DELAURO CALLS FOR ACTION ON TANNING BEDS CLASSIFICATION

Washington, DC— Congresswoman Rosa DeLauro (CT-3), Ranking Member on the Labor, Health, and Human Services Appropriations Subcommittee, called today for the FDA to move forward with the re-classification of tanning beds as medical devices to better inform the public about the potential health threats tanning beds pose.

Currently, tanning beds are classified as Class I devices, which is the same class that band aids are included in. This is despite overwhelming evidence that tanning beds increase the risk for basal cell carcinoma and melanoma, the deadliest form of skin cancer. DeLauro originally called for this change in July of 2009, and a March 2010 Advisory Committee recommended that the agency reclassify these known carcinogens. But no progress has been made since then.

"Tanning beds do not belong in the same regulatory category as cotton swabs and bandages when considering a risk-based system. They are dangerous, cancer causing devices that must be treated as such," said Congresswoman DeLauro. "I urge the agency to act on the March 2010 Advisory Committee recommendations regarding the medical device classification of tanning beds – the health of the American public should not have to continue to wait for the agency to act on the recommendations of an Advisory Committee."

The text of the letter is below.

February 03, 2012

Margaret Hamburg, M.D.

Commissioner

U.S. Food and Drug Administration

U.S. Department of Health and Human Services

10903 New Hampshire Ave

Silver Spring, MD 20993-0002

Dear Commissioner Hamburg:

I write to strongly urge you to move forward with the medical device reclassification of tanning beds.

The FDA's General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee convened in March 2010 to address the issue of reclassification of tanning beds. At the time, the Advisory Committee unanimously recommended that these carcinogens no longer be classified as Class I devices – the same category that products generally recognized as safe, including band aids and tongue depressors, fall under.

Almost two years later, we have not seen any progress since the Advisory Committee made its recommendations to the agency. In the Fiscal Year 2012 House report for the agency, the Congress encouraged the agency "to act in a timely fashion to finalize its review and make formal recommendations regarding this classification." Yet, we are still waiting.

Tanning beds are considered carcinogens by the World Health Organization's International Agency for Research on Cancer (IARC). In 2009, the IARC noted that "tanning beds can be deleterious to…health" and urged "governments to formulate restrictions and regulations" for their use.

Moreover, there is an overwhelming body of scientific literature that illustrates the association between skin cancers and the use of tanning beds. The IARC has shown that melanoma risk, the deadliest form of skin cancer, is increased by 75 percent if tanning bed usage begins before the age of 30. Research from the Yale Cancer Center showed that young people who have ever tanned indoors have a 69 percent increase in risk for developing basal cell carcinoma before the age of 40. As the agency responsible for protecting the public health and the safety of devices such as tanning beds, the FDA has the responsibility to protect the American public from this known health risk.

Just this week a Congressional investigative report, "False and Misleading Health Information Provided to Teens by the Indoor Tanning Industry," was released that highlighted the impact of improperly regulated tanning beds. This investigation found that 90 percent of the interviewed tanning salons stated that indoor tanning did not pose a health risk and 51 percent denied that indoor tanning would increase a fair-skinned teenager's risk of developing skin cancer. The direct-to-consumer advertising and promotion of tanning beds is blatantly providing misleading and dangerous information, especially to teens and young adults.

Tanning beds do not belong in the same regulatory category as cotton swabs and bandages when considering a risk-based system. They are dangerous, cancer causing devices that must be treated as such. I urge the agency to act on the March 2010 Advisory Committee recommendations regarding the medical device classification of tanning beds – the health of the American public should not have to continue to wait for the agency to act on the recommendations of an Advisory Committee.

Thank you for your prompt attention to this important public health issue. I look forward to our continued work protecting the American people from the harmful effects of tanning beds.

Sincerely,

ROSA L. DeLAURO

Member of Congress