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.”