Tobacco Center Faculty Blog

July 27, 2014

Stanton A. Glantz, PhD

My UCSF colleagues just submitted this comment to FDA:
 
FDA should prohibit of use of flavors in deemed tobacco products as part of the current rulemaking
 
Docket No. FDA-2014-N-0189
 
Elizabeth Couch, RDH, MS, Benjamin Chaffee DDS, MPH, PhD, Gwen Essex, RDH, MS, EdD, Margaret Walsh, RDH, MS, EdD
 
School of Dentistry
University of California San Francisco
 
July 28, 2014
 
Page 23147 of the proposed Rule the FDA states: “The prohibition against characterizing flavors established in the Tobacco Control Act applies to cigarettes only. Consequently, when this regulation is finalized and other tobacco products are deemed subject to FDA’s tobacco product authority, the statutory prohibition against characterizing flavors will not apply automatically to those deemed products (147).”  
 
The FDA specifically states that they may establish a product standard prohibiting flavors in those products only after the rule has been established and requests information and data that would support establishing such a standard (147).
 

July 23, 2014

Stanton A. Glantz, PhD

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:
 
FDA Should Prohibit All Non-Face-to-Face (Including Internet) Sales of Tobacco Products as FDA Originally Proposed to the OMB
 
Docket No. FDA-2014-N-0189

July 23, 2014

Stanton A. Glantz, PhD

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.
 
Here is my public comment:
 
July 23, 2014
 
Docket No. FDA-2014-N-1009
 
AGENCY INFORMATION COLLECTION ACTIVITIES; PROPOSED COLLECTION; COMMENT REQUEST; INFORMATION REQUEST REGARDING PH OF SMOKELESS TOBACCO PRODUCTS
 
There are several places in which the FDA proposes to only request "final" data analyses and reports. 
 

July 23, 2014

Stanton A. Glantz, PhD

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:
 

July 23, 2014

Stanton A. Glantz, PhD

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”.
 
Super high nicotine concentrations are available in youth appealing flavors such as Peppermint Party, Banana Split, Marshmallow, Tutti Fruti Gumballs, My Birthday Cake, Carnival Cotton Candy, Totally Toffee, Strawberrylicious, Chocolate, and Energy Drink.   These e-liquids are marketed online with bright and colorful images (see accompanying Powerpoint) and dispensed in similarly colorful bottles.  It is quite evident that these are designed to appeal to teens.  The numerous sweet flavored variety are also attractive to younger children.
 
As measured by Calafat and co-workers, Marlboro has 0.92 mg nicotine per cigarette. A 10 cc bottle of 36mg/ml chocolate e-liquid has the nicotine equivalent of 391 cigarettes. 
 

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