FDA Issues Final Order Requiring Warnings on Sunlamps
FDA's final order requires a warning label on sunlamp products and UV lamps that states they should not be used by anyone under 18.
The FDA has issued a final order regarding the reclassification of sunlamp products and UV lamps intended for use in sunlamp products from low to moderate risk devices, according to a press release from the FDA. The FDA's order requires sunlamp products to carry a "visible black-box warning on the device that explicitly states that the sunlamp product should not be used on persons under the age of 18 years." The final order also requires certain marketing materials for sunlamp and UV products contain warning statements.
Due to the final order, manufacturers will now have to submit a premarket notification to the FDA to obtain FDA clearance before marketing their devices. Previously, the devices were exempt from premarket review. The manufacturers must provide information showing their products meet certain performance testing requirements and address certain product design characteristics, while also including certain warning and contraindications.
The FDA has taken these steps because sunlamp products, such as tanning booths, emit UV radiation that could cause skin cancer. People who have been exposed to UV radiation from indoor tanning experience a 59 percent increase in the risk for melanoma, according to the agency.
"The FDA has taken an important step today to address the risk to public health from sunlamp products," said Dr. Jeffrey Shuren, M.D., director of FDA's Center for Devices and Radiological Health. "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."