FDA Toughens Sunscreen Rules - Spokane, North Idaho News & Weather KHQ.com

FDA Toughens Sunscreen Rules

USATODAY.COM - Consumers will soon have a way to know how well a sunscreen protects them from skin cancer and wrinkles, not just sunburns.

In a long-anticipated announcement, the Food and Drug Administration said Tuesday that new rules — set to take effect by no later than next summer — will allow sunscreens to claim "broad spectrum" protection against both forms of ultraviolet radiation, called UVA, which causes wrinkles, and UVB, which causes burns. Both forms of radiation can cause skin cancer, according to the American Cancer Society.

Consumer advocates praised the rule, four years in the making, saying that the new labels will be less confusing than current labels and will help people make more informed choices.

Although sunscreens now tout their sunburn protection factor, or SPF, this system only measures protection against ultraviolet radiation B, or UVB, which can cause burns.

New sunscreen labels, which may begin appearing as soon as manufacturers can produce them, will allow products to claim "broad spectrum" protection only if they pass specific FDA tests for blocking UVA rays, and if they have an SPF value of at least 15, says Janet Woodcock, director of the FDA's Center for Drug Evaluation. This is the first standard for UVA.

Products that protect against UVA, but which don't have an SPF of at least 15, will have to carry a warning, Woodcock says. Sunscreens also will have to carry a "drug facts" box that provides detailed information about what products do or don't do.

"This really is quite a remarkable day," says Ronald Moy, president of the American Academy of Dermatology, who spoke at the FDA press conference.

The new labels will give consumers confidence that they're getting very good protection, since the minimum standard for earning the "broad spectrum" label will protect people from 90% of UVA radiation, says Urvashi Rangan, a scientist with Consumers Union, which publishes Consumer Reports.

Rangan says the sunscreen rules — which haven't been thoroughly updated in 20 years — are a "great step forward."

Under the new rule, sunscreens will no longer be allowed to market themselves as "sun block" or "water proof," Woodcock says. Instead, sunscreens will be allowed to call themselves "water resistant" for either 40 minutes or 80 minutes.

In a proposed rule, which has not yet taken effect, the FDA would also bar sunscreens from claiming SPF values above 50, because there is no way to scientifically prove these claims. Instead, sunscreens will be allowed to claim only that products are "SPF 50+."

The FDA also has been looking into the safety of nanoparticles used in many sunscreens, such as those with titanium dioxide or zinc oxide. These particles, which are spectacularly small, do not penetrate the skin, meaning that they don't pose a health risk, Woodcock says.

Consumer groups also have called for greater scrutiny of sunscreen ingredients, arguing that some tests suggest that retinyl palmitate, a commonly used ingredient, could actually increase the risk of skin cancer. Woodcock says FDA research doesn't support this conclusion, however.

But the FDA is looking into the safety of sunblock sprays. At the press conference, officials suggested that consumers take care that wriggling children don't accidentally inhale the sunscreen sprays as they're being applied. Rangan says it's safer to spray the products in one's hands, then apply them manually.

The American Academy of Dermatology recommends both adults and children use a sunscreen with an SPF of at least 30. Babies under 6 months old shouldn't get any direct sunlight, according to the American Academy of Pediatrics.

It may be even more important to use enough sunscreen, says dermatologist Henry Lim, who spoke at the FDA event. He notes that most people get much less sunburn protection than they might think simply because they don't use enough of the product.

The average person needs about 1 ounce of sunscreen — enough to fill a shot glass — to cover the body. Most people use only one-quarter to one-half that amount, Lim says.

More than 2 million Americans are diagnosed with skin cancer each year, according to the Skin Cancer Foundation. While most skin cancers are curable, squamous cell carcinomas kill 2,500 Americans a year and melanoma kills 8,700, according to the American Cancer Society.

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