WASHINGTON - Tanning beds and sun lamps will carry new warnings that they should not be used by anyone under age 18, part of a government action announced Thursday aimed at reducing skin cancer linked to the radiation-emitting devices.
The Food and Drug Administration has regulated tanning machines for over 30 years, but the agency is now requiring more prominent warnings about the cancer risks of indoor tanning.
Makers of sun lamps and related devices must include a bold label, known as a black box warning stating that they should not be used by people under age 18. Additionally, manufacturers must provide more warnings about cancer risks in pamphlets, catalogues and websites that promote their products. Those materials must warn that the devices shouldn't be used by people who have had skin cancer or have a family history of the disease.
For years, medical groups have urged the U.S. government to take action on tanning beds because of rising rates of skin cancer among teenagers and 20-somethings, particularly women. Over 76,000 new cases of melanoma, the deadliest form of skin cancer, are expected to be diagnosed this year, and the disease is expected to cause 9,710 deaths, according to the American Cancer Society. While most cases are diagnosed in people in their 40s and 50s, the disease is linked to sun exposure at a young age. But melanoma is also the second-most common form of cancer among young adults, according to the American Academy of Dermatology.
An estimated 2.3 million U.S. teenagers tan indoors each year.
A spokeswoman for the American Academy of Dermatology said she hoped the federal move would spur more states to take action. Twenty four states already have laws banning minors from using indoor tanning equipment.
"The FDA has taken a very strong stand about indoor tanning and this will, I think, really encourage additional states to strengthen their indoor tanning restrictions," said Dr. Mary Maloney of the University of Massachusetts Medical School.
The FDA is also requiring manufacturers to meet certain safety and design requirements, including timers and limits on the radiation levels the products produce.
Previously the FDA classified tanning machines as low-risk devices, in the same group as bandages and tongue depressors. As part of Thursday's action the FDA reclassified all tanning beds and sun lamps as higher-risk, class II devices. The switch allows FDA to review their safety and design before manufacturers begin selling them.
An industry spokesman said the new requirements would drive up costs for companies, which would likely be passed on to consumers.
"It would be a lot better if the FDA had not decided to place another layer of regulation, another layer of costs and difficulty on an already struggling industry," said John Overstreet, executive director of the Indoor Tanning Association. "We're obviously disappointed that they decided to take this step."
The association represents makers of various tanning products - including tanning beds, lotions and sunglasses - and indoor tanning facilities.
Companies will have roughly 15 months to place the warning labels on devices already used in tanning facilities but no longer marketed. Companies looking to sell new devices will have to comply with the new labeling and premarket review requirements in 90 days.
The FDA requirements only apply to makers of indoor tanning devices, not salon operators.
"The FDA is not trying to burden salons but rather to educate consumers who choose to voluntarily use sun lamp products about the potential risks," said FDA deputy director for policy, Nancy Stade, on a call with reporters.