Why the U.S. is behind on sunscreen

When Texas dermatologist Adewole “Ade” Adamson sees people spritzing sunscreen as if it’s cologne, he wants to intervene. “My wife says I shouldn’t,” he said, “even though most people rarely use enough sunscreen.”

At issue is not just whether people are using enough sunscreen, but what ingredients are in it.

Skin cancer is the most common cancer in America: 1 in 5 people will develop it by age 70. Though treatment success rates are excellent, every hour, at least two Americans die of skin cancer. The disease costs the health care system $8.9 billion a year, according to the Centers for Disease Control and Prevention. And unlike many other cancers, most forms of skin cancer can largely be prevented.

But the Food and Drug Administration has not yet approved chemical filters that are used in countries such as Japan, South Korea and France. In particular, bemotrizinol is the bedrock ingredient in nearly all European and Asian sunscreens.

Although American sunscreens labeled “broad spectrum” should, in theory, block the UVA light that penetrates more deeply and causes up to 90% of skin aging, some studies have shown they fail to meet the European Union’s higher standards.

“It looks like a number of these newer chemicals have a better safety profile in addition to better UVA protection,” said David Andrews, deputy director of Environmental Working Group. “We have asked the FDA to consider allowing market access.”

The FDA is hamstrung by a 1938 law that requires sunscreens to be tested on animals and classified as drugs, rather than as cosmetics as they are in much of the world. So Americans are not likely to get better sunscreens this summer, or even next.

Sunscreen makers say the requirement is unfair because companies submitted safety data on the newer sunscreen chemicals to EU authorities some 20 years ago.

“It goes back to sunscreens being classified as over-the-counter drugs,” said Carl D’Ruiz, a senior manager at DSM-Firmenich, a Switzerland-based maker of sunscreen chemicals. “It’s really about giving the U.S. consumer something that the rest of the world has.”

The FDA defends its review process as a way to ensure the safety of products that many people use daily, rather than just a few times a year at the beach.

“Many Americans today rely on sunscreens as a key part of their skin cancer prevention strategy, which makes satisfactory evidence of both safety and effectiveness of these products critical for public health,” Cherie Duvall-Jones, an FDA spokesperson, wrote in an email.

D’Ruiz said, “People aren’t dying from using sunscreen. They’re dying from melanoma.”

‘Physical’ vs. ‘chemical’

Complicating matters, a heavy dose of misinformation has permeated the sunscreen debate. Some people question the safety of sunscreens sold in the United States, which they deride 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,” said E. Dennis Bashaw, a retired FDA official who ran the agency’s clinical pharmacology division that studies sunscreens.

Such concerns were partly fed by the FDA itself after it published a study that said some sunscreen ingredients had been found in trace amounts in human bloodstreams. When the FDA said in 2019, and then again two years later, that older sunscreen ingredients needed to be studied more to see if they were safe, sunscreen opponents saw an opening, said Nadim Shaath, president of Alpha Research & Development, which imports chemicals used in cosmetics.

“That’s why we have extreme groups and people who aren’t well-informed thinking that something penetrating the skin is the end of the world,” Shaath said. “Anything you put on your skin or eat is absorbed.”

Adamson, the Texas dermatologist, said some sunscreen ingredients have been used for 30 years without any population-level evidence that they have harmed anyone. “The issue for me isn’t the safety of the sunscreens we have,” he said. “It’s that some of the chemical sunscreens aren’t as broad-spectrum as they could be, meaning they do not block UVA as well. This could be alleviated by the FDA allowing new ingredients.”

D’Ruiz’s company, DSM-Firmenich, has spent the past 20 years trying to gain approval for bemotrizinol. D’Ruiz said the process has cost $18 million and advanced only fitfully, despite attempts by Congress in 2014 and 2020 to speed along applications for new UV filters. It is the only company currently seeking to have a new over-the-counter sunscreen ingredient approved in the United States.

Steven Goldberg, a retired vice president of BASF Corp., a company that makes sunscreen chemicals, said companies are wary of the FDA process because of the cost and their fear that additional animal testing could ignite a consumer backlash in the European Union, which bans animal testing of cosmetics, including sunscreen. The companies are asking Congress to change the testing requirements before they take steps to enter the U.S. marketplace.

In a rare example of bipartisanship last summer, Sen. Mike Lee, R-Utah, thanked Rep. Alexandria Ocasio-Cortez, D-N.Y., for urging the FDA to speed up approvals of new, more effective sunscreen ingredients. A bipartisan bill is pending in the House that would require the FDA to allow non-animal testing.

D’Ruiz said bemotrizinol could secure FDA approval by the end of 2025. If it does, he said, bemotrizinol would be the most vetted, safest sunscreen ingredient on the market.

As Congress and the FDA debate, many Americans have taken to importing their own sunscreens from Asia or Europe, despite the risk of fakes.

“The sunscreen issue has gotten people to see that you can be unsafe if you’re too slow,” said Alex Tabarrok, a professor of economics at George Mason University. “The FDA is just incredibly slow. They’ve been looking at this now literally for 40 years. Congress has ordered them to do it and they still haven’t done it.”

Dermatologists’ tips on keeping skin safe and healthy

• Stay in the shade during peak sunlight hours, 10 a.m. to 4 p.m.

• Wear hats and sunglasses.

• Use UV-blocking sun umbrellas and clothing.

• Reapply sunscreen every two hours.

You can order overseas versions of sunscreens from online pharmacies such as Cocooncenter in France. Keep in mind that the same brands may have different ingredients if sold in U.S. stores. But importing your sunscreen may not be practical. “The best sunscreen is the one that you will use over and over again,” said New York City dermatologist Jane Yoo.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – an independent source of health policy research, polling and journalism.

This article originally appeared on USA TODAY: FDA lags on sunscreen approvals