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FDA Keeps its Sights on E-Cigarettes


Posted in Regulatory and Compliance by Chris Wiltz on February 7, 2014

 After failing to regulate e-cigarettes as medical devices the agency intends to extend its reach over tobacco products.


In October, the European Parliament rejected a proposal by health officials to regulate electronic cigarettes (e-cigarettes) as medical devices and many expected the United States to follow suite. FDA has, however, announced it intends to propose to regulate the products on different terms – by extending its reach over tobacco products. 

E-cigarettes produce a nicotine vapor that is less pungent and potentially less harmful than tobacco smoke. 
FDA previously tried to regulate e-cigarettes as drug delivery devices. However a 2010 court decision ruled that the agency could only do so if companies marketed e-cigarettes as a therapeutic product. So far, e-cigarette companies have been very careful in the their marketing, selling e-cigs as an alternative to traditional tobacco products and not as a means of quitting smoking akin to nicotine patches. An FDA spokesman comments via email, “Electronic cigarettes are battery-operated products that turn nicotine, which is highly addictive, and/or other chemicals into a vapor that is inhaled by the user. FDA regulates electronic cigarettes that are marketed for therapeutic purposes as drugs or devices. FDA intends to propose a regulation that would extend the agency’s “tobacco product” authorities – which currently only apply to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco – to other categories of tobacco products that meet the statutory definition of 'tobacco product.' ”
 
Rather than burning tobacco, E-cigarettes contain a cartridge of nicotine solution that is heated into a vapor via a battery-powered coil inside the cigarette. The resulting vapor contains nicotine, but isn't as pungent or thick as tobacco smoke. Many adopters of e-cigarettes have done so because it affords them the opportunity to smoke indoors again. Critics however worry that wide adoption of e-cigarettes will be a huge, regressive step leading to a return to smoking in places such as restaurants, bars, movie theaters, and airplanes that legislation has eliminated with traditional tobacco.
 
A recent article in Bloomberg Businessweek cites a a 2011 study published in the Journal of Public Health Policy that concluded that “a preponderance of the available evidence shows [e-cigarettes] to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products...[there's also] reason to believe that they offer an advantage over traditional nicotine delivery devices.” However FDA comments, “Further research is needed to assess the potential public health benefits and risks of electronic cigarettes and other novel tobacco products.”
 
As of yet no e-cigarette manufacturer markets its products for therapeutic purposes, but if one finally does FDA would likely resume the fight to regulate e-cigs as devices.
 
According to projections by Bloomberg Industries, total e-cigarette sales could reach $1.5 billion worldwide in 2014.
 
 -Chris Wiltz, Associate Editor, MD+DI
Christopher.Wiltz@ubm.com 

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