U.S. Reps. Dave Joyce (R-OH) and John Joyce (R-PA) on June 3 introduced bipartisan legislation that would update regulatory standards and place an administrative order on sunscreens.
Rep. John Joyce sponsored the Supporting Accessible, Flexible, and Effective (SAFE) Sunscreen Standards Act, H.R. 3686, with three original cosponsors, including Rep. Dave Joyce and U.S. Rep. Debbie Dingell (D-MI) to modernize the Food and Drug Administration’s (FDA’s) review process for over-the-counter sunscreen ingredients to improve access to newer, effective sunscreens.
“As a physician legislator and a board-certified dermatologist, I have seen firsthand the benefits of sunscreens to help prevent melanoma and other skin cancers,” said Rep. John Joyce, co-chair of the Skin Cancer Caucus. “It is very disappointing that the FDA has ignored congressional intent and continues to stall the approval of new sunscreen ingredients despite legislation to streamline this process.”
Through the introduction of H.R. 3686, he added, it will ensure that the FDA quickly approves new sunscreen ingredients, “giving the American public access to the best skin protection available.”
If enacted, the bill would direct the FDA to establish clearer, more flexible standards for evaluating sunscreen ingredients and to allow the use of real-world evidence, observational studies, and non-traditional scientific data — not just standard clinical trials — to determine safety and effectiveness, according to a bill summary provided by the lawmakers.
“As skin cancer rates continue to rise across the country, it’s unacceptable that sunscreen innovation has remained virtually stagnant,” said Rep. Dave Joyce, also a co-chair of the Skin Cancer Caucus. “It’s high time for the [FDA] to start a new chapter in skin health and embrace new advancements that will expand access to cutting-edge sunscreens for all Americans.”
Additionally, H.R. 3686 would place an administrative order on sunscreens, requiring the FDA to update its final administrative order on pending sunscreen ingredients to consider historical data on ingredients already used safely in the U.S.; reinforce that sunscreen is a proven cancer prevention tool; and use the new evidence and testing standards established in the bill, the summary says.
The measure also would increase transparency and reporting by requiring the U.S. Secretary of Health and Human Services to submit annual reports to Congress detailing the progress on implementing new standards; how many applications were reviewed under the new process; and the FDA’s use of non-animal testing methods, among other provisions.