May 20, 2014
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.
May 20, 2014
We just submitted the following public comment to the FDA (comment number 1jy-8c7f-bqh8):
E-cigarette and cigar companies and trade associations have petitioned the FDA to extend the comment period by up to an additional 105 days, bringing the total comment period to 180 days. There is a real health cost to granting such a delay. Based on 2012 use patterns of e-cigarettes alone, we estimate that during the requested 105 day extension we estimate that an additional 26,000 youth will start experimenting with e-cigarettes and 8,000 youth will become established e-cigarette users.
These estimates are probably low because they do not account for the fact that e-cigarette market penetration continues to accelerate. These estimates do not include new experimenters and established users for cigars and other products covered by the proposed deeming rule.
The FDA needs to include these health costs when evaluating the industry’s request and deny it. This rule has been years in the making and 75 days is enough time for industry to respond.
DETAILS OF CALCULATIONS:
May 16, 2014
Stanford Professor Robert Jackler has submitted a series of public comments to the FDA accompanied by rich collections of advertising images for e-cigarettes to support the conclusions he draws.
His comments appear below, together with links to the collections of images from the Stanford Research into the Impact of Tobacco Advertising (SRITA) collection that Dr. Jackler and his colleagues continue to build.
The comment numbers refer to the corresponding postings on www.regulations.gov. You can locate the original comments and attachments by putting the comment numbers into the search box on that site. You can also cite these comments and the collegting images in your public comments.
Safety
May 16, 2014
We just submitted this comment to the FDA:
SUMMARY OF THE SCIENTIFIC EVIDENCE ON E-CIGARETTES
Comment Submitted in Response to FDA Regarding Proposed Rule
Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for
Tobacco Products
Docket No. FDA-2014-N-0189
Rachel Grana, PhD MPH
Neal Benowitz, MD
Stanton Glantz, PhD
Center for Tobacco Control Research and Education
Department of Medicine
University of California San Francisco
May 16, 2014
We are submitting two recent reviews of the scientific evidence on the marketing, behavioral, and health effects of e-cigarettes for the FDA's consideration:.
May 14, 2014
In its latest version of “Where’s Waldo?,” FDA buried in the Paperwork Reduction Act of 1995 section of its recently published proposed deeming rule (79 FR 23142 at p. 23184) a gigantic loophole in its minimum age and identification restrictions for covered tobacco products: internet sales.
In addition to extending the agency’s tobacco authority to cover additional products, including e-cigarettes and cigarillos popular among young people, FDA also proposed restrictions requiring retailers to verify by means of photographic identification that buyers of tobacco products are at least 18 years of age. With much fanfare, FDA touted these new proposed rules as a way “to prevent sales to underage youth” and to “reduce the public health burden of tobacco use on the American public, including youth.” (FDA press release, April 24, 2014)
However, the proposed rule includes an exception for “mail-order sales” which are permitted without the age verification requirements set forth in proposed section 1140.14(b)(2)(i) for newly covered tobacco products and which are also an exception to the age verification requirements and “direct, face-to-face exchange” requirements set forth in sections 1140.14(a)(2)(i) and 1140.14(a)(3) for cigarettes and smokeless tobacco.