At the Tanning World Expo’s opening session on Saturday morning, Greg Henson and I talked about an important FDA-related issue about which the vast majority of the industry is unaware. If this issue had been left unaddressed, our industry would have suffered immense damage.
In 2014, the FDA reclassified sunlamp products from Class I to Class II medical devices. Class I is the lowest class of medical devices, and sunlamps have been in this class since the mid-1980s. A Class II designation means the FDA can subject manufacturers and users to a higher level of regulation and can require a number of things from mandated training to a prescription from your doctor for use. As of August 26th, in order to sell beds or lamps, manufacturers now have to submit documents to the FDA to secure approval to sell the equipment. This is called a 510(k).
Filling out a 510(k) is complicated and expensive, but one of the boxes you have to check indicates to the FDA whether the device will be sold over the counter or by medical doctor’s prescription.
Last summer, as manufacturers began filing the paperwork, the FDA said all sunlamp products were considered prescription and told the manufacturers they had to go through an expensive and long process to show otherwise.
By the FDA’s logic, the whole purpose of “up-classing” sunlamps and sunbeds was to make them prescription devices! This is the real scary part – prescription status means individual states would determine who is eligible to use the devices.
The ITA – our industry – has what many people think is the best FDA lawyer in the country working for us. She did the research, she crafted the arguments, she presented the arguments and the FDA agreed that sunlamp product would stay over-the-counter. It was a significant win for the industry.
Protecting your livelihoods: that is what money from your ITA dues and profits from the Tanning World Expo pay for. If you’re not an ITA member, it’s time for you to join us.
Executive Director’s Report:
Thanks for Supporting the Tanning World Expo!
On behalf of the ITA Board of Directors, I want to thank everyone who joined us in Columbus in September for the return of the Tanning World Expo – exhibitors, attendees, speakers and our sponsors: Devoted Creations, SunEvolutions, Cosmedico Light, Inc. and Ultraviolet Resources International.
This gathering was a great success by any standard. For the exhibitors, our first priority was to make the show floor more affordable as it relates to the costs. We also worked to make set-up easy and fast for the product vendors, and I am pleased that we accomplished these goals.
As for attendees, our primary objective was affordability, as well as offering an education program that would provide a set of tools each business operator could take back and use immediately. From super-selling EFT memberships to social media marketing techniques, the breakout sessions generated a lot of interest, discussion and engagement.
We also strived to bring new faces to the show. Multiple exhibitors told me the Columbus crowd was full of first-time show attendees.
Perhaps the highlight of the show came on Saturday, when Jeffrey HayzLett told us how to “think big and act bigger.” Jeff travels in rarified air in the business world, but he certainly knew his audience and spoke to us in language that was insightful, entertaining … and down to earth.
Planning is already underway to bring the Tanning World Expo back to Columbus in 2016. Be sure to visit tanningworldexpo.com to see photos from the show and check for updates on our plans for 2016. See the TWE wrap-up on page 60.
Thanks,
John Overstreet
