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Letter to Margaret Hamburg, Commissioner U.S. Food and Drug Administration - Take Action on Recommendations from the FDA's General and Plastic Surgery Devices Panel

Letter

By:
Date:
Location: Unknown

Today Reps. Henry A. Waxman, Diana DeGette, Frank Pallone, Jr., Rosa L. DeLauro, and Carolyn B. Maloney sent a letter to FDA Commissioner Margaret Hamburg urging the agency to take action on recommendations by the FDA's General and Plastic Surgery Devices Panel. Over two years ago, the panel recommended many safeguards that FDA could implement to protect consumers from the serious and deadly cancer risks posed by tanning beds.

In the letter, the members cite their recently released undercover staff investigation, which found that tanning salons target teenage girls with advertising and promotions, deny known risks of indoor tanning, provide false information on the benefits of tanning, and fail to follow recommendations by the FDA on tanning frequency.

In the letter, the members state, "Indoor tanning beds present a serious risk of skin cancer, yet as our investigation demonstrates, they are not being properly regulated. …Your own expert panel reached a similar conclusion nearly two years ago. Nonetheless, these dangerous devices are still widely available to young people, and salons do not provide accurate warnings or guidance. We believe further delay is not in the interest of the health of teenage girls."

February 17, 2012

The Honorable Margaret A. Hamburg
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20903

Dear Commissioner Hamburg:

We are writing to provide you with a recent investigation we requested into the information tanning salons provide to young, female consumers. This investigation shows that most tanning salons surveyed provided false and misleading information to young women about the cancer risks from tanning beds and failed to follow FDA recommendations on usage.

Nearly two years ago, an FDA advisory committee recommended that FDA prohibit the use of tanning beds by children and teenagers and take other steps to protect the public from the risks posed by tanning salons. We believe you should act on these recommendations without further delay. As our investigation shows, too many tanning salons are misleading youth and needlessly endangering their health.

Background

Indoor tanning beds are classified by the World Health Organization and the National Toxicology Program as "known" human carcinogens. Their use is increasing, especially among teenage girls, and this has coincided with a significant increase in skin cancer.[1] Melanoma is now the most common form of cancer for white women between the ages of 15 and 29 years old. Since 1980, the rate of melanoma in this group has increased by 50%.[2] The rate of non-melanoma skin cancer in the United States is "reaching epidemic proportions."[3]

Concerns about the link between exposure to the ultraviolet radiation in tanning beds and skin cancer led the Food and Drug Administration to convene a review of these devices by the agency's General and Plastic Surgery Devices Panel on March 25, 2010. The experts on that panel concluded unanimously that the current classification of tanning beds as Class I medial devices -- a category of devices that also includes band-aids and tongue depressors -- was insufficient to address the dangers they present. While the members of the panel were divided as to whether tanning beds should be Class II or Class III devices, not a single expert participating in the meeting concluded that current Class I regulations for the devices were sufficient.[4]

Panel members recommended many safeguards that FDA could implement to protect consumers from the serious -- and sometimes deadly -- risks posed by tanning beds. A majority of the panel favored age restrictions for tanning bed use. The panel recommended special restrictions and education for users with very fair skin or a family history of skin cancer. These experts also concluded that strengthened education, training, testing, and certification of tanning bed operators as well as improved warnings and warning review processes would help prevent skin cancer diagnoses and deaths.[5]

Nearly two years have passed since the panel issued its recommendations, but FDA has not yet taken action.

Our Investigation

We recently requested that the Democratic Staff of the Committee on Energy and Commerce conduct an investigation to determine if tanning salons were providing accurate information about cancer and other risks to teenage girls who purchase indoor tanning sessions. Committee investigators representing themselves as fair-skinned teenage girls contacted 300 tanning salons nationwide, including at least three in each state and the District of Columbia. The investigators asked each salon a series of questions about its policies and the risks and benefits of tanning. Committee investigators also reviewed the print and online advertising of tanning salons.

The results of this investigation are alarming. Ninety percent of the salons denied that indoor tanning presented a health risk; over half of the salons denied any link between indoor tanning and skin cancer, calling assertions of such a link "rumor," "hype," and "a big myth." Four out of five salons claimed that indoor tanning would be good for a teenage girl's health, providing benefits from increased Vitamin D production, to treatment for depression or lupus, to cancer prevention. Three-quarters of the salons permitted daily tanning for first-time tanning bed users, contrary to FDA guidance and the salons promoted daily tanning through "unlimited" tanning specials. [6]

Committee investigators also found that the tanning salons specifically target teenage girls and young women. Print and online advertising to teenage and college-age girls frequently offer student discounts and "unlimited" tanning specials for teenage and college-aged girls, as well as "prom", "homecoming", and "back-to-school" specials.[7]

The investigation further revealed that salons cite the current regulatory environment for indoor tanning as evidence of a lack of risk. Salons suggested that the current state of regulation amounted to confirmation of the practice's safety, telling Committee investigators: "If it was incredibly bad for you, you wouldn't be allowed to do it"; "It's got to be safe, or else they wouldn't let us do it"; "you can get skin cancer from being outside . . . but our [tanning] beds are certified and regulated"; and "the FDA wouldn't approve tanning salons if it weren't safe."[8]

Request for Action

Indoor tanning beds present a serious risk of skin cancer, yet as our investigation demonstrates, they are not being properly regulated. Indoor tanning salons provide false and misleading information to teenage girls about the risks of cancer from indoor tanning. They target teenage girls in their advertisements. And they do not follow FDA guidance on limiting exposure.

Your own expert panel reached a similar conclusion nearly two years ago. Nonetheless, these dangerous devices are still widely available to young people, and salons do not provide accurate warnings or guidance.

We believe further delay is not in the interest of the health of teenage girls. We urge you to act upon the findings and recommendations of your General and Plastic Surgery Devices Panel.

We have provided a copy of the report with this letter and look forward to working with you to protect our youth.

Sincerely,

Henry A. Waxman

Diana DeGette

Frank Pallone, Jr.

Rosa L. DeLauro

Carolyn B. Maloney

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