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FDA reclassifies tanning bed risk, requires warnings on products
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The U.S. Food and Drug Administration today issued a final order that reclassifies sunlamp and ultraviolet lamp products used for indoor tanning from low-risk to moderate-risk devices.
The agency’s ruling also requires that sunlamp products carry a visible black box warning stating that the products should not be used by children aged younger than 18 years. Additionally, certain marketing materials for the devices must include specific warning statements and contraindications, including warning of skin cancer risk.
“The FDA has taken an important step today to address the risk to public health from sunlamp products,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “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 18 and people with a family history of history of skin cancer.”
Manufacturers of sunlamp products and ultraviolet lights intended for use in the products will now have to submit a premarket 510(k) notification to the FDA and obtain clearance from the agency before marketing the devices. The products must be shown to meet certain performance testing requirements and design characteristics, the release stated.
Brett M. Coldiron
“Restricting teens’ access to indoor tanning is critical to preventing skin cancer,” Brett M. Coldiron, MD, FAAD, president of the American Academy of Dermatology, said in a separate press release. “As medical doctors who diagnose and treat skin cancer, dermatologist are committed to reducing its incidence and saving lives. Therefore, we will continue to communicate the FDA the need for stricter regulations on the use and sale of indoor tanning devise for minors under the age of 18.”
The FDA’s final order for reclassification follows the recommendations from a March 2010 panel meeting of outside experts, according to the release. There was a public comment period after the FDA released the proposed order in May 2013.