Rep. Maloney presses FDA on tanning bed age restrictions
WASHINGTON – Congresswoman Carolyn B. Maloney (D-NY) today urged the Food and Drug Administration (FDA) to move forward with a proposal to ban the use of tanning beds by minors. Maloney first called for the restriction in a letter to FDA in June 2014. The FDA responded in November, indicating that an age restriction rule had been submitted to the Office of Management and Budget for review, but no action has been taken since.
“Thanks to the FDA, every tanning bed now has a warning label explaining the risks to those under 18,” said Maloney. “That’s an important first step. Yet given the known health risks tanning beds present, especially to minors, along with the steep climb in skin cancer rates we’ve seen over the last two decades, children really shouldn’t be allowed to use these devices. I’m pleased the FDA appears to be moving in this direction, and I’m urging them to act as quickly possible to enact these important protections.”
Maloney led the fight to reclassify tanning beds as Class II medical devices. Under the new classification, the FDA now requires black box warning labels on all tanning beds, indicating that the products should not be used by those under the age of 18. Manufacturers are also required to include additional warnings in their marketing materials and show that their products meet performance testing requirements. Maloney’s TAN Act, which passed as part of the FDA Amendments Act of 2007, required the FDA to study the efficacy of warning labels for tanning beds and began the process that led to this reclassification of UV tanning lamps as Class II medical devices, which was finalized in May 2014.
In 2013, Maloney formed the Congressional Skin Cancer Caucus, which she co-chairs with Reps. Charles Dent (R-PA), Jim Cooper (D-TN), and David Joyce (R-OH), in an effort to bring greater attention on Capitol Hill and to the public at large about this public health crisis.
Maloney’s letter to the FDA follows:
April 8, 2015
Dr. Stephen Ostroff
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Dr. Ostroff:
Thank you again for your continued efforts to protect the public from excessive Ultraviolet (UV) radiation from tanning beds. I strongly supported the agency’s decision last June to reclassify UV tanning lamps as Class II medical devices and, as you know, believe additional steps are warranted to protect minors from the risks of tanning beds. In response to a letter I wrote to Dr. Hamburg calling for the FDA to prohibit minors from using tanning beds, the FDA indicated that further protections were under consideration. Additional restrictions on minors’ use of tanning beds would be another welcome step in the fight against skin cancer and melanoma. I request an update on where the agency stands on developing those additional measures.
As you know, indoor tanning increases the risk of melanoma by 59 percent, and the American Cancer Society estimates that 9,940 Americans will die from melanoma just in 2015. These troubling figures urge swift action to address the swelling public health crisis of skin cancer. Indeed, a 2014 study published in Mayo Clinic Proceedings found that incidence of skin cancer for women had increased 24-fold between 1970 and 2009.
I applaud FDA’s final order in June 2014 to re-classify UV tanning lamps as Class II medical devices, and impose additional controls on their use including a black-box warning for those under 18 years old. This announcement was a strong first step to stem the alarming growth in skin cancer and melanoma.
Yet, I remain concerned about the use of tanning beds by young Americans, and particularly young women. In spite of widely available information on the dangers of UV tanning lamps, American adolescents continue to use these dangerous products at high rates. According to the CDC, 20.2 percent of female high school students used tanning devices in 2013, and the rate climbed to 27.2 percent for 12th-grade female students. However, evidence from the states shows that laws to restrict the use of tanning for minors reduce this dangerous behavior, particularly among female high school students.
I welcomed FDA’s response, dated November 17, 2014, which indicated that the Agency was developing proposed restrictions on indoor tanning lamps. Can you please provide me an update on when the agency plans to move forward with this proposal and submit a rule for review and comment? This critical public health issue requires continued attention and further action. I look forward to hearing more about FDA’s efforts.
Thank you again for your attention to this important health concern.
CAROLYN B. MALONEY
Member of Congress