FDA's Final Guidance Regarding Over-the-Counter Sunscreen Safety and Effectiveness Continues to Fall Short While Two Year Anniversary of Sunscreen Innovation Act Becoming Law Looms

For Immediate Release: November 22, 2016

Contact: Aimee Steel Lubin, This email address is being protected from spambots. You need JavaScript enabled to view it. / 202-828-1895

(Washington, D.C.) – Today the Food and Drug Administration (FDA) published “Nonprescription Sunscreen Drug Products — Safety and Effectiveness Data - Guidance for Industry," as required by the Sunscreen Innovation Act (Public Law 113 - 195). The Public Access to SunScreens (PASS) Coalition issued the following statement in response to the FDA’s final guidance:

"The PASS Coalition’s mission is to work collaboratively with FDA, Congress and stakeholders to ensure Americans have access to the latest sunscreen technology.  We are pleased the FDA met the statutory deadline under the bipartisan Sunscreen Innovation Act to publish a final guidance on sunscreen ingredient testing. We support the changes from the earlier draft - especially changes to the formulations and the body surface area to be tested. However, we were disappointed that the agency’s approach remains inconsistent with the recommendations made by independent scientific reviewers that were published in peer-reviewed literature. We look forward to continuing to work with FDA and the new Administration to ensure that safe ingredients get to market as quickly as possible."

The bipartisan Sunscreen Innovation Act was signed into law by President Obama on November 26, 2014. The law streamlined the approval process for new sunscreen ingredients to ensure that these ingredients receive a transparent review within a predictable timeframe. The intent of the Act was to ensure Americans gain access to the latest safe, effective and innovative sunscreen products to protect against the sun’s most harmful rays.

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