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FDA Requires Warning on Tanning Beds

Article date: May 30, 2014

By Eleni Berger

The US Food and Drug Administration (FDA) says people under age 18 should not use tanning booths/beds or sunlamps, and these products will now have to carry a warning stating that. The requirement is part of a final order the agency issued Thursday that re-classifies these devices as moderate risk (Class II) instead of low risk (Class I).

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The order also requires warnings on some marketing materials used for sunlamps and tanning devices. One of the warnings says “Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”

Just like tanning in the sun, indoor tanning in a booth/bed or under a sunlamp exposes skin to ultraviolet (UV) radiation and has been linked to an increased risk of skin cancer, including melanoma, the deadliest type of skin cancer.

“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,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, in a statement announcing the new rule.

Thursday’s order follows the recommendations of an FDA panel that said children and teens should not use tanning devices, and encouraged FDA to regulate them more tightly.

Reviewed by: Members of the ACS Medical Content Staff


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