According to news sources, the U.S. Food and Drug Administration (FDA), which has long delayed approving the use of eight sunscreen ingredients available in many foreign countries, but not in the United States, expects to issue a proposed rule addressing five of the ingredients in September 2013. Citing applications to approve three of the ingredients “sitting at the FDA since 2002,” lawmakers, skincare companies and public health organizations said that it “just doesn’t make any sense” that products available on the market in other developed countries are not available in the United States.
At issue is a process called time and extent applications (TEA) that FDA established in 2002 to streamline the review of over-the-counter (OT C) products that have been used safely in other countries. Apparently, no product has been approved through the TEA process. According to FDA Deputy Commissioner Sally Howard, the agency has recently prioritized its review of safety and efficacy data for those ingredients “because of the public health importance of OT C sunscreens.” Howard reported that reviews are being completed for the eight TEA sunscreen ingredients and the agency expects to take further action in the “near future.”
Members of the advocacy group Public Access to Sunscreens Coalition said, “we are hopeful that FDA will engage with stakeholders and Congress in a bipartisan manner to enact policies that clear the 10-year backlog in sunscreen applications and allow for new sunscreen products to receive a transparent review within a predictable timeframe.” See CQ News, August 16, 2013; TheHill.com, August 18, 2013.