Published in The Hill
By Julian Hattem
Public health advocates are seeing red over the federal government’s failure to approve new ingredients for sunscreen.
The Food and Drug Administration (FDA) has spent more than a decade reviewing sunscreen products that have long been on store shelves in Europe, Canada, Mexico and other countries.
The delay has gone on long enough, say lawmakers, skincare companies and public health organizations who want to do something about the 3.5 million Americans who are diagnosed with skin cancer every year.
“The fact that we have things on the market in other developed countries for over a decade that are not available here just doesn’t make any sense,” said Tim Turnham, executive director of the Melanoma Research Foundation.
Applications to approve three new sunscreen chemicals have been sitting at the FDA since 2002 with no response. Five more have since been added to the list.
The applications have been tied up in an arcane FDA process for reviewing products that have been on the market “to a material extent and for a material time” in other countries. That process, known as the Time and Extent Application (TEA), is broken, according to advocates who want the new sunscreen ingredients approved.
FDA spokeswoman Andrea Fischer told The Hill in an email that the agency is “working diligently to evaluate the submitted data” according to current standards.
Fischer added that the FDA was “also investigating ways, consistent with existing regulations, to inform stakeholders in a more expedited fashion on the status of TEAs that are currently being evaluated.”
Supporters of the new sunscreen ingredients aren’t satisfied with that response.
Wendy Selig, head of the Melanoma Research Alliance, compared the delay to a halt for a new cancer treatment.
“If we’re basically saying what’s out there now is what we knew about 10 years ago, think about what we knew on the treatment side. That would be ridiculous, right?” she said.
FDA approval would allow sunscreen manufacturers to make a wider variety of products. The new formulations might be appealing to people who don’t currently use sunscreen, industry officials told The Hill, and get more people to protect themselves from ultraviolet rays.
The delay is also discouraging skincare companies from even trying to develop new products for the U.S. market.
“There are other fillers that have been developed and launched within the past decade that haven’t even been submitted because the backlog has not been cleared out yet,” said Al Pearce, a senior marketing manager at the BASF skincare company.
The health and skincare groups are part of a coalition that has been launched to pressure the FDA to act on the submissions.
But they’re not alone, as lawmakers in Congress have also taken notice of the delays.
In recent weeks, nine legislators including Sens. Jack Reed (D-R.I.), Dianne Feinstein (D-Calif.) and Chuck Schumer (D-N.Y.) sent a letter to FDA Commissioner Margaret Hamburg calling it “critical”” that sunscreens “contain ingredients that offer the strongest possible protection from the sun.”
Reed has been working with Sen. Johnny Isakson (R-Ga.), to “explore possible ways to improve this process so that new sunscreens with demonstrated safety and effectiveness can come to the market,”” according to a statement to The Hill from Isakson spokeswoman Lauren Culbertson.
She added that Isakson was “very troubled by the lengthy delays“ in approving the applications. “As a skin cancer survivor, Sen. Isakson believes it is important for Americans to have access to the best sunscreen products,” she said.
In the House, the annual agriculture appropriations bill under consideration instructs the FDA to finish its review of the sunscreen ingredients by next June.
The legislation also requires the FDA to work with Congress, cancer groups and manufacturers “to develop a new process that will allow safe and effective sunscreen ingredient market applications to receive a final decision from FDA within one year of application date.”
In a letter to Rep. John Dingell (D-Mich.) earlier this month, FDA Deputy Commissioner for Policy, Planning and Legislation Sally Howard wrote that a proposed rule on three of the sunscreen ingredients is expected in September.
But that’s little comfort to the coalition looking for the ingredients to be approved.
“I wouldn’t say that we’re cynical and skeptical, except there is a little bit of wait-and-see attitude,” said Turnham, “except not very much interest in waiting very long.”
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