Tobacco Issues

After three years of diligent policy-related work, the AAPHP Tobacco Control Task Force finds itself in the unexpected position of being a major advocate for the widespread use of electronic cigarettes, and in favor of adding a harm reduction component to current tobacco control programming based on informing actual and potential users of tobacco products of the relative risk profiles of each type of product, compared to conventional cigarettes.
It’s important to note that neither I nor AAPHP have received or anticipate receipt of any financial support from any electronic cigarette enterprise, any other tobacco-related enterprise, or any pharmaceutical enterprise. The time, energy and costs we have incurred in pursuit of the E-cigarette issue are all based on our perception that the requested reclassification could pave the way to a harm reduction initiative that, in turn, with FDA oversight, could result in rapid and substantial reductions in tobacco-related illness and death without increasing the numbers of teens initiating nicotine use.
With all this in mind, and after being invited to do so by top level FDA leadership, I, on behalf of the AAPHP task force have submitted two Citizen Petitions to FDA relative to reclassification of E-cigarettes from “drug-device combinations” to “tobacco product.”
To learn more about how we developed this policy stance, and the action we are now taking, please check out the two-page “Lessons Learned” summary of all this, and the petition-related documents posted today.
Joel L. Nitzkin, MD, MPH, DPA
Chair, AAPHP Tobacco Control Task Force
jln-md@mindspring.com or jln@jln-md.com  
February 11, 2010

Update on Harm Reduction, July 2010

AAPHP Statement re State Regulation of E-cigarettes April 2, 2010

E-cigarette Petitions to FDA February 10, 2010
The petition related documents consist of a one page summary, the text of the two petitions, and the tables of contents for the three sets of attachments. The 303 pages of attachments are presented in the form of 3 “A” files, 3 “B” files and a single “C” file. These can be downloaded as .pdf files.

The petitions, but not the attachments are accessible and available for comment on the www.regulations.gov web site. To access the petitions there, go to www.regulations.gov and type in the docket number in the Keyword field.  The docket number for the petition to reclassify is FDA-2010-P-0095-0001. The docket number for the petition regarding the press conference is FDA-2010-P-0093-001.

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Links to Petition Documents

Summary (one page)
Petition 1 -- Reclassification of E-cigarettes to "tobacco product" including annotated index to attachments (21 Pages)
Petition 2 -- Follow-up to July 22, 2009 Press conference including annotated index to (same) attachments (10 Pages)
Attachments - Tables of Contents. (Three parts, A-C)
A. Harm Reduction References (2 pages)
B. E-Cigarette References (2 pages)
C. Pharmaceutical Nicotine Replacement Product References (one page)

pdf Attachments to download.

A1 Pages 1-40 (3.8MB)
A2 Pages 41-80 (5.2MB)
A3 Pages 81-138 (8.3MB)

B1 Pages 1-53 (3.7MB)
B2 Pages 54-102 (2.4 MB)
B3 Pages 103-145 (4.2MB)

C Table of Contents and pages 1-20

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AAPHP Tobacco Policy- Lessons Learned 2007-2009 and Current Policy Orientation

AAPHP Letter to Dr. Deyton at FDA Urging Action to Reduce Tobacco-Related Illness and death among current smokers August 29, 2009

FDA: What Does it Mean for Investors? June 18.2009 (With Permission of UBS)

Promoting Snus, Response to Zhu et al, February 6, 2009 "The Zhu paper summarizes the most recent survey data strongly suggesting that encouraging smokers to switch to lower risk smokeless products is likely to result in substantial public health benefits. His summary, however, concludes that such benefits might not occur -- apparently because there are no case-control studies to back up these impressions. His conclusions have been taken out of context by anti-harm-reduction activists as "proof" that harm reduction will not result in public health benefits in the United States."
The abstract and our response are accessible from TC at http://tobaccocontrol.bmj.com/cgi/eletters/tc.2008.028209v1

Resolution and White Paper on Harm Reduction - (October 26, 2008)

HR1108/S625 The Myth of the Safe Cigarette (with technical references) written while Bush was still President 8/19/08

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