FDA Sets New Labeling Rules for Sunscreens - WSJ.com
http://online.wsj.com/article/SB1000142405270230466590457...
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HEALTH INDUSTRY
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JUNE 15, 2011
Sunscreens Get New Labeling Rules By JENNIFER CORBETT DOOREN
The U.S. Food and Drug Administration released long-awaited sunscreen regulations Tuesday requiring products to pass certain effectiveness tests and adopt new labels designed to make it easier for consumers to choose a sunscreen. The SPF (sun-protection factor) number on sunscreens is currently based on how well and how long the product protects against ultraviolet B (UVB) rays that primarily cause sunburn, not UVA rays. Both types of rays contribute to wrinkles and skin cancer. The new regulations will require products that are labeled "broad spectrum"—as is the case with many currently marketed ones—to pass tests for both UVB and UVA rays. Sunscreens that don't offer enough protection against UVB and UVA rays will be required to carry a warning label stating that the products haven't been shown to prevent skin cancer. Although currently marketed "broad spectrum" sunscreens do offer protection against UVA rays, there is currently no standard.
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Sharon Doyle puts sunscreen on the arm of 9-year-old Savannah Stidham as they visit the beach in Fort Lauderdale, Fla.
"You can be labeled broad spectrum and have wimpy UVA protection," explained Janet Woodcock, the head of FDA's drug division. Right now there's no way for consumers to tell how much UVA protection they are getting when they use a "broad spectrum" sunscreen.
Sunscreens that meet the new "broad spectrum" tests and receive a SPF rating of 15 or higher will be allowed to state that they reduce the risks of skin cancer and signs of early skin aging if used as directed and in combination with other sun protection measures. Sunscreens that have an SPF rating less than 15 will be required to carry a warning label saying the product hasn't been shown to help prevent skin cancer or early skin aging. Large companies, including Merck & Co., which sells Coppertone, and Johnson & Johnson's Neutrogena unit will have a year to make changes to product labels. Companies with annual sales of less than $25,000 will have two years to comply, the FDA said. In 2007, the FDA had proposed a "star" rating system for sunscreens but that plan was dropped. Dr. Woodcock said that many of the 3,000 comments the agency received on the proposal said it was confusing. She said the new rules are simple. Consumers looking for the most protection will be able to look for products that are labeled
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FDA Sets New Labeling Rules for Sunscreens - WSJ.com
http://online.wsj.com/article/SB1000142405270230466590457...
to help prevent skin cancer. The rules will also require companies to drop terms like wateror sweat-proof and instead pass a test for water resistance to keep a water claim on the label. The FDA issued new guidelines for sunscreens Tuesday requiring products to pass certain effectiveness tests and adopt new labels that make it easier for consumers to choose a sunscreen. Jennifer Corbett-Dooren reports.
The FDA announced a separate proposal that would cap the maximum SPF value at "50+," on the grounds there aren't enough data to show products with a value higher than 50 offers more protection.
Rep. Nita Lowey, (D., N.Y.), who has been pushing the FDA to issue new sunscreen regulations for several years, said the new rules "are an important first step." She said she still believes the products that offer appropriate UVB and UVA protection should carry some type of symbol, such as a star, so consumers can easily figure out which sunscreens help prevent skin cancer.
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