WebMD Medical News
Daniel J. DeNoon
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:
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.
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
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 Indoor Tanning Association says tanning salons already:
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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