From the Guidelines
The FDA's approval of newer UV filters is hindered by the classification of sunscreens as over-the-counter drugs, requiring extensive safety and efficacy testing, as noted in the context of broad-spectrum sunscreens by the American Family Physician in 2012 1. The FDA's regulatory process for approving new UV filters has been slow, with the last major update occurring in 2014, and the agency has requested additional safety data for newer filters, particularly regarding systemic absorption and long-term effects. Some key points to consider include:
- The FDA's guidance on broad-spectrum sunscreens highlights the importance of sun protection factor and the reduction of skin cancer and early skin aging risks 1.
- The regulatory gap between the US and other countries, such as Europe, Australia, and Asia, means that US consumers do not have access to some of the most photostable and effective broad-spectrum UV filters available globally.
- The FDA's approval process has been effectively stalled since the 1990s, limiting the availability of new and potentially more effective UV filters in the US market.
- The use of broad-spectrum sunscreens with a sun protection factor of 15 or greater is recommended, as they protect against UV A and UV B radiation, and reduce the risk of skin cancer and early skin aging, as indicated by the FDA's information on sunscreen use and effectiveness 1.
From the Research
FDA Approval Process for UV Filters
- The FDA approval process for UV filters in the United States differs from that in the European Union, resulting in a delay in the availability of new UV filters in the US 2.
- The FDA requires rigorous testing and evaluation of UV filters before approving them for use in sunscreens, which can be a time-consuming process.
Comparison of US and EU UV Filters
- There are currently 17 UV filters approved for use in the US, compared to 29 in the EU, with 18 EU-approved filters not available in the US 2.
- The majority of US-approved UV filters have sensitization data available, with most showing minimal skin sensitization, while only a minority of EU-approved only filters have sensitization data available 2.
Human Safety Data for UV Filters
- Human safety data for UV filters are limited, but available data suggest that the known human risks of sunscreen appear minimal 2.
- Some UV filters, such as oxybenzone, octinoxate, octisalate, homosalate, and octocrylene, have been shown to have plasma levels exceeding the FDA exposure threshold 2.
Alternative UV Filters
- Inorganic UV filters, such as zinc oxide and titanium dioxide, have become increasingly popular due to concerns over the environmental and human health impacts of organic UV filters 3.
- These inorganic filters have been shown to have low human health risks and are considered safe alternatives to organic UV filters 3.