Zinc Oxide Deemed GRASE under the CARES Act
The Over-the-Counter Monograph Safety, Innovation, and Reform Act (OTC Monograph Reform Act), which impacts how sunscreens are regulated by the U.S. Food and Drug Administration (FDA), as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law.
This portion of the bill will reform and modernize the way certain OTC drugs are regulated in the US to promote innovation and improve the safety and efficacy of OTC monograph drugs.
Sunscreen actives were previously under review through their own process through the Sunscreen Innovation Act of 2014. Passage of the CARES Act will now require sunscreen actives to fall in line with the new procedures for OTC drugs outlined in CARES act. This will temporarily halt the reclassification of the current 16 sunscreen drugs on the market that have been under recent review. However, within 18 months, the FDA must propose an order addressing the currently marketed substances. As it stands, the FDA review has produced sufficient safety data on both zinc oxide and titanium dioxide to support that sunscreen products containing these ingredients (at concentrations of up to 25 percent) would be GRASE, and are proposed that these ingredients are Category I in the sunscreen monograph.
Prior to the enactment of CARES Act, many products have languished for years under “tentative final monographs”. With passage of this bill, the mechanics and features of the prior system will be modified in a number of ways to have accelerated review of new to market OTC monograph drugs through an administrative order process which will replace the notice-and-comment rule currently in place. In addition, the Act provides 18 months of marketing exclusivity for a company that requests and receives a final order that allows a sunscreen to contain a new active sunscreen ingredient.
