FDA encourages Alternatives to Animal Testing for Sunscreens

by | Oct 28, 2025 | FDA, OTC Drugs, Our View, U.S. Regulatory

The U.S. Food and Drug Administration (FDA) is encouraging the development of new, reliable alternatives to animal testing for sunscreen products. This comes as the agency continues its work on a proposed order, first issued in September 2021, to update the monograph for over-the-counter (OTC) sunscreens to improve their safety, efficacy and quality.

Key takeaways:

  • No Animal Testing Mandate for Marketed Sunscreens: The FDA does not require animal testing for individual sunscreen products that are marketed under the current monograph. Companies can rely on existing data on active ingredients to formulate their products.
  • Minimizing Animal Testing for New Ingredients: For new sunscreen active ingredients to be considered ‘generally recognized as safe and effective’ (GRASE), some animal testing has been historically necessary. However, the FDA is actively working to reduce this reliance. For instance, they do not request testing in large animals like dogs or non-human primates, and for ingredients with minimal skin absorption and limited safety concerns, they do not require fertility or extensive cancer studies.
  • Call for Innovation: The FDA is strongly urging companies to invest in and develop new, reliable non-animal testing methods. The goal is to have alternative methods that can provide the necessary data for the FDA to make GRASE determinations for new sunscreen active ingredients without the use of animals.
  • Collaboration: The FDA is collaborating with other federal partners, including the National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), to advance this goal.

The FDA is signaling a clear move towards reducing and ultimately replacing animal testing for sunscreens and is looking to the industry to help lead the way in developing and validating new alternative testing methods.

Read the full article here.