Tobacco Center Faculty Blog

May 29, 2014

Stanton A. Glantz, PhD

Several people have asked me to collect all the public comments that we have submitted to the FDA.  I have also added comments submitted to other agencies on tobacco issues.  I will update this posting as new comments are submitted.  This post is current as of May 4, 2020.

Avoiding EVALI

In identifying additives and design elements known to increase severe lung disease, FDA should not create a "safe harbor" list for e-cigarettes

22nd Century VLN MRTP Application

Letter to Mitch Zeller raising question about the VLM PMTA

22nd Century’s VLN cigarettes marketing with modified exposure claims has not been tested and will likely be appealing to youth and young adults

May 26, 2014

Stanton A. Glantz, PhD

On May 21, 2014 Andrea King and colleagues published a nice experimental study, "Passive exposure to electronic cigarette (e-cigarette) use increases desire for combustible and e-cigarettes in young adult smokers," in Tobacco Control, showing that when young adult smokers saw someone using an e-cigarette it made them want to smoke as much as if they saw someone smoking a cigarette.  (The "passive exposure" is watching someone use an ecig during a conversation.)
 
Seeing an ecigarette being used did not make smokers who did not already use ecigarettes want to use an ecigarette, but did stimulate desire for an ecigarette among ecigarette users.  Exposure to to a neutral stimulus (seeing someone drink a bottle of water) did not affect desire for either a cigarette or ecigarette.
 

May 24, 2014

Stanton A. Glantz, PhD

Wendy Max and Yingning Wang, two economists at UCSF have submitted a public comment on  the FDA's regulatory impact (cost-benefit) analysis.  Here is a summary from the beginning of their comment:

May 20, 2014

Stanton A. Glantz, PhD

Several people have asked me how to submit comments.  It is easy.
 
1. Go to www.regulations.gov.
 
2. Type (or cut and paste) FDA-2014-N-0189 into the search box and press "search."
 
3.  This will open the page for the deeming rule docket.
 
4. Type your comment into the text box or upload any files that you want the FDA to consider (or do both).
 
5. Fill in your name and the other identifying information that is requested and click the button to submit the comment.
 
 
 
 

May 20, 2014

Stanton A. Glantz, PhD

Robert West and colleagues just published a large population-based cross-sectional study of the relationship between e-cigarette use and having stopped using cigarettes in England that shows that, among smokers who made at least one quit attempt in the last year, smokers who used ecigs as part of their quit attempt were statistically significantly more likely to no longer be smoking cigarettes than smokers who used unassisted NRT or no aids.
 
Subject to all the usual caveats about cross-sectional studies, this is a reasonably done study for what it claims to compare.  The use of statistical methods to adjust for differences between the groups is the standard way to analyze such real world studies.  Like others, they found that the adjustments did not change the results very much.
 
I agree with West that, for mass-marketed products like e-cigarettes, this kind of real-world study is more meaningful than randomized clinical trials.
 
It is important, when interpreting their findings, to remember what they studied:  They limited themselves to people who were using ecigs as part of quit attempts.
 

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