FDA Encourages Alternatives to Animal Testing in Sunscreen Research

Sunscreen is more than a summer essential—it’s a vital tool for preventing skin cancer. Because so many people use sunscreen daily throughout their lives, the U.S. Food and Drug Administration (FDA) is committed to ensuring that these products are both safe and effective.

In a recent update, George Tidmarsh, M.D., Ph.D., Director of the FDA’s Center for Drug Evaluation and Research, reaffirmed the agency’s commitment to reducing reliance on animal testing while continuing to uphold rigorous safety standards.

Under a proposed order issued in September 2021, the FDA aims to improve over-the-counter (OTC) sunscreen quality and safety by revising the sunscreen monograph—the framework that defines how sunscreen products can be marketed and tested. The order proposes classifying sunscreens containing zinc oxide and titanium dioxide as generally recognized as safe and effective (GRASE), while additional data are being gathered for other common ingredients such as oxybenzone, avobenzone, and octinoxate.

As part of this process, the FDA is taking meaningful steps to minimize animal testing. The agency does not require animal testing for individual sunscreen products marketed under the monograph and has reduced traditional toxicity and fertility studies in animals when sufficient safety data or long-term marketing history already exist.

The FDA continues to collaborate with partners like the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Toxicology Program’s NICEATM to encourage the development of non-animal, human-relevant testing methods—such as organ-on-a-chip technology and computational modeling. These innovations can help ensure safety without causing animal suffering.

Why It Matters

Millions of animals are still used in research and product testing each year, even when alternatives exist. The FDA’s encouragement of reliable non-animal methods for sunscreen testing reflects a growing shift toward ethical and science-based innovation. Supporting this shift helps protect animals and improves the accuracy and relevance of testing results for human health.

Take Action

Join Ohio Animal Advocates in urging federal lawmakers to Support the Prioritization of Non-Animal Methods in Research and Testing. This important federal action would help agencies like the FDA accelerate the transition toward humane, effective, and innovative testing approaches.

Source: US FDA