The recent passage of the SAFE Sunscreen Standards Act (H.R. 3686/S. 2491), which modernizes how the U.S. Food and Drug Administration (FDA) reviews and approves sunscreen ingredients, marks an important advancement in the fight against skin cancer. The law facilitates innovation of new sunscreen options for Americans, helping ensure access to effective sun protection.
Passed in early November as part of the reauthorization of the Over-the-Counter Monograph User Fee Act (OMUFA), the SAFE Sunscreen Standards Act provides the FDA with clear directives regarding standards, data, and evidence for qualifying sunscreen solutions.
Key Provisions
- Streamlined FDA Review: The law directs the FDA to establish clear standards for evaluating the safety and efficacy of sunscreen active ingredients.
- Nonanimal Testing & Real-World Evidence: The law requires the FDA to consider nonanimal data and scientifically valid real-world evidence.
- Access to Global Ingredients: The FDA will review sunscreen filters already approved and safely used worldwide, giving Americans access to advanced sun protection options.
Reforming Sunscreen Oversight
The FDA has not approved a new active sunscreen ingredient since 1999, despite skin cancer being the most common cancer in the U.S., with one in five Americans developing the disease by age 70. The SAFE Sunscreen Standards Act offers a much-needed opportunity to modernize the approval process, align the U.S. with global standards, and expand patient access to effective sunscreens.
By providing a broader selection of sunscreen options, The Skin Cancer Foundation (SCF) believes the new law will be instrumental in preventing sun damage and reducing skin cancer risk.
“Americans deserve continued innovation in sun protection,” said Deborah S. Sarnoff, MD, president of the SCF. “More options make it easier for the public to find sunscreens that they like and will use on a daily basis. The SAFE Sunscreen Standards Act is a step in the right direction in our battle against the world’s most common cancer.”
Sun Protection Strategy
While the SCF applauds the new legislation, it also emphasizes the importance of its effective implementation and encourages the FDA to expedite sunscreen active ingredient reviews. The SCF remains committed to educating the public about skin cancer prevention, early detection, and treatment, adding that new sunscreens are only effective if used consistently.
The SCF points out that even when sunscreen is available, usage lapses and sun-exposure behaviors continue to put Americans at risk. In addition to daily sunscreen use, the foundation recommends a comprehensive sun protection strategy, including:
- Wearing protective clothing, hats and UV-blocking sunglasses
- Seeking shade, especially between 10 a.m. and 4 p.m.
- Visiting a dermatologist at least once a year for a professional skin exam
- Performing monthly self-examinations of the skin, head to toe, between visits
