Urges Warning Labels to be Revised and to be Featured More Prominently
Washington, DC – Congresswoman Rosa L. DeLauro (D-CT) today sent a letter to Commissioner Margaret Hamburg of the Food and Drug Administration (FDA) urging the FDA to expedite its review and promulgation of regulations in order to reclassify indoor tanning devices to reflect the threat these devices pose, and require warning labels to be located in a prominent location so that they could be seen by consumers.
“The agency’s current regulations on indoor tanning devices do not match the severity of the health threat these devices pose,” said Congresswoman DeLauro. “Currently, indoor tanning devices are subject to the same restrictions as those imposed on tongue depressors and bandages, and that is unacceptable given that 11,600 people die each year from skin cancer. Urgent action is needed by the FDA because this is one of the few cancers for which a preventative option truly exists.”
The full text of the letter is as follows:
October 21, 2009
Margaret Hamburg, M.D.
U.S. Food and Drug Administration
U.S. Department of Health and Human Services
5600 Fishers Lane
Rockville, MD 20857
Dear Dr. Hamburg:
Thank you very much for your letter of October 5 in which you expressed the commitment of the Food and Drug Administration (FDA) to review current regulations of indoor tanning devices, with the intent to revise warning labels and classification of these devices. The agency’s current regulations do not match the severity of the health threat these devices pose. Therefore, I strongly urge the FDA to expedite its review and promulgation of regulations and revise the warning label and its location for indoor tanning devices as well as their medical device classification.
There is no doubt that tanning devices pose a significant health threat to the American public, particularly to millions of young women who use them on a frequent basis. As you know, recently the International Agency for Research on Cancer (IARC), a working group of the World Health Organization (WHO), added tanning beds to its “Group One” list, meaning tanning beds are considered carcinogenic to humans. The IARC made this designation based on consistent evidence linking UV radiation from indoor tanning devices and all major forms of skin cancer, including melanomas of both the skin and eyes.
However, the FDA currently classifies indoor tanning devices as class I medical devices, which means these dangerous devices are subject to the same restrictions currently imposed on tongue depressors and bandages. While current regulations require manufactures to post a warning label on these devices, in most cases the labels are located on the upper canopy, and out of sight of consumers prior to tanning. I am very concerned that FDA’s classification of indoor tanning devices as ones that present the least risk gives consumers false assurance of the safety of such devices and fails to convey the severity of the health threat.
The science linking indoor tanning devices and cancer is unequivocal, and the threat to the public health is undeniable. Thus, it is imperative that the FDA revise its current warning label and classification of such devices at the earlier possible date. It is for these reasons that I am urging the Agency to expedite its review and promulgation of regulations to revise the warning label and its location for indoor tanning devices as well as their medical device classification.
Each day, 31 people die from skin cancer, and approximately 3,000 people are diagnosed with it. This results in over 11,600 deaths and 1 million new cases each year. Therefore, any delays in acting on this issue are unacceptable because this is one of the few cancers for which a preventative option truly exists.
It is very reassuring that this is an issue on which the agency is focused. Please let me know of the actions, including specific timelines, the FDA intends to take to expedite its review and promulgation of regulations to revise the warning label and its location for indoor tanning devices as well as their classification. I would appreciate a response to this letter and an accompanying action plan by November 16, 2009.
I look forward to working with the Agency to revise and adopt these new standards and regulations to ensure that they reflect the dangers indoor tanning devices pose.
ROSA L. DeLAURO Chairwoman House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies