The United States Congress has passed the Sunscreen Innovation Act (H.R. 4250/S. 2141), which gives the Food and Drug Administration (FDA) the authority to prioritize the review and approval of more effective sunscreen ingredients that have been available to consumers outside the U.S. for several years.
The new bill amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients. It allows any person to request that the Secretary of Health and Human Services (HHS) determine whether an OTC sunscreen active ingredient or combination of ingredients is safe and effective and requires the director of the 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.
Since 2002, eight new sunscreen applications have been filed and are still awaiting review 12 years later. Once signed by the President, the bipartisan Sunscreen Innovation Act would streamline the approval process for new sunscreen ingredients to ensure that new ingredients and products receive a transparent review within a predictable timeframe.
Both American Academy of Dermatology (AAD) and the Public Access to SunScreens Coalition (PASS Coalition) praised passage of the bill. “Americans lack access to the latest sunscreen ingredients, which have been widely available in Europe, Asia, and Central and South America, in some cases for over 15 years. The Sunscreen Innovation Act will ensure FDA approves the latest sunscreens in a predictable timeframe, and enable future generations of sunscreen products to reach American consumers in a timely fashion,” said Michael Werner, policy advisor for the PASS Coalition.