How Safe Are E-Cigarettes?

Editors Note: 

There appears to be considerable interest regarding  CRE’s background, please see

Given the very large public response to this post, CRE will analyze the comments and prepare a White Paper for transmittal to the FDA.

TPSAC and CTR have a lot on their agenda but eventually they are going to have to develop an algorithm for addressing the “reduced harm” provisions of the new tobacco statute.  In doing so they will have to be mindful of the applicability of the Data Quality Act to the resultant proceedings.  Smokeless tobacco and e-cigarettes will be two issues leading the parade.

Canada flunking in contraband battle: Report

OTTAWA — The lobby group representing Canada’s tobacco companies, convenience stores and customs officers has given the federal government a failing grade for weak efforts to crack down on black-market cigarettes.

The National Coalition Against Contraband Tobacco (NCACT) assigned the government an F overall for failing to make progress on contraband tobacco, downgrading them from a D on a report issued in last May.

“The Harper government’s response to this problem amounts to unfulfilled promises or activities that have more public relations value than real impact,” Gary Grant, a spokesperson for NCACT, said at a news conference on Parliament Hill Wednesday morning. “It’s a government that talks tough on crime, but doesn’t follow through, in this area at least.”

Should menthol cigarettes be banned?

By Dr. Gilbert Ross

The Daily Caller

Here’s a word of advice to the Food and Drug Administration (FDA) regulators deciding this week whether or not to ban menthol cigarettes: Cool it. If the FDA sows this wind, I fear we will reap the whirlwind.

It was only last year that the agency prohibited the sale of all other flavored cigarettes, but would outlawing menthol be a good idea?

The FDA’s power to ban it goes back to the 2009 “Family Smoking Prevention and Tobacco Control Act” — the law giving the Food and Drug Administration (FDA) authority to regulate tobacco. That bill contained a provision barring all flavorings except menthol.

Questions Raised by the NCI Presentation to TPSAC: “What Menthol Smokers Report They Would Do If Menthol Cigarettes Were No Longer Sold”

Editors Note: Hopefully the very talented staff of NCI can shed additional light on the questions which follow.   Recognizing, however, that they have a wide range of commitments, CRE, as a safeguard, is initiating its own in-depth review of this subject. This action is warranted because a number of press articles reported the following  conclusions but without any caveats.

 In a January 10, 2011 presentation to TPSAC, a representative of NCI concluded:

   o   “Behavioral intention is associated with actual behavior

   o     ” 39% of menthol smokers say they would quit all tobacco use if menthol cigarettes were no longer sold”

Outlook For Flavored Tobacco Looks Sweet

Ideas from Forbes Investor Team
Posted by Jack Adamo
 Banning the sale of menthol cigarettes would cripple Lorillard.

 In my October 23 letter I explained in detail how I am vehemently opposed to smoking and try my best to advise young people on the hazards of smoking.

 Nonetheless, people have the right to smoke, and despite my rage and railing, youngsters continue to take up smoking. So, I’ve decided I’m not going to get an ulcer over it anymore, better to get a dividend check.

“Substantial Equivalence” and the Regulation of the Tobacco Industry: Part 1

Editors Note:  The term “substantial equivalence” is going to determine in large part the initial—and possibly— the ultimate regulatory regime for the tobacco industry.  The term has its genesis in non-tobacco regulatory programs which have  been the subject of CRE interventions for a number of years.

 CRE will be making periodic posts regarding this important subject notwithstanding the  longstanding  American disdain for  reviewing historical developments on pending topics.

 For starters, the term substantial equivalence goes back to the work of Food and Agriculture Organization, the World Health Organization and subsequently  OECD recommendations in 1991 dealing with genetically modified foods.  The Congressional Research Service offers the following definition of “substantial equivalence”

New Surgeon General’s Report Blows FDA Tobacco Act Out of the Water; Shows that Anti-Smoking Groups Were Untruthful in Their Public Statements

Editors  Note:  The following is  from Professor Siegel’s blog.  Send your views to FDA by  expressing your views in the comment section below.
Although the Surgeon General’s claim that a single cigarette can kill you has been gaining the most attention, there is another major conclusion of the Surgeon General’s report that is far more meaningful. The report reviews evidence regarding the basic approach to reducing tobacco-related disease that was taken in the Family Smoking Prevention and Tobacco Control Act (the Tobacco Act): lowering levels of specific toxic constituents in tobacco smoke.

A major conclusion of the report is that there is no evidence that reducing levels of specific tobacco smoke constituents will lead to a decrease in human disease.

Goldman’s Takeaway from the TPSAC Hearings: Ban on Menthol Cigarettes Unlikely

By Joe Young
Benzinga Staff Writer
Goldman Sachs has published a report on America’s Tobacco industry after attending day 1 of the Tobacco Products Scientific Advisory Committee (TPSAC) hearings that were concerning the impact of menthol cigarettes on public health.


In the report, Goldman writes “Today’s meeting revealed little incremental news. While there remains a potential headline risk as we head into the March 23 deadline of TPSAC’s recommendation, we still believe that a ban or any draconian measure on menthol by the FDA is highly unlikely. In addition, TPSAC also appears to be struggling to come up with any drastic recommendation, given the limited time, lack of finished research, and the risk of a large-scale contraband market. Following are key takeaways from today’s meeting.”

CRE Submits Study of Contraband Cigarettes to TPSAC

Whatever one thinks about a menthol ban, the attached report prepared by CRE makes it clear that:

l. Contraband cigarettes are a lot worse for smokers than legitimate cigarettes. For one contaminant alone, lead, contraband cigarettes have been found to contain more than ten times the level found in legal cigarettes.

2. The very negative health effects of a ban will be the burden of two groups; adolescents who purchase contraband cigarettes with no age check, and African American smokers, over 80% of which smoke menthol.

3. Non-smokers will suffer also because of increased crime and violence.

Live From FDA Headquarters: TPSAC January 10-11 Meeting

Editors  Note:  CRE will  make periodic  posts of  statements  having major regulatory implications made by TPSAC and meeting attendees.

TPSAC is on course to issue a report on March 23, 2011 as required by statute.

TPSAC has asked Dr. David Mendez to develop a model to assess impacts of menthol on initiation/cessation. The author claims the model results are comparable with published results.  The basis for this conclusion was not obvious from the presentation.

The fact that TPSAC is sponsoring  a model to generate additional information on initiation/cessation suggests that the committee agrees with the thrust of the CRE DQA petition that the existing initiation/cessation studies are not ready for prime time.

A Nod Towards Regulating Tobacco Products Similar to a Medical Device: The Significance of the Menthol Review

 Editors Note:  We aplogize for not  responding to the many emails we receive. But our readers must understand we have a very select audience of experts in science, law, public affairs and politics. Consequently any response requires a very well  reasoned response, not necessarily in length but in content.  The following post is made in response to inquiries regarding a likely regulatory scenario for tobacco  regulation by the FDA.  Nonetheless we encourage you to continue to express your opinions either by posting on this website or sending us an email through the link provided to the right of this article under “Important Sites”.

CRE Review of FDA Commissioned Studies

 CRE has reviewed the studies commissioned by FDA on menthol. CRE’s review focuses on initiation/cessation studies.

 Major conclusions:

1.  Only one study investigated the association between smoking initiation and use of   menthol cigarettes .  This was a secondary analysis of the American Legacy Longitudinal Tobacco Use Reduction Study (ALLTURS), a large longitudinal school-based survey of middle school and high school youth conducted in three waves from 2000 through 2003. In this study, subjects were aged 12 to 17 at baseline. It found that starting smoking with menthol (initiating first to menthol) is associated with each of the six indicators of smoking initiation in this study. However, this relationship was not adjusted for well known confounders including race, family income, and parents/caregivers’ education and smoking status.

If You Torture Data Enough It Will Speak To You!

 FDA has commissioned a number of studies of menthol based upon secondary analyses, meaning that the survey had been completed in past years and the data is then reexamined by researchers, often against study objectives that do not match the intent of the original survey.  For example, in the studies by Okuyemi (2003 and 2007), National Survey data was re-categorized into menthol and non-menthol sub-groups which became disproportional and not adequate for computing statistics.

CRE is not alone in this conclusion in that authors of one of the FDA commissioned studies state:

FDA Tobacco Adviser Resigns


A member of a key tobacco-advisory committee for the Food and Drug Administration who came under industry criticism has stepped down.

Gregory N. Connolly, a Harvard School of Public Health professor, no longer is listed on the agency’s website as a member of the panel. He didn’t respond to requests for comment.

In an email, FDA spokesman Jeff Ventura said: “Dr. Connolly has resigned from the Tobacco Products Scientific Advisory Committee. His departure will not impede the schedule or progress of the Committee.”

The FDA’s website now says the 12-member committee has one vacancy.

Two Studies That TPSAC Should Review in Detail

Two Studies That TPSAC Should Review in Detail

In an effort to attempt to disgorge CRE conclusion that studies to date regarding the impact menthol has on smoking initiation/cessation proponents of a menthol ban are in a rush to publicize studies however meritorious.

Examples include the eleven reviews of the literature studies commissioned by the FDA, the midnight publication of a special edition of Addiction as well as the recent barrage of studies submitted to TPSAC and so posted as meeting materials for its January 10 and 11 meetings.

Graphic cigarette warnings ignore contraband problem: Tobacco company

OTTAWA — The federal government’s intention to launch updated, larger and more graphic health warnings on cigarette packs is being applauded by anti-smoking and health advocates. But one tobacco company is questioning whether Thursday’s announcement evades a bigger problem — the sale of contraband cigarettes.

“Health Canada is ignoring the real tobacco problem in Canada today, and has decided to put further regulations on a legal industry that is already operating with a ton of regulations,” said Eric Gagnon, a spokesman for Imperial Tobacco.