The Food and Drug Administration on Thursday announced stricter regulation of tanning beds that are used by millions of Americans. The agency said that it would require manufacturers to put a black-box warning — one of its sternest — on the devices stating that they should not be used by anyone under the age of 18, but stopped short of banning their use by minors.
Indoor tanning before the age of 35 increases the risk of developing melanoma, the deadliest type of skin cancer, by 59 percent to 75 percent, studies have shown.
Manufacturers will also have to assure the agency and consumers that tanning beds do not deliver too much ultraviolet radiation, potentially causing burns, and that timers or alarms intended to prevent the overuse of the tanning beds work properly.
The agency reclassified so-called sunlamp products, which include tanning beds and booths, from low-risk items like adhesive bandages to moderate-risk ones. That change will allow the agency to review the safety and design of tanning beds before they are sold. Manufacturers will have to get F.D.A. clearance before they can market the products.
“It’s huge,” said Dr. Eleni Linos, an assistant professor of dermatology at the University of California, San Francisco. “We’ve been trying to get the F.D.A. to change its rules both on labeling and classification of tanning beds for a really long time. It indicates the F.D.A. is finally taking into account the evidence that tanning beds are dangerous.”
By late 2015, the agency will expect manufacturers to stop selling models that do not meet the new standards.
John Overstreet, the executive director of the Indoor Tanning Association, which represents tanning facilities, said the new requirement for federal clearance was “going to add another layer of difficulty getting products to market, and certainly the cost will ultimately be borne by the consumer.”
Nearly 30 million Americans use tanning beds each year, and over two million of them are teenagers, according to the American Academy of Dermatology.
Almost three in 10 white girls in high school use tanning beds, and over half of them used sunlamps more than 10 times in the last year, federal data shows.
Repeated exposure to indoor tanning during childhood is associated with the greatest increase in the risk for melanoma, researchers say.
“We think the main driver for the increase of melanoma in young women is their greater use of tanning beds compared with young men,” said Alan C. Geller, a senior lecturer at the Harvard School of Public Health.
Eight states have banned indoor tanning for minors under 18, according to the National Conference of State Legislatures.
The agency’s action falls short of a national ban for minors, but Nancy Stade, the deputy director for policy at the Center for Devices and Radiological Health at the F.D.A., did not rule one out in the future.
A recent study by researchers at the Washington University School of Medicine in St. Louis found that 43 percent of tanning facilities claimed that there were no risks in indoor tanning.
“Now they won’t be able to deny that there’s any risk to indoor tanning because there will be a label and warnings,” said Dr. Mary E. Maloney, a former chairwoman of the regulatory policy committee at the American Academy of Dermatology. In addition to the black-box warning on tanning beds, brochures and websites must also have warnings.
But Sherry Pagoto, an associate professor at the University of Massachusetts Medical School, cautioned that users may not read labels, especially if they are not prominently displayed on tanning beds. She said it was vital to get the message out to parents that children should not use tanning beds, “because in most states, there are parental consent requirements where there aren’t bans.”
Ideally, she said, states will include information about the federal warning on consent forms. “That would be really important information for a parent’s decision,” Dr. Pagoto said. “We can’t just expect them to know.”
Courtesy of The New York Times