From the Guidelines
Yes, there are ongoing legislative and advocacy efforts to expedite FDA approval of new UV filters for sunscreens in the United States. The most significant is the Sunscreen Innovation Act (SIA), passed in 2014, which was specifically designed to create a faster pathway for reviewing new sunscreen ingredients. Despite this legislation, progress has been slow, with no new UV filters approved since its passage. The Public Access to SunScreens (PASS) Coalition, comprising dermatologists, sunscreen manufacturers, and public health advocates, continues to lobby for faster approvals. Additionally, the FDA Modernization Act 2.0, while not specifically targeting sunscreens, aims to streamline approval processes for various products. The slow approval process stems from the FDA's classification of sunscreens as over-the-counter drugs rather than cosmetics, requiring extensive safety data, as noted by the U.S. Food and Drug Administration 1. This regulatory approach has created a situation where many effective UV filters used in Europe, Australia, and Asia remain unavailable to American consumers, despite their proven track records abroad. Some key points to consider include:
- The FDA has determined that broad-spectrum sunscreens with a sun-protection factor of 15 or greater protect against both UV-A and UV-B radiation and reduce the risk for skin cancer and early skin aging 1.
- Community-based interventions to promote and support sun safety, such as direct peer-to-peer support, social marketing initiatives, workplace initiatives, and public policy actions, may offer additional sizeable benefits 1.
- Various education materials using different media were found to be effective in counseling children, adolescents, and young adults on sun safety and skin cancer prevention 1.
From the Research
Legislation and Advocacy Efforts
- There is no direct evidence of legislation or advocacy efforts to speed up FDA approval of new UV filters for sunscreens in the provided studies 2, 3, 4, 5, 6.
- However, studies have highlighted the importance of sunscreens in preventing skin cancer and photoaging, and the need for safe and effective UV filters 2, 3, 4.
- Some studies have discussed the environmental impact of organic UV filters, such as oxybenzone and octinoxate, and the potential benefits of using inorganic UV filters like zinc oxide and titanium dioxide 3, 4.
- The safety and efficacy of different UV filters, including avobenzone, zinc oxide, and titanium dioxide, have been evaluated in various studies 5, 6.
FDA Approval Process
- The FDA approval process for new UV filters is not directly addressed in the provided studies.
- However, the studies suggest that the development of new UV filters and sunscreen products is an ongoing process, with researchers exploring new ingredients and formulations to improve safety and efficacy 2, 3, 5, 6.
Advocacy for Sunscreen Safety and Efficacy
- Some studies emphasize the importance of proper photoprotection practices, including seeking shade, wearing protective clothing, and using sunscreens with safe and effective UV filters 3, 4.
- The studies also highlight the need for continued research and development of new UV filters and sunscreen products to address the ongoing concerns about skin cancer and photoaging 2, 3, 5, 6.