Sunscreens that have been available in Europe and other foreign markets for years remain banned from U.S. stores because of a backlog in the federal bureaucracy.
The ingredients that make the sunscreen superior have been awaiting approval — or any sort of decision — from the Food and Drug Administration for at least 12 years. There are currently eight such ingredients stuck in the system.
Without access to the ingredients, consumers may be blocked from buying the sunscreens that provide the most effective protections against harmful rays.
Congress has a plan to break the 12-year backlog: The House Energy and Commerce Committee on Monday is looking at legislation that would expedite the FDA’s approval process for sunscreen ingredients. Should the panel approval the measure, it would put the bill one step closer to passage.
A companion version of the House bill is pending with the Senate’s Health Committee.
The legislation aims to improve on the federal government’s latest attempt to make itself more nimble in keeping up with sunblock technology: a 2002 procedural change from the FDA that the agency hoped would speed up its approval process.
But without a single ingredient being approved since then, advocates say it’s time for another try.
“FDA’s goal was to create a more streamlined process; it just didn’t work out that way,” says a staff member of the Public Access to SunScreens Coalition. “Everyone — melanoma researchers, the community, manufacturers, patients, even the FDA — everyone agrees the current situation is not working. When you combine that with the increasing rates of skin cancer, it’s a serious public-health concern.”
At stake is more than sunburns: Skin cancer is the most common form of cancer in the United States. more than 2 million cases are diagnosed each year, many of which could be prevented by protecting the skin from sun exposure, according to the American Cancer Society.
Congressional advocates hope they can improve the FDA’s existing procedure without upending the entire system.
Under current law, if an ingredient is on the market in another country for five years, it may go through a process to be determined eligible by the FDA. An advisory committee of experts then weighs in on the safety and effectiveness of the product, and the agency makes the final determination as to whether it is approved.
The Sunscreen Innovation Act makes two primary changes to this process. First, it would institute an eight-month deadline for the FDA to make a decision, replacing a current review process that lacks a mandatory end date. Second, the bill would no longer require the FDA to issue a regulation every time it wants to approve an ingredient.
The FDA declined to comment on the bill, but a spokesperson said the agency has “prioritized reviewing the safety and effectiveness of additional sunscreen ingredients as quickly as possible given the agency’s resources.”
This frustration has boiled over to Capitol Hill, with matching House and Senate bills to address the problem. The House version being considered Monday was introduced by Republican Ed Whitfield and Democrat John Dingell. The Senate version came from Democrat Jack Reed and Republican Johnny Isakson.
With backing from both parties, advocates are cautiously optimistic about the bills becoming law, but they recognize that bipartisan support is no guarantee of passage — particularly in the current gridlocked environment.
“Trying to predict what Congress is going to do is kind of like having a perfect March Madness bracket,” the sunscreens coalition staff member said. “But I will say there has been tremendous bipartisan, bicameral support.”