|05-14-2013, 03:08 PM||#1 (permalink)|
Join Date: Aug 27 2002
Location: East Coast
Rep Power: 15
ITA Update 5/14/13
Indoor Tanning Association, Inc., 2025 M St, NW Suite 800 Washington, DC 20036 · Phone: 888-377-0477 · Fax: 202-367-2142
Member Update 05/14/2013:
I take this opportunity to call to your attention the work and contributions of a truly unselfish ITA Board member, Jim Shepherd, owner of Sperti Sunlamps in Crescent Springs, Kentucky. Most of you don't know Jim because he prefers to work in the background. However, since the day I was first elected to the ITA board, I have gotten to know Jim very well and have developed tremendous respect for him as a person and as an advocate for our industry.
Not only does Jim serve on the ITA Board, he is also president of Ultraviolet Light Research and Education Foundation (UV Foundation). The UV Foundation was established in 2003 and through fundraising and unrestricted grants from the ITA, the foundation has funded independent research investigating the benefits and risks of ultraviolet light on the human body.
In 2004, Jim was appointed to TC61/MT16 Division of the International Electrotechnical Commission (IEC). This organization is an international electrical standards organization that focuses on ultraviolet equipment and is responsible for determining the standards by which tanning beds and other ultraviolet tools are used. The only other U.S. representative on this prestigious international body is Sharon Miller from the U.S. Food and Drug Administration.
For all his service on these three organizations, attending regular meetings, traveling to meetings in Europe and across the U.S., Jim does not receive any compensation! In fact, it costs him both in out-of-pocket expenses and the significant time he is away from his business.
Each of these three organizations is important in its own way but probably Jim's biggest contribution is through his service on the IEC. From helping us stay on top of regulatory developments in Europe to serving on the front line fighting efforts to harmonize US regulations with European standards, Jim is our advocate. Jim was recently appointed as an expert to yet another working group within the IEC along with Sharon Miller of the FDA. This group is charged with creating a standard for the manufacture of red-light and other beauty therapy lamps.
In addition to making Jim an important part of an international regulatory body, his service on the IEC has clearly put Jim in a position to develop closer ties with key people at the FDA who oversee our industry. This was evident in April when Jim set up a meeting for the ITA with very senior staff at the FDA. Meetings of this type on a regular basis are good for the industry and regulators.
We all owe Jim a debt of gratitude.
ITA to Combat FDA Reclassification Proposal
By John P. Ribner
On May 6, the U.S. Food and Drug Administration announced its intentions 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 a pre-market notification (510(k)) to the FDA for these devices, 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 add additional cost to every unit. As a result, the Indoor Tanning Association is asking the industry to come together to combat this proposal.
The FDA order would reclassify tanning equipment to a mid-risk category setting the stage for possible additional special controls later. It would require indoor tanning manufacturers to feature revised warning labels prominently on their tanning units, 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 The Tanning Bed chain in W. Seneca, NY. "Regulations issued by the FDA are the most important challenge facing the industry because what could be at stake here is whether or not we, as industry professionals, are able to deliver a 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 President of the ITA, Humiston knows this issue firsthand – he was one of 13 industry professionals who attended the FDA hearing in March 2010 to discuss this matter. "When we first discussed this issue with the FDA three years ago, we were facing 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.
It has been a busy and difficult year for the industry in the state legislative fights with approximately 46 bills introduced in 30 different states. Early in the session, New Jersey followed its neighbor New York's lead and passed an under 17 band. Colorado has passed an under 15 ban and West Virginia passed an under 14 ban.
Although the governors in Oregon and Illinois have not yet signed bills passed in those states' legislatures, in all likelihood laws to ban teen tanning under 18 will be go into effect . However, a pleasant surprise came in April when Maine's Governor vetoed a teen tan ban that passed both houses of the Maine Legislature.
A number of other state legislatures have adjourned without enacting similar teen restrictions -- Arizona, Indiana, Iowa, Maryland, Minnesota, Montana, Nebraska, Oklahoma and Washington. Still other states remain in session and the fight to stop these bills continues. State legislatures with legislation restricting teen access still pending at press time include Alabama, Connecticut, Delaware, Massachusetts, Michigan, Missouri, Nevada, North Carolina, Ohio, Pennsylvania, and Texas.
Although the ITA is not directly involved in the state legislative battles in a strategic or tactical sense, we have been closely cooperating with the salon association in an effort to protect the business interests of the entire industry.
Superior UV Technologies
(888) 526-7712 x77
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