U.S. Food and Drug Administration
FDA News Release (FDA)
May 7, 2013
Today, the U.S. Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.
According to the American Academy of Dermatology, there is a 75 percent increase in the risk of melanoma, the deadliest type of skin cancer, in those who have been exposed to ultraviolet radiation from indoor tanning, and the risk increases with each use. The proposed order does not prohibit the use of sunlamp products by those under the age of 18, but it provides a warning on the consequences.
The order would reclassify sunlamp products from a low risk device (class I) to a moderate risk device (class II).
“Using indoor tanning beds can damage your skin and increase your risk of developing skin cancer,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s proposed changes will help address some of the risks associated with sunlamp products and provide consumers with clear and consistent information.”
If the order is finalized, manufacturers would have to submit a pre-market notification (510(k)) to the FDA for these devices, which are currently exempt from any pre-market review. Manufacturers would have to show that their products have met certain performance testing requirements, address certain product design characteristics and provide comprehensive labeling that presents consumers with clear information on the risks of use. The order proposes to include a contraindication against use on people under 18 years old, and the labeling would have to include a warning that frequent users of sunlamp products should be regularly screened for skin cancer.
The FDA will take comments on the proposed order for 90 days.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.