FDA: Sunlamps, Tanning Beds Require Skin Cancer Warnings

FDA: Sunlamps, Tanning Beds Require Skin Cancer Warnings

The U.S. Food and Drug Administration reclassified sunlamp products and ultraviolet lamps from low-risk to moderate-risk and now requires a warning that sunlamps should not used by those age 18 and younger.

The FDA order requires sunlamp products — which include tanning beds and tanning booths — carry a visible black-box warning on the device that states the product should not be used by anyone age 18 and younger.

In addition, certain marketing materials for sunlamp products and UV lamps must include additional and specific warning statements including: “Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”

Sunlamp products emit UV radiation that may cause skin cancer. The American Academy of Dermatology said people exposed to UV radiation via indoor tanning have a 59 percent increase in the risk of melanoma, the deadliest type of skin cancer.

Manufacturers will have to submit a premarket notification — a “510(k)” — to the FDA and obtain FDA clearance prior to marketing their devices. Before this order, the sunlamp manufacturers were exempt from premarket review.


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