FDA Updates Sunlamp Warnings

An order reclassifying sunlamp products and ultraviolet (UV) lamps from low-risk (Class I) to moderate-risk (Class II) has been finalized by the U.S. Food and Drug Administration (FDA). The order will also require sunlamp products to carry visible black-box warnings on the device stating the sunlamp product should be used on persons older than 18 years that will be visible to consumers.

Sunlamp products refer to tanning beds and booths that emit UV radiation that have the potential to cause skin cancer. People exposed to UV radiation from indoor tanning experience a 59 percent increase in the risk of melanoma, a deadly skin cancer, according to the American Academy of Dermatology.

The agency’s final order of sunlamp products and UV lamps follows recommendations from a panel meeting of outside experts dating back to March 2010. The panel was charged with evaluating the risks associated with sunlamp products and recommended the agency increase regulation of these devices as well as recommending children and teens not use these products because they have the highest risk for skin cancer.

“The FDA’s decision to more strictly regulate tanning beds will save lives and serve as a valuable resource in efforts to slow down the increasing rate of melanoma, particularly in the young. By classifying tanning beds as Class II devices, tanning salons will now be required to demonstrate they are properly maintaining their equipment,” Tim Turnham, executive director for the Melanoma Research Foundation.

The FDA’s press release regarding the final order on sunlamp products can be read in its entirety on the FDA Website.