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FDA Proposes New Rules for Sunscreens
Date:8/23/2007

In addition, the definition of SPF would change from "sun protection factor" to "sunburn protection factor." This change will prevent "the impression of solar invincibility and a false sense of security," according to the agency's proposal.

One expert thinks it's about time the FDA set standards for UVA protection.

"This is an important step forward," said Dr. James Spencer, a professor of clinical dermatology at Mount Sinai School of Medicine in New York City, who also is in private practice in St. Petersburg, Fla. "UVA protection is important for the prevention of skin cancer and wrinkles," he said.

In fact, Spencer would like to see the same star rating system proposed for UVA to replace the SPF number used for UVB.

This label changes were partly spurred by a report from a Washington, D.C.-based nonprofit, the Environmental Working Group, in June. The EWG faulted the FDA for missing a deadline imposed by Congress to set sunscreen safety standards by last year.

In their report, the group found that of 386 sunscreens with SPF ratings higher than 30, 13 percent protected users from UVA radiation.

More information

Find out more about sunscreen use and sun safety from the U.S. Food and Drug Administration.



SOURCES: Aug. 23, 2007, teleconference with Douglas C. Throckmorton, M.D., deputy director, Center for Drug Evaluation and Research; Matthew R. Holman, Ph.D., Office of Nonprescription Products, U.S. Food and Drug Administration; also James Spencer, M.D., M.S., professor, clinical dermatology, Mount Sinai School of Medicine, New York City, practice, St. Petersburg, Fla.


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