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Of note, one of the larger importers of e-cigarette products just sued the FDA to prevent seizure of product at customs.
The statement from Heather Zawalick of the FDA's Office of Legislation is as follows:
From: Zawalick, Heather (CBER) [mailto:Heather.Zawalick@fda.hhs.gov]
Sent: Wednesday, April 29, 2009 4:08 PM
To: Zawalick, Heather (CBER)
Subject: [LIKELY_SPAM]FDA Outreach: FDA Takes Enforcement Action on Electronic Smoking Products, Entering Clearance
Subject/Headline: FDA Takes Enforcement Action on Electronic Smoking Products
Planned Release Date: May 5
Driving Event: Compliance action
Rollout Plan: Extensive rollout planned including press conference at HHS, press release, fact sheet, video for upload to YouTube, podcast, consumer article, consumer Q &A, key message points, internal media Q & A, Op-Ed, photos of products for posting on Internet.
Other background, hidden factors: Action involves three largest distributors. One of the distributors has just sued FDA seeking a restraining order to prevent us from holding their product at the border. There is keen interest in this subject. E-cigarette kiosks are all over town, including Montgomery Mall. They're being advertised as a safer alternative to cigarettes. Our concern is that this might introduce nonusers to nicotine use. This is a drug delivery device. The content of the products have not been analyzed by FDA. To be sold, they would have to be approved by the agency.
Spokespersons: Janet Wood**** and Deborah Autor
Heather Zawalick
FDA/OC/Office of Legislation
301-827-0090
Heather.Zawalick@fda.hhs.gov
Sent: Wednesday, April 29, 2009 4:08 PM
To: Zawalick, Heather (CBER)
Subject: [LIKELY_SPAM]FDA Outreach: FDA Takes Enforcement Action on Electronic Smoking Products, Entering Clearance
Subject/Headline: FDA Takes Enforcement Action on Electronic Smoking Products
Planned Release Date: May 5
Driving Event: Compliance action
Rollout Plan: Extensive rollout planned including press conference at HHS, press release, fact sheet, video for upload to YouTube, podcast, consumer article, consumer Q &A, key message points, internal media Q & A, Op-Ed, photos of products for posting on Internet.
Other background, hidden factors: Action involves three largest distributors. One of the distributors has just sued FDA seeking a restraining order to prevent us from holding their product at the border. There is keen interest in this subject. E-cigarette kiosks are all over town, including Montgomery Mall. They're being advertised as a safer alternative to cigarettes. Our concern is that this might introduce nonusers to nicotine use. This is a drug delivery device. The content of the products have not been analyzed by FDA. To be sold, they would have to be approved by the agency.
Spokespersons: Janet Wood**** and Deborah Autor
Heather Zawalick
FDA/OC/Office of Legislation
301-827-0090
Heather.Zawalick@fda.hhs.gov
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