Experts call for FDA to address dramatic rise in skin cancer rates in the U.S.



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Today keynote speaker Congresswoman Nita Lowey (NY-18) joined with experts from New York Presbyterian Hospital; the Skin Cancer Foundation; 2006 Miss Maryland, a skin cancer survivor; Fallene LTD, and Ciba Corporation to call on the Food and Drug Administration (FDA) to address the dramatic rise in skin cancer rates in the United States.

The panel was organized by Citizens for Sun Protection (CFSP), a coalition of national, state, and local organizations and individuals advocating for U.S. sunscreen standards that meet or exceed the sunburn and skin cancer protection requirements available in Europe.

As much of the country moves into the colder, winter months, the panel sought to turn up the heat on a health care crisis that requires immediate action before another summer passes. Panelists called upon the FDA to set a strong sunscreen standard requiring protection from both UVB and UVA rays, with transparent labeling, and approve photostable, broad-spectrum sunscreen ingredients to defend against both UVB and UVA rays.

“The FDA continues to delay action on implementing sunscreen standards which would provide more effective and informative labeling, an important line of defense against the damaging rays of the sun,” said Rep. Lowey. “The American public is under-protected and operating with a false sense of security in the face of the life-threatening dangers of sun exposure. I stand in full support of initiatives that would reduce the occurrence of skin cancer.”

In her remarks, Rep. Lowey expressed deep concern with the FDA’s delayed action to provide Americans with more complete and informative sunscreen standards and labeling, and their failure to approve highly effective sunscreen ingredients available in every other country except the U.S. The New York Congresswoman sought to focus the FDA’s attention on rising skin cancer rates which many public health experts point to as a growing health care crisis, particularly in young women.

“People need to take better precautions when spending time outdoors and the U.S. government needs to be supportive of standards and ingredients that could further protect Americans from all the sun’s rays — UVB and UVA alike,” said melanoma survivor and 2006 Miss Maryland Brittany Lietz. “Speaking from experience, we are not as protected as we think we are.”

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 over 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 4-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.    

Under TEA consideration before the FDA is Ciba(R) Tinosorb(R), a photostable, broad-spectrum UV filter that provides protection against UVA rays. Ingredients such as this have been approved in every major sunscreen market outside of the U.S., including countries in Europe, Australia, Brazil, Canada, Japan and Mexico. Panelists addressed the need for the FDA to approve sunscreen ingredients that provide a photostable, broad-spectrum UV filter for use in U.S. 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.”

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