FDA Prepares to Limit Use of Sunlamps
June 21, 2000 (Washington) -- After reports of a melanoma "epidemic" and some tanning salon owners' failure to follow established guidelines, FDA officials said Wednesday they will pursue implementation of a rule that could provide more consumer protections from the dangers posed by sunlamps.
The statement was made to a committee of experts who meet on a regular basis to advise agency officials on policy matters and the merits of specific products.
Melanoma is a deadly form of skin cancer, and reported cases have been rising over the past few years. As a result, U.S. health officials now anticipate that 7,300 Americans will die of melanoma this year, out of an estimated 38,300 cases -- even though the condition is curable if caught in the very early stages.
The FDA has no plans to ban the use of sunlamps, choosing instead to cooperate with the industry, said Howard Cyr, MD, a member of the agency's sunlamp review team. However, considering dangers posed by melanoma and recent evidence linking melanoma to ultraviolet A (UVA) radiation, the FDA plans to outline the risks on a more stringent warning label, he told committee members.
Although there is no direct evidence linking sunlamps to melanoma, most sunlamps emit UVA radiation, which recently has been linked to malignant melanoma, and -- like ultraviolet B (UVB) rays -- to damage to the immune system. UVB, or short-wave radiation, is more likely to cause sunburn, according to the FDA.
Under the FDA's proposed rule, sunlamps will be required to carry a simpler warning label outlining this risk, Cyr said. The FDA will also establish an exposure schedule, modify the label to recommend lower cumulative doses of UVA exposure, and develop standards for replacing sunlamp bulbs, he said.
The FDA is not pursuing a ban of these products because consumers appear to understand the risks, informed consent forms are being used, and the FDA wants to respect individuals' right to choose whether to use these products, Cyr said. The FDA is also not pursuing a specific melanoma warning on the label because there are insufficient data to support this type of action, he said.
But the FDA's position does not have universal support. Among other things, members of the industry say that the listing of ultraviolet light as a carcinogen on sunlamps' warning labels is an oversimplification that ultimately will lead to greater consumer confusion.
The establishment of an exposure schedule is also a de facto ban, says Don Smith, executive director of North American Alliance of Tanning Salon Owners, an industry trade group.
Still, a rule appears imminent. There must be an exposure schedule and, at the very least, a simpler warning label on these products, committee members agreed with agency officials. "Tanning salon booths are devices that can be regulated," added Jerry Thomas, MS, a committee member and chief of radiological physics at the Uniformed Services University of Health Science.
At present, the regulation of sunlamps is based upon an FDA policy letter written in 1986. The proposed new rule would establish a legal standard. Despite industry objections and the lack of conclusive evidence linking melanoma directly to the use of sunlamps, the new rule would also require that labels state that long-term exposure to both UVA and UVB radiation can contribute to potentially fatal skin cancer.
For more information from WebMD, visit our Diseases and Conditions Melanoma page.