This bill directs the FDA to establish modern, science-based standards for evaluating the safety and effectiveness of sunscreen active ingredients, including alternatives to animal testing, and mandates transparency regarding this process.
John Joyce
Representative
PA-13
The SAFE Sunscreen Standards Act aims to modernize how the FDA evaluates sunscreen active ingredients by prioritizing consumer safety through scientifically sound evidence, including real-world data and alternatives to animal testing. This legislation directs the FDA to finalize long-pending rules for over-the-counter sunscreen ingredients, emphasizing their role in skin cancer prevention. Furthermore, it mandates annual public reporting to Congress on the progress of implementing these new testing standards and reviewing ingredient applications.
New SAFE Sunscreen Act Forces FDA to Fast-Track Ingredients Stuck Since 1999, Prioritizing Public Health Over Animal Tests
If you’re wondering why your sunscreen options seem stuck in 2005 while the rest of the world has moved on, the SAFE Sunscreen Standards Act is aiming to fix that. This bill tackles a serious public health problem—skin cancer is the most common cancer in the U.S.—by forcing the FDA to modernize how it approves new sunscreen ingredients.
The core issue is a regulatory logjam: the FDA hasn't approved a new active sunscreen ingredient since 1999, even though the Surgeon General issued a major call to action on sun safety a decade ago. This bill tells the FDA, led by the Secretary of Health and Human Services (HHS), to finally set new standards for safety and effectiveness. Crucially, Section 3 allows the FDA to use modern science—like real-world evidence and observational studies—instead of relying only on old-school clinical tests. This is a big deal because it could speed up the review of ingredients that have already proven safe and effective in other countries, giving American consumers access to better protection sooner.
The End of the Regulatory Ice Age
For anyone who works outdoors, has kids who play sports, or just wants to lower their risk of skin cancer, this bill is about access. By allowing the FDA to consider a broader range of scientific proof, the bill aims to unlock the pipeline of new, potentially more effective ingredients. Think of it like this: currently, the FDA demands a paper map when satellite navigation exists. Section 3 tells them to start using the GPS.
Furthermore, the bill pushes for ethical science by requiring the FDA to specifically look at using non-animal testing methods when evaluating safety. Within 180 days of the law passing, the Secretary must issue guidance on how companies can use these alternatives. This provision is a win for both animal welfare and efficiency, as non-animal tests can often be faster and more relevant to human biology.
Clearing the Backlog and Adding Transparency
Section 4 addresses the biggest frustration: the ingredients that have been in regulatory limbo for years. It mandates that the FDA issue a final administrative order on all the sunscreen applications that have been waiting since the CARES Act. This means the FDA can no longer put off decisions on ingredients that are already in the queue. When they issue this order, they must incorporate the historical safety data of these ingredients and emphasize that sunscreen is an effective tool for preventing skin cancer.
Finally, Section 5 introduces much-needed accountability. Starting one year after the bill becomes law, the HHS Secretary must send an annual report to Congress detailing the status of the new testing standards, how many applications have been reviewed under them, and the progress on adopting non-animal testing. To ensure the public—you and me—knows what’s going on, the FDA must post this entire report publicly on its website within seven days of sending it to Congress. This transparency ensures the agency actually follows through on the modernization promised in the bill and doesn't just let the new rules gather dust.