Tobacco Center Faculty Blog

May 7, 2014

Stanton A. Glantz, PhD

Philip Morris and the Cigar Association of America have both requested that the FDA extend the current 75 day comment period on the deeming rule for another 75 days (which would make it nearly 6 months long).
 
The 75 day comment period is already 50% longer than the minumum 50 days required by law.
 
Despite the generally tepid nature of the draft rule (exemplified by the fact that all the investment analysts are saying, correctly, that the proposed rule is even weaker and more pro-industry than expected), the tobacco interests are saying that they don't have enough time to respond.
 
That's ridiculous.  All they want is delay so they can keep selling their addictive products and work to get an even more sympathetic Congress.
 

May 7, 2014

Stanton A. Glantz, PhD

There are several examples in the deeming rule of the FDA laying out a good scientific case to do something, then ignoring the evidence they present and saying that they are going to do the opposite thing that the evidence suggests.  (More evidence of White House meddling?)  A great example of this is the FDA's decision not to have a warning on cigars about reproductive toxicity.
 
I just submitted the following public comment on this point:
 
May 7, 2014
 
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA–2014–N–0189
 
RE: FDA proposal not to include reproductive warning on cigars
 
            On page 23168 of the Proposed Rule the FDA states: “FDA is not proposing the fifth FTC warning (Tobacco Use Increases The Risk Of Infertility, Stillbirth And Low Birth Weight), because although cigarette smoking has been shown to cause these health effects and cigar smoke is similar,
the Agency is not aware of studies specifically linking cigars to these reproductive effects.”
 
            FDA specifically requested comment on its proposal to require the use of only four of the five current FTC warnings for cigars.
 

May 4, 2014

Stanton A. Glantz, PhD

I just submitted this public comment on the FDA deeming rule on Regulations.gov:
 
May 4, 2014
 
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. Docket No. FDA–2014–N–0189
 
RE: 2014 Surgeon General Report and Deeming Rule
 
            In reviewing the proposed rule I could not find a single citation to the 2014 Surgeon General's Report, The Health Consequences of Smoking: 50 Years of Progress (available at http://www.surgeongeneral.gov/library/reports/50-years-of-progress/index...).  This report contains important information that is directly relevant to the proposed deeming rule, including:
 

May 3, 2014

Stanton A. Glantz, PhD

I was at a meeting last week of NIH and FDA scientists on tobacco regulatory science at which FDA officials repeatedly urged people to submit public comments in response to the scientific questions raised in the draft deeming rule.
 
The absolute best source of data for answering many of these questions is the FDA PATH study, a giant national study of tobacco use, including exposure to tobacco advertising.  While the data for Wave 1 is still being collected, the FDA already has a huge amount of information collected that could form the basis for providing scientific guidance to the rule making process.
 
The problem is that none of this data is scheduled to be released until next year, well after the comment period on the deeming rule is closed (even allowing for the fact that the Obama Administration will almost certainly once again ignore the health community and extend the comment period for the tobacco industry).  While under normal circumstances it would be reasonable to wait until  the entire sample was collected before releasing the public use data set, we are not experiencing normal situations.
 

May 2, 2014

Stanton A. Glantz, PhD

Here is Legacy's press release:
 
FDA Deeming Regulations Released Last Week Fail to Safeguard Young People from Pervasive E-Cigarette Advertising
 
Washington, D.C. – A new report titled Vaporized: E-Cigarettes, Advertising, and Youth by Legacy, examines the recent rise of e-cigarette use among youth, and the entry of the major tobacco companies into the e-cigarette market. Legacy, the nation’s largest public health foundation devoted to achieving a culture where all youth and young adults reject tobacco, released the report today, amid growing concerns about the rising popularity of e-cigarettes among youth. Legacy’s report provides further evidence for the rapid implementation and expansion of the recently announced deeming regulations by the Food and Drug Administration (FDA). While the proposed regulation would take the very important step of instituting a national minimum age of 18 for the purchase of e-cigarettes, it is essential that the regulation also prohibits marketing of these products to youth, something not included in the proposal.
 

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