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

The FDA has requested comments  on  “Tobacco Product Advertising and Promotion to Youth and Racial and Ethnic Minority Populations.

In response to this request,  

Mr. Zachary Ryan Morgan writes:

“The FDA has even been looking at banning flavored cigarettes, including menthols, but “Joshua Rising, a researcher for the FDA, found no casual link between smoking menthols and an earlier initiation of smoking.”

Roswell Cancer Center states:

“We find no evidence that those who self-report smoking a menthol cigarette brand have different quit rates than those who self-report smoking a non-menthol cigarette brand, after adjusting for other smoking and demographic factors.”

In that CRE was founded and is presently managed by former officials of the White House Office of Management and Budget, CRE often follows the money.

We call our readers attention to Section 919 of the Act which places a levy on the tobacco industry to pay for FDA’s cost of implementing the Act–these costs escalate to nearly three quarters of a billion dollars in the last year of  the authorization.

CRE believes third-party  regulatory audits of these funds is advisable.  A regulatory audit often  differs from a financial audit in that it examines if the funds are spent solely for the purposes set forth in the Act, as opposed to looking primarily for waste, fraud and abuse

On this IPD we are fortunate to have a very well informed readership. Hopefully they will share some their knowledge to address questions raised by our readers.

Tracker June 24, 2010 at 2:42 pm  Re: http://www.thecre.com/tpsac/?p=324

Great post. Where can one find FDA waivers? Do they post waivers on their website??

    CRE Response

    CRE will look into this matter

 April Zavutu
June 18th, 2010 at 12:10 pm  Re; http://www.thecre.com/scur/?p=138

The following  is a comment received from a reader on the FDA’s  request for comments on harmful constitutents, please  see this post .  How was the request for information approved under the Paperwork Reduction Act? See this CRE  post  which explains that FDA received an emergency clearance  from OMB.

Express your views below in the comments section,; CRE will forward them to FDA and OMB.

Anonymous
June 9th, 2010 at 10:55 am

Members of TPSAC:

June 21, 2010

The Interactive Public Docket (IPD)  which established a continuous public and on the record dialogue with your committee is beginning to receive a wide range of comments on a number of the important topics under review by your committee.

At this time we make no claims on neither the adequacy of the sample size nor its attendant statistical properties; nonetheless comments to date are representative of the information in this post

As the number of comments increases, we will publicly submit a revised summary for your review and consideration.

We recommend that our readers review comments made on the articles posted on the Studies and Concepts Under Review Discussion Forum. There appears to be a growing concensus, based upon comments received to date , that, as one person making a comment stated, :

“There actually is a lot of data proving that menthol cigarettes are JUST LIKE OTHER cigarettes, but with menthol flavoring, the same menthol flavoring that is used in Listerine or medicine. Unfortunately, this data is often overlooked because people have already made up their minds. Regardless of whether you are a smoker or not, you should still consider this science if you think its important for the FDA to maintain is objective credibility and integrity.”

A group of scientists have formed a shadow panel of TPSAC; their website is at this address http://www.fdashadowpanel.com/Recommendations.html

CRE believes their work will have the greatest impact if they communicate with game changers on a continuous basis.  Consequently we welcome their posting their views on any of the three discussion forums provided herein as well as continuing to post comments on posts on the home page.

To this end we encourage members of the Shadow Panel to post their views on the CRE posts made during the July 15 and 16 TPSAC meeting; the posts will be on the homepage.

The Use of Colors Does Not Impact Consumer Perceptions of Modified Risk and is Protected by Manufacturers’ First Amendment Right to Differentiate Products

As with any product, different consumers quite simply have different tastes and preferences. Accordingly, many tobacco product manufacturers sell several different products within each brand family that have different tastes and provide different smoking experiences. Historically, these variants have been identified through the use of colors or terms that convey information related to product characteristics, formulation or style – associated with the product. The use of colors communicates important information about these differing products to consumers. Indeed, the Supreme Court has recognized that tobacco product manufacturers have a First Amendment right to convey such information stating that “the tobacco industry has a protected interest in communicating information about its products andadult consumers have an interest in receiving that information.” not the relative health risks

“As noted in our prior correspondence, SMARTT is a coalition of Subsequent Participating Manufacturers (“SPMs”) to the multi-state Master Settlement Agreement (“MSA”).”

ACSH has posted its indepth analysis of  the menthol issue in the Studies Discussion Forum of the this Inteactive Public Docket.

The public is encouraged to express its views by submitting comments thereto–merely by typing in the comments section provided at the end of this post or in the alternative making a separate post in the Studies Forum.   All comments received by the public will be displayed on the Forum.

In that the ACSH study address many of the topics before the Advisory Commitee, if there is sufficient public dialogue, CRE will  send a summary report on comments received to the Advisory Committee.

 Federal Recognition of Interactive Public Dockets

The FDA earns high praise for publicizing the availability of an Interactive Public Docket (IPD) on its transparency blog; please see the FDA Transparency Blog  ( Please read comment # 3)

As described by Wikipedia, an IPD is “an eRulemaking tool created and managed by” private parties. IPDs “provide the public with the capability to: 1) publicly post data and other materials pertaining to federal proceedings on a continuous basis, including after the close of the Administrative Procedure Act comment period; and 2) post comments on already submitted materials.”

Should menthol cigarettes be banned?

Since the 1960s and 1970s, tobacco companies have largely marketed menthols to younger people and blacks, who now smoke the cigarettes at higher rates than other groups.

STORY HIGHLIGHTS

• FDA considering whether to ban, put limits on menthol cigarettes
• Critics say menthols are more addictive, harder to quit and appeal too much to young people
• Research findings not as strong as some detractors’ opinions

TPSAC  Subcommittee Meeting July 7 and July 8

CRE on Judical Review of  FDA Actions (Comment #3)

Citizens for Responsibility and Ethics in Washington (CREW) on conflict of interest

Member statements at Gaithersburg June 8 and June 8

FDA guidance on harmful constituents

NOTE TO READERS: See the ‘Studies and Concepts Under Review” discussion forum to the right of this post to read an advanced copy of the FDA FR notice announcing the June 10 release of guidance on harmful constitutents. Please see CRE comments in the comment section at the end of this post.

NOTE: The public is encouraged to express their views in the “comments” section at the end of this post.

The FDA has supported the use Interactive Public Dockets, although it does not necessarily support their content; if you wish to communicate with the Adivsory Committee in a public forum this is your chance.

During  the course of TPSAC meeting,  Board members ask a number of questions to FDA  who then furnishes  information to the Board at a subsequent date.

Will the FDA responses be made public and will the public have the opportunity to comment on the responses?

See for example the following discussion among Board members:

The Member Statements Forum is dedicated to venting comments made by members of  the Advisory Committee. The Members Statements Forum may be accessed by clicking on the aforementioned title in the box to the right of this article.

To this end Dr.  Henningfield made the following statement at the March 30, 2010 meeting:

Congressional Quarterly article on the Advisory Committee            

           See the TPSAC News Forum

ACSH on CRE  Transparency                                                                            

           See the TPSAC  News Forum

An Assessment of Menthol on Smoking Initiation,  Cessation and Addiction

            See  Studies and Reports Forum

As a result of a recent court action, the Data Quality Act is now a formidable watchdog to ensure that the FDA accepts only those reports from the Advisory Committee that are DQA compliant. Read the following from Inside EPA: