{"id":12339,"date":"2013-05-07T08:16:35","date_gmt":"2013-05-07T12:16:35","guid":{"rendered":"https:\/\/smarttan.com\/news\/?p=12339"},"modified":"2013-05-07T08:16:35","modified_gmt":"2013-05-07T12:16:35","slug":"fda-proposes-new-sunbed-rules","status":"publish","type":"post","link":"https:\/\/news.smarttan.com\/index.php\/fda-proposes-new-sunbed-rules\/","title":{"rendered":"FDA Proposes New Sunbed Rules"},"content":{"rendered":"

The U.S. Food and Drug Administration on Monday announced a proposal to change pre-market manufacturing standards for sunbeds, including a suggestion that sunbed labels add a statement urging young people not to use sunbeds.<\/p>\n

\u201cFDA\u2019s proposal is in line with the views of those who are advocating informed parental consent in state regulations as the best standard for teenage access to sunbed salons, as FDA did not call for a ban on tanning for minors,\u201d Smart Tan Executive Director Joseph Levy said. \u201cBecause FDA is just releasing this proposal for public comment, Smart Tan will work with the American Suntanning Association and industry manufacturers to participate in the process with FDA constructively.\u201d<\/p>\n

FDA\u2019s proposal comes three years after a non-binding FDA advisory panel urged the agency to seek changes, including reclassifying sunlamp products as Class II medical device instead of a Class I device. The reclassification would require manufacturers to change the way they introduce new sunlamp products \u2014 a change that, by itself, does not change the end-consumer experience with sunbeds.<\/p>\n

\u201cIf 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,\u201d the FDA said in a statement. \u201cManufacturers 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.\u201d<\/p>\n

Sunbeds already include clear warning labels \u2014 labels the sunbed market worked with FDA to create. In a 2002 meeting with FDA, the sunbed community and FDA constructively agreed on changes to that warning label spurred by a 1999 request that sunbed rules be reviewed.<\/p>\n

FDA has not involved the American Suntanning Association in development of the current proposal.<\/p>\n

\u201cThe professional sunbed community has not had any input in this preliminary proposal thus far. We remain dedicated to sunburn prevention and look forward to working with the FDA to improve consumer protection and to assure that all information regarding indoor tanning is in accordance with the science,\u201d the ASA said in a statement released to the media 30 minutes after Monday\u2019s press conference.<\/p>\n

The FDA will take comments on the proposed order for 90 days.<\/p>\n

To read the FDA\u2019s press release\u00a0click here<\/a>.<\/p>\n

To read the FDA\u2019s proposal,\u00a0click here<\/a>.<\/p>\n

To read current FDA regulations,\u00a0click here<\/a>.<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

The U.S. Food and Drug Administration on Monday announced a proposal to change pre-market manufacturing standards for sunbeds, including a suggestion that sunbed labels add a statement urging young people not to use sunbeds. \u201cFDA\u2019s proposal is in line with the views of those who are advocating informed parental consent in state regulations as the […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-12339","post","type-post","status-publish","format-standard","hentry","category-news"],"yoast_head":"\nFDA Proposes New Sunbed Rules - Smart Tan News<\/title>\n<meta name=\"description\" content=\"The U.S. Food and Drug Administration on Monday announced a proposal to change pre-market manufacturing standards for sunbeds, including a suggestion that sunbed labels add a statement urging young people not to use sunbeds.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/news.smarttan.com\/index.php\/fda-proposes-new-sunbed-rules\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Proposes New Sunbed Rules - 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