Gopal Patel - Comment

Document ID: FDA-2013-N-0461-0142
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: June 19 2013, at 12:00 AM Eastern Daylight Time
Date Posted: June 21 2013, at 12:00 AM Eastern Standard Time
Comment Start Date: May 9 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: August 7 2013, at 11:59 PM Eastern Standard Time
Tracking Number: 1jx-8603-b5no
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Dear Dr. Shuren, As a board-certified dermatologist, I am writing to provide comments on the proposed order to reclassify sunlamp products as published in the Federal Register on May 9, 2013. I appreciate the Food and Drug Administration (FDA) for taking this important first step in protecting the public from the dangers of tanning devices and urge the agency to continue their efforts to ensure the safety of our nation’s youth. The FDA’s proposed order to reclassify sunlamp products is an important first step for protecting my patients from these dangerous devices. While I am pleased to see this first step, I urge the FDA to consider additional restrictions in the future and encourage the agency to move forward with supplemental regulations that will completely restrict minors under the age of 18 from using tanning devices. The science is clear. Research indicates that the risk for developing melanoma increases by 75 percent in individuals who have been exposed to UV radiation from indoor tanning devices, and the risks increase with each subsequent use. Approximately 12,000 people will die each year from skin cancer. More than 9,000 skin cancer deaths are due to melanoma. Sadly, melanoma is no longer a cancer reserved for older individuals. Instead, melanoma is the most common form of cancer for young adults 25-29 years old and the second most common form of cancer for adolescents and young adults 15-29 years old. As a dermatologist, I have had to diagnose too many young people with melanoma due to indoor tanning. Nearly 2.3 million teens tan indoors annually in the United States. Restricting teens’ access to these devices is paramount to protect our nation’s youth. Thank you for your efforts to increase regulations on these dangerous devices. I urge you to finalize your proposed order and work toward further regulations that will completely restrict access to minors under the age of 18 years. Sincerely, Gopal Patel, MD

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