Waiting Game continued...
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.