Tobacco Center Faculty Blog

May 20, 2014

Stanton A. Glantz, PhD

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

Stanton A. Glantz, PhD

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

Stanton A. Glantz, PhD

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

Stanton A. Glantz, PhD

           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.

May 12, 2014

Stanton A. Glantz, PhD

We just published a major review of the scientific literature on e-cigarettes in the journal Circulation.  The paper, as well as a "cardiology patient page" on e-cigarettes are available for free on the Circulation website. 
 
Here is the press release UCSF put out about the paper:
 
E-Cigarettes Expose People to More than ‘Harmless’ Water Vapor and Should be Regulated, UCSF Scientists Find
First Comprehensive Analysis Shows that Industry Health Claims are Unsupported by Data   
 
In a major scientific review of research on e-cigarettes, UC San Francisco scientists found that industry claims about the devices are unsupported by the evidence to date, including claims that e-cigarettes help smokers quit. 
 
The review marks the first comprehensive assessment of peer-reviewed published research into the relatively new phenomenon of electronic cigarettes. 
 

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