NCPA - National Center for Policy Analysis

More Effective Sunscreens Held Up by the Food and Drug Administration

March 28, 2014

Applications for newer and more-effective sunscreen ingredients have sat for years in U.S. Food and Drug Administration (FDA) bureaucracy, says the Washington Post.

  • The agency must approve new sunscreen products before consumers can access them, yet the agency has not processed these applications, some of which have been waiting for approval since 2003.
  • Currently, there are eight ingredient applications pending before the FDA, which has not expanded its list of approved sunscreen ingredients since 1999.

Many of these new ingredients provide broader UV protection. Generally, the UVA filters in sunscreens in the United States are oxybenzone and avobenzone. These are effective ingredients, according to dermatologists, but they can break down quickly and do not protect against all UVA rays. The pending applications, on the other hand, include UVA filters that offer stronger protection and could be used to create longer-lasting sunscreens. European, Asian and South American countries have already approved the updated sunscreens.

The delay has led interest groups, dermatologists and sunscreen manufacturers to join together in a public push for FDA approval of the backlogged applications.

  • Darrell S. Rigel, dermatology professor at New York University and former president of the American Academy of Dermatologists, says, "These sunscreens are being used by tens of millions of people every weekend in Europe, and we're not seeing anything bad happening... We're depriving ourselves of something the rest of the world has."
  • The FDA says that it is required to undergo a lengthy rule-writing process before it can grant approval to the ingredients. Some applications have lacked required safety data.

The FDA told the Washington Post that it has prioritized its sunscreen review and "is proceeding as quickly as practicable given available review resources and competing public health responsibilities." However, 11 months ago FDA Commissioner Margaret Hamburg also told lawmakers that the sunscreen issue was "one of the highest priorities" in the agency.

Source: Brady Dennis, "FDA Review of New Sunscreen Ingredients Has Languished for Years, Frustrating Advocates," Washington Post, March 20, 2014.


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