I’m 41, and I still shed a tear if American sunscreen gets in my eyes. It stings, smells, and no wonder American parents struggle to get their children to put it on. It doesn’t have to be this way, and people in Sydney, Athens, and Saint-Tropez have known this for 25 years. European sunscreen provides broader UVA coverage, triggers fewer allergic reactions, and irritates skin and eyes substantially less than what’s available in the United States. These ingredients were the global standard, just not in the U.S.
On June 9, the FDA approved bemotrizinol, a sunscreen ingredient Europeans have used safely since 2000. It is the first new sunscreen active ingredient the agency has cleared since the 1990s. While Americans were told to reapply and cover up, the rest of the developed world moved on. Going to the beach in America is like going to regulatory Jurassic Park.
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Bemotrizinol has more than two decades of post-market safety data from Europe, Asia, and Australia, but the Food and Drug Administration has historically refused to accept foreign real-world evidence. That’s why in 2014, Congress passed the Sunscreen Innovation Act to force faster review of ingredients proven safe abroad.
Despite the law’s intent, the FDA said, “Pass!” Why? Because the FDA insisted that, even with 20-plus years of global use, companies must still conduct expensive, U.S.-based clinical trials using protocols the agency alone recognized. Congress said real-world evidence was enough. The FDA said it wasn’t. As a result, the Sunscreen Innovation Act functionally stalled, not sped up modernization.
The FDA responded the way NIMBYs respond to apartment buildings: endless process, new objections. This is regulatory NIMBYism: American businesses lose, and American consumers lose. The current FDA leadership deserves credit for finally changing its mind. This approval came from listening to Congress and engaging with decades of real-world evidence. This is the starting pistol, not the finish line.
The sunscreen fiasco united Rep. Alexandria Ocasio-Cortez (D-NY) and Sen. Ted Cruz (R-TX)! This problem isn’t politics. It’s institutional stubbornness. Sunscreen feels low-stakes. If the FDA drags its feet, you can wear a hat. Why stop there? Quit smoking. Eat better. Use a condom. Behavior change is easy to prescribe.
I’m in fertility, a field where many technologies are not available in the U.S., and patients are denied access because of it. Before that, I worked in HIV prevention. It took the FDA until 2012 to approve an at-home HIV test.
HIV is a disease where early detection is everything. People who do not know their status cannot start treatment or avoid transmitting the virus. This delay preserved ignorance and put lives in danger.
When the FDA finally approved the test, it arrived in a suitcase full of books — a monument to treating access as the risk and denial as the default.
The blindness to the cost of denying access can, in the most charitable reading, be described as arrogance. The FDA commissioner recently admitted the agency moves too slowly, leaving Americans with fewer options than consumers abroad. He was talking about SPF. He could have been describing a much larger pattern.
Safety review matters. Rigor matters. But refusing to read the science already written is not rigor. It’s regulatory NIMBYism dressed up as caution.
THE FDA WANTED TO DRILL INTO PATIENTS’ SKULLS FOR A PLACEBO. HEIDI OVERTON CAN END THAT ERA
If we want to win in technology, medicine, and science, we should be the world leaders in developing products and in bringing them safely to market. We have failed at that.
In one fell swoop, we made Americans safer and shut down the illegal Korean sunscreen trade. Let’s bag the win and go back to work.
Hans Gangeskar is the CEO of Overture Life, a fertility technology company.
