Whether the Food and Drug Administration reclassifies tanning units and sunlamps or not, the Indoor Tanning Association will continue to protect the industry from over-zealous regulators … and YOU can help!
For the past three years, the ITA has been monitoring the FDA’s proposed reclassification and fighting to stop it. Hundreds of hours of have been put into this effort by the organization’s board members, and their efforts have been aided by the ITA’s special fund. Now, as the tanning industry awaits the FDA’s announcement regarding the proposal, the ITA is calling upon tanning salon owners to help the group prepare for this and any other future battles it might face on behalf of indoor tanning. To help prepare the ITA for future regulatory battles, the organization is encouraging salon owners to donate to its Special Fund.
Having recently submitted its objections to the FDA’s proposed reclassification prior to the August 7 deadline, the ITA now awaits the governmental organization’s final ruling on the matter. This is the culmination of the three-year battle that began in March 2010 when a panel recommended that the FDA reclassify tanning units and sunlamps to Class II medical devices.
“In response, we organized a panel of 13 experts and issued a 33-page document arguing that the current regulatory controls are more than adequate,” said John Overstreet, ITA Executive Director, “and that no new science supports a change to the current classification or performance standards. We also submitted a 133-page literature review of the science to support our original submission, worked with our many contacts on Capitol Hill to ensure the FDA’s process remained fair, and recruited respected epidemiologists to delve into the 2009 WHO/IARC report, which the FDA uses as the basis of its recommendation.”
After the March 2010 meeting with the FDA ended, there was a three-year hiatus, but the ITA knew the issue wasn’t just going to go away. “Since 2010, more than $600,000 in Special Fund money was raised and used in this fight,” Overstreet said. “This Fund is the result of monies donated by ITA member companies, which goes above and beyond the money raised through their membership dues, and without it, we would be very vulnerable right now. As a result of all the work that was done during the past three years, the fund needs to be replenished so that we can continue to do everything we’ve been doing, as well as for any big battles we’re likely to have ahead of us.” Overstreet urges tanning salon professionals to contribute to the ITA’s Special Fund by sending donations to the ITA marked ‘Special Fund,’ or by donating on theita.com.
Efforts of this magnitude don’t just require money, they also require time and energy spent by those who care enough about it to generously give of themselves. Such is the case with several of the ITA’s Board of Directors members. “Rob Quinn, Dan Humiston, Jim Shepherd, Greg Henson and Bill Pipp have all generously given a great deal of personal time to this fight,” Overstreet said, “and they deserve our thanks. In addition, special credit goes to Allen Miller, general counsel for Palm Beach Tan. He has led the charge in recruiting researchers and documenting the inadequacy of the body of science to which the FDA constantly refers.”
While the ITA awaits the FDA’s response on this very important matter, Overstreet urges everyone in the tanning industry to keep current with it. “This process is by no means over,” he said. “The FDA could act quickly and issue a final order or it could be years before they act. Alternatively, they could start over from square one, which would be the right thing to do.” Beyond the current proposed order, the ITA is also aware that the FDA is planning to issue amendments to the performance standard (§ 1040.20) in the form of a proposed rule. “This is a lengthy and more cumbersome process that the FDA started more than a decade ago,” Overstreet added.
On May 6, the FDA announced its intention to reclassify tanning equipment and sunlamps to Class II medical devices, and is considering several other safety control measures. If the order is finalized, manufacturers will have to submit a pre-market notification (510(k)) showing that their products have met certain performance testing requirements, address certain product design characteristics and provide comprehensive labeling regarding risks of use. The FDA’s proposal was opened for public comment for a 90-day period that ended on August 7. If approved, the tanning industry will have one year to comply with the new requirements.
In response to the FDA’s announcement, the ITA listed and submitted its questions regarding what the organization believes are inaccuracies in the reclassification recommendation. “This isn’t a reclassification, at all!” Overstreet exclaimed. “The current device classification regulation is entitled ‘Ultraviolet lamps for tanning,’ so adding tanning equipment – which is regulated under the electronic product standards provisions of the statute and 21 CFR 1040.20 – would be an ‘initial classification’ that’s being labeled as a reclassification. According to the FDA’s own guidelines, they can’t do that.” The ITA is also convinced that the process to comply with the 510(k) testing and submission requirements called for by the reclassification will be expensive and time consuming for tanning equipment and sunlamp manufacturers.
The ITA firmly believes the proposed FDA regulations represent the most important challenge facing tanning businesses because this industry’s ability to deliver a cosmetic tan is at stake. If the FDA decision makes all current tanning equipment obsolete and new equipment unable to produce a tan, the tanning industry as a whole would be finished.
