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Tanning beds will no longer be considered as harmless as dental floss or a Band-Aid under new regulations unveiled today. Until now the U.S. Food and Drug Administration has lumped all three items into the same regulatory class. None of those devices have needed to clear expert scrutiny or submit health and safety information before going to the market. Now the FDA will treat tanning beds and sunlamps like other devices that expose users to radiation, such as CT scanners. This new action is “very important to ensure that people who use tanning [beds] are fully informed of the risks associated with tanning,” says Nancy Stade, deputy director for policy at the FDA’s Centers for Devices and Radiological Health.
Years of data have linked the sunlamps to dangerous forms of cancer-causing radiation. Indoor tanning is currently estimated to cause about 419,000 cases of skin cancer every year, according to the U.S. Centers for Disease Control and Prevention—almost double the number of cases of lung cancer linked to smoking. Melanoma, the most lethal form of skin cancer, is the second-most common cancer among women in their 20s in the U.S. And many experts point to the surge in tanning bed use (and subsequent elevated melanoma risk) as a key factor in those figures. People under the age of 35 who use tanning beds and sunlamps increase their melanoma risk by 59 percent and the probability increases with each use. The devices have also been linked to eye damage such as cataracts. Five years ago the World Health Organization’s cancer division moved the devices into the highest cancer risk category—“carcinogenic to humans.”
Tanning is inherently a cellular response to injury. When skin cells are damaged by ultraviolet light they produce more pigment, which makes skin appear darker. Sunbeds emit two kinds of ultraviolet rays, called UVA and UVB. Exposure to these rays can damage the DNA in skin cells, which increases the risk of developing cancer.
Tanning beds, as part of new FDA action, will now come with a new mandatory warning label that advises minors under the age of 18 not to use the sunlamps (although it will still be legal to do so). Other warnings will have to appear either on tanning salons’ Web sites, brochures or pamphlets. Those warnings will state tanners face an amplified risk of skin cancer that increases with repeated sunlamp use, and the devices should not be used by individuals with open wounds or a family history of skin cancer.
A panel that advised the FDA first proposed such changes about four years ago. The FDA proposed a version of the new regulatory changes last May. Its final rules stopped short of following the advice of some advisory panel members who said the agency should ban minors from using tanning beds. California, Illinois, Minnesota, Nevada, Oregon Texas and Vermont have already done so.
The final order will become effective in 90 days, so manufacturers of new devices will need to start submitting data to the FDA about product safety before their products receive clearance to go on the market. Existing devices will need to comply within 450 days.
Indoor tanning is estimated to be a more than $2-billion business in the U.S. Brazil and one state in Australia—New South Wales—have banned the practice completely. Meanwhile a bevy of European Union countries, including the U.K., Austria, France and Italy, as well as Norway and Iceland have banned indoor tanning for minors.
Indoor tanning does not protect a user against sunburn because the resulting tan only provides a sun protection factor (SPF) of roughly 3. By comparison, sunscreens come with SPF 15, 30, 55 or greater.
