FDA Leaked Letter on The Electronic Cigarette

The Following email, which was leaked from the FDA, has been taken from an email by William Godshaw of Smokefree Pensylvania. You can read his reply here: Smoke Free Email to the FDA.

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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 Woodcock and Deborah Autor

Heather Zawalick
FDA/OC/Office of Legislation
301-827-0090
Heather.Zawalick@fda.hhs.gov