FDA Tobacco Advisory Committee “Grasping at Straws”

Editors Note: CRE will be making periodic reports on the recent action taken against FDA/TPSAC. CRE has a website dedicated to such actions, titled  FACA Under Fire   Influential regulators have followed the reports on these sites for years, see archives

 Grasping at Straws: “Making wild and often times unbelievable assumptions or using far fetched ideas and possibilities to reach the desired conclusion”. (Urban Dictionary)


ABC News reports:

Two of the nation’s largest cigarette makers on Friday asked a federal court to stop the Food and Drug Administration from relying on recommendations made by an advisory panel on issues such as menthol cigarettes.”

FDA’s Tobacco Advisory Committee’s Failure to Address the Health Effects of Contraband Cigarettes is an Invitation to a Legal Challenge

FDA’s tobacco advisory committee continues to ignore statements by the Center for Regulatory Effectiveness that its organic statute requires it to address the negative health impacts of contraband cigarettes, see http://www.thecre.com/tpsac/?p=1119

 Consequently, in the attached letter CRE is requesting that the General Counsel of the FDA apprise the  FDA Center for Tobacco Products and TPSAC of their statutory responsibilities to study, and report, in detail on the well documented negative impacts that counterfeit cigarettes have on the health of smokers and the violence sustained by non-smokers resulting from attacks by  drug cartels.

 The letter states, in part,

FDA Must Examine Counterfeit Cigs, CRE Says


The Center for Regulatory Effectiveness (CRE) has informed the US Food and Drug Administration and its Tobacco Products Scientific Advisory Committee that “contraband cigarettes pose a serious health problem and that TPSAC is required by statute to address this issue in its study of menthol.”

 The CRE sent the FDA three documents that make its case for the FDA’s responsibilities regarding counterfeit cigarettes. Those documents contain information regarding the health risks posed by counterfeit tobacco products and wording in the law that created the TPSAC requiring it to protect public health.

A note to the e-cigarette community

Editors  Note:  CRE  is interested in the views of  the e-cigarette community on the February 17 post  http://www.thecre.com/tpsac/?p=1119     which  describes   the extremely  adverse health effects sustained  from smoking counterfeit cigarettes.

Also see  http://www.thecre.com/tpsacnews/?p=369

Who is CRE?

 CRE is a regulatory watchdog which ensures that federal regulators do not exceed their statutory charge to regulate. In doing so CRE acts to ensure that federal regulators comply with the “good government” laws which “regulate the regulators”.

The “good government” laws include the Data Quality Act, the Paperwork Reduction Act and Executive Order 12866-regulatory review.

Center for Regulatory Effectiveness (CRE) Provides FDA with Evidence Which Compels an Examination of the Health Effects of Counterfeit Cigarettes

 Notwithstanding a law that directs the FDA Tobacco Advisory Committee to review the health effects of counterfeit tobacco, the Tobacco Advisory Committee continues to ignore the law. In response to this dereliction of duty, the Center for Regulatory Effectiveness sent the following email to the FDA and its Advisory Committee.

It should  be noted that when FDA regulates tobacco it is imperative  that it not be able to pick and choose at will which studies  are to be considered and those which are to be ignored; it  must examine the totality of the record.   It is difficult to understand why an agency charged with protecting public health would not want to examine the health effects of counterfeit cigarettes which are recognized throughout the world  as  having a demonstrable record of extremely adverse health impacts.

FDA offers plans to improve 510(k) device clearance process, punts hard decisions to IOM

Editor’s  Note.  Leading articles on te 510(k) process for medical devices are posted herein because they are based upon the term “substantial equivalence”– the  same term applied to new tobacco products  in the recently enacted tobacco control legislation.

January 21, 2011 | Reed Miller


Silver Spring, MD – The FDA has outlined plans to make the 510(k) device clearance process “more predictable and smarter” but acceded to industry pressure by declining to act yet on some of the most controversial issues [1]. The news is being hailed by industry advocates as progress and booed by critics who call the plan “not forceful enough.”

Why Does TPSAC Refuse to Examine the Health Effects of Contraband?

Editors Note:  Please view the following to ascertain the  public  acceptance of this message.

CNBC covered the CRE press release  .

Youth Use of Contraband Cigarettees  Out of Control In Ontario  .

Read News Feeds  Which Carried the CRE  Press Release Throughout the US



                                 —  CRE Press Release —


At today’s TPSAC meeting, the committee presented its outline of topics to be reviewed in its analysis  of the contraband which will result if there were  a ban on menthol cigarettes.

Debate Over e-Cigarette Safety

WAMC New York News

Dave Lucas (2011-02-11)

 ALBANY, NY (WAMC) – A paper purporting to be the latest e-cigarette research concludes that electronic cigarettes are much safer than tobacco cigarettes. But Capital District Bureau Chief Dave Lucas reports the manner in which the research was conducted raises questions about a new report…

An e-cigarette is a battery-powered tube that looks like a regular cigarette but instead of tobacco, it houses a battery-operated heating element that turns a liquid ingredient into a vapor mist which is inhaled into the lungs like a traditional cigarette. According to USA Today, more than one million Americans claim to have used the device to quit smoking since it first became available in the United States in 2006.

Are E-Cigarettes Evil?

Huffington Post

In case you somehow missed it, President Obama has quit smoking. That’s right, the Commander in Chief no longer smokes. And while there’s no clear word on Obama’s chosen method — cold turkey, nicotine gum, etc. — we wonder if he gave any thought to a cessation tool that’s been getting a lot of attention recently. The electronic cigarette.

So what, pray tell, is an e-cigarette? It’s a smokeless, battery-operated mechanism — either plastic or metal — that heats a liquid nicotine solution, letting users inhale doses of nicotine in vapor form. E-cigarettes don’t contain tobacco or create smoke, which is why manufacturers claim they “provide you with a similar experience without the tar and second-hand smoke that is related to traditional smoking.”

An Invitation to Federal and State Regulators of Tobacco

 The TPSAC Interactive Public Docket is rapidly becoming a forum for informed  public comments on tobacco issues. CRE appreciates  your continued visits to the site.

Members of  the public are encouraged to express their views on tobacco issues on the Studies and Concepts forum on the right hand side of this page–no registration is needed. CRE will post leading comments on the home page.

Very Informed Comments on e-cigarettes

CRE is  impressed with the thoughtfulness of the comments received on e-cigarettes, see http://www.thecre.com/tpsac/?p=1027

Those members of  the public who wish to supply additional comments or studies on e-cigarettes are encouraged to post them on the “Studies and Concepts Forum” on the right hand side of this page at http://www.thecre.com/scur/.

Each article is also equipped to take comments.

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

In a January 10, 2011 presentation to TPSAC, Ms. Anne Hartman1, a representative of NCI, used the newest May 2010 Tobacco Use Supplement to the Current Population Survey (TUS-CPS) data to allege that:

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

2.     Behavioral intention is associated with actual behavior-therefore, results suggest a potential substantial reduction in tobacco use if menthol cigarettes were no longer sold”.

See the  attachment for the complete article.

Also attached are two influential studies regarding the relationship between intention/behavior.

February 10-11 2011 TPSAC Meeting

 TPSAC is making a deliberate effort to complete its first major undertaking; a report on menthol in cigarettes.

TPSAC is to be complimented for writing the report from scratch in lieu of marking up a draft prepared by FDA.

Much to its credit TPSAC has released a draft of the first two chapters of the report, available    here  .

TPSAC is conducting the review in an open and transparent method and has made every effort to accommodate public comments.

CRE encourages its readers to offer comments on these chapters on this post.

ECF- “The Worlds Largest e-cigarette Forum” on the CRE IPD (Interactive Public Docket) for TPSAC

Editors Note: The CRE Board is reviewing a proposal to have CRE  follow in detail regulatory actions related to e-cigarettes. Also see the previous post on this topic at http://www.thecre.com/tpsac/?p=1027. The following is taken from ECF’s Forum at http://www.e-cigarette-forum.com/forum/campaigning-discussions/155402-public-participation-forum-fda-advisory-committee-tpsac.html

 A Public Participation Forum for the FDA Advisory Committee (TPSAC)

Question: Does anyone know anything about this website:
January « 2011 « A Public Participation Forum for the FDA Advisory Committee (TPSAC)

”A Public Participation Forum for the FDA Advisory Committee (TPSAC).
I have been looking around on the net to find wesibtes where I can leave comments. Does anyone esle feel that this something worth doing?”

Banning Menthol Cigarettes: The Disproportionate Effects and the Illegal Underground Market…

February 7, 2011 by Staff  

The National Black Police Association (NBPA) has a firm foundation, a strong commitment, and an unbreakable connection to the Black community. The NBPA is obligated to address any issues in the Black community that are not equitable, fair or just. Our role is advocacy and activism to protect the greater good.

Justice Department Wants Public Release of Tobacco Warning Statements


WASHINGTON — The Justice Department plans to ask a federal judge to make public the proposed statements the government wants tobacco companies to publish about the dangers of their products.

Department spokesman Charles Miller said the agency planned to file the proposed statements in a Washington, D.C., court Thursday, but ran into resistance from cigarette makers about whether the information should be made public now.

“It was our understanding that this would be publicly filed, but there is a difference of opinion on that,” Mr. Miller said.

Virginia tobacco maker seeks new FDA designation

Editors Note:   CRE looks forward to FDA’s  program to allow the public to express its views on this matter as well as the weight to be accorded to the Data Quality Act in making the resultant determination.


Tobacco maker Star Scientific Inc. is asking the Food and Drug Administration to certify a moist smokeless tobacco it has developed as less harmful than other forms of tobacco on the market.

The small Virginia company said Wednesday it has filed an application with the FDA to approve its Stonewall Moist-BDL as a “modified risk” product under the 2009 law that gave the FDA authority over tobacco.

Recent Comments Received on the TPSAC Interactive Public Docket(IPD)

Editors Note: CRE is receiving a substantial volume of comments on menthol. We are particularly impressed with the thoughtfulness of the comments.  Based upon our experience in  running a number of IPD’s, when public participation  on an IPD increases there is a corresponding increase in visits and reviews of the IPD  by  federal regulators. Consequently, we encourage the public to continue to post on the IPD.


Please do not ban menthol cigarettes. I have smoked for 39 years and tried to quit twice and could not stand the coughing and stress on my heart. Also my blood pressure rose 20-30 points.