FDA Mandates ‘Black Box’ Warning Label On Tanning Beds

May 29, 2014 by  

FDA Mandates ‘Black Box’ Warning Label On Tanning Beds, The U.S. Food and Drug Administration said tanning beds and booths now have to carry a warning label that they should not be used by people below the age of 18 because of a higher risk of skin cancer.

The regulator also said makers of tanning beds and booths now have to obtain regulatory approval before putting them on the market. (

The FDA said it imposed the new requirements after deciding that tanning beds and booths that use ultraviolet lamps pose a moderate risk of causing skin cancer, up from the previous classification of low-risk.

The decision is based on a study by the American Academy of Dermatology that found people exposed to ultraviolet radiation from indoor tanning faced a 59 percent higher risk of melanoma, a deadly form of skin cancer.

“Repeated UV exposure from sunlamp products poses a risk of skin cancer for all users – but the highest risk for skin cancer is in young persons under the age of 18 and people with a family history of skin cancer,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

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