Posted on 22nd Nov 2009 @ 4:23 PM

Anti-Smoking and Public Health advocate, Bill Godshall warned the FDA prior to their disasterous press release that they would create a public health disaster if they did ban the e cigarette. We would like to thank such a prominent and credible advocate for breaking away from the group and using some of his great knowledge and experience to potentialy help million from move to the smarter alternative. Used with permission from Mr. Godshall

                                         e-mail smokesfree@compsurve.com   Phone 412-351-5880   FAX 412-351-5881

(sent via e-mail)

May 1, 2009

Ms. Heather Zawalick
US Food and Drug Administration

Per your recent e-mail (below), Smokefree Pennsylvania strongly urges the FDA to cancel its planned activities next Tuesday, and to consider the enormous public health disaster the agency would create by banning smokefree nicotine inhalers called e-cigarettes.

Denying 45 million cigarette smokers access to exponentially less hazardous smokefree nicotine alternatives would result in millions of preventable deaths among smokers, millions of nonsmokers continuing to be exposed to tobacco smoke pollution, and tens of thousands of e-cigarettes users
reverting back to smoking cigarettes.  It is absurd for the FDA to even contemplate protecting the deadliest nicotine products (cigarettes) from market competition by the least hazardous nicotine products.

Cigarette smoking is 100 times deadlier than smokeless tobacco use, while smokefree nicotine products pose even fewer risks.  Switching from cigarettes to smokefree tobacco/nicotine alternatives reduces smoker's health risks nearly as much as quitting all tobacco/nicotine use.  And millions of smokers have already sharply reduced their health risks by switching to smokefree tobacco/nicotine alternatives.  Please review a report I coauthored: "Tobacco harm reduction: an alternative cessation strategy for inveterate smokers" at http://www.harmreductionjournal.com/content/3/1/37

In contrast to recent claims by e-cigarette prohibitionists, hundreds of thousands of smokers have quit smoking and/or reduced cigarette consumption by switching to e-cigarette products, and thousands have written testimonials at http://www.thepetitionsite.com/1/keep-life-saving-electronic-cigarettes-available and http://www.e-cigarette-forum.com/forum/ describing their experiences with these less hazardous nicotine alternatives.  Meanwhile, test results on the Ruyan e-cigarette
http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf found no product hazards.

Also in contrast to claims by prohibitionists, there is no evidence that e-cigarette products have been marketed to youth, nor is there evidence of youth use of e-cigarette products (most of which cost more than $100).  And most e-cigarette companies do not make claims that their products are smoking cessation aids.  As such, the FDA should not be classifying these products as drugs (in an thinly disguised effort to ban them).

The sensible policy solution is for US Congress to enact reasonable and responsible tobacco/nicotine regulatory policies to allow e-cigarettes and other smokefree nicotine products (that are marketed as alternatives to cigarettes) to remain on the market, and be regulated as a separate category of tobacco products.  Smokefree tobacco harm reduction provisions in legislation recently introduced by Rep. Buyer (H.R. 1261) and Senators Burr/Hagan (S. 579) would achieve this policy goal.  The US Senate also can amend pending FDA tobacco legislation by Rep. Waxman (H.R. 1256) or soon-to-be-introduced legislation by Senator Kennedy with these or similar harm reduction provisions.

Most e-cigarette companies support reasonable and responsible regulations for their products.  If the

FDA is truly interested in reducing the leading cause of preventable disease, death and disability, it would join us in urging the US Senate to enact these sound public health policies.

Since 1990, Smokefree Pennsylvania has advocated policies to reduce tobacco smoke pollution indoors, increase cigarette taxes, reduce tobacco marketing to youth, preserve civil justice remedies for victims, expand smoking cessation services, and inform smokers that smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes.

For disclosure, neither Smokefree Pennsylvania nor I have received any funding from tobacco, drug or e-cigarette companies.

Thank you for your consideration, and feel free to contact me anytime. 

Sincerely,

William T. Godshall, MPH
Executive Director
- - -

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