I'm sure other letters like this have been read, but thought I would post it as it was the response I received today. Its a canned response and that is fine. Just posting for information.
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Thank you for contacting me regarding electronic cigarettes. I appreciate having the benefit of your views.
An electronic cigarette is a battery-powered device that provides inhaled doses of nicotine by delivering a vaporized propylene glycol/nicotine solution, as an alternative to conventional smoked tobacco products. In addition to nicotine delivery, this vapor also provides a flavor and physical sensation similar to that of inhaled tobacco smoke, while no tobacco, smoke, or combustion is actually involved in its operation.
The Food and Drug Administration (FDA) considers electronic cigarettes to be a nicotine delivery system, subject to its approval. The Federal Food, Drug, and Cosmetic Act (the Act) prohibits the marketing of drugs and devices unless and until the product sponsor submits and obtains FDA approval of an application that establishes the product's safety and effectiveness for its intended use. The Act also directs the FDA to refuse the admission of a drug or device into the United States if it appears to be adulterated, misbranded, or unapproved.
The FDA has determined that several shipments of electronic cigarettes fall within the definition of "drug" or "device" under the Act. Because electronic cigarettes are not covered by an approved drug application, the FDA currently prohibits the marketing and import of electronic cigarettes. Should an application be submitted that establishes electronic cigarettes' safety, the FDA would allow marketing and import. Other manufacturers and distributors successfully gained approval to market nicotine replacement therapies, including gum, transdermal patches, nasal sprays, inhalers, and lozenges.
Thank you for contacting my office. I appreciate having the opportunity to represent the interests of Nebraskans in the United States Senate, and I will keep your views in mind should this issue come up for debate on the Senate floor. Feel free to contact me any time. For further information on legislative issues and constituent services, visit my website, www.johanns.senate.gov.
Very truly yours,
Mike Johanns
United States Senator
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Thank you for contacting me regarding electronic cigarettes. I appreciate having the benefit of your views.
An electronic cigarette is a battery-powered device that provides inhaled doses of nicotine by delivering a vaporized propylene glycol/nicotine solution, as an alternative to conventional smoked tobacco products. In addition to nicotine delivery, this vapor also provides a flavor and physical sensation similar to that of inhaled tobacco smoke, while no tobacco, smoke, or combustion is actually involved in its operation.
The Food and Drug Administration (FDA) considers electronic cigarettes to be a nicotine delivery system, subject to its approval. The Federal Food, Drug, and Cosmetic Act (the Act) prohibits the marketing of drugs and devices unless and until the product sponsor submits and obtains FDA approval of an application that establishes the product's safety and effectiveness for its intended use. The Act also directs the FDA to refuse the admission of a drug or device into the United States if it appears to be adulterated, misbranded, or unapproved.
The FDA has determined that several shipments of electronic cigarettes fall within the definition of "drug" or "device" under the Act. Because electronic cigarettes are not covered by an approved drug application, the FDA currently prohibits the marketing and import of electronic cigarettes. Should an application be submitted that establishes electronic cigarettes' safety, the FDA would allow marketing and import. Other manufacturers and distributors successfully gained approval to market nicotine replacement therapies, including gum, transdermal patches, nasal sprays, inhalers, and lozenges.
Thank you for contacting my office. I appreciate having the opportunity to represent the interests of Nebraskans in the United States Senate, and I will keep your views in mind should this issue come up for debate on the Senate floor. Feel free to contact me any time. For further information on legislative issues and constituent services, visit my website, www.johanns.senate.gov.
Very truly yours,
Mike Johanns
United States Senator
