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March 12, 2010

FDA Responds to EWG’s Letter Concerning Sunscreen Guidelines

Lynn L. Bergeson

In a March 2, 2010 letter, the Food and Drug Administration (FDA) responded to the Environmental Working Group’s (EWG) July 15, 2009, letter concerning sunscreen guidelines. EWG criticized the FDA for not having guidelines for sunscreen safety and efficacy. According to EWG, companies continue to profit by misleading consumers about the protection offered by their products. EWG urged FDA to publish a final rule for its August 2007 draft sunscreen guidelines. In its March 2, 2010, response, FDA stated that most sunscreen products are currently marketed under an over-the-counter drug monograph entitled “Sunscreen Drug Products for Over-the-Counter Human Use.” According to the letter, FDA received over 3,000 comments in response to its August 2007 draft sunscreen guidelines. FDA concludes its response by stating:

Although we understand your concern regarding the protracted nature of this process, we trust that you will appreciate the need for us to continue to fully investigate and evaluate new research and development for sunscreen products, permit adequate opportunity for public comment, and weigh all research and development fairly and with full input from FDA subject area experts as well as industry stakeholders and the American public.