FDA Proposes New Rules for Sunscreens

New labeling would indicate UVA protection, not just UVB.

By Steven Reinberg
HealthDay Reporter
Thursday, August 23, 2007; 12:00 AM

Copyright © 2007 ScoutNews, LLC. All rights reserved.

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.