ingredients.
Finally, the law directs the GAO to report on progress establishing the new OTC sunscreen ingredient review process, the role of the FDA’s Commissioner in issuing determinations on pending requests, the amount of time taken by FDA to issues such decisions, and other performance criteria.