The US Food and Drug Administration announced on Thursday that it will now require sunlamps used in tanning salons to carry a black-box warning stating that the product should not be used by children under the age of 18. But the action falls short of what the agency’s own advisory committee recommended in 2010: a federal government ban on the use of tanning beds in teens, similar to the ban in place for selling tobacco to minors.
Materials used to market the UV lamps and tanning beds -- like websites, brochures, or user instructions -- must now include information on cancer risks including a recommendation that regular tanning bed users “should be regularly evaluated for skin cancer” due to repeated exposure to the lamps UV radiation and that the use of UV lamps can be particularly dangerous for those with a family history of skin cancer.
The agency reclassified the devices as “moderate-risk” from “low-risk” and now requires manufacturers to demonstrate that their products meet certain performance testing requirements and have certain elements in their product design in order to receive FDA clearance to put them in tanning salons or to sell them directly to consumers.
“The FDA has taken an important step today to address the risk to public health from sunlamp products,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Repeated UV exposure from sunlamp products poses a risk of skin cancer for all users.”
Those who use an indoor tanning salon, even once, have a 59 percent increased risk of melanoma, the deadliest type of skin cancer, according to the American Academy of Dermatology. The risk increases each time they use a tanning bed since radiation exposure is cumulative.
“The FDA’s decision to more strictly regulate tanning beds will save lives,” Tim Turnham, executive director of the non-profit Melanoma Research Foundation, said in a statement. “Now, it’s critical for every parent, family physician, schoolteacher and public health advocate to promote greater understanding of the grave risk people, especially young people, take when they enter a tanning bed.”
During a press briefing, Nancy Stade, the FDA’s deputy director for policy, said the agency considered enacting a ban on the use of tanning beds in minors but that FDA officials ultimately determined that the regulation they issued was an “adequate measure” to inform consumers and help them make better decisions about whether to use tanning beds.
A handful of states, including Vermont, New York, and New Jersey, have banned those under 18 from using tanning beds, and Massachusetts is currently considering a bill, though the legislation has been put on hold for years. The state currently requires minors to get written parental consent before tanning; those under 14 need to be accompanied by a parent or guardian.
The federal health care law added a 10 percent “sin” tax on tanning beds, in an effort to reduce the estimated 2.3 million teens who visit indoor tanning salons each year.
Manufacturers of new sunlamp products must apply to the FDA for clearance before they can market them. Those with products already on the market have up to 15 months to submit paperwork to the agency.
The Indoor Tanning Association, a trade group that represents sunlamp manufacturers, submitted comments to the FDA after the rule was first proposed a year ago, stating that “sunlamp products are not medical devices but instead are electronic products” and that reclassifying them into a higher risk category is “contrary to law” and “exceeds the agency’s statutory authority.” The group has not yet decided whether to file a lawsuit against the FDA to try to thwart the new regulation, executive director John Overstreet said in an interview.
“We’ve always maintained that the science isn’t there on the risks of sunlamps,” Overstreet said. “We’re disappointed that [the FDA] decided to go this route.”Deborah Kotz can be reached at email@example.com. Follow her on Twitter @debkotz2.