SAFE Sunscreen Standards Act
The SAFE Sunscreen Standards Act would amend the Federal Food, Drug, and Cosmetic Act to overhaul how nonprescription (OTC) sunscreen active ingredients are reviewed and approved. It creates formal standards for evaluating safety and effectiveness that can rely on real-world evidence and other scientifically valid approaches in addition to traditional tests, and it encourages the use of non-animal testing methods. The bill also directs the FDA to issue guidance within 180 days on how sponsors can use nonclinical testing alternatives, and it requires the final administrative order for pending sunscreen ingredient applications to reflect these new standards and to emphasize sunscreen as a key skin cancer prevention tool. Additionally, the act imposes ongoing reporting and transparency requirements to Congress and the public about implementation and progress. Overall, the bill aims to modernize and accelerate the regulatory review process for sunscreen ingredients by allowing broader types of evidence and non-animal testing, while maintaining safety and effectiveness standards and increasing accountability.
Key Points
- 1Establishes regulatory standards for evaluating the safety and efficacy of sunscreen active ingredients, permitting real-world evidence and other scientifically valid approaches to supplement or replace traditional clinical tests.
- 2Allows and promotes non-animal testing methods; requires the FDA to issue guidance within 180 days on using nonclinical testing alternatives for sunscreen ingredients.
- 3Applies a prima facie safe nonprescription marketing standard to sunscreen ingredients, meaning initial evidence must support safety for consumer use before marketing.
- 4Updates the pending OTC sunscreen ingredient final order to account for historical safe use, affirm the role of sunscreen in cancer prevention, and incorporate the new testing and evidence standards.
- 5Imposes annual reporting to Congress beginning within 1 year, detailing implementation progress, adjustments to standards, the types of applications reviewed, and the status of nonclinical testing alternatives; requires FDA publication of these reports on its website within 7 days of submission.