FDA proposes new tanning age
FDA Proposes Tanning Bed Age Limit
Adds other proposed restrictions for adults.
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The FDA proposed two regulations for tanning bed use today, one restricting use of sunlamp products to individuals 18 and older, and another requiring certain safety features on the equipment.
Under the proposed regulations, first-time users would have to sign a risk acknowledgment certification, stating that they have been told about the risks that come with use of sunlamp products. They would also be required to sign the certification every 6 months, said the FDA, which posted the announcement to their website.
The proposed rules will be available for a 90-day public comment period at www.regulations.gov starting Dec. 21, the FDA said. Final rules will be issued sometime later.
Specific changes that tanning bed salons would need to implement under the proposal include:
- Making warnings more prominent
- Requiring an emergency shut-off switch
- Limiting the amount of light through protective eyewear
- Improving labeling on replacement bulbs
- Prohibiting uncertified and potentially dangerous device modifications such as adding stronger bulbs
In July of last year, the Surgeon General issued a "call to action" to prevent skin cancer, which included strategies for reducing the number of minors that frequent tanning salons. About 1.6 million minors tan indoors each year, according to numbers cited by the FDA, most of them (70%) Caucasian girls and young women. And according to the CDC, there's an average of more than 3,000 emergency room visits related to indoor tanning each year. There are about 18,000 indoor tanning salons in the U.S., and up to 20,000 other facilities with tanning services, the agency added.
"The FDA understands that some adults may decide to continue to use sunlamp products," said Stephen Ostroff, MD, the FDA's acting commissioner. "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."
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Mark Lebwohl, MD, the president of the American Academy of Dermatology, said in a statement that the FDA should be commended for their decision. He called the decision a "monumental step to protect the public's health," adding that those who have been exposed to UV radiation from indoor tanning have a 59 percent greater risk of developing melanoma than those who haven't.
"Restricting teens' access to indoor tanning and educating all users about the dangers of tanning devices are critical steps to preventing skin cancer," wrote Lebwohl. "As medical doctors who diagnose and treat skin cancer, dermatologists are committed to reducing its incidence and saving lives. We encourage the FDA to finalize this proposed rule as it would as it would be a historic victory in our nation's fight to eradicate skin cancer."
And in a statement, the American Cancer Society Cancer Action Network said: "The FDA's long-awaited tanning device proposals are an important step that will help to reduce skin cancer diagnoses and deaths. We commend the FDA for educating the public about the dangers of exposure to harmful ultraviolet radiation and restricting use for our nation's youth. Indoor tanning devices are not safe."
Michael Holick, MD, at Boston University School of Medicine, a vitamin D expert who has previously criticized efforts to limit ultraviolet radiation exposure, supported the proposed informed-consent requirement.
"It's not unreasonable for people to be aware of potential risk factors associated with tanning bed use," he toldMedPage Today. "Teens in particular need to be aware of these issues as well -- they're not always the best about making good decisions about their short-term and long-term health, and require consent from their parents."
But, said Holick, who has received grants from the Indoor Tanning Association, "using a tanning bed responsibly" might not lead to a significant increase of risk for melanoma. He added that people should also be aware of the risks of sunburn.
Video: FDA Proposes to Prohibit Minors From Tanning Beds
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