The following information relates to FDA’s Environmental Impact Statement (EIS) for Certain Sunscreen Drug Products for over-the-counter (OTC) use. FDA has published in the Federal Register a notice of intent (NOI) to prepare an EIS under the National Environmental Policy Act (NEPA) to evaluate the potential environmental effects of revised conditions for marketing certain sunscreen products for OTC use without prior approval of a new drug application (NDA). This web page will house information related to the NEPA EIS process.
Before engaging in a major Federal action, NEPA requires federal agencies to consider the potential environmental consequences of proposed actions, and any reasonable alternatives. Under FDA regulations, FDA will prepare an EIS when data or information in an environmental assessment or otherwise available to the agency leads to a finding that the proposed agency action may significantly affect the quality of the human environment. 1
As explained in the NOI, the Coronavirus Aid, Relief, and Economic Security (CARES) Act, signed into law on March 27, 2020, requires FDA to issue a proposed order addressing sunscreens by September 27, 2021. FDA expects that the future final sunscreen order will establish revised conditions for marketing a sunscreen product without the prior approval of an NDA, and that among the conditions addressed will be the permissibility of including certain active ingredients in sunscreen products marketed without an NDA. Because of questions raised about the extent to which two sunscreen active ingredients (oxybenzone and octinoxate) may affect coral and/or coral reefs, FDA is issuing this NOI and initiating the public scoping process to consider any potential environmental impacts associated with the use of oxybenzone and octinoxate in sunscreens so that an EIS, if necessary, can be completed prior to issuance of a final sunscreen order addressing sunscreens containing these ingredients.
The NOI is available in the Federal Register. If you would like to submit a comment on the NOI, please do so according to the instructions set forth in that document.
FDA will update this webpage periodically.
- Proposed administrative order for OTC sunscreen products
- 1. See 21 CFR 25.22(b); 40 CFR 1508.27.