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Sunday, May 19, 2013

FDA releases proposal to strengthen tanning bed regulations.


The Food and Drug Administration's release of a proposal Monday to reclassify sunlamp products and require labels warning against the use of the devices by young people garnered extensive print and online media coverage. Nearly all of the news sources provided excerpts of comments made by FDA officials and by the American Academy of Dermatology's Regulatory Policy Committee Chair Dr. Mary Maloney during a conference call with reporters yesterday to announce the proposal for stricter regulations.
        The New York Times (5/7, A14, Tavernise, Subscription Publication, 1.68M) reports that the FDA on Monday announced"proposed new regulations for tanning beds that would require their makers to affix labels warning young people not to use them." The agency "said the proposal was its first step toward potentially restricting access to the beds altogether for minors." According to the American Academy of Dermatology, "nearly 28 million Americans use tanning beds every year."
        The Los Angeles Times (5/7, Healy, 692K) "Science Now" blog notes that in announcing the proposed regulation on Monday, FDA Commissioner Dr. Margaret A. Hamburg said the changes would "address some of the risks associated with sunlamp products" and would ensure consumers have "clear and consistent information." Essentially, the FDA's proposed new rule "would require manufacturers to show that their products meet certain performance and safety standards and that they are prominently labeled with warnings against their use by people younger than 18. The warnings would also be required to encourage all frequent users to be screened regularly for skin cancer."
        Bloomberg News (5/7, Edney) adds that during a conference call with reporters, FDA Center for Devices and Radiological Health Director Dr. Jeffrey Shuren explained that the warnings would "go on tanning beds as well as in brochures on the machines." The FDA is accepting public comments on the proposed rules for 90 days and the earliest it would "issue a final order is the end of this year and then there would be a 15-month implementation period, Shuren said."
        The Wall Street Journal (5/7, B3, Dooren, Subscription Publication, 2.29M) notes that the FDA's proposal was prompted by a 2010 recommendation from an independent panel of experts, which suggested the agency strengthen the regulation of tanning beds, which are presently listed in the same medical device category as band aids. The Journal quotes AAD's Regulatory Policy Committee Chair Dr. Mary Maloney as saying during the conference call, "Skin cancer no longer affects [only] older men." Dr. Maloney says melanoma is the most common form of cancer among young people between age 25 and 29. Moreover, 32 percent of girls in their senior year of high school reported using tanning beds in 2011, according to the data from the Centers for Disease Control and Prevention.
        CQ (5/7, Adams, Subscription Publication) adds that during the conference call, Dr. Shuren said the FDA "is not trying to burden salons but rather to educate consumers." He said the "responsibility for the new warnings falls on the companies that make the products, not salons." According to CQ, Shuren also noted that the AAD "found a 75 percent increase in the risk of melanoma" among individuals who "have been exposed to ultraviolet radiation from indoor tanning, and the risk ratchets up every time someone steps into a tanning bed."
        Meanwhile, Washington Post (5/7, Dennis, 489K) reports National Research Center for Women and Families President Diana Zuckerman "described the FDA proposal as 'very weak,'" noting that proposal "would not require clinical testing, 'which would entail making sure that consumers are not burned if the tanning bed is used as directed,'" and objecting to the fact that although the FDA is "recommending that children under 18 not use tanning beds, there is no enforcement mechanism to stop them."
        The AP (5/7, Perrone) adds that Dr. Maloney "said the FDA action is an important first step, but that her group would continue to push for a ban on the sale and use of tanning beds for people under age 18." According to data from the AAD, an "estimated 2.3 million US teenagers tan indoors each year."
        USA Today (5/7, Szabo, 1.71M) notes that several states, including "California and Vermont, already prohibit minors from using tanning beds, as do the cities of Chicago and Springfield, Ill. New York and New Jersey ban children under age 17 from using tanning beds."
        The FDA's proposal to bolster tanning beds regulations is also covered by the New York Times (5/7, Tavernise, 1.68M) "Well" blog, Reuters (5/7, Clarke), The Hill (5/7, Wilson, 21K) "RegWatch" blog, the Time (5/7, Sifferlin, 3.38M) "Healthland" blog, MedPage Today (5/7, Gever), HealthDay (5/7, Reinberg) and MyHealthNewsDaily (5/7, Rettner).

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