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05-06-2013, 03:46 PM | #1 (permalink) |
Team TanTalk Join Date: Aug 27 2002 Location: East Coast Age: 56
Posts: 2,888
Rep Power: 22 | FDA - Tanning Beds FDA NEWS RELEASE For Immediate Release: May 6, 2013 Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA issues proposal to increase consumer awareness of tanning bed risks Today, the U.S. Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices. According to the American Academy of Dermatology, there is a 75 percent increase in the risk of melanoma, the deadliest type of skin cancer, in those who have been exposed to ultraviolet radiation from indoor tanning, and the risk increases with each use. The proposed order does not prohibit the use of sunlamp products by those under the age of 18, but it provides a warning on the consequences. The order would reclassify sunlamp products from a low risk device (class I) to a moderate risk device (class II). “Using indoor tanning beds can damage your skin and increase your risk of developing skin cancer,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s proposed changes will help address some of the risks associated with sunlamp products and provide consumers with clear and consistent information.” 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 order 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 will take comments on the proposed order for 90 days. For more information:
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05-06-2013, 04:33 PM | #2 (permalink) |
Team TanTalk Join Date: Jul 13 2004 Location: Menomonie, Wi. Age: 82
Posts: 3,145
Rep Power: 22 | Re: FDA - Tanning Beds Another nail in our coffin. (no pun intended) Tanning can't be considered a viable business adventure now-a-days. Like I said, back awhile ago, the landfills will be overflowing with spent tanning equipment in less then 10 years. |
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