FDA’s plan to phase out animal testing could accelerate approval of new sunscreens in US
Key takeaways:
- The U.S. has not seen the approval of a new sunscreen ingredient since the 1990s.
- The FDA’s plan to phase out animal testing removes one of the obstacles standing between Americans and new sunscreens.
The FDA announced it will be reducing, refining and potentially replacing the animal testing requirement for the approval of certain drugs, which could have implications for the approval of new sunscreen ingredients in the United States.
“The agency is paving the way for faster, safer and more cost-effective treatments for American patients,” a spokesperson from the FDA told Healio. “As we restore the agency’s commitment to gold-standard science and integrity, this shift will help accelerate cures, lower drug prices and reaffirm U.S. leadership in ethical, modern science.”
In a press release, FDA stated that animal testing for the development of monoclonal antibody therapies and other drugs will be replaced with “more effective, human-relevant methods,” — also known as New Approach Methodologies, or NAMs.
The FDA encourages companies filing investigational new drug applications to immediately begin including NAMs data, as outlined in the agency’s “Roadmap to reducing animal testing in preclinical safety studies” document, which was published in conjunction with the announcement.
In an effort to reduce animal testing, the agency also disclosed it will begin using pre-existing, real-world safety data from other countries with comparable regulatory standards to make determinations of the efficacy of drugs that have already been studied in humans.
Implications for sunscreen
As Healio previously reported, the FDA has not approved a new sunscreen ingredient since the 1990s due to a 1938 law that classified sunscreens as over-the-counter drugs instead of cosmetic products. For this reason, sunscreen ingredients must undergo the same rigorous approval process as other drugs, which included animal testing requirements.
“Phasing out animal testing is a big deal and one that has implications for many drugs as well as OTC drugs such as sunscreen,” Anthony Rossi, MD, FAAD, FACMS, assistant attending of dermatologic, Mohs, cosmetic and laser surgery at Memorial Sloan Kettering Cancer Center, assistant professor at Weill Cornell Medical College and founder of Dr. Rossi Derm MD Skincare, told Healio. “This could mean that many of the Europe- and Asia-approved sunscreen ingredients can seek approval in the U.S.”
As Healio previously reported, the EU has banned animal testing for cosmetics, which include sunscreens, according to the EU’s drug classification system. Companies in these countries were facing the risk for consumer backlash if they wanted their sunscreen products approved in the U.S., creating an obstacle to Americans wanting newer sunscreen options.
“For the sunscreen ingredients that are already on the market overseas, some of them have the testing to submit applications to the FDA,” Rossi said.” So, we shall see if the FDA approves them.”
According to Heather D. Rogers, MD, FAAD, a dermatologist in Seattle, the FDA’s announcement to phase out animal testing is “overall... positive news,” but ultimately does not remove other hurdles for new sunscreen ingredient approvals.
“Phasing out animal testing is a necessary and long-overdue step toward modernizing the FDA’s approval process,” Rogers told Healio. “That said, while removing this requirement could help streamline the review of new sunscreen ingredients ... the FDA’s current regulatory framework still treats sunscreens more like drugs than cosmetics, which adds layers of complexity in approval and profound costs that slow innovation.”
In 2019, the FDA issued a proposed rule stating that only two of the 16 ingredients used in sunscreens — zinc oxide and titanium dioxide — are considered generally recognized as safe and effective (GRASE). Two other ingredients previously used in chemical sunscreens — aminobenzoic acid (PABA) and trolamine salicylate — are no longer considered GRASE.
The FDA has called for more safety information on the remaining 12 ingredients, as well as those in the EU attempting approval in the U.S., before it can administer a GRASE rating.
“While animal testing will no longer be needed, it is still unclear what testing the FDA would require to deem active sunscreen ingredients GRASE,” Rossi said.
Regardless of what the FDA may require for GRASE classification specifically, Rossi said the new testing options overall are “future forward thinking.”
New methods: Benefits and concerns
According to the FDA’s roadmap document, a growing body of evidence suggests animal testing does not accurately reflect human health and disease, with over 90% of drugs deemed safe in animals failing to receive approval due to safety and efficacy issues.
The FDA’s official acceptance of NAMs as suitable replacements for animal studies was fueled by the 2022 FDA Modernization Act 2.0, which authorized the use of nonanimal alternatives for investigational new drug applications and the Science Board’s 2024 recommendations for the adoption of NAMs by the FDA.
The FDA is now encouraging and promoting two alternatives to animal testing: human-based lab models, including lab-grown organoids, and advanced AI-driven computer simulations for toxicity and cell lines.
According to Rossi and Rogers, implementing AI into clinical trials comes with both benefits and concerns.
“AI drug discovery is exciting and can be faster in many aspects compared to traditional drug discovery,” Rossi said. “Using AI modeling of drug-receptor affinity is often faster and more efficient than manually creating a library of drug assays.”
Rogers said the replacement of animal testing with AI is interesting, but “needs to be approached with caution.”
“AI can help model safety and efficacy, but it’s only as good as the data it’s trained on,” Rogers said. “It will take a great deal of work to see if it can be a better option and require rigorous validation before we can trust it to protect human health.”
Rossi agreed, expressing concern over the possible inherent bias programmed into AI.
“If AI models are trained on poor or limited data, mostly white skin types for example, predictions could be misleading,” Rossi said. “AI may miss complex systemic effects, and there is a risk of skipping proper validation if AI is over-trusted.”
Next steps
According to the FDA’s roadmap document, there is time to address these concerns. The process of phasing out animal testing and implementing NAMs will follow an estimated 3-year time line, the agency reported.
The program will initially focus on reducing animal use in preclinical safety testing for monoclonal antibodies and will eventually expand to include other biological molecules, chemical entities and medical countermeasures, according to the document.
“With this new approval process, we will have to be open to real-world feedback,” Rossi said. “Once the drug or OTC drug is approved, there may be real patient use that gives positive or negative feedback that needs to be listened to and accounted for.”
Concerning sunscreen initiatives, experts believe this news is a step in the right direction.
“While the American Academy of Dermatology does not take a position on animal testing, we hope that recent developments will allow the FDA to evaluate and potentially approve additional sunscreen ingredients,” Susan C. Taylor, MD, FAAD, president of the AAD, told Healio. “As the FDA’s guidance evolves, the Academy will continue to update its recommendations to ensure the public has access to the best tools for protecting their skin.”
Despite this hopeful progress, there is still room for further reform, according to Rodgers.
“Until the system evolves to better reflect how sunscreens are used and evaluated around the world, delays will persist when compared to other nations,” she said. “But this is not all bad news. The more we know about sunscreen ingredients that are widely used, absorbed into our bodies and accumulated in the world, the better.”
For more information:
Heather D. Rogers, MD, FAAD, can be reached at drrogers@mdinseattle.com.
Anthony Rossi, MD, FAAD, FACMS, can be reached at Anthony@RossiDerm.com and on Instagram at @DrAnthonyRossi.
References:
- Roadmap to reducing animal testing in preclinical safety studies. https://www.fda.gov/media/186092/download?attachment. Accessed April 15, 2025.