Last Updated on May 10, 2022 by Ithos Global Regulatory Team
The FDA has given advance notice of publication of a notice titled “Intent to Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-The-Counter Use.”
The Coronavirus Aid, Relief, and Economic Security (CARES) Act, signed into law in March 2020, requires FDA to issue a proposed order addressing sunscreens by September 27, 2021, which prompted the notice.
The FDA intends to prepare an environmental impact statement (EIS) to evaluate the potential environmental effects of revised conditions for marketing certain octinoxate and oxybenzone over-the-counter (OTC) use without prior approval of a new drug application (NDA). By this notice, FDA is announcing the beginning of the scoping process to solicit public comments and identify issues to be analyzed in this EIS. Instructions for making comments may be found here. A 30-day comment period from the date of publication, expected to be on or about May 13, 2021.
The FDA identifies four potential outcomes for use of these ingredients without a new drug application:
- both oxybenzone and octinoxate are permissible
- both oxybenzone and octinoxate are impermissible
- oxybenzone is permissible and octinoxate is impermissible
- oxybenzone is impermissible and octinoxate is permissible