The Wall Street Journal - European Sunscreen Roadblock on US Beaches
Eight sunscreen ingredient applications have been pending before the U.S. Food and Drug Administration for years—some for up to a decade—for products available in many overseas countries. The applications were filed through the federal TEA process (time and extent application), which allows the FDA to approve the ingredients if they have been used for at least five years abroad and have proved effective and safe. Dr. Julie Russak, a dermatologist in Manhattan and clinical instructor at the Icahn School of Medicine at Mount Sinai, said it's understandable why the FDA would be cautious in approvals for new sunscreen ingredients because of a paucity of research and concerns that some may be highly allergenic or affect estrogen levels. "I know patients bring sunscreens with them from Europe and it's very hard for us to give recommendations because we really don't have much data" on such products, Dr. Russak said.
-Dr. Julie Russak, Clinical Instructor, Dermatology, Icahn School of Medicine at Mount Sinai