Children and Teens Would Need Parental Consent in Proposed Regulation
Daniel J. DeNoon
WebMD Health News
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Reviewed By Laura J. Martin, MD
March 25, 2010 -- The FDA should keep children and teens from using tanning beds -- or at least make sure their parents have signed a consent form warning of tanning-bed dangers, an FDA advisory panel today recommended.
The panel also appeared likely to recommend that the FDA further restrict tanning beds and tanning lamps. At press time -- 10 hours after the meeting began -- panel deliberations continued.
Tanning beds and tanning lamps are listed as FDA Class 1 devices -- those least likely to cause harm. Elastic bandages are an example of Class 1 devices.
The 16-member panel seemed likely to advise the FDA to list tanning beds as Class 2 devices, which require special assurances, such as labeling requirements or mandatory performance standards, that they will not cause harm. Class 2 devices include X-ray machines and powered wheelchairs.
The panel did not directly vote on its recommendations, but instead will present a consensus opinion to the federal regulatory agency.
Tannings Beds: No Benefit, Small to Moderate Risk
Getting a tan, whether from a tanning bed or the sun, raises cancer risk. Last year, tanning beds were declared "carcinogenic to humans" by the World Health Organization's International Agency for Research on Cancer (IARC).
In its presentation to its panel of experts, the FDA relied heavily on the IARC's analysis of tanning-bed research. However, the FDA noted that the IARC's report, added to previous research, suggests only "a small to moderate risk of skin cancer independently due to the use of tanning beds or lamps."
However, the FDA stressed that the risk appears greater when tanning bed use begins in childhood.
On the other hand, the FDA told the panel that tanning beds offer no credible medical benefit.
Medical groups have weighed in on the issue. The American Academy of Dermatology Association (AADA) opposes indoor tanning and supports a ban on the sale of indoor tanning equipment for nonmedical purposes. Short of a ban, the AADA would like the FDA at least to restrict tanning facilities and equipment from being marketed as safe.
And the American Academy of Pediatrics (AAP) would like to see a ban on the use of tanning beds by children. The AAP advises anyone under age 21 to avoid indoor tanning.
The advisory panel's actions are not binding, but the FDA relies heavily on its outside experts in reaching regulatory decisions.
The Indoor Tanning Association (ITA) opposes further regulation of tanning beds. The ITA was not able to comment before the panel finished its deliberations.
SOURCES: FDA General and Plastic Surgery Devices Advisory Panel Meeting, Executive
Summary, March 25, 2010.
Mary Long, spokeswoman, FDA.
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