AINEWS
Your SPF 50 is a 1999 formula. The FDA is why.
Europe approved modern UVA filters a quarter century ago. The U.S. drug approval system has kept them out of American bottles, and melanoma is the cost.
Europe approved modern UVA filters a quarter century ago. The U.S. drug approval system has kept them out of American bottles, and melanoma is the cost.
The number on a sunscreen bottle tells you almost nothing about whether it will save your life. SPF 50 means it takes fifty times longer for the sun's UVB rays to redden your skin than going bare. UVB causes sunburn. UVA is the longer wavelength that penetrates deeper, ages skin, and drives melanoma, the deadliest form of skin cancer. The FDA does not require U.S. sunscreens to pass the same broad-spectrum UVA test the EU uses. The result is what economist Alex Tabarrok, writing in an MSNBC opinion column, calls a safety inversion: a stricter regulatory regime has produced weaker, not stronger, protection against the wavelength that actually kills.
The cause is a single regulatory choice made decades ago. In the United States, sunscreen is an over-the-counter drug, regulated by the FDA through a slow, expensive process called GRASE, generally recognized as safe and effective. Any new UV filter has to clear that process before it can be sold. In the European Union, sunscreen is a cosmetic, and new filters can be approved faster once safety data is in. That classification difference, not chemistry or consumer preference, is the reason American drugstores sell a 1990s-era filter menu while European pharmacies stock modern, photostable UVA filters like Tinosorb S, Tinosorb M, Mexoryl SX, Mexoryl XL, and Uvinul A Plus, several of which the EU cleared in the late 1990s and early 2000s, as the Environmental Working Group's comparison report documents.
UVA protection matters because UVA and UVB are not the same threat. SPF is a sunburn metric. UVA penetrates clouds and window glass, reaches the dermis where melanocytes live, and is the primary driver of melanoma and of the photoaging that shows up as wrinkles and sunspots. Many U.S. broad-spectrum sunscreens would fail the EU's UVA-protection standard, which requires a minimum UVA-to-UVB ratio of one to three. American consumers can buy a sunscreen labeled "broad spectrum SPF 50" that filters far more UVB than UVA, the opposite of what melanoma prevention requires.
The stakes are visible in the epidemiology. Skin cancer is the most common cancer in the United States, and melanoma incidence has risen over the last four decades even as sunscreen use has become routine, according to the American Academy of Dermatology's skin cancer statistics page. That trend is not proof that U.S. sunscreens are failing, but it undermines the assumption that the existing regulatory framework is delivering on its own terms. The filter menu has barely changed since 1999, while the European menu has expanded multiple times.
The FDA's caution is not a pose. The agency has long argued, as Tabarrok notes, that newer filters lack long-term systemic-safety data. Absorption studies in the past decade showed that several sunscreen active ingredients, including older ones, can enter the bloodstream at levels above the FDA's own safety threshold, raising legitimate questions about chronic exposure. Those concerns are real, and they deserve a fair hearing. The problem is not that the FDA is wrong to ask for safety data. The problem is that the question has been open for more than twelve years under a system designed for prescription drugs, while a parallel regulatory track in the EU, Japan, and Australia has approved the same filters and generated the data the FDA wants.
The mechanism for change exists, and it is bipartisan. In 2019, Sen. Ted Cruz introduced the RESULT Act, a bill to fast-track U.S. approval of drugs and devices already cleared by WHO-stringent regulators, including newer sunscreen filters. As Cruz's office described the proposal at the time, the goal is to stop treating foreign approvals as zero. A companion version was filed in the House. Neither has passed, in part because sunscreen is a low-visibility issue compared to cancer drug pricing or insulin costs, even though it touches more lives. Other reform paths are also on the table: reclassifying sunscreens as cosmetics, clearing the Time and Extent Application (TEA) backlog at the FDA, or issuing a GRASE determination for filters already approved by trusted peer regulators for a decade or more.
Two things can be true at once. The FDA's precautionary instinct is defensible, and that same precaution has left American consumers with a narrower UVA toolkit than Europeans had in 1999. Sunscreens do not need to be deregulated. They need a different regulatory home, one that matches the actual risk profile of a product people apply daily to beach-going children. Until that happens, the number on the bottle is a sunburn number, and the cancer that kills is being filtered by a 1999 formula.