FDA orders warning labels on tanning beds

The Food and Drug Administration announced on Monday afternoon they would be placing stricter rules on UV lights, tanning beds and tanning booths – making them subject to agency approval.

The Federal Food, Drug, and Cosmetic Act gives FDA the authority to reclassify products if new safety information is made available.

In 2010, an FDA advisory panel asked the regulator to take action on tanning beds, citing serious health concerns – including skin cancer, potential eye damage and early aging -- and the agency began to seek feedback on the findings.

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The FDA said Monday that out of the document’s 139 total comments, only six disapproved of more regulation.

Last December, the American Cancer Society wrote to the Department of Health and Human Services, charging Secretary Kathleen Sebelius with ignoring the panel’s 2010 report.

“Sunlamps used for tanning are currently regulated by FDA as Class I medical devices. This classification is reserved for the lowest risk products such as tongue depressors and bandages and is inappropriate for a product that has been elevated by the International Agency for Research on Cancer (IARC) to its highest cancer risk category – ‘carcinogenic to humans,’” wrote Dr. Len Lichtenfeld, the American Cancer Society’s deputy chief medical officer, in the letter.

The lights in tanning beds and booths will now become Class II medical devices, according to the proposed order, which will be published on Tuesday.

Under the new draft rules, manufacturers would have to prove to the FDA the devices are safe for individuals and take steps to adjust UV wavelength to “appropriate” levels, install alarms and timers to prevent sunburn, among other health- and safety-conscious efforts.

Users would also have to read labels warning them of the dangers of UV exposure, including discouraging individuals under the age of 18 or those with a family history of cancer.

“Clear communication of these risks and identification of susceptible populations would help potential users make an informed choice about use of sunlamp products and mitigate the increased risk of skin cancer,” wrote Leslie Kux, the assistant commissioner for policy at the FDA, in the Federal Register document.

The agency, though, notes that the safeguards might not stop all use by young people.

“One study reported that 47 percent of college students had reported using a sunlamp product during the last year because it improved their appearance, despite 92 percent being aware of potential health risks,” the proposal noted.