New Initiatives by FDA
FDA has proposed revisions and updates to OTC-drug sunscreen requirements related to maximum sun protection factor (SPF) values, active ingredients, broad-spectrum requirements, and product labeling, among other provisions. This effort aims to ensure adequate ultraviolet A rays (UVA) protection given the growing body of data linking UVA exposure to skin cancers and other harms.
Through a deemed final order per the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act, marketing requirements for sunscreens without approved applications are established. This includes a 1999 final monograph regulation for OTC sunscreen products, which never took effect and labeling and effectiveness requirements from a final 2011 labeling and effectiveness testing rule.
The deemed final order essentially preserves the pre-CARES status quo marketing conditions for these sunscreens, as, before CARES was passed, sunscreens were marketed according to nearly identical terms that were described in an FDA enforcement discretion policy.
Though the CARES Act did not change the scientific standards for determining whether a sunscreen may be legally marketed without an approved application, it did establish conditions under which FDA permits certain OTC drugs to be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE), so long as they comply with all other applicable requirements.
FDA had been required by the CARES Act to issue a proposed revised order by Sept. 27, 2021. The proposed order, launched September 24, 2021, will be used by FDA as a vehicle to efficiently transition its ongoing consideration of the appropriate requirements for OTC sunscreens marketed without approved applications from the previous rulemaking process to this new order process.
The agency will consider comments on the proposed order during a 45-day public comment period before issuing a revised final order (and is considering all comments timely submitted to the 2019 proposed rule to be constructively submitted to the proposed order). The CARES Act specifies that the effective date for the revised final order cannot be earlier than one year after its issuance.