The Food and Drug Administration made good Thursday on a vow to heighten its oversight of sunlamps used in tanning salons, saying additional warnings are needed to educate consumers about the cancer risks involved.
The agency is reclassifying the devices from “low risk” to “moderate risk,” a designation that will require manufacturers to demonstrate to regulators that their products meet certain standards before they are allowed to market them.
In addition, sunlamps used in tanning salons now must include a black-box warning stating that anyone under the age of 18 should steer clear of the products. Marketing materials for the devices also will have to include details about their potential cancer risks, as well as a recommendation that frequent users of tanning beds should get regular checks for skin cancer, given their repeated exposure to UV radiation.
“The FDA has taken an important step today to address the risk to public health from sunlamp products,” Jeffrey Shuren, director of the agency’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—but the highest risk for skin cancer is in young persons under the age of 18 and people with a family history of skin cancer.”
Consumer advocates and medical groups such as the American Academy of Dermatology were quick to praise the FDA for Thursday’s move. The organization said statistics show that 2.3 million teens tan indoors annually, and that the risk of developing melanoma increases by 59 percent for people exposed to UV radiation through indoor tanning.
“Restricting teens’ access to indoor tanning is critical to preventing skin cancer,” the group’s president, dermatologist Brett M. Coldiron, said in a statement. “Therefore, we will continue to communicate to the FDA the need for stricter regulations on the use and sale of indoor tanning devices for minors under the age of 18.”
Thursday’s move comes a year after the FDA announced its intention to move forward with stricter regulations on sunlamps. Since then, the agency said it has received a multitude of comments from patient groups, health professionals and the tanning industry, which has said it take safety seriously but worries about unnecessary and burdensome new regulations.
The FDA’s actions are a first move for the federal government, but numerous states have cracked down on indoor tanning in recent years. Some have outlawed tanning by minors altogether, while others have barred the practice for children under 16 or insisted on parental permission.