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FDA issues warning against tanning bed use by teens

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In a May 29 final order, the Food and Drug Administration (FDA) issued its strongest warning ever against the use of indoor tanning by anyone under the age of 18. The agency’s action, along with new requirements for tanning bed manufacturers, is aimed at reducing the rising rate of skin cancers, especially melanoma.

Melanoma, the deadliest form of skin cancer, has been on the rise over the last three decades. The American Cancer Society (ACS) estimates that nearly 13,000 people die each year from skin cancers, and of those, 9,700 die from melanoma. Because an estimated 2.3 million teens tan indoors each year, and because melanoma is the second most common form of cancer among young adults – especially in women ages 15 to 29 -- physician groups have been urging the government to take action on tanning beds for years.

The concern is that indoor tanning devices emit UV rays that have been linked to skin cancer, burns and eye damage. According to an FDA news release, people exposed to UV radiation from indoor tanning are at a 59 percent greater risk of melanoma. And the risk increases with each use of a sunlamp product.

“Repeated UV exposure from sunlamp products poses a risk of skin cancer for all users – but the highest risk for skin cancer is in young persons under the age of 18 and people with a family history of skin cancer,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in the news release.

The new FDA orders require that a visible “black-box” warning be placed on indoor tanning products advising against their use by children under 18. In addition, marketing materials promoting sunlamp products and UV lamps must carry other warnings and contraindications, and include the statement “Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”

The FDA has also reclassified tanning machines from low-risk, class I devices to moderate-risk, class II devices. This move means manufacturers of tanning products will have to submit a pre-market notification to the FDA and obtain FDA clearance prior to marketing their devices. Until now, no such review was required.

The FDA's new requirements apply to manufacturers of indoor tanning machines and not to salon owners. Owners will not face fines if they allow under 18-year-olds to use tanning beds or booths.

While some dermatologists and public health advocates would like to see restrictions that would penalize violators, healthcare providers and skin care experts in general applaud the FDA’s efforts to make the public aware of the dangers of indoor tanning and its risks to teens.

“I support this legislation as it will help protect the help of youth, who may feel invincible, but in reality are at the most risk because they are not properly protecting their skin from the harmful effects of UV light,” Joshua Zeichner, MD, director of cosmetic and clinical research in the department of dermatology at The Mount Sinai Hospital in New York City, told Health Day.

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