smart Tan Magazine is the leading source of information for indoor tanning salons, covering everything from the newest tanning technology, Vitamin D and the lastes tanning lotions to detailed ways to improve your salon's success.
Issue link: https://smarttan.epubxp.com/i/144509
ASA AMERICAN SUNTANNING ASSOCIATION UPDATE We have received many inquiries about the recent action by the U.S. Food and Drug Administration and what it will mean for your businesses. As most of you are probably aware, the FDA announced a proposed order to reclassify ultraviolet tanning lamps to a class II medical device in early May. This proposal would change pre-market manufacturing standards for sunbeds, including a suggestion that sunbed labels add a contraindication against use on people under 18 years old. The American Suntanning Association is currently working to constructively represent salons in the process with the FDA, while other industry groups represent manufacturers and other interested parties. The reclassifcation would require manufacturers to change the way they introduce new sunlamp products – which, by itself, does not change the end-consumer experience with sunbeds. As the FDA said in a statement, "…manufacturers would have to submit a pre-market notifcation (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." Though this appears to be a manufacturer issue, the impact could signifcantly impact salons by driving up the cost of equipment. There are additional concerns regarding the unclear language in the reclassifcation that the ASA is working on with the FDA through a variety of venues. What will happen to the industry's existing equipment in the market? Will salons be required to get new classifcations on equipment where the manufacturer is no longer in business? The order also proposes to "include a contraindication against use on people under 18 years old, and the labeling would have to include a warning that frequent users of sunlamp products should be regularly screened for skin cancer." The FDA has stated that these changes are based on new science like the WHO report 37 SMART TAN MAGAZINE ❘ SmartTan.com from 2009. There is considerable science that we have presented that challenges that report and the others that they have noted. This recent proposal was a major point of conversation when ASA representatives traveled to Washington D.C. in May for a series of 21 meetings with key legislators and political organizations. ASA representatives will be back in D.C. this summer to continue these discussions. The ASA has and is representing the best interest of salons on this issue, while other industry groups represent manufacturers. After seeking opinions from salon owners, the ASA issued a response to the FDA on behalf of all U.S. salons, and has helped salons create their own personal response to the FDA. Thank you to all who helped with this process. State Updates In mid-June, Texas Gov. Rick Perry declined to neither sign nor veto the under-18 ban for teenagers, meaning the bill will become law without his signature starting Sept. 1. Texas will become the ffth state to ban under-18 indoor tanning. Other states include California, Vermont, Oregon and Nevada. Obviously, we are very disappointed that Perry did not follow through and veto the bill, which would have been completely within his value set. In other legislative news, Delaware's legislative session adjourned June 30 with an under-18 ban bill still on the table. ASA representatives met with six of eight committee members that did not advance the bill before the end of the session. The bill will remain active when the new legislative session opens in January 2014. Legislative sessions in Ohio, Pennsylvania, Massachusetts and Michigan remain open throughout the year, and under-18 ban bills remain active in the four states. In Ohio, several ASA representatives presented the industry's case at a hearing on June 19. As of July 12, the under-18 ban bill in that state had not advanced to the House or Senate.