The agency also is proposing that before their first tanning session, and every six months thereafter, adults over the age for 18 would be required to sign a risk acknowledgment certification “that states that they have been informed of the risks to health that may result from use of sunlamp products,” according to a press release.
“Today’s action is intended to help protect young people from a known and preventable cause of skin cancer and other harms,” acting FDA Commissioner Stephen Ostroff, MD, said in the release. “Individuals under 18 years are at greatest risk of the adverse health consequences of indoor tanning.”
While indoor tanning is a known contributor to skin cancer, including melanoma, there are 1.6 million minors who use indoor tanning each year, according to the release.
A second proposed rule would require that sunlamp manufactures and tanning facilities include additional measure to improve overall safety of the devices, according to the release. These include making warnings easier to read and more prominent on the device, requiring an emergency shut off switch or “panic button,” limiting the amount of light allowed through protective eyewear; improving labeling on replacement bulbs to reduce the risk of accidental burns; and prohibiting device modifications, including installing stronger bulbs without going through the FDA rectification process.
“The FDA understands that some adults may decide to continue to use sunlamp products,” Ostroff said in the release. “These proposed rules are meant to help adults make their decisions based on truthful information and to ensure manufactures and tanning facilities take additional steps to improve the safety of these devices.”
The proposed restrictions would apply to manufactures and tanning facility operators, according to the release. In the United States, there are 18,000 to 19,000 indoor tanning salons and 15,000 to 20,000 other facilities, including health clubs, that offer tanning services, the release reported.
The rules are available for public comment for 90 days at www.regulations.gov, with comments being accepted beginning Dec. 21.
Reference: www.fda.gov
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