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FDA Targets E-Cigarettes
by admin on: January 6th, 2012

On Thursday September 9th 2010 the FDA issued warning letters to five distributors of electronic cigarettes. These letters detailed various violations of the Federal Food, Drug and Cosmetic Act, such as poor manufacturing practices and making unsubstantiated claims, perpetrated by e-cigarette companies. A sixth letter was also sent by the FDA to the Electronic Cigarette Association, a non-profit trade organization whose mission is to provide accurate information about e-cigarettes to the media, opinion leaders, policy makers and private sector companies so that they can make informed decisions regarding the product. This letter explained what e-cigarette companies must do to conform to FDA standards.

After reviewing the information regarding electronic cigarettes, the FDA decided that these products are ???drugs??? and, as such, are subject to FDA regulations. Essentially, what e-cigarette companies are going to have to do is demonstrate that their product is as safe and effective as they claim. In addition, the manufacturers of e-cigarettes must be able to demonstrate that their methods for producing e-cigarettes are adequate to preserve the purity, the strength, and the quality of their products.

Electric cigarettes are marketed as a tar- and tobacco-free way to smoke. These products are modeled to feel, look, and taste like real (tobacco-containing) cigarettes without the associated adverse effects of the real cigarettes. These products are odorless, produce a vapor described as ???harmless,??? and are purported to have no risk of inhalation or injury of smoke. Rather than containing tobacco, these products contain a cartridge filled with liquid nicotine. The liquid-filled cartridge, in part, drew the attention of the FDA when it was discovered that certain companies had included unapproved drugs (for example, tadalafil, a drug used for erectile dysfunction) in their nicotine cartridges.

However, wether or not e-cigarettes will be legally classified as a drug remains to be seen.

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