Sunscreen bill to speed up FDA review of new ingredients made in U.S. becomes law

Sunscreen May Fail To Prevent Skin Cancer

The Food and Drug Association has a backlog of pending sunscreen ingredients to review, dating back to 2003. A bill passed Thursday by the U.S. House of Representatives is designed to speed up the process so that active sunscreen ingredients made in Ohio - but not approved for use in the U.S. - can finally be reviewed.

(Joe Raedle/Getty Images)

The U.S. House of Representatives has passed the Sunscreen Innovation Act,  designed to strengthen the potency of sunscreen sold in the United States. The bill, which will now be delivered to President Obama for his signature, is designed to speed up the bureaucratic review process of active ingredients in sun protection products that are already used in sunscreen sold in Canada and the European Union, but not in the U.S.

The bill, passed on Thursday, originally was introduced in the Senate last March by Democrat Jack Reed of Rhode Island and Republican Johnny Isakson of Georgia. Co-sponsored in July by U.S. Sen. Sherrod Brown, an Ohio Democrat, the bill gained bipartisan support.

A House version, sponsored by Republican Ed Whitfield of Kentucky and John Dingell of Michigan, included several Ohio lawmakers as co-sponsors.

"This law will ensure Ohioans have access to the best possible sun protection," Brown said Friday in a statement. "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."

Sunscreens protect against ultraviolet A (UVA) and ultraviolet B (UVB) rays. American sunscreen is less effective at blocking UVA, which can penetrate the skin more deeply. The Food and Drug Administration has only approved three ingredients that block UVA that can be sold in the U.S.; in Europe, seven ingredients are available.

Eight additional products to help protect against UVA and UVB rays have been waiting for a review of key ingredients since 2003. Meanwhile, companies such as Columbus-based Ashland Inc. and BASF and L'Oreal, both of which have operations in Northeast Ohio, make and exports sunscreen that blocks both UVA and UVB. Their products, however, can't be bought in the U.S.

The last time a sunscreen active ingredient was approved by the FDA was in 2006.

The new law includes the following:

  • Require the FDA to reduce the existing regulatory backlog of sunscreen applications.
  • Streamlining the review of applications for ingredients that have been used safely for at least five years in another country, and provide the option for pending ingredients to undergo review by an external advisory committee of experts that can recommend to the FDA if 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 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.

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