Sunscreens in the U.S. are lacking compared to sunscreens abroad and it's because the FDA hasn't approved any new ingredients in years. That might all change this summer
Ask anyone you know if they a) wear sunscreen every day and b) actually enjoy wearing sunscreen and you are likely to get a no to both. But what if newer, better products—ones that are appealing to use and work better to protect against both UVA and UVB rays—were on the market? Better ingredients do exist, say experts, but they have been tied up for years in the Food and Drug Administration’s drug-approval process. Active ingredients like SPF are regulated as drugs in the United States. Now, a bipartisan bill called the Sunscreen Innovation Act—currently under review by congress called—is hoping to speed the process.
The last over-the-counter sunscreen ingredient was approved in the 1990s and eight ingredients have been waiting for approval for over 10 years. Most of these ingredients have been widely used in countries like Europe and Asia and are generally considered safe and effective, and in many cases protect against UVA rays better than some American products. European makers have around 27 sun-protective ingredients to choose from, compared to 16 in the U.S.
The holdup lies in the way sunscreen ingredients are regulated. In Europe, sunscreen is regulated as a cosmetic, but in the U.S., sunscreens go through a drug approval-like process, which takes much longer. The FDA implemented a system in 2002 in an effort to streamline the approval process for ingredients used in over-the-counter products whose safety has been determined by at least five years of use. Part of the issue is that a lot of the safety information needed for a drug-approval process is not available for some of these products, since their approval process is simpler outside the U.S.
On Thursday, the House Appropriations Committee showed significant disappointment in the lack of FDA movement on sunscreen ingredients and demanded that the agency make decisions by December 2014, writing:
The Committee is extremely concerned that another year has passed without FDA completing its review of the pending…rulemakings on sunscreens. Immediate action on sunscreens should be a priority since the need for sunscreens is evidenced by the nearly one million people that are currently living with skin cancer and the fact that melanoma is the fifth leading cause of cancer in the U.S. this year. FDA has listed actions related to sunscreen as a high priority in the Unified Agenda since 2008.
Given the recent attention, the FDA has finally started looking at product applications. In February, it released two rules on two ingredients, saying they needed more safety information.
If the new bill is passed, which advocates hope will happen this summer, the FDA will be required to make rulings on the ingredients within nine months. “The legislation has to be a win-win-win,” says Michael J. Werner, a member of the Public Access to SunScreens (PASS) Coalition which is supporting the bill. “It is a win for the FDA because they are administering a process that works and they can have confidence that when they approve a product it is safe and effective. It will be a win for manufacturers because they will know that their products will be reviewed in a timely manner. And of course consumers will win because we will have more safe and effective sunscreens to choose from.”
This is not the first time the FDA has been called out for their sluggishness. In the video below, California Representative Sam Farr questions FDA Commissioner Margaret Hamburg in April of last year on why it is taking so long. His brother-in-law died of melanoma, and he says he cannot understand the holdup.
The FDA has expressed frustration with the process and is open to making changes. “The FDA is actively considering alternative regulatory and administrative approaches to [a new] OTC monograph process,” an FDA spokesperson told TIME in an email.
Given the fact that skin cancer is the most common cancer in the United States, with some estimates showing that over two million Americans are diagnosed each year, having better, more effective products on the market is a good step in the direction of prevention.