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Dermatologists and skin cancer groups urge FDA to act on new sunscreen ingredients

Ashley Rossi applies sunscreen last year at lifeguard tower No. 3 on Clearwater Beach. Doctors say U.S. sunscreens have limited ingredients that filter deeper-penetrating UVA rays.
Published Jul. 5, 2014

Few items that beachgoers use this Fourth of July weekend are as distinctly American as their bottles, tubes and cans of sunscreen. But that shouldn't be a point of pride, according to a coalition of dermatologists, cancer research groups and sunscreen makers.

Sunscreens sold in the United States are missing some of the latest and most effective ingredients for blocking the type of ultraviolet rays associated with premature aging and serious skin cancer, says the Public Access to Sunscreens Coalition, called PASS for short.

Those ingredients, though widely used in European and Asian countries, have been held up for years at the Food and Drug Administration. Federal law treats sunscreen as an over-the-counter drug, meaning new formulas must undergo rigorous and costly scrutiny before they hit store shelves.

Now the coalition is making a public push for the FDA to get moving. The centerpiece of their efforts is proposed federal legislation, called the Sunscreen Innovation Act, which would give FDA a timeline for acting on sunscreen applications.

"Everybody agrees that the process is broken down," said Wendy Selig, president of the Melanoma Research Alliance, which is part of the PASS coalition.

• • •

It's difficult to pinpoint the reasons for the delays. FDA officials have cited staffing shortages and a lengthy rule-writing process. In 2002, the agency set up what was intended to be a streamlined process for sunscreens, allowing officials to approve ingredients if they have been used for at least five years abroad and have proven effective and safe.

But no ingredients have been approved through that process. Eight applications are pending, some dating to 2003.

FDA spokeswoman Andrea Fischer said Americans have many effective products from which to choose. Still, she said, the agency is committed to acting on the applications as soon as possible.

She pointed to the FDA's notifications to three applicants earlier this year that their scientific evidence is lacking. In other countries, sunscreen is treated as a cosmetic and the safety data that is available from its use there doesn't always meet the FDA requirements.

"The FDA recognizes the public health importance of sunscreen use and has prioritized reviewing the safety and effectiveness of additional sunscreen ingredients as quickly as possible given the agency's resources," Fischer said.

The FDA has methods for fast-tracking approvals of drugs for serious or life-threatening conditions. Selig noted that in just the last four years, there have been at least six new drugs approved for melanoma, the deadliest skin cancer. But there has not been one new sunscreen ingredient approved in that time.

"It's the same agency," she said.

• • •

Dr. James Spencer, a St. Petersburg dermatologist, said American sunscreens are good at protecting against ultraviolet B rays, which are primarily responsible for sunburns and can cause skin cancers. Protection from UVB is what people shop for when they select sunscreen by its SPF rating.

But he and other dermatologists say sunscreens here have limited ingredients that filter the deeper-penetrating ultraviolet A rays. UVA rays, which can pass through window glass, cause premature aging and are also associated with melanoma.

Four of the eight pending applications with the FDA are for ingredients that fight UVA rays, according to the Environmental Working Group, a consumer organization that puts out an annual report on sunscreens.

The best UVA filter in the United States is avobenzone, which is less effective than several products safely used in Europe for years, said Dr. Mary Lien, a dermatologist who practices at several Tampa Bay area hospitals, including Moffitt Cancer Center. Another kind of chemical UVA filters used in the United States, the benzophenones, have caused allergic reactions in some people, she added.

Certain physical blockers like titanium oxide also work against UVA rays but are impractical for daily use because they deposit a chalky film that few users except lifeguards will tolerate.

In recent years, the FDA has toughened up labeling standards to help consumers pick the best "broad spectrum" sunscreens, those that protect against both UVA and UVB rays. For instance, the agency now requires that sunscreens pass a test before they can be labeled broad-spectrum. Critics, including the Environmental Working Group, say that test isn't stringent enough.

European countries, for instance, require that sunscreens offer UVA protection that is at least a third as potent as the UVB protection measured by SPF. The group estimates that about half of the 456 American sunscreens it evaluated this year would be too weak to be sold on the European market.

So do our weaker sunscreens result in higher skin cancer rates than other countries? Dr. Steven Wang, director of dermatologic surgery and dermatology at Memorial Sloan-Kettering Cancer Center in New Jersey and a member of the PASS coalition, said that's a difficult question to answer. That's partly because so many people, in every country, aren't using their sunscreen correctly: They don't reapply it nearly enough, he said, or they assume any use at all gives them license to bake.

"People think it makes them invincible," he said.

Jodie Tillman can be reached at jtillman@tampabay.com or (813) 226-3374. Follow @jtillmantimes.

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