FDA raises tanning bed risk, orders all beds to display warning

WASHINGTON (WLS) -- The U.S. Food and Drug Administration issued an order Thursday reclassifying tanning beds and other sunlamp devices from low risk to moderate risk and requiring that they carry a "visible black-box warning" that explicitly states the devices are not for use on people under the age of 18.

The FDA has been pushing for the elevated risk level and visible warnings for some time. Research from the American Academy of Dermatology shows that indoor tanning increases a person's risk of melanoma by 59 percent.

"Repeated UV exposure from sunlamp products poses a risk of skin cancer for all users," said Jeffery Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, "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."

As part of the order, manufacturers will now have to submit a premarket notification and obtain FDA clearance before they can market their products, a process from which they were previously exempt. Manufacturers will also be required to show their products meet specific performance testing requirements and will have to include warnings and contraindications in marketing materials that present consumers with clear information on the risks involved in using those products.

In addition to the warning advising against allowing children under 18 to use tanning beds and other sunlamp products, certain marketing materials will also be required to carry additional warnings and contraindications, including a reminder that "Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer."
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