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

New labeling would indicate UVA protection, not just UVB

THURSDAY, Aug. 23 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) proposed Thursday a new rating system for sunscreens that would, for the first time, alert consumers as to how well they block dangerous ultraviolet A (UVA) rays.

Right now, most commercial sunscreens only screen out ultraviolet B (UVB), not UVA, which is associated with longer and more serious damage deep within the skin.

Labels would have up to four stars indicating their effectiveness against UVA rays, the FDA said. Both UVA and UVB increase skin cancer risks and skin aging.

The new changes are undergoing a 90-day period of public comment before being published in a final draft form. According to the agency, those rules would only go into effect 18 months later, pushing the appearance of any new labeling to 2009 at the earliest.

The agency has long been looking into making recommendations on UVA protection, Dr. Douglas C. Throckmorton, the deputy director of FDA's Center for Drug Evaluation and Research, said during a mid-afternoon teleconference. Only now has the agency settled on which tests it will accept for rating UVA protection, he said.

"We believe this proposed regulation does, in fact, provide sunscreen labeling that clearly communicates information related to UV protection," Matthew R. Holman, from the FDA's Office of Nonprescription Products, said during the teleconference.

Called "extra UVA protection," the new rating would be in addition to the SPF, or sun protection factor, already on sunscreens. SPF measures the effectiveness of the product in preventing sunburn from UVB rays.

UVB radiation causes sunburn, but UVA can damage skin tissue below the surface. "Both UVA and UVB cause skin cancer and aging such as wrinkles and sunspots," Holman said.

"FDA considers both UVB and UVA radiation protection equally important at this time, because scientific data demonstrates that both have harmful effects on the skin," the agency said.

The proposed ratings system for UVA sunscreens would rate them on a scale of one to four stars. One star for low UVA protection, two stars medium protection, three stars high protection, and four stars the highest protection available in an over-the-counter sunscreen. If a sunscreen does not have at least one star of protection, the agency would require that the product have a "no UVA protection" marking on the label near the SPF value.

Ratings for UVA would be based on two tests. The first measures the sunscreen's ability to reduce the amount of UVA radiation that passes through it. The second measures a product's ability to prevent tanning. This test is similar to the SPF test used to determine the effectiveness of sunscreens to block UVB rays, according to the FDA.

Sunscreens would carry a "Warnings" statement in the "Drug Facts" box. The warning will say that "UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen."

In addition, the label would also warn that "UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen." Directions would tell people to reapply sunscreen "at least every 2 hours."

The intent of the warning is to alert consumers that sunscreen is only a part of protecting yourself from sun exposure, Holman said.

According to the FDA, the proposal has guidelines for testing that manufacturers need to do to support their claims. Under the rule, sunscreens could have a maximum SPF of 50+ unless test data shows that a higher number is warranted.

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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