The Food and Drug Administration on Thursday announced stricter regulation of tanning beds that are used by millions of Americans. The agency said that it would require manufacturers to put a black-box warning — one of its sternest — on the devices stating that they should not be used by anyone under the age of 18, but stopped short of banning their use by minors.
Dermatologist Dr. Elaine Cook said regulation on sunlamp products has been a long time coming. “We’ve known for many years that they’re instrumental in causing skin cancer, sun damage, and skin aging, so I think they need to be regulated, just like any other device that affects the human body.”
Part of the new regulation consists of reclassifying tanning beds from a Class I to a Class II medical device. This stricter classification now requires FDA approval before tanning beds can go on the market.
“Class I is a regulation for things like dental floss and tongue depressors,” explained Dr. Cook. “And I do think these tanning bed devices have potential for harm like medical lasers and some of the other things that ought to be Class II. So I do think this is a step forward.”
The changes go into effect for new sunlamp products in 90 days. For sunlamps already on the market, warning labels must be placed within the next 15 months.
Agencies/Canadajournal
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