(Aug. 16, 2013) Skin cancer; eye injury; discomfort, pain and tenderness of the skin; skin damage; transmission of infectious diseases; electrical shock and mechanical injury. These are all risks tied to indoor tanning, according to a new proposal by the U.S. Food and Drug Administration that would ramp up controls on tanning beds and sunlamps.
The proposed changes reclassify the ultraviolet lamps used for tanning from class I, general controls, to class II, special controls, based on comments from a 2010 reclassification panel and the FDA’s assessment of data on the health risks and benefits of using sunlamp products, FDA Press Officer Morgan Liscinsky said.
“General controls alone are insufficient to provide reasonable assurance of safety and effectiveness” of tanning beds, Liscinsky said, “and there is sufficient information to establish special controls to provide such assurance.”
As required by law, the FDA gave the public the opportunity to comment on the proposal. The comment period ended last Wednesday with 633 written and online statements by medical professionals, business owners and other stakeholders posted on the regulations.gov Web site, though some appear to be reposts made under multiple names.
“Regulation of tanning beds is very much needed,” Lynn Tucker wrote in her comment. “The message that damage is done is not present in the tanning parlors. Please change this to a medical device that needs oversight.”
“The proposed rule is a wonderful step forward in protecting the public from the well documented dangers of tanning,” William Daniel James wrote. “There is so little we can do to prevent cancer in general, but with melanoma, squamous cell carcinoma and basal cell carcinoma, the connection to ultraviolet light is straightforward.”
The FDA will review the comments, but cannot predict how long that will take, Liscinsky said. “It will really depend upon the number of comments we receive and incorporate into a final order.”
If the changes pass, sunlamp manufacturers will have to get a 510(k) clearance from the FDA — meaning they would need to register three-plus months before marketing their lamps, allowing the FDA to review lamps for “specific technical considerations, including software validation and performance testing, so that these devices are safe to operate,” Liscinsky said.
Current classification of sunlamp products prevents the FDA from reviewing such features before they’re used on the market, she said.
Manufacturers would also have to give salon owners a warning sign to display reading, “Attention: This sunlamp product should not be used on persons under the age of 18 years,” Liscinsky said.
The “proposed order is intended to help consumers better understand the risks of using these devices,” she said.
Those risks include increased chances of developing skin cancer and eye injury from recurrent exposure to UV radiation; sunburn and permanent skin damage; transmission of diseases from tanning beds that were not properly cleaned; electric shock from manufacturing defects or repeated use; and other injuries from user error.
However, many tanning businesses said the change could drive them out of the market.
“If such measures were to pass I would most certainly be put out of business,” wrote Shanna Cassetta, owner of Tahiti Tan in Greensboro, N.C., in her comment.
“(Re)classification would make the cost of the sunlamps skyrocket,” wrote Tim McCray of Tropic Tanz in Kingsport, Tenn., driving tanners outdoors to “exposure that is not in a controlled environment.”
Locally, one operator said that with barriers like a higher tanning tax (currently 10 percent) and barring the under-18 crowd from using tanning beds even with a parent’s signed consent, businesses might drop tanning from the services they offer.
If passed, the proposal would also rename lamps used for tanning from ultraviolet lamps to sunlamps. The device classification regulation calls them “ultraviolet lamps for tanning,” but the electronic product performance standard calls them a “sunlamp product,” Liscinsky explained.
The proposed renaming would provide “consistency and clarity,” she said. The definition includes tanning beds and booths and UV bulbs sold separately.
Visit www.regulations.gov and search “FDA-2013-N-0461” to read more public comments on the proposed changes.