New Legislation Improves Sunscreen Evaluation through Nonanimal Testing

As part of the funding package that ended the recent government shutdown, Congress passed legislation to improve and reauthorize over-the-counter drug programs. Included in this legislation was language the Physicians Committee advocated for to modernize the FDA’s process for approving nonprescription topical products, including sunscreens, by requiring the FDA to consider and allow for nonanimal data and real-world evidence. These changes will not only help replace the use of animals but will improve Americans’ access to more appealing and effective sun protection products, many of which have been widely available in Europe and Asia for years.

The adoption of nonanimal data for sunscreen evaluation is long overdue. Because the FDA regulates sunscreens as over-the-counter drugs, their approval for marketing is subject to onerous animal testing requirements, despite the availability of more predictive nonanimal approaches and evidence from real-world use in humans. These outdated testing standards have significantly delayed innovation—a new sunscreen active ingredient has not been approved since 1999.

In contrast, animal testing for sunscreen products is banned in certain other areas, like Europe, where they are considered cosmetics. As a result, additional sunscreen filters that have been evaluated using nonanimal technologies are available in other countries. Because they have been in use for many years, there is a wealth of human data, or real-world evidence, that can be leveraged to support the safe use of these sunscreen ingredients.

Nevertheless, the FDA has continued to rely on animal testing, even though results from animal tests do not accurately demonstrate how these products will react in humans. Despite its recent call to move away from animal testing, the FDA has continued to ask for more animal testing of filters that have already been approved in the U.S. market for decades. Adopting human-relevant evaluation strategies is necessary to ensure Americans can access newer, more effective sun protection products to prevent skin cancer and save animals from invasive and deadly experiments. The Physicians Committee commends Congress for directing the agency to adopt these non-animal approaches.

With the passage of provisions from the SAFE Sunscreen Standards Act, the FDA is now required to consider and allow for nonanimal testing and real-world evidence in its evaluations of sunscreens and over-the-counter topical products. Importantly, the law also requires the development of guidance to explain how nonanimal testing strategies and existing human data can be used to meet safety and efficacy standards. This shift will support the integration of technological advancements for better, more ethical science, and also align with the FDA’s goals to prioritize human-based approaches.

The Physicians Committee advocated in support of this legislation and looks forward to continuing to work in collaboration with industry, the FDA, and nonanimal scientists to advance modern testing strategies for improved public health, good scientific practices, and animal protection. We urge the FDA to swiftly implement these provisions.