June 3, 2014 -- Some patients of Manhattan dermatologist Darrell Rigel, MD, return from trips abroad with a rather unusual souvenir: sunscreen.
Rigel's patients can't buy similar products in the United States because they contain sun-filtering compounds -- classified as over-the-counter drugs in the United States and Canada but cosmetics elsewhere. These compounds don't yet have FDA approval, even though in some cases they've been used for decades in other countries.
"There's no good reason why the FDA hasn't approved these," says Rigel, a past president of the American Academy of Dermatology and a clinical professor at NYU Langone Medical Center.
"As a physician, it's frustrating to me that we can't seem to get an answer about when the FDA will approve these ingredients that have already been proven safe in Europe."
The eight sun filters awaiting FDA approval "have the potential to be different and better," Rigel says. They tend to last longer and lend themselves to more "elegant" formulations than some of the goopy sunscreen products on the U.S. market, he says.
If it seems like there's no shortage of sunscreen choices on store shelves, you might be surprised to learn the FDA hasn't approved a new active sunscreen ingredient since before 2002. That year, the agency published regulations aimed at streamlining the review of over-the-counter drugs, such as sun filters, with track records in other countries.
Under a different review process, though, the FDA in 2006 allowed L'Oreal to market Anthelios SX, a daily moisturizer that contains a sun filter used in products sold in Europe and Canada since 1993. The approval only applies to Anthelios SX products sold by L'Oreal brands.
"The FDA remains committed to allowing sunscreens containing additional ingredients to be made available to consumers if there are enough data to show that they are generally recognized as safe and effective for use in over-the-counter sunscreens," the agency says in a statement to WebMD. "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."
Manufacturers of the eight different sun-filtering compounds have applied to the FDA for approval under the 2002 "time and extent" regulations. This is another way to approve over-the-counter drugs sold outside the U.S., says Michael Werner. He's a Washington, D.C., lawyer who advises the PASS (Public Access to Sunscreen) Coalition.
"Time" refers to having been marketed continuously for at least 5 years in the same country, while "extent" refers to marketing a sufficient quantity.
The time and extent regulations allow applicants, when requesting FDA approval, to use data from other countries to demonstrate safety and effectiveness, Werner says. "That's why it requires at least 5 years of continuous marketing in other countries."
After years of no action on the eight applications, the most recent of which was submitted in 2009, according to the PASS Coalition, the FDA in late February sent letters to two manufacturers that had filed applications in 2002. The agency said there wasn't enough scientific evidence that their sun filters were generally recognized as safe and effective for use in sunscreens. (You can read the letters here and here.)
"With regard to the other sunscreen ingredients under review under the time and extent application process, the FDA will issue responses to the safety and efficacy data submitted for each ingredient in the near future," FDA spokeswoman Andrea Fischer says.
Consumers Union, the policy and advocacy arm of Consumer Reports, and the PASS Coalition, a group of doctors, public health organizations, and sunscreen manufacturers, sent letters in May urging FDA Commissioner Margaret Hamburg, MD, to speed up her agency's review of new sunscreen ingredients.
While the manufacturers in the PASS coalition stand to benefit financially, consumers will also benefit from the approval of more sun filters, Werner says. "There's no question that giving folks more choice is likely to increase use of sunscreen products in general," he says.
In March, the Sunscreen Innovation Act was introduced in the House and the Senate. The legislation, which has support from Democrats and Republicans, seeks to speed up the approval of sunscreen active ingredients that have been used widely outside the U.S.
"We've not heard any real objections to the legislation," Werner says. "We're optimistic that this is going to be a bill that everybody can get behind and we can get it enacted this summer."
Are New Filters Needed?
Meanwhile, what can Americans do to protect themselves against skin cancer? For one, Rigel says, don't order unapproved sunscreens online. Web sites might look like they're based in Canada, he says, but you could end up getting packages postmarked Nepal or Pakistan, raising questions about what you're really getting.
And even if you live near the border, says Henry Lim, MD, "there is no need to go to Canada or other parts of the world to obtain sunscreen. In the U.S. now, we do have very good sunscreen." Lim is chair of dermatology at Detroit's Henry Ford Hospital and a charter member of the PASS Coalition.
Whether Americans will buy products with new sun filters remains to be seen. Mona Gohara, MD, an associate clinical professor of dermatology at Yale, says her patients are overwhelmed with the choices already on the market.
Sixteen sun filters already are approved by the FDA. "The majority of people are walking into Walmart and thinking, ‘What's going to work?'" Gohara says.
Plus, she says, many of her patients are reluctant to slather on chemicals to protect themselves against the sun, even though speculation that some sunscreens might actually raise the risk of cancer has never been proven. Instead, they prefer sunscreens that physically block UV rays -- namely the minerals titanium oxide or zinc oxide, the reason lifeguard's noses used to look white and chalky. Today, nanotechnology has enabled manufacturers to shrink the size of titanium oxide and zinc oxide molecules for use in makeup and moisturizers that get rid of the ghostly look of old, Gohara says.
"The range of sunscreens is so diverse right now," she says. "What we have here [in the U.S.] is perfectly efficient to protect people against cancer, regardless of their lifestyle."
Still want to bring sunscreen home from abroad? While importing unapproved drugs -- including sunscreens with unapproved sun filters -- violates the federal Food, Drug, and Cosmetic Act, the FDA's web site says the agency is likely to look the other way -- if you import no more than a 3-month supply of a drug that's not considered to represent an unreasonable risk.
Americans' sunscreen choices improved as a result of recent steps taken by the FDA, says Lim, who has served as a consultant to L'Oreal, Pierre Fabre and Uriage. Last summer was the first that all products labeled "broad spectrum" had to prove to the FDA that they protected against ultraviolet B radiation, the main cause of sunburn, as well as ultraviolet A, which can cause sunburn, skin cancer, and premature skin aging.
Also, products that don't offer broad spectrum protection or have an SPF below 15 have to carry a warning on their label that says they only prevent sunburn, not skin cancer and premature aging. The FDA also has proposed a rule that would set "50+" as the highest SPF value that sunscreen manufacturers could put on their labels, since there's not enough data to show that anything above 50 provides greater protection.
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