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Modernizing U.S. Sunscreen Regulations: How Newer Filters Can Improve Public Health
Clayton Wade Turner1, Leslie Torgerson1
1Rocky Vista University School of Osteopathic Medicine, Parker, Colorado, USA.
Background:
Skin cancer is the most common cancer in the United States, with over 5 million cases diagnosed annually. Despite being largely preventable, incidence rates continue to rise, largely due to inadequate protection from ultraviolet (UV) radiation, the primary environmental cause of skin cancer. Although global innovation has advanced sunscreen technology, the U.S. regulatory system has not kept pace, limiting public access to more effective UV filters.
Methods:
This review examines the current U.S. Food and Drug Administration (FDA) sunscreen filter regulatory framework, including the Generally Recognized As Safe and Effective (GRASE) criteria and maximal usage trial (MUsT) protocols. We compare U.S. approved filters with newer filters used internationally and analyze barriers to their domestic approval.
Results:
International markets currently use advanced filters such as bemotrizinol, bisoctrizole, drometrizole trisiloxane (DT), and terephthalylidene dicamphor sulfonic acid (TDSA), which offer broader and more stable UV protection. These filters have demonstrated favorable safety and efficacy profiles but remain unavailable in the U.S. due to regulatory inertia. The FDA's new Over-the-Counter (OTC) Monograph Order Request (OMOR) process may provide a pathway to modernize sunscreen regulations.
Conclusion:
Modernizing U.S. sunscreen regulations to allow approval of newer, evidence-backed UV filters is a critical step in improving public health. Broader access to more effective sunscreens could play a significant role in reducing the incidence of UV-induced skin cancer.
Insights
The U.S. needs updated sunscreen regulations to approve advanced UV filters, improving public health and reducing skin cancer rates. Access to better sunscreens is key to preventing UV-induced cancers.
Area of Science:
- Dermatology and Public Health
- Regulatory Science
Background:
- Skin cancer is a prevalent, largely preventable disease in the U.S., with rising incidence linked to insufficient UV protection.
- Despite global sunscreen advancements, U.S. regulations restrict access to more effective UV filters.
Purpose of the Study:
- To review the U.S. FDA's sunscreen regulatory framework.
- To compare U.S. approved filters with internationally available advanced filters.
- To analyze barriers hindering the approval of novel UV filters in the U.S.
Main Methods:
- Examination of the FDA's Generally Recognized As Safe and Effective (GRASE) criteria and maximal usage trial (MUsT) protocols.
- Comparative analysis of U.S. versus international sunscreen filters.
- Identification of regulatory hurdles for new UV filter approvals.
Main Results:
- Advanced UV filters like bemotrizinol and bisoctrizole offer broader, stable protection and are approved internationally.
- These filters are unavailable in the U.S. due to regulatory delays.
- The FDA's Over-the-Counter (OTC) Monograph Order Request (OMOR) process presents a potential avenue for regulatory modernization.
Conclusions:
- Updating U.S. sunscreen regulations is crucial for public health.
- Approving newer, evidence-based UV filters can significantly decrease skin cancer incidence.
- Enhanced access to superior sunscreens is vital for combating UV-induced skin damage.
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