FDA proposes sunblock testing

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The Food and Drug Administration yesterday proposed requiring makers of sunscreen products to test — for the first time — for the level of protection against ultraviolet A rays, which are harmful to the skin over a long period.

The agency is proposing a new rating system that would rank sunscreens and some cosmetic products on how effectively they block ultraviolet A, or UVA, rays. Under the new proposal, the products would receive one to four stars, designating how well they block UVA rays. The protection level would be described as low, medium, high and highest.

In addition, the FDA is calling for new warning language on sunscreens that would tell consumers that exposure to the sun increases the risk of skin cancer and can cause premature aging. The agency would not allow manufacturers to purport that their products can prevent skin cancer because no data suggests it can, said FDA scientist Matt Holman.

The proposed rules would keep in place the sun-protection factor, or SPF, rating system for UVB protection but propose capping the SPF claims that companies can make at 50-plus.

"The proposed one- to four-star rating of a sunscreen's UVA protective effect will allow consumers to more easily understand the degree of protection afforded by a particular product against the long wave, UVA, rays of the sun," said Diane Baker, president of the American Academy of Dermatology Association. "This warning is a measurement of protection against the shorter wavelength rays emitted by the sun."

For more than 30 years, consumers have known the level of protection provided by sunscreens or ultraviolet B rays, the sun's light associated with sunburns. Now the FDA is proposing to require manufactures of sun-protection products to display the level of protection for ultraviolet A sunlight. Both types of sunlight can damage the skin and increase the risk of skin cancer, according to the FDA.

The primary focus of the approximately 3,000 sunscreen products on the market, despite manufacturers' claims that their sunblocks protect against UVA rays, historically has been to protect against ultraviolet B rays, the FDA said. Large sunscreen manufacturers include Johnson & Johnson, Playtex Products Inc. and Schering-Plough.

If a manufacturer decides not to test for UVA protection, the FDA is seeking to require it to say "no UVA protection" on the product.

The measure probably will not take effect for at least a year because the agency must collect public comments, make revisions and then publish a final rule.

More than 1 million Americans are diagnosed each year with skin cancer, the leading type of cancer, according to the American Cancer Society. Melanoma, a type of skin cancer, can be life threatening.

Yesterday's proposal comes after more than a decade of research on the effect of ultraviolet A rays on people's skin.

"We've been working on this for a number of years. The science has gotten tight enough for us to do something," said Doug Throckmorton, deputy director for the Center for Drug Evaluation and Research.

Dr. Holman added that the reason for the delay in proposing UVA testing standards and labeling requirements stems from a lack of consensus among scientists and manufacturers on the best available testing method for UVA rays.

He said that 16 tests are used to determine UVA protection and that "nobody knows the best one."

The FDA ultimately decided on a test that combines lab work and tests performed on people. The final UVA star rating will be the less protective of the two tests, Dr. Holman said.