Fall from GRASE: The Sunsetting of the Sunscreen Innovation Act

Abstract

The 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act terminated the Sunscreen Innovation Act (SIA) that the Food & Drug Administration (FDA) uses to determine sunscreen actives as safe and effective for human use. The Act also nullified a recent FDA proposal that reclassified 14 organic sunscreen actives as either not safe for human use or requires more data before being used in humans. Most sunscreen actives were approved in 1978; since that time the FDA has determined that over the last 20 years several changes have occurred leading to a substantial increase in sunscreen usage and exposure that increases the potential health risks associated with their use. Based on the scientific literature for the actives reviewed, it is clear that the SIA is needed to assure that sunscreen and other over-the-counter drugs are safe and efficacious for human use prior to entering the marketplace.