November 5, 2009
Margaret Hamburg, M.D.
Food and Drug Administration
10903 New Hampshire Ave
Building 1, Room 2217
Silver Spring, MD 20993
Re: Tanning Beds
Dear Commissioner Hamburg:
Members of the Patient and Consumer Coalition urge your immediate attention to appropriately regulate tanning devices. As you know, currently, tanning devices are Class I devices (the same as bandages), which is the U.S. Food and Drug Administration’s (FDA) lowest risk device class and does not require comprehensive safety data. Because of inadequate regulation by the FDA, tanning beds are falsely assumed to be safe by too many of the 30 million Americans (including more than 2 million teens) who use these devices every year.
Earlier this year, the World Health Organization’s International Agency for Research on Cancer (IARC) released a report that placed tanning beds in the highest cancer risk category, “carcinogenic to humans.” Previously IARC had classified tanning beds as “probably carcinogenic.” The IARC changed the category after more than 20 epidemiological studies indicated that people who began using tanning devices before age 30 are 75 percent more likely to develop cutaneous melanoma, the most serious type of skin cancer.
The Center for Devices and Radiological Health (CDRH) is responsible for ensuring that medical devices “provide reasonable assurance of safety and effectiveness and do not pose a threat to public health.” Clearly, a device that increases the likelihood of developing the most serious type of skin cancer is a threat to public health. Yet, CDRH cleared tanning beds as Class I devices-the class that receives the least amount of scrutiny by the FDA. These devices have serious risks associated with them and virtually no medical benefit. (Although UV radiation stimulates the skin to synthesize vitamin D, tanning beds are not used on a daily basis and are therefore not a practical strategy for providing vitamin D, especially compared to other, safer options.) These devices warrant increased scrutiny by the FDA to ensure the safety of children and adults that use them. We therefore strongly urge CDRH to stop clearing tanning devices because they do not provide a “reasonable assurance of safety.”
We strongly support Congresswoman Rosa DeLauro’s efforts to enhance the warning label on the devices and to have the devices moved into Class III. We ask that this be done expeditiously–with all newly developed tanning devices reviewed through the premarket approval (PMA) process. We also strongly urge that FDA rescind its clearance of devices currently on the market, and require that they also submit to review through the PMA process, allowing them to be sold only if they can prove that they are safe over the long-term. The safety standards applied by the FDA should be rigorous to balance out the lack of medical benefits. Skin cancer is preventable and removing unsafe devices from the market and requiring higher safety standards in the future will mean that millions of Americans will be less likely to develop the disease.
American Medical Women’s Association
American Public Health Association
Community Access National Network
National Consumers League
National Research Center for Women & Families
National Women’s Health Network
Our Bodies Ourselves
cc: Jeff Shuren, Acting Director for the Center for Devices and Radiological Health
For additional information, contact Paul Brown at the National Research Center for Women & Families, 202-223-4000 or at email@example.com