FDA Wants Cancer Warning and UVA Protection Rating on Sunscreen Labels

ROCKVILLE, Md., Aug. 23 -- The FDA called today for sunscreen labels to include a warning about skin cancer and add information about ultraviolet A (UVA) protection as well as the ultraviolet B (UVB) ratings that are now standard.

The FDA agency said at press briefing that if the regulation gains final approval all sunscreens would include this warning: "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 the past, the FDA focused its attention on UVB rays because they cause sunburn, whereas UVA rays cause tanning. But Matthew R. Holman, Ph.D., an FDA interdisciplinary scientist who worked on the team that drafted the proposed regulation, said that both UVB and UVA are associated with increased risk of skin cancer.

The problem, Dr. Holman said, has been identifying the best way to test products for UVA protection. "There are both in-vitro and in-vivo tests," Dr. Holman said. In the end, the FDA decided to require manufacturers to test efficacy with both "laboratory and human studies."

And the UVA rating -- a star system with one star indicating low protection and four stars for highest UVA protection -- will be determined by the lowest score on either test. "So if a product gets one star on the in-vitro test and two stars on the in-vivo test, the rating would be low or one star," he said.

Manufacturers would not be required to test for UVA protection, but products without testing would be required to state on the label that the product does not offer UVA protection.

The new rule would also expand the SPF rating that is used to indicate the amount of UVB protection. When the FDA last looked at sunscreens it certified SPF ratings up to 30, but didn't confirm the reliability of higher claims. Holman said the FDA can now certify SPF ratings up to 50, a claim that is already made by many sunscreen products.

The new rule is now subject to a 90-day public comment period after which the FDA will conduct a final review and may actually put the regulation into effect.

In 1999 the FDA went through a similar process with sunscreens, but the proposed rule issued then has been on hold for eight years.

Staying the rule meant that manufacturers were encourage to voluntarily follow its recommendations, but the FDA has no policing teeth to use against companies that claim their products last all day or are waterproof, two claims that the 1999 proposal called false.

Douglas C. Throckmorton, M.D., deputy director of the Center for Drug Evaluation and Research, said the FDA had been working on the new sunscreen regulation for several years and he maintained that today's action was not the result of any outside pressure on the agency.

Sunscreen labeling was the subject of a scathing analysis released in June by the Environmental Working Group. That analysis of 785 products found that 84% of those with an SPF of 15or higher did not give users the claimed protection. (See Sunscreen Users Could Get Burned, Assert Critics)