A Public Participation Forum for the FDA Center for Tobacco Products and its Federal Advisory Committee (TPSAC)

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 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,

• Written By: TOB Editor
• 2-21-2011

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.

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.

 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.

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

theheart.org

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

 NO RESPONSE FROM FDA

                                 —  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.

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.

 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.

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.

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.

 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.

“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?”

By BRENT KENDALL

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.

RICHMOND, Va.

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.

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.

     Anonymous

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.