E-cigarette companies under FDA scrutiny owing to violations

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You might have heard about Electronic cigarettes which are battery operated devices, an alternative to smoked tobacco products, such as cigarettes, cigars, or pipes. It produces no fire and is safe to use anywhere. E-Cigarette allows customers to safely smoke without the danger of fire or annoying other people nearby. However, it contains a cartridge of nicotine, when heated, converts the contents of the cartridge into a vapor. The vapor provides a flavor and physical sensation similar to that of inhaled tobacco smoke, while no smoke or combustion is actually involved in its operation.

They’re currently sold in shopping malls and over the Internet. The FDA sent a warning letter to 5 major companies that produce E-Cigarettes saying that they are unapproved drug delivery devices that cannot be legally sold until proven safe and effective. However, in 2009, the e-cigarette industry filed lawsuits that blocked an FDA ban.

Why FDA issued the warning letters to five distributors of electronic cigarettes?
According to the FDA, all the five firms violated the Federal Food, Drug, and Cosmetic Act (FDCA). Firms claimed that their products can help people quit smoking cigarettes. Some of the firms also had poor manufacturing practices and adulterated products with the ingredients which were different than those listed on the product label.

Who are the companies received the warning letter?
The companies that received FDA warning letters are:

  • Cixi E-Cig Technology Inc. Ltd., Las Vegas, Nev.
  • E-CigaretteDirect LLC, Parker, Colo.
  • Gamucci America/Smokey Bayou Inc., Jacksonville, Fla.
  • Johnson Creek Enterprises LLC, Johnson Creek, Wis.
  • Ruyan America Inc., Minneapolis, Minn.

Why E Cigarettes require an approval from FDA?
FDA noted that e-cigarettes meet the legal definition of both a drug and a device. As such, e-cigarettes would require FDA approval.

FDA noted that people who opted e-cigarettes as an aid to quit smoking, there are a number of other FDA-approved smoking cessation aids, including nicotine gum; nicotine skin patches, nicotine lozenges, nicotine oral inhaled products, and nicotine nasal spray are available for smokers to reduce their dependence on nicotine.  Free help is available to all smokers who want to quit at 1-800-QUIT-NOW or by visiting http://www.smokefree.gov/.

Source: WebMD



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The companies that received FDA warning letters are:

  • Cixi E-Cig Technology Inc. Ltd., Las Vegas, Nev.
  • E-CigaretteDirect LLC, Parker, Colo.
  • Gamucci America/Smokey Bayou Inc., Jacksonville, Fla.
  • Johnson Creek Enterprises LLC, Johnson Creek, Wis.
  • Ruyan America Inc., Minneapolis, Minn.

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Source: WebMd

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You might have heard about Electronic cigarettes which are battery operated devices, an alternative to smoked tobacco products, such as cigarettes, cigars, or pipes. It produces no fire and is safe to use anywhere. E-Cigarette allows customers to safely smoke without the danger of fire or annoying other people nearby. However, it contains a cartridge of nicotine, when heated, converts the contents of the cartridge into a vapor. The vapor provides a flavor and physical sensation similar to that of inhaled tobacco smoke, while no smoke or combustion is actually involved in its operation.

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