FDA Proposes New Risk Classification for Sunlamps

The agency's proposed order would require labels that include a recommendation warning young people not to use them.

The U.S. Food and Drug Administration issued a proposed order May 6 to reclassify sunlamp products and require labels that warn young people not to use them. According to the American Academy of Dermatology, there is a 75 percent increase in the risk of melanoma, the deadliest type of skin cancer, among people 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 provides a warning about 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 Dr. 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 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 labeling would have to include a warning that frequent users of sunlamp products should be screened regularly for skin cancer.

FDA will take comments on the proposed order for 90 days.

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  • OHS Magazine Digital Edition - January 2019

    January 2019

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