Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061 (HFA-305)
Rockville, Maryland 20852
August 7, 2013
Comments of the Patient, Consumer, and Public Health Coalition
on Proposed Order
“General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products”
[Docket No. FDA-2013-N-0461]
As members of the Patient, Consumer, and Public Health Coalition, we urge you to finally follow the recommendations made by FDA classification panels in 1977 and upclassify sunlamp products. All sunlamps should be reclassified as Class III devices because of their known risks, especially the increased likelihood of developing the most serious type of skin cancer.
By law, high-risk devices that can cause substantial harm or even death are Class III. Clearly, sunlamps satisfy those criteria.
Over 30 million Americans, including 2 million adolescents between age 11 and 18, use tanning devices each year. Those who began using tanning beds before age 30 are 75 percent more likely to develop cutaneous melanoma, a potentially fatal cancer. There are virtually no medical benefits to using sunlamp products. Despite claims, there is no clear evidence that sunlamp products are safe and effective for treating depression, seasonal affective disorder, or vitamin D deficiency. A device that has only minor cosmetic benefits and that the World Health Organization’s International Agency for Research on Cancer has called “carcinogenic to humans” is a threat to public health and should be more strictly regulated.
While we agree with the FDA that sunlamp products should be reclassified, we do not agree that the proposed special controls will adequately protect consumers from the harms associated with indoor tanning. We strongly urge the FDA to require the following safeguards:
- Sunlamp products currently are allowed to use a mix of UVA and UVB rays. FDA should set a standard for the UVA/UVB mix that is based on scientific research. Performance testing should disclose the percent of UVA and UVB rays used and this information should be included in labeling.
- Because of how sunlamps are used, even the best labeling would not be sufficient to inform consumers of the risks of using sunlamp products. Patients should have to read and sign a patient disclosure form prior to a tanning session. This disclosure form, written at a 6th grade reading level, should briefly describe the risks of indoor tanning, skin cancer warning signs, and recommended limits on using sunlamps for tanning. Copies of the disclosure form should be given to consumers to take home.
- Tanning facilities should be required to post very visible warning information about cancer risks in waiting/reception areas and also on or near the machine itself.
- The American Academy of Pediatrics and American Academy of Dermatology both recommend banning minors from tanning salons. We strongly agree. If no ban is imposed, parents should be required to sign informed consent forms in person at the time a minor is using the tanning facility.
- The FDA should consult with scientific advisors to create a recommended limit on sunlamp use for tanning. The limits should include time per exposure, amount of UV radiation per exposure, and number of exposures per year. Customers should be limited to a number of minutes per year that the FDA advisors consider safe. Recommended limits should be included on labels, posted warnings, and patient disclosure forms. Safety and performance testing of sunlamp products should meet the limits.
The classification of sunlamp products should reflect the known safety risks and lack of medical benefits of these devices. Skin cancer is preventable, and requiring higher safety standards for unsafe devices will reduce healthcare costs and save millions of Americans from developing this disease.
American Medical Women’s Association
American Public Health Association
Cancer Prevention and Treatment Fund
Connecticut Center for Patient Safety
National Consumers League
National Physicians Alliance
National Women’s Health Network
Our Bodies Ourselves
Center for Science and Democracy, Union of Concerned Scientists
For more information, contact Paul Brown at (202) 223-4000 or email@example.com
 The General and Plastic Surgery Device Classification Panel and the Physical Medicine Device Classification Panel.