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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, especially since the rise in skin cancer, especially in young people, has been documented. I hope that this legislation keeps more sunlamps off the shelves and away from consumers."

Dr. Jennifer Stein, assistant professor of dermatology at NYU Langone Medical Center in New York City, agreed, calling the reclassification of tanning beds "an important step in making the public aware of the dangers of tanning beds."

She said that "indoor tanning damages the skin and is associated with skin cancers, including melanoma -- a potentially fatal form of skin cancer. Fortunately many states have passed bans on tanning bed use in minors. We have seen an increase in skin cancers among young women who have used tanning beds."

The American Suntanning Association, a trade association of tanning salons, issued this statement Monday evening: "The professional sunbed community has not had any input in this preliminary proposal thus far. We remain dedicated to sunburn prevention and look forward to working with the FDA to improve consumer protection and to assure that all information regarding indoor tanning is in accordance with the science."

The FDA's reluctance to impose an outright ban on access to tanning beds for minors runs counter to a decision from an advisory panel the FDA commissioned to look at the issue in 2010. That ruling advocated barring minors from using tanning beds, or at least requiring parental consent.

In the same year, the American Academy of Pediatrics also came out in favor of a ban on tanning bed use by people under the age of 18. "Pediatricians should support and advocate for legislation to ban access to tanning parlors for children younger than 18 years," the AAP said in its policy statement.

The AAP also noted that other organizations, including the World Health Organization, the American Medical Association and the American Academy of Dermatology, already support such a ban.

Speaking at the time of the AAP recommendations, one expert said the link between indoor tanning and skin cancer is clear.

Dr. Doris Day, a dermatologist at Lenox Hill Hospital in New York City, applauded the AAP's move to support the tanning bed ban for minors.

"A review of seven studies found a statistically significant increase in the risk of melanoma in those who had been exposed to UV radiation from indoor tanning before the age of 35," said Day. "Studies have demonstrated that exposure to UV radiation during indoor tanning damages the DNA in the skin cells."

Day also said that "on an average day in the United States, more than 1 million people tan in tanning salons. Of the customers, nearly 70 percent are girls and women, primarily 16 to 29 years old."

More information

Find out more about the indoor tanning-skin cancer link at the U.S. Centers for Disease Control and Prevention.

SOURCES: Jeffrey Shuren, M.D., director, Center for Devices and Radiological Health, U.S. Food and Drug Administration; Michele Green, M.D., dermatologist, Lenox Hill Hospital, New York City; Jennifer Stein, M.D., assistant professor of dermatology, NYU Langone Medical Center, New York City; U.S. Food and Drug Administration, news release, May 6, 2013; May 6, 2013, news release, American Suntanning Association, Jackson, Mich.


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