On May 6, the U.S. Food and Drug Administration announced its intention to reclassify tanning equipment and sunlamps to Class II medical devices, and is considering several other safety control measures, as well. If the order is finalized, manufacturers would have to submit to the FDA a pre-market notification (510(k)) for these products, which are currently exempt from any pre-market review. Manufacturers would have to show that their products have met certain performance testing requirements, address certain product design characteristics and provide comprehensive labeling that presents consumers with clear information on the risks of use. The 510(k) process is an expensive and time consuming process for the bed and lamp manufacturers and will increase the cost of every unit. As a result, the Indoor Tanning Association is asking the industry to come together to combat this proposal.
The FDA order proposal would reclassify tanning equipment to a mid-risk category setting the stage for possible additional special controls later. It would require tanning system manufacturers to feature revised warning labels prominently on their products, as well as supply brochures informing people – mostly those under 18 – that multiple use increases the risk of cancer. The FDA cited a 2011 report from the Centers for Disease Control and Preventions Division of Cancer Prevention and Control as the basis for its recommendation, and representatives from the CDC have publically stated that the UV rays in tanning units are about seven times stronger than the summer sun at noon. The FDA’s proposal is open for public comment for 90 days. After the comment period closes, the agency will review the comments before final recommendations are issued. If approved, the industry will have one year to comply with the new requirements.
The ITA has been following this issue for over three years, and the organization was the first to respond to the FDA’s announcement on behalf of the tanning industry. “The ITA represents reputable small businesses throughout the U.S. that already adhere to the highest professional standards, including good manufacturing practices. We embrace any product labeling changes that will lead to a better understanding of the potential risks of overexposure and thereby, enhance our customers’ safety; however, we are concerned that the proposed requirements will burden our members with additional, unnecessary governmental costs in an already difficult economic climate.” The ITA is now asking tanning professionals from every industry sector to stand behind the group’s efforts to help persuade the FDA that following the panel’s recommendations will have a detrimental impact on the way we all earn a living.
“It’s very easy for people in this industry to become complacent and think that someone else will fight this battle,” said Dan Humiston, President of the 30-store chain, The Tanning Bed, in W. Seneca, NY. “Regulations issued by the FDA are the most important challenge facing us, because what could be at stake here is whether or not we as industry professionals are able to deliver a cosmetic tan to our clientele. If the FDA makes a decision that would render our tanning equipment unable to deliver a tan, we’ll be done as an industry.” As former ITA President, Humiston knows this issue firsthand: he was one of 13 industry professionals who attended the FDA hearing in March of 2010 to discuss this matter. “When we first debated this issue with the FDA three years ago, we faced a panel of 18 ‘independent experts’ whose predisposition was unmistakably anti-tanning, and these are the same people we find ourselves up against today,” he added.
Another concern for Humiston and other ITA members is whether or not the FDA will choose to go even further with its new rules. “During the hearings three years ago, a panel of 18 people – most of them dermatologists – recommended the FDA adopt a number of European standards, based on the findings in the WHO/IARC report of 2009. If that were to happen, it could make all current tanning equipment obsolete, and new equipment built to that standard would not allow the unit to produce a tan. The bottom line is that if we as salon owners can no longer help our customers develop a tan, we will cease to be in business.” Humiston added that in 2010, the FDA was also considering a possible limit on annual UV dosage.
Want to help the ITA prepare for the biggest battle this industry has ever faced? Contact the organization and ask how you can help its members protect everyone’s right to tan.
