FDA Shoots Down Next-Gen Sunscreens
In December 2014, US President Barack Obama signed into law the Sunscreen Innovation Act (SIA), a law intended to get new sunscreen ingredients approved more quickly.
FDA now has an answer for all existing sunscreen applicants: Your applications don’t contain enough data.
“We tentatively determined … that we need more data to decide if these ingredients are, in fact, GRASE for use in OTC sunscreen products,” wrote Theresa Michele, FDA’s director of Nonprescription Drug Products. As such, all eight ingredients have been rejected and sent back to applicants with requests for additional data.