The Electronic cigarette is legal in the United States, but may be subject to legislation at state level. TheFood and Drug Administration(FDA) lost its battle in the courts in January 2010 to have them classified as a drug delivery device and thus bring them under FDA regulation pursuant to theFood, Drug, and Cosmetic Act(FDCA). In September 2010 and appeal, the FDA announced that it would begin regulating e-cigarettes, on the premise that they comprise both a drug and adrug delivery device.The FDA began regulatory action against five American companies "for violations of the Federal Food, Drug, and Cosmetic Act (FDCA), including unsubstantiated claims and poor manufacturing practices."On 7 December 2010, the appeals court ruled against the FDA, in 3-0 unanimous decision, clearing the way for marketing of electronic cigarettes.
Until late of 2006, e-cigarettes didn't become easily available in the U.S., but now there are several million users worldwide, with tens of thousands new e-smokers every week, so at 25 April 2011, FDA plans to regulate smokeless electronic cigarettes as tobacco products and won't try to regulate them under stricter rules for drug-delivery devices.
In May 2009, theFood and Drug Administration(USFDA) Division of Pharmaceutical Analysis tested the contents of 19 varieties of electronic cigarette cartridges produced by two vendors (Enjoy and Smoking Everywhere).Diethylene glycolwas detected in one of the cartridges manufactured by Smoking Everywhere. In addition,tobacco-specific nitrosamines(TSNAs), known cancer-causing agents, were detected in all of the cartridges from one brand and two of the cartridges from the other brand. The study found that the actual nicotine levels did not always correspond to the amount of nicotine the cartridges purported to contain.The analysis found traces of nicotine in some cartridges that claimed to be nicotine-free. Further concerns were raised over inconsistent amounts of nicotine delivered when drawing on the device.In July 2009, the FDA issued a press release discouraging the use of electronic cigarettes and repeating previously stated concerns that electronic ciga rettes may be marketed to young people and lack appropriate health warnings.
The Electronic Cigarette Association said that the FDA testing was too "narrow to reach any valid and reliable conclusions."Exponent, Inc., commissioned by one manufacturer to review the FDA's study in July 2009, objected to the FDA analysis of electronic cigarettes lacking comparisons to other FDA-approvednicotine replacement therapyproducts where similar levels of TSNA were detected. Exponent concluded that the FDA's study did not support the claims of potential adverse health effects from the use of electronic cigarettes.
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