Rep. Rosa DeLauro, Ranking Member on the Labor, Health, and Human Services Appropriations Subcommittee, sent the following letter to Dr. Margaret Hamburg, Commissioner of the Food and Drug Administration, urging the agency to act on recommendations made two years ago to regulate tanning beds.
The Congresswoman included a letter from two leading melanoma experts, Dr. David Fisher and Alan Geller, in support of her call for action. Melanoma is the most common cancer diagnosed in young adults and the most deadly type of skin cancer. The National Cancer Institute estimates that 76,250 Americans will be diagnosed and that more than 9,100 Americans will die because of melanoma in 2012.
Though they are internationally recognized as carcinogens and their use is associated with a greater risk of skin cancer, tanning beds are currently classified in the same device category as band aids and tongue depressors. They are not appropriately classified or labeled with the health information that could help Americans make informed choices about the use of these known carcinogens. Congresswoman DeLauro has consistently called for stronger regulation of these devices, but the FDA has yet to act.
“During the two-year period since that hearing, we estimate that tanning bed use is primarily responsible for more than 5,000 cases of new melanomas in women resulting in an estimated 750 unnecessary deaths,” Dr. Fisher and Geller’s letter states. “How can the established skin cancer risk from tanning beds be continuously permitted, in the face of so much scientific and clinical evidence?”
“As a member of Congress, and a cancer survivor, I simply cannot accept this inaction,” Congresswoman DeLauro’s letter states. “When will we have honest and accurate regulations and labels in place to protect Americans and end these unnecessary deaths caused by an inappropriately-regulated device?”
The Letter
Margaret Hamburg, M.D.
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993 – 0002
Dear Commissioner Hamburg:
Enclosed is a copy of a letter that I received from leading melanoma experts Dr. David Fisher and Allan Geller. I urge you to read it and share it with your colleagues immediately, as it raises a very serious question: does our government have an obligation to ensure that current science is utilized to protect citizens exposed to known carcinogens. In this case, that includes the use of tanning beds.
Nearly two years ago, the General and Plastic Surgery Devices Panel of the Food and Drug Administration (FDA) Medical Devices Advisory Committee met and discussed this subject. The scientists at that meeting, including Dr. Fisher, made compelling remarks on the carcinogenic dangers of unregulated tanning bed use.
The scientific data supporting the need for effective, appropriate regulation of tanning beds is overwhelming. For example, we know that melanoma is the most common cancer diagnosed in young adults and that an individual’s risk of melanoma increases by 75 percent if they begin using tanning beds before they are 30 years old. Women using tanning beds more than once a month are 55 percent more likely to develop melanoma than women that do not use tanning beds at that frequency. And, unfortunately, while the incidences of many cancers are decreasing, the incidence of melanoma continues to rise.
The Advisory Committee made clear recommendations in March 2010 to better protect the public from these loosely regulated carcinogenic devices. But the FDA has yet to act on those recommendations.
Since that time, without any further action by the FDA, an American has died every day. That will continue until the FDA acts decisively to properly regulate and label this known carcinogen. These deaths are largely preventable, and continued inaction is simply unacceptable.
I asked you last week, when you appeared before the House Appropriations Subcommittee on Agriculture when we would see action. That was before I received this letter. As a member of Congress, and a cancer survivor, I simply cannot understand this continued inaction.
When will we have honest and accurate regulations in place to protect Americans and end these unnecessary deaths caused by an inappropriately-regulated device? On March 25, 2012 we will reach the two-year anniversary of the Advisory Committee meeting. I am incredibly discouraged that the agency is unlikely to have improved regulations for tanning beds by this anniversary. What is the agency’s timeline for moving forward on this issue to protect the public health? Will the agency act on the March 2010 recommendations before May 25, 2012?
