Other countries have better sunscreens. This is why we can’t get them in the US

When dermatologist Adewole “Ade” Adamson sees people spraying sunscreen like it’s perfume at the pool where he lives in Austin, Texas, he wants to intervene. “My wife tells me not to do that,” he said, “even though most people rarely use enough sunscreen.”

It’s not just about whether people use enough sunscreen, but also about what ingredients it contains.

In countries such as Japan, South Korea and France, sunscreens contain newer chemical filters, some of which have been shown to provide broader protection against UV rays than those used in the US.

The Food and Drug Administration’s ability to approve such ingredients is hampered by a 1938 U.S. law that required sunscreens to be tested on animals and classified as drugs, rather than cosmetics, as in much of the world. world is the case.

So Americans aren’t likely to buy those other sunscreens — which better block UVA rays that can cause skin cancer and lead to wrinkles — this summer or even next.

Sunscreen makers say U.S. approval standards are unfair because companies including BASF Corp. and L’Oréal, which makes the newer sunscreens, provided sunscreen safety data to European Union authorities about 20 years ago.

Steven Goldberg, a retired vice president of BASF, said companies are wary of the FDA process because of the cost and their fear that additional animal testing could trigger a consumer backlash in the European Union, which bans animal testing for cosmetics, including sunscreen. prohibits.

The companies are asking Congress to change testing requirements before taking steps to enter the U.S. market.

In a rare example of bipartisanship last summer, Sen. Mike Lee, R-Utah, said thanked Rep. Alexandria Ocasio-Cortez, DN.Y., for urging the FDA to accelerate approval of new, more effective sunscreen ingredients. Now a bipartisan bill is pending in the House of Representatives that would require the FDA to allow testing without animals.

“It goes back to the classification of sunscreens as over-the-counter drugs,” says Carl D’Ruiz, senior manager at DSM-Firmenich, a Swiss-based manufacturer of sunscreen chemicals. “It’s really about giving the American consumer something that the rest of the world has. People don’t die from using sunscreen. They die from melanoma.”

Safer sunscreen? Misinformation in the sunscreen debate

At least two people die from skin cancer every hour in the United States. Skin cancer is the most common cancer in America, and according to the Centers for Disease Control and Prevention, 6.1 million adults are treated for basal cell and squamous cell carcinomas each year. The country’s second most common cancer, breast cancer, is diagnosed about 300,000 times annually, although the disease is much more deadly.

Although skin cancer treatment success rates are excellent, 1 in 5 Americans will develop skin cancer by age 70. According to CDC researchers, the disease costs the health care system $8.9 billion per year. One study found that annual costs for skin cancer treatment in the United States more than doubled between 2002 and 2011, while average annual costs for all other cancers increased by only 25%.

And unlike many other cancers, most skin cancers can be largely prevented by using sunscreen and taking other precautions.

But the sunscreen debate is steeped in a large dose of misinformation, and some people are questioning the safety of common sunscreen ingredients (such as avobenzone, homosalate, octisalate and octocrylene) in the United States, which they deride as ‘chemical’ sunscreens.

These sunscreen 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 led the agency’s clinical pharmacology division that studies sunscreens.

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

“That’s why we have extreme groups and people who are uninformed and think that something that penetrates the skin is the end of the world,” Shaath said. “Everything you put on your skin or eat is absorbed.”

Ingredients that work better to block UVA rays

Adamson, the Austin dermatologist, said some sunscreen ingredients already available in the U.S. have been used for 30 years without any population-level evidence that they have harmed anyone.

“The issue for me is not 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 also don’t block UVA. This could be alleviated if the FDA allows new ingredients.”

Ultraviolet radiation falls between x-rays and visible light on the electromagnetic spectrum. Most of the UV rays that humans come into contact with are UVA rays that can penetrate the middle layer of the skin and cause up to 90% of skin aging, along with a smaller amount of UVB rays that are responsible for sunburn.

The sun protection factor, or SPF, on American sunscreen bottles only indicates a sunscreen’s ability to block UVB rays. Although American sunscreens labeled “broad spectrum” should theoretically block UVA light, some studies have shown that they do not meet the European Union’s higher UVA blocking standards.

“It appears that some of these newer chemicals have a better safety profile in addition to better UVA protection,” says David Andrews, deputy director of Environmental Working Group, a nonprofit organization that researches the ingredients in consumer products. “We have asked the FDA to consider allowing market access.”

The FDA is defending its review process and its call for testing of the sunscreens sold in U.S. stores as a way to ensure the safety of products that many people use every day, rather than just a few times a year at the beach.

“Many Americans today rely on sunscreens as an important part of their skin cancer prevention strategy, providing satisfactory evidence of both the safety and effectiveness of these products that are critical to public health,” wrote Cherie Duvall-Jones, an FDA spokesperson, in an email.

The path to approval for one overseas ingredient: bemotrizinol

D’Ruiz’s company, DSM-Firmenich, is the only one currently looking for a new over-the-counter sunscreen ingredient that could be approved in the United States. The company has spent the past two decades trying to get approval for bemotrizinol, a process that D’Ruiz says has cost $18 million and has moved forward with turmoil, despite efforts by Congress in 2014 and 2020 to block applications for new UV filters to speed up.

Bemotrizinol is the basic ingredient in almost all European and Asian sunscreens, including those from the South Korean brand Beauty of Joseon and Bioré, a Japanese brand.

D’Ruiz said bemotrizinol could win FDA approval by the end of 2025. If so, bemotrizinol would be the most controlled and safest sunscreen ingredient on the market, even outperforming the safety profiles of zinc oxide and titanium dioxide.

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

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

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