SAFE Sunscreen Standards Act Signed Into Law

The SAFE Sunscreen Standards Act (H.R. 3686) was signed into law on November 13 as part of the reauthorization of the Over-the-Counter Monograph User Fee Act (OMUFA). This legislation modernizes how the U.S. Food and Drug Administration (FDA) reviews and approves sunscreen ingredients, facilitating innovation of new sunscreen options for Americans.

Reforming Sunscreen Oversight

• Streamlined FDA Review: The law directs the FDA to establish clear standards for evaluating the safety and efficacy of sunscreen active ingredients, while maintaining high standards for safety.
• Nonanimal Testing & Real-World Evidence: The FDA must consider nonanimal data and scientifically valid real-world evidence when assessing safety and efficacy, replacing outdated animal testing requirements.
• Access to Global Ingredients: The FDA will review sunscreen filters already approved and safely used around the world, giving Americans access to advanced sun protection options.

Skin cancer is the most common cancer in the U.S., with 1 in 5 Americans developing the disease by age 70. Despite this, the FDA has not approved a new active sunscreen ingredient since 1999. By modernizing the approval process, this law helps the U.S. catch up with global standards, ensuring patients have more choices for effective sunscreens. That will make it easier for people to find sunscreens they like and will use consistently, which is critical for preventing sun damage and reducing skin cancer risk.

“Americans deserve continued innovation in sun protection,” said Deborah S. Sarnoff, MD, president of The Skin Cancer Foundation, in a news release.” 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.”