FDA Panel: New Tanning Bed Restrictions Needed

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.




Sun-Damaged
Skin: Sunburn, Melanoma and Other Reasons to Shun the Sun

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