When Texas dermatologist Adewole “Ade” Adamson sees people spraying sunscreen on their skin like it’s cologne, he wants to step in. “My wife says I shouldn’t do that,” he says, “even though most people rarely use enough sunscreen.”
It’s not just about whether people use enough sunscreen, but also about the ingredients it contains.
Skin cancer is the most common cancer in America, affecting one in five people by age 70. Although treatment success rates are excellent, at least two Americans die from skin cancer every hour. According to the Centers for Disease Control and Prevention, the disease costs the health care system $8.9 billion annually. And unlike many other cancers, most forms of skin cancer are largely preventable.
However, the American Food and Drug Administration (FDA) has not yet approved the chemical filters used in countries such as Japan, South Korea and France. Bemotrizinol in particular is the main ingredient in almost all European and Asian sunscreens.
Although American sunscreens labeled “broad spectrum” should theoretically block UVA radiation, which penetrates deeper and causes up to 90% of skin aging, some studies have shown that they do not meet the European Union’s stricter standards.
“It appears that some of these newer chemicals have better UVA protection as well as a better safety profile,” said David Andrews, deputy director of the Environmental Working Group. “We have asked the FDA to consider marketing approval.”
The FDA is hampered by a 1938 law that requires sunscreens to be tested on animals and classified as drugs, rather than cosmetics as they are in much of the world, so it’s unlikely Americans will get better sunscreen this summer, or even next.
Sunscreen manufacturers consider the requirement to be unfair because the companies had already submitted safety data on the newer sunscreen chemicals to the EU authorities around 20 years ago.
“This goes back to the classification of sunscreens as over-the-counter drugs,” says Carl D’Ruiz, senior manager at DSM-Firmenich, a Switzerland-based sunscreen maker. “It’s really about giving U.S. consumers something the rest of the world has.”
The FDA defends its testing process by saying it is intended to ensure the safety of products that many people use every day, not just a few times a year at the beach.
“Many Americans now rely on sunscreens as an important part of their skin cancer prevention strategy, so satisfactory evidence of the safety and effectiveness of these products is critical to public health,” Cherie Duvall-Jones, an FDA spokeswoman, wrote in an email.
D’Ruiz said, “People aren’t dying from using sunscreen. They’re dying from melanoma.”
“Physical” vs. “chemical”
To make matters worse, the sunscreen debate is permeated by a large amount of misinformation. Some people question the safety of sunscreens sold in the United States and deride them as “chemical” sunscreens. These opponents prefer “physical” or “mineral” sunscreens such as zinc oxide, even though all sunscreen ingredients are chemicals.
“It’s an artificial categorization,” says E. Dennis Bashaw, a retired FDA official who headed the agency’s clinical pharmacology division, which studies sunscreens.
Such concerns were fueled in part by the FDA itself, after it released a study saying some sunscreen ingredients had been found in trace amounts in the human bloodstream. When the FDA said in 2019 and again two years later that older sunscreen ingredients needed to be studied more closely to test their safety, sunscreen opponents saw an opportunity, said Nadim Shaath, president of Alpha Research & Development, which imports chemicals for cosmetics.
“That’s why there are extreme groups and people who are not well informed and think that anything that penetrates the skin is the end of the world,” Shaath said. “Anything you put on your skin or eat will be absorbed.”
Adamson, the Texas dermatologist, said some sunscreen ingredients have been used for 30 years without any evidence at the population level that they have harmed anyone. “To me, the problem is not the safety of the sunscreens that we have,” he said. “It’s that some of the chemical sunscreens are not as broad-spectrum as they could be, meaning they don’t block UVA as well. This could be mitigated by the FDA approving new ingredients.”
D’Ruiz’s company, DSM-Firmenich, has been trying to get approval for bemotrizinol for 20 years. D’Ruiz says the process has cost $18 million and has been slow, despite attempts by Congress in 2014 and 2020 to speed up applications for new UV filters. DSM-Firmenich is currently the only company seeking approval of a new over-the-counter sunscreen in the United States.
Steven Goldberg, a former vice president of sunscreen maker BASF, said the companies are wary of the FDA process because of the cost and fear that additional animal testing could lead to a consumer backlash in the European Union, where animal testing for cosmetics, including sunscreen, is banned. The companies are urging Congress to change the testing requirements before they take steps to enter the U.S. market.
In a rare example of bipartisanship last summer, Senator Mike Lee (Republican of Utah) said, thanked Representative Alexandria Ocasio-CortezDN.Y., for urging the FDA to speed up approval of new, more effective sunscreens. A bipartisan bill is pending in the House of Representatives that would require the FDA to allow animal testing.
D’Ruiz said bemotrizinol could receive FDA approval by the end of 2025. If that happens, bemotrizinol would be the most tested and safest sunscreen ingredient on the market.
While Congress and the FDA debate this, many Americans are increasingly importing their own sunscreens from Asia or Europe, despite the risk of counterfeiting.
“The sunscreen issue has shown people that if you go too slow, it can be dangerous,” says Alex Tabarrok, an economics professor at George Mason University. “The FDA is just incredibly slow. They’ve been doing this for literally 40 years. Congress has asked them to do it, and they still haven’t done it.”
Dermatologists’ tips for safe and healthy skin
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Stay in the shade during the hours of strongest sunlight (10 a.m. to 4 p.m.)
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Wear hats and sunglasses.
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Use parasols and clothing with UV protection.
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Reapply sunscreen every two hours.
You can order sunscreen from overseas from online pharmacies like Cocooncenter in France. Keep in mind that the same brands in U.S. stores may contain different ingredients, but it may not be practical to import your sunscreen. “The best sunscreen is the one you’ll use over and over again,” says New York City dermatologist Jane Yoo.
KFF Health News is a national newsroom that produces in-depth journalism on health issues and is one of the core operating programs of KFF – an independent source of health policy research, polling and journalism.
This article originally appeared on USA TODAY: FDA lags in sunscreen approval
