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US: FDA Asked to Step Into E-Cigarette Debate

  

An advocacygroup associated with the American Cancer Society is asking the FDA tore-examine the safety of electronic cigarettes and whether they can actuallyhelp people quit.


"E-cigaretteshave not been scientifically shown to be effective tobacco cessation tools, yetsome distributors are marketing them either directly or indirectly for thatpurpose," Chris Hansen, president of the American Cancer Society CancerAction Network (ACS CAN), said in a statement.


Hansenpointed to an ad from Arizona-based NJOY, which ran during the Oscars.


"E-cigarettesare often manufactured to resemble traditional cigarettes, and are available infruit and candy flavors that are appealing to youth. The familiar appearanceand enticing flavors could actually encourage kids to try traditionalcigarettes, rather than avoid them," according to Hansen.


ACS-CAN'srequest comes in the wake of a study from the Centers for Disease Control(CDC), which found an increased awareness of e-cigarettes. In 2010, about 40.9percent of those surveyed on the Web were aware of e-cigarettes; that jumped to57.9 percent in 2011. About 3.3 percent used e-cigarettes in 2010, a numberthat increased to 6.2 percent in 2011.


Accordingto the FDA, e-cigarettes are battery-operated devices that turn nicotine andother chemicals into a vapor that is inhaled by the user.


Between2008 and 2010, the FDA found that e-cigarettes "were unapproveddrug/device combination products," and prevented companies like Sottera(which markets the NJOY electronic cigarettes) from importing them. Sotterasued and the court found that e-cigarettes and other products made or derivedfrom tobacco are not drugs/devices unless they are marketed for therapeuticpurposes, but suggested they be regulated as "tobacco products" underthe Tobacco Control Act of 2009.


TheFDA lost on appeal, but ultimately decided not to fight that decision anyfurther and agreed to "comply with the jurisdictional lines established bySottera," the agency said.


ThatTobacco Control Act, however, requires the Department of Health and HumanServices to consider new nicotine replacement therapies (NRTs) - like gums,patches, and lozenges. Earlier this year, HHS solicited comment on possibleadditions to the list of approved NRTs. E-cigarette advocates pushed supportersto demand that the gadgets be added to that list. More on that is expected inApril.


InJanuary, meanwhile, Consumer Advocates for Smoke-free Alternatives (CASAA),backed a White House petition that asked the administration to stop the FDAfrom regulating or banning the sale and use of electronic cigarettes,accessories, and associated liquids. At the time of its posting, White Housepetitions required 25,000 signatures for an official response (they now require100,000) and it topped that with 27,638 supporters. It's unclear if the WhiteHouse has issued its response yet.


Theissue is not limited to the U.S.,meanwhile. Officials in Australiaand the U.K.have also been examining how to classify e-cigarettes, according to The SydneyMorning Herald.