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Indoor tanning beds, booths and sunlamps that emit ultraviolet radiation must now carry a visible black box warning that they should not be used by anyone under age 18 because they increase the risk of skin cancer, according to new regulations issued today by the U.S. Food and Drug Administration.
“Repeated UV exposure from sunlamp products poses a risk of skin cancer for all users,” said Dr. Jeffery Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement. “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.”
A black box warning—so called because it is outlined in black—is the sternest warning that the FDA issues while still allowing a product to remain on the market. It is intended to call attention to serious or life-threatening risks.
Dr. Emily White of Fred Hutchinson Cancer Research Center’s Cancer Prevention Program applauded the new regulations.
“UV exposure at young ages, particular extreme exposure leading to sunburns, is the likely cause of melanoma,” she said.
The incidence of melanoma, the most deadly form of skin cancer, has increased dramatically in the last four decades. The American Cancer Society estimates that nearly 13,000 people die each year from skin cancers, 9,700 of them from melanoma. It is the most common form of cancer among young adults.
Researchers point to tanning beds and their accompanying UV radiation as a likely contributor to the rising numbers, particularly with regard to the high rate of skin cancer in younger women. According to the American Academy of Dermatology, 2.3 million U.S. teenagers tan indoors each year even though indoor tanning increases the risk of developing melanoma by 59 percent. The risk goes up with each use.
The FDA on Thursday reclassified sunlamps from a class 1 “low-risk” device to a class 2 “moderate risk.” The new regulations also mandated that marketing materials such as web sites, brochures and instructions carry additional warnings, including this one: “Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”
As much as she welcomes the new warnings against indoor tanning, the Hutch’s White reminds people to protect themselves against outdoor tanning as well. Melanoma is most commonly diagnosed in people in their 40s and 50s, but the disease is linked to sun exposure at a young age.
“Young children and teenagers should avoid being in the sun or use high SPF sunscreen or protective clothing, in addition to avoiding sun lamps and sun beds,” White said.
Mary Engel is a staff writer at Fred Hutchinson Cancer Research Center. Previously, she was a writer covering medicine and health policy for newspapers including the Los Angeles Times, where she was part of a team that won a Pulitzer for health care reporting. She also was a fellow at the year-long MIT Knight Science Journalism program. Reach her at firstname.lastname@example.org.
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