The U.S. Food and Drug Administration Thursday issued its final order reclassifying tanning beds from low-risk (class I) to moderate-risk (class II) devices — a controversial move some say was not unexpected, but others insist violated FDA’s rule-making protocol.

The order primarily impacts bed manufacturers, in that (1) it requires that manufacturers include language on tanning beds that explicitly warns against use by persons under the age of 18 years; and (2) certain marketing materials promoting tanning beds must carry additional warning language and contraindications, including “Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”

“This order will do little to alter the consumer experience in a professional tanning facility,” Smart Tan’s Joseph Levy said. “It will increase the cost of bringing a new sunbed to market. But initial press coverage of this announcement seems to be missing the point that we already warn consumers about the dangers of overexposure, we already have warning labels and we already practice informed consent, skin typing and sunburn prevention.”

Manufacturers will have about 15 months to implement new warning labels. Salons will have about 15 months to work with manufacturers to update labels on existing equipment.

FDA first announced its desire to explore changes in its rules in 1999, and held meetings with the industry through 2002 to discuss ways to improve warning labels and lamp standards. FDA did little to advance that cooperative process following 2002, but announced in 2010 it would hold an advisory committee meeting to explore the possibility of new rules.

That March 2010 advisory committee — which included several former lobbyists who had lobbied FDA to ban indoor tanning completely in 1995 — led to the publication of these new proposed rules in May 2013. FDA announced the proposal at a joint press conference with the American Academy of Dermatology Association, which had actively lobbied for the changes.

FDA rules say the agency should have put that proposal in front of a public meeting, but FDA maintained that its 2010 meeting was adequate for review.

You may click on this link to access the FDA order.

The American Suntanning Association issued the following statement to the media Thursday: “This action by the FDA was expected based on its proposed order in July 2013. While we are disappointed that the FDA did not hold stakeholder meetings or actively include our industry in this process, we remain willing to work with regulators to promote a professional tanning environment. We continue to support responsible access to UV exposure, both indoors and outdoors, for the millions of Americans who choose to tan.”

What should salons tell clients or local press:

• This action does little to alter the consumer experience in a professional salon. We remain dedicated as always to sunburn prevention and educating clients about the risks of UV overexposure — as we always have been.
• Suntanning professionals remain committed to teaching sunburn prevention in our communities for people of all ages.