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FDA Proposes Tougher Warnings for Tanning Beds
Date:5/7/2013

By Steve Reinberg
HealthDay Reporter

MONDAY, May 6 (HealthDay News) -- Despite a prior recommendation from its own expert advisory panel, the U.S. Food and Drug Administration on Monday announced that it has no immediate plan to ban the use of indoor tanning devices by children.

Instead, the agency is proposing bumping up "sunlamp products" from a low-risk, class I device to a moderate risk, class II device, and mandating that tanning devices have labeling warning against their use by young people.

Numerous studies have supported strong links between use of UV ray-emitting indoor tanning devices and a raised risk for skin cancer.

According to a statement released by the FDA, "the proposed order does not prohibit the use of sunlamp products by those under the age of 18, but it provides a warning on the consequences. The labeling would have to include a warning that frequent users of sunlamp products should be regularly screened for skin cancer."

Moving tanning beds from a class I to class II device designation also means manufacturers will face tougher pre-market review from the FDA, something these devices are exempted from at the present time. The proposal is subject to a 90-day period of public comment.

Speaking to reporters Monday, Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health at the FDA, said a ban on tanning bed use by minors is still a possibility.

"We view [warning labels] as a first step, nothing is off the table," he said. "Right now we are seeking public comment on our proposed order and, based upon public feedback, we'll decide what we will do in the final order and if there are other steps we should be taking."

Responding to Monday's announcement, Dr. Michele Green, a dermatologist at Lenox Hill Hospital in New York City, said: "It is about time that these sunlamps were reclassified and held to a higher standard. I applaud this move, espec
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FDA Proposes Tougher Warnings for Tanning Beds
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