FDA Sets High Bar For Sunscreen Approval

FDA has insufficient data to establish whether six chemicals are generally recognized as safe and effective for use in sunscreens, the agency says in letters to companies seeking approval to use the compounds as active ingredients. The substances are bemotrizinol, bisoctrizole, drometrizole trisiloxane, octyl triazone, amiloxate, and diethylhexyl butamido triazone. FDA announced its decisions earlier this month, along with a description of the data that are needed, as required under the newly enacted Sunscreen Innovation Act. That law, which went into effect in November 2014, is intended to accelerate FDA’s process for approving new active ingredients in sunscreens. Some of the six chemicals have been under review at FDA for more than a decade, even though they are approved in other countries. In some cases, the agency is asking for additional data from human irritation and sensitization studies, as well as data from animal carcinogenicity, reproductive, and developmental tests. FDA is also seeking summaries of “adverse event” reports—describing people’s adverse effects after using sunscreens—from countries that have approved these chemicals.