FDA Panel: New Tanning Bed Restrictions Needed

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Pale-Skin Ban, User Registry, User Fees Advised for Tanning Beds

By Daniel J. DeNoon
WebMD Health News

Reviewed By Laura J. Martin, MD

March 30, 2010 -- A ban on tanning-bed use by people with the palest skin is among several new restrictions recommended by an FDA advisory panel.

Earlier reports from the panel's March 25 meeting focused on its advice to restrict tanning bed use to adults age 18 and older. But that wasn't the only restriction the panel advised the FDA to adopt.

Perhaps the most interesting change would be the panel's recommendation to prohibit the use of tanning beds by people with Fitzpatrick skin type 1. People with this very pale skin type (such as red-haired people with freckles) get sunburns instead of tans when exposed to sunlight or tanning lamps.

The biggest recommended change is the panel's unanimous proposal to change tanning beds' Class I device designation, the least restrictive classification intended for devices that pose minimal risk to users or operators. Elastic bandages and hand-held surgical devices are examples of Class I devices.

Half the panel supported making tanning beds Class II devices, which require special assurances -- such as labeling requirements or mandatory performance standards -- that they will not cause harm. Class II devices include X-ray machines and powered wheelchairs.

The other half of the panel wants tanning beds listed as Class III devices, which not only require special controls such as operator training requirements but require premarket approval by the FDA. Class III devices include implanted pacemakers and silicon breast-augmentation gels.

The panel also recommended other special controls:

• Strengthening current requirements for protective eyewear
• Equipping tanning beds with mechanisms that prevent their activation until a customer acknowledges reading and accepting a series of warnings about indoor tanning risks
• A registry program for all tanning bed users, possibly supported by a user fee
• Strengthening requirements for tanning bed operator education, training, testing, and recertification
• Collection of data on the irradiance put out by tanning beds, possibly to be included in the user registry
• Restricting tanning bed use by pregnant women and by people who take certain drugs or use certain cosmetics that interact with UV light
• Even stronger restrictions on tanning beds sold for in-home use

The panel said there was no need to separately regulate tanning beds that are UV-A only, UV-B only, or a mixture of both.

Response to Panel's Proposed Tanning Bed Restrictions

Medical groups praised the panel's recommendations.

"The skin cancer and dermatologic communities came together and presented compelling personal stories and rigorous scientific evidence demonstrating the dangers of indoor tanning," Allan Halpern, MD, vice president of the Skin Cancer Foundation, says in a news release. "The advisory panel made excellent recommendations and now it's up to the FDA to take action."

The panel's recommendations are another blow to the tanning industry, which just last week was hit by a 10% tax as part of the health care reform law.

The Indoor Tanning Association, which represents the 18,000 tanning salons in the U.S., says it "respectfully disagrees" with the panel recommendations.

In a statement provided to WebMD, the group says it feels that current FDA regulations are sufficient to protect "the millions of Americans who use our services each year."

"Industry standard practices already are far more stringent than the current FDA regulations require," the statement says. "In fact, the U.S. tanning industry abides by the strongest set of industry regulations found anywhere in the world."

The Indoor Tanning Association says tanning salons already:

• Provide customers with information on tanning bed risks via a signed consent form
• Require teen users to have a parent's signed approval
• Train staff members to recommend tanning schedules tailored to each customer's skin type to avoid sunburn or overexposure

SOURCES: FDA, 24-Hour Summary, General and Plastic Surgery Devices Panel Meeting, March 25, 2010.

FDA web site.

News release, Skin Cancer Foundation.

News release, Indoor Tanning Association.

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