Stanton Glantz, PhD's blog

FDA Should Prohibit All Non-Face-to-Face (Including Internet) Sales of Tobacco Products as FDA Originally Proposed to the

This is yet another example of the Obama White House OMB watering down the FDA's proposed deeming rule in a way that seriously harms public health.  FDA wanted to end non-face-to-face sales, which would have ended internet sales of tobacco products (including, but not limited to ecigarettes).  The OMB deleted this action and replaced it with a limited vending machine restriction.  Here is the public comment we submitted on this issue:
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FDA requesting information on effects of pH changes in smokeless tobacco

The FDA has posted a request for industry research on the effects of pH (acidity) in smokeless tobacco for public comment.  This is an important request that could have substantial regulatory implications (if OMB and  the White House let FDA do anything).
 
There are a couple fine points in the request that need tweaking to avoid inadvertently creating loopholes that the industry could use to avoid dislosing important information.
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Transparency as a remedy against racketeering: preventing and restraining fraud by exposing Big Tobacco's dirty secrets

Monique Muggli, Howard Crystal, and Kim Klauser just published an excellent paper in Tobacco Control outlining the recent history of keeping the tobacco industry documents flowing into public view, including listing some of the improvements to the UCSF Legacy Tobacco Documents Library that will be released for public use in September, including:
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“Super High” Nicotine Youth Appealing Electronic Cigarette Flavors

Maya Ben-Efraim and Robert Jackler from Stanford just submitted this comment to the FDA on the deeming rule:
 
“Super High” Nicotine Youth Appealing Electronic Cigarette Flavors
 
Electronic cigarette liquid (ejuice) is available in a variety of nicotine strengths ranging as high as 36 mg/ml and even 54 mg/ml.  Nicotine levels of 16mg/ml are usually advertised by the electronic cigarette industry as “full flavored” while nicotine levels of 36 mg/ml are described as “super high” or “unfiltered”. Read more »

Submitted to FDA deeming docket: E-Cigarette Makers Are in an Arms Race for Exotic Vapor Flavors

July 23, 2014
 
Docket No. FDA-2014-N-0189
 
On July 15, 2014, the New York Times published the attached article, "E-Cigarette Makers Are in an Arms Race for Exotic Vapor Flavors," that documents the importance of flavored e-cigarettes, particularly in attracting youth to the use of nicotine.
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FDA Should Not Exclude Accessories from the Scope of the Deeming Rule

We just submitted this comment to FDA on the deeming rule.
 
 FDA Should Not Exclude Accessories from the Scope of the Deeming Rule
 
Docket No. FDA-2014-N-0189

Lauren K. Lempert, JD MPH and Stanton A. Glantz, PhD
 
Center for Tobacco Control Research and Education
University of California San Francisco
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New paper: Clean indoor air laws and state tobacco control spending are effective in reducing young adult smoking

Matthew Farrelly and collaegaues at RTI and the CDC Office on smoking an health recently published a nice paper, "Are tobacco control policies effective in reducing young adult smoking?" in Journal of Adolescent Health that shows that spending on state tobacco control programs and clean indoor air laws are associated with less young adult smoking.
 
Here is the abstract:
 
PURPOSE: Read more »

Judge Leon strikes again: His ruling on FDA’s Tobacco Advisory Committee is misguided and must be appealed

Judge Richard Leon, who has consistently ruled against the FDA on everything related to tobacco, is at it again, ruling that the FDA Tobacco Products Scientific Advisory Committee is flawed.  (Why does every tobacco case on the FDA end up in front of the same hostile judge?)
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FDA cost-benefit analysis ignores that tobacco companies pass costs through to smokers, raising prices & reducing smoking

My colleagues at UCSF just submitted this comment to the FDA on the deeming rule:
 
The Regulatory Impact Analysis Must Consider the Benefits of the Likelihood that the Regulated Companies will Pass the Costs of Compliance on to Smokers, which Will Raise the Cost of the Regulated Products, thereby Reducing Consumption and Improving Health
 
Docket No. FDA-2014-N-0189
 
Hai-Yen Sung, PhD Read more »

The Regulatory Impact Analysis Fails to Adequately Document the Sources the Benefit and Cost Estimates upon Which it is Based

My UCSF colleagues just put in this public comment on the FDA deeming rule:
 
The Regulatory Impact Analysis Fails to Adequately Document the
Sources for the Benefit and Cost Estimates upon Which it is Based
 
Docket No. FDA-2014-N-0189
 
Wendy Max, PhD
Professor of Health Economics
 
Hai-Yen Sung, PhD Read more »

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