The U.S. House of Representatives passed legislation to speed up Food and Drug Administration approvals of new sunscreen ingredients and to eliminate a backlog.
The Sunscreen Innovation Act (H.R. 4250) was passed by a voice vote and now awaits action by the Senate. The companion bill in the Senate, S. 2141, was introduced by Jack Reed (D-R.I.) and has been referred to the Committee on Health, Education, Labor, and Pensions but has not received a hearing yet.
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The markers of the bill hope to eliminate part of the administrative backlog of sunscreen ingredients under review.
Backers of the legislation are encouraging the Senate to move quickly.
"Even though the Food and Drug Administration has listed action on sunscreen ingredient applications as a priority since 2008, no new sunscreen ingredients have been approved by the FDA in 15 years," Rep. Ed Whitfield (R-Ky.), one of the lead sponsors of the House bill, said in a statement after the approval.
"The framework outlined in this legislation strikes an appropriate balance between consumer safety and access to new sunscreen products," he said, adding, "I am pleased to see my legislation pass the House of Representatives, and call on the Senate to act."
The bill requires the FDA to make final decisions within a year on the backlog of ingredients under review, and within a year and a half on new applications. It also sets up more Congressional oversight of the process and makes "sunscreens that have been marketed for five continuous years in the United States or other countries and in sufficient quantity eligible for review under this Act."
Currently, according to the American Cancer Society Cancer Action Network (ACS CAN), only three of the seven UVA-blocking ingredients sold in Europe are approved in the United States.
The Sunscreen Innovation Act has many supporters in the health care field and among consumer advocates and manufacturers, many of whom belong to the PASS (Public Access to SunScreens) Coalition. In a statement issued by the coalition, the American College of Mohs Surgery said, "This important legislation will go a long way in helping prevent skin cancers by improving the availability of more effective sunscreen products, and we are committed to its passage."
The Environmental Working Group, a frequent critic of the FDA’s regulation of sunscreens and of manufacturers, also applauded House passage of the bill.
The American Cancer Society was pleased as well. "The House took a critical step today to fix a broken process at FDA for the review of new sunscreen ingredients that could potentially help more Americans prevent skin cancer," Chris Hansen, president of the ACS CAN, said in a statement.
"American consumers should have access to the broadest choice of sunscreens – including those in use for years in other countries – once they are shown to be safe and effective," he noted.
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