Brown-Sponsored Bill to Expedite Approval for Safe Sunscreen Ingredients Heads to President's Desk

Ohio Companies BASF, L’Oreal, and Ashland Inc. Manufacture Safe Sunscreen Ingredients that Are Used in Canada and the EU but Have Been Awaiting FDA Approval for Sale in the U.S. for More than a Decade

WASHINGTON, D.C. –  A bill that will protect Ohioans from the effects of harmful exposure to the sun – including skin cancer – will become law following House passage last night. The Sunscreen Innovation Act, cosponsored by U.S. Sen. Sherrod Brown (D-OH), will strengthen the potency of U.S. sunscreen by expediting the bureaucratic review process of the active ingredients in sun protection products – manufactured in Ohio by BASF, L’Oreal, and Ashland Inc. – that are already used in sunscreen technologies available to consumers in Canada and the European Union (EU), but not in the U.S.

“This law will ensure Ohioans have access to the best possible sun protection,” Brown said. “With more than two million cases of skin cancer and nearly 10,000 deaths in the U.S. each year, it’s well past time that we have the best defense against a largely preventable disease.”

There are more than two million cases of skin cancer in the United States each year and 90 percent are the result of harmful sun exposure. Melanoma, the most deadly type of skin cancer, kills nearly 10,000 Americans a year, and yet Americans do not have access to the most advanced sunscreen products that Canadians and those in the EU do.

The U.S. Food and Drug Administration (FDA) is responsible for ensuring the safety and effectiveness of all drugs, including over-the-counter (OTC) drugs, such as sunscreen, and their ingredients. But the FDA has a backlog of pending sunscreen ingredients to review, which dates as far back as 2003. The FDA last approved a new ingredient for use in sunscreen products in 1999.

Two types of ultraviolet radiation (UVB and UVA) damage the skin, age it prematurely, and increase the risk of skin cancer. While American sunscreen blocks UVB—which primarily causes sunburn—American sunscreen is not as effective in blocking UVA, which can penetrate the skin more deeply and cause greater damage to the skin, and in some instances, cancer. The FDA has only approved three ingredients that block UVA that can be sold in the United States, compared with seven that have been approved for use in Europe.

The new law will: 

  • Require the FDA to reduce the existing regulatory backlog of sunscreen applications and ensure an improved, reliable approval pathway for future sunscreen applications while maintaining the existing safety and effectiveness requirements for sunscreens;
  • Require the FDA to provide expedited approval pathways for pending sunscreen ingredients by:
    • Streamlining the review of applications for ingredients that have been used safely for at least five years in another country;
    • Providing the option for pending ingredients to undergo review by an external advisory committee of experts and empower the committee to make a recommendation to the FDA on whether the application should be approved or denied;
  • Require the FDA to regularly report to Congress on its efforts to reduce the backlog of existing applications and review of new ingredients;
  • Require independent reporting by the Government Accountability Office (GAO) on the regulatory pathway for sunscreen products and other OTC products; and
  • Require the FDA to finalize its regulations related to all OTC sunscreens, including those reviewed by the agency as a result of this bill, within five years.

In addition, the FDA is required to provide a written timeline for review to companies with applications currently pending at the FDA, like BASF, L’Oreal, and Ashland, Inc., upon request from the sponsor. The Sunscreen Innovation Act now heads to President Obama’s desk for his signature.

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