The Food and Drug Administration took aggressive steps on Friday to restrict the use of sunlamp products, including tanning beds, declaring them a risk to public safety.
The proposed rules, which would go into effect only after a public comment period, include banning their use by minors and requiring adults who use them to sign a waiver every six months acknowledging that they understand the heightened risk of skin cancer and other damage. The FDA also outlined several additional measures that manufacturers of the equipment and tanning bed facility owners would have to take to improve their safety.
Should Friday's proposals go into effect, they could amount to a huge dent in the tanning industry's bottom line. The FDA estimates that the new rules would lead to "reduced demand" that could cut revenues by $500 million to $825 million at year over the next decade.
Tanning beds, which bestow a sun-kissed look to their users even in the dead of winter, are known to be a major contributor to an increased risk of skin cancer because the technology bombards the user with ultraviolet radiation. The American Academy of Dermatology says studies show that people exposed to radiation from indoor tanning are 59 percent more likely to develop melanoma, the most deadly type of skin cancer, than those who have never tanned indoors.
Yet millions of Americans, including 1.6 million minors, use such technology each year.
FDA officials said the new regulations are aimed primarily at helping protect young people from a known and preventable cause of skin cancer, not to mention other potential harms such as burns, premature wrinkles and age spots and eye diseases such as cataracts.
"We know that adolescents are a primarily vulnerable population," said Vasum Peiris, chief medical officer of pediatrics and special populations in the FDA's Center for Devices and Radiological Health. "We want to make sure they are protected from this, and that’s why we're taking the actions we are today."
The FDA emphasized that the effects of exposure to UV radiation are cumulative, so being exposed as a young child or teen could result in greater risk for skin damage over the course of a lifetime. Tanning beds also pose other types of safety risks such as skin burns, fainting spells, eye injuries, lacerations, strains, sprains, bruises or dislocations.
Among the additional steps the FDA is proposing for manufacturers and operators of the estimated 18,000 to 19,000 salons and 15,000 to 20,000 other facilities, such as health clubs, spas, and other commercial establishments, that offer tanning services are:
- making warnings easier to read and more prominent on the device;
- requiring an emergency shut off switch, or “panic button”;
- improving eye safety by adding requirements that would limit the amount of light allowed through protective eyewear;
- improving labeling on replacement bulbs so tanning facility operators can make sure they are using the proper replacement bulbs, reducing the risk of accidental burns; and
- prohibiting dangerous device modifications, like installing stronger bulbs, without recertifying and reidentifying the device with the FDA.
“The FDA understands that some adults may decide to continue to use sunlamp products,” Stephen Ostroff, the FDA's acting commissioner, said in announcing Friday's action. “These proposed rules are meant to help adults make their decisions based on truthful information and to ensure manufacturers and tanning facilities take additional steps to improve the safety of these devices."
American Academy of Dermatology president Mark G. Lebwohl said in a statement that the FDA's action follows the lead of 42 states that have already enacted tanning bed restrictions.
"Restricting teens’ access to indoor tanning and educating all users about the dangers of tanning devices are critical steps to preventing skin cancer," he said. If the rules are adopted, he said, it would represent a "historic victory in our nation’s fight to eradicate skin cancer."
Friday's proposed rules come roughly a year and a half after a surgeon general's "call to action" that detailed a troubling rise of skin cancer in the United States, particularly in its most deadly form, melanoma. There are 63,000 new cases of melanoma diagnosed each year, and an estimated 9,000 annual deaths from the disease, many of them involving teens and young adults.
"The facts are that indoor tanning is a source of ultraviolet radiation, period. Ultraviolet radiation is a known carcinogen, period. This is a needless exposure to ultraviolet radiation," acting U.S. Surgeon General Boris D. Lushniak told the Post at the time. "So I have to look at this as being a major problem. We certainly know it's something that's become popular amongst youth. And much like the surgeon general comes out very vehemently against youth smoking, I am coming out quite vehemently against youth exposing their skin to ultraviolet radiation in tanning booths."
This post has been updated.
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