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FDA Proposes Rules to Improve Tanning Bed Safety

February 5, 2016

Sunlamp manufacturers would be required to take additional measures to improve the overall safety of tanning beds under new rules proposed by the FDA.

The proposal would make warnings easier to read and more prominent, require an emergency shutoff switch or “panic button,” and prohibit dangerous device modifications, like installing stronger bulbs, without re-certifying the device with the FDA.

The FDA’s proposal also would add requirements to limit the amount of light allowed through protective eyewear and improve labeling so tanning facility operators can make sure they are using the proper replacement bulbs, reducing the risk of accidental burns.

Indoor tanning is a known contributor to skin cancer, including melanoma, and other skin damage.

The proposed rules are intended specifically for sunlamp devices used for tanning for an aesthetic reason, and are not intended for a restriction on devices like those used to treat dermatological conditions or cancer, Vasum Peiris, chief medical officer for pediatrics and special populations at the FDA’s Center for Devices and Radiological Health told reporters during a media briefing last in December.

U.S. House Energy and Commerce Ranking Member Frank Pallone Jr. (D-N.J.) applauded FDA’s proposal. This past June, Pallone, along with Energy and Commerce Chairman Fred Upton (R-Mich.), wrote a letter urging the agency to publish the proposed rules in order to protect public health.

The FDA previously took steps to gain more premarket regulatory control over the devices. The agency issued a final reclassification order in June 2014 moving tanning bed ultraviolet and sunlamps from Class 1 to Class 2, subjecting them to 510(k) scrutiny.

Comments are due by March 20. 

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