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Skin Cancer Slideshow
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Gallery of Skin Problems as well as Images Collection
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Sun-Damaged Skin Slideshow
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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 take by people with the palest skin is
among several recent restrictions recommended by an FDA advisory panel.
Earlier reports from the panel’s March 25 meeting focused on its advice to
restrict tanning bed take to adults age 18 as well as 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 take of tanning beds by people with Fitzpatrick skin class 1. People
with this very pale skin class (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 as well as 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 as well as powered wheelchairs.
The other half of the panel wants tanning beds listed as Class III devices,
which not only require distinguished controls such as operator training requirements
but require premarket approval by the FDA. Class III devices include implanted
pacemakers as well as silicon breast-augmentation gels.
The panel as well as recommended other distinguished controls:
- Strengthening current requirements for protective eyewear
- Equipping tanning beds with mechanisms that halt their activation until
a customer acknowledges reading as well as 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, as well as recertification
- Collection of data on the irradiance put out by tanning beds, possibly to
be included in the user registry
- Restricting tanning bed take by pregnant women as well as by people who take
certain drugs or take certain cosmetics that work 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
Health examination groups praised the panel’s recommendations.
“The skin cancer as well as dermatologic communities came together as well as presented
compelling personal stories as well as 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 as well as now it’s up to the FDA to take action.”
The panel’s recommendations are another blow to the tanning industry, which
just final 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 take 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 possess a parent’s signed approval
- Train staff members to recommend tanning schedules tailored to each
customer’s skin class to avoid sunburn or overexposure
SOURCES: FDA, 24-Hour Summary, Common as well as Plastic Surgery Devices Panel Meeting,
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