When dermatologist sees people spritzing sunscreen as if it鈥檚 cologne at the pool where he lives in Austin, Texas, he wants to intervene. 鈥淢y wife says I shouldn鈥檛,鈥 he said, 鈥渆ven though most people rarely use enough sunscreen.鈥
At issue is not just whether people are using enough sunscreen, but what ingredients are in it.
The Food and Drug Administration鈥檚 ability to approve the chemical filters in sunscreens that are sold in countries such as Japan, South Korea, and France is hamstrung by a 1938 U.S. law that has required 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 those better sunscreens 鈥 which that can cause skin cancer and lead to wrinkles 鈥 in time for this summer, or even the next.
Sunscreen makers say that requirement is unfair because companies including and , which make the newer sunscreen chemicals, submitted on sunscreen chemicals to the some 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 ignite a in the European Union, which 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) (D-N.Y.) for urging the FDA to speed up approvals of new, more effective sunscreen ingredients. Now a bipartisan bill is pending in the House that would to allow non-animal testing.
鈥淚t goes back to sunscreens being classified as over-the-counter drugs,鈥 said Carl D鈥橰uiz, a senior manager at DSM-Firmenich, a Switzerland-based maker of sunscreen chemicals. 鈥淚t鈥檚 really about giving the U.S. consumer something that the rest of the world has. People aren鈥檛 dying from using sunscreen. They鈥檙e dying from melanoma.鈥
Every hour, at least two people in the United States. Skin cancer is the in America, and 6.1 million adults are treated each year for basal cell and squamous cell carcinomas, according to the . The nation鈥檚 second-most-common cancer, breast cancer, is diagnosed about , though it is far more deadly.
Though skin cancer treatment success rates are excellent, 1 in 5 Americans will develop skin cancer by age 70. The disease costs the health care system , according to CDC researchers. One study found that the annual cost of treating skin cancer in the United States from 2002 to 2011, while the average annual cost for all other cancers increased by just 25%. And unlike many other cancers, most forms of skin cancer can largely be prevented 鈥 by using sunscreens and taking other precautions.
But a heavy dose of misinformation has permeated the sunscreen debate, and some people question the safety of sunscreens sold in the United States, which they deride as 鈥渃hemical鈥 sunscreens. These sunscreen opponents prefer 鈥減hysical鈥 or 鈥渕ineral鈥 sunscreens, such as zinc oxide, even though all sunscreen ingredients are chemicals.
鈥淚t鈥檚 an artificial categorization,鈥 said E. Dennis Bashaw, a retired FDA official who ran the agency鈥檚 clinical pharmacology division that studies sunscreens.
Still, such concerns were partly after it published a study that said some sunscreen ingredients had been found in trace amounts in human bloodstreams. When the , and then again , that older sunscreen ingredients needed to be studied more to see if they were safe, sunscreen opponents saw an opening, said , president of Alpha Research & Development, which imports chemicals used in cosmetics.
鈥淭hat鈥檚 why we have extreme groups and people who aren鈥檛 well informed thinking that something penetrating the skin is the end of the world,鈥 Shaath said. 鈥淎nything you put on your skin or eat is absorbed.鈥
Adamson, the Austin dermatologist, said some sunscreen ingredients have been used for 30 years without any population-level evidence that they have harmed anyone. 鈥淭he issue for me isn鈥檛 the safety of the sunscreens we have,鈥 he said. 鈥淚t鈥檚 that some of the chemical sunscreens aren鈥檛 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.鈥
falls between X-rays and visible light on the electromagnetic spectrum. Most of the UV rays that people come in contact with are UVA rays that can penetrate the middle layer of the skin and that cause up to 90% of skin aging, along with a smaller amount of UVB rays that are .
The sun protection factor, or SPF, rating on American sunscreen bottles denotes only a sunscreen鈥檚 ability to block UVB rays. Although American sunscreens labeled 鈥渂road spectrum鈥 should, in theory, block UVA light, to meet the European Union鈥檚 higher UVA-blocking standards.
鈥淚t looks like a number of these newer chemicals have a better safety profile in addition to better UVA protection,鈥 said , deputy director of Environmental Working Group, a nonprofit that researches the ingredients in consumer products. 鈥淲e have asked the FDA to consider allowing market access.鈥
The FDA defends its review process and its call for tests of the sunscreens sold in American stores 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.
鈥淢any 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,鈥 Cherie Duvall-Jones, an FDA spokesperson, wrote in an email.
D鈥橰uiz鈥檚 company, DSM-Firmenich, is the only one currently seeking to have a new over-the-counter sunscreen ingredient approved in the United States. The company has spent the past 20 years trying to gain , a process D鈥橰uiz said has cost $18 million and has advanced fitfully, despite attempts by Congress in 2014 and 2020 to speed along applications for new UV filters.
Bemotrizinol is the bedrock ingredient in nearly all European and Asian sunscreens, including those by the South Korean brand and , a Japanese brand.
D鈥橰uiz said bemotrizinol could secure FDA approval by the end of 2025. If it does, he said, bemotrizinol would be the most vetted and safest sunscreen ingredient on the market, outperforming even the safety profiles of zinc oxide and titanium dioxide.
As Congress and the FDA debate, many Americans have taken to importing their own sunscreens from Asia or Europe, despite the .
鈥淭he sunscreen issue has gotten people to see that you can be unsafe if you鈥檙e too slow,鈥 said , a professor of economics at George Mason University. 鈥淭he FDA is just incredibly slow. They鈥檝e been looking at this now literally for 40 years. Congress has ordered them to do it, and they still haven鈥檛 done it.鈥
