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Panel Urges FDA to Revise Sunscreen Standards

Posted: December 4, 2008

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In 1999, the FDA recognized the significant need for more effective UVA radiation filters. Since then, concerns regarding the U.S. public health risks from UVA radiation have continued to mount. In August 2007, the FDA issued a proposed rule to amend the OTC Sunscreen Drug Product Monograph by promoting a UVA labeling standard. To date, action has not been taken to finalize the improved standards.

Following the panel, a citizen’s petition signed by the panelists and other leading skin cancer experts, medical professionals and sunscreen manufacturers was presented to the FDA. The petition calls on the FDA to immediately act to approve sunscreen ingredients that provide a photostable, broad-spectrum UV filter with excellent protection against UVA rays. Previous attention had focused on UVB exposure and the link to sunburn. Recent evidence shows that UVA rays are even more damaging and linked to skin cancer. The panel cited:

 

  • Skin cancer is the most prevalent form of cancer, with more than 1.2 million cases diagnosed annually. Accumulating evidence indicates that radiation across the entire ultraviolet spectrum (UVA and UVB) contributes to skin cancers including melanoma, a major U.S. public health threat and the deadliest form of skin cancer with more than 60,000 cases diagnosed and more than 8,000 deaths each year
  • Modern sunscreens combining high levels of protection across the UVA and UVB spectra can be expected to be four-fold more effective in preventing melanoma than sunscreens providing just UVB protection
  • The American public needs to be educated on the importance of using these broad spectrum products; the FDA must implement sunscreen standards that clearly outline the amount of protection that sunscreen products offer against cancer-causing rays; and the agency needs to expedite the now stagnant review of sunscreen filters under the Time & Extent Application (TEA) process. FDA action is required to issue an Enforcement Action so that broad-spectrum photostable UVA/UVB sunscreen active ingredients can be incorporated into products for the U.S. population without further delay.

 

“It is an incredible disservice to the American population that ingredients to improve sunscreens exist yet remain unavailable in the U.S. market,” said Catherine Ehrenberger, president of Home & Personal Care for Ciba. “The FDA must address this critical health issue and expedite the approval of new sunscreen filters before another summer passes.”