Director, Center for Devices and Radiological Health

June 4, 2013

Jeffrey Shuren, M.D., J.D. Director, Center for Devices and Radiological Health U.S. Food and Drug Administration 10903 New Hampshire Avenue WO66-54442 Rockville, MD 20852

Re: Docket No. FDA-2013-N-0461

Dear Dr. Shuren,

I am writing to you as a member of the American Society for Dermatologic Surgery Association (ASDSA) to urge the US Food and Drug Administration (FDA) to adopt and enact the regulatory changes proposed in Docket No. FDA-2013-N-0461. The changes to the regulations imposed on sunlamp devices are necessary step to improve consumer and user safety from a public health perspective.

As a dermatologist, I <<<<<<<<<<<<<>>>>>>>>>>

The current regulatory controls imposed on sunlamp devices that are sold and used within the indoor tanning industry are currently subjected to general control regulations – the same standard as a tongue depressor or a band-aid. Devices that emit UV radiation in high concentrations for the purpose of tanning the skin are much more harmful to the user, yet are classified in such a way that does not guarantee that their use will be safe for all consumers.

It is estimated that nearly 30 million Americans use sunlamp devices every year; almost 10% of those individuals are teens, and most of them women. Using a sunlamp device even once in a year increases an individual’s risk of developing melanoma by 20%, and persons who frequently use such devices are up to 75% more likely to develop melanoma.

Such a proposal will help reduce skin damage caused by artificially-sourced UV radiation. Sunlamp devices can expose the body with the equivalent of up to 3 hours of midday, summer sun in a 20 minute session. Such exposure can cause damage to the skin’s DNA, which over time, significantly increases the risk of cancer.

The International Agency for Research on Cancer, the cancer division of the World Health Organization, classified tanning beds as "carcinogenic to humans,” which is the agencies’ highest risk category, placing sunlamp devices alongside asbestos, plutonium, and tobacco smoking.

It is prohibited to sell cigarettes to minors at the federal level, and such a ban was enacted as a measured step towards improving public health. While this proposed regulation will not prohibit minors from tanning, this is an important step forward for the FDA to move towards better youth protection from sunlamp products. Nationwide, 34 states and the District of Columbia, enacted some level of youth access prohibitions to indoor tanning devices. Of the 16 states with no indoor tanning prohibitions for minors, 13 states introduced legislation that would restrict access to tanning devices for minors. 31 states introduced bills to enact or strengthen existing youth indoor tanning restrictions for minors. At the state level, there is a greater recognition that indoor tanning devices may harm the health of today’s minors tomorrow, and that this is an issue that should garner attention from the federal government.

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For these reasons, I support the proposed changes introduced in Docket # FDA-2013-N-0461. I urge the FDA to enact these regulatory changes and help improve consumer safety related to sunlamp devices. For more information on this subject, please contact John Geahan, Public Policy Specialist with the ASDSA, at (847) 956-9121 or by email, at [email protected].

Sincerely,

, ASDSA Member