Congressional Quarterly Review on the CRE Interactive Public Docket (IPD) on TPSAC

May 29, 2010 Saturday

Filtering Out Tobacco Laws

By Shawn Zeller, CQ Staff
Tobacco companies weren’t able to stop or greatly change last year’s law regulating their products, but they have been trying after the fact to tone it down. Last summer, two of the biggest cigarette makers, R.J. Reynolds Tobacco Co. and Lorillard Inc., filed suit in federal court challenging the new federal advertising restrictions on First Amendment grounds.

Now the tobacco industry is bankrolling a campaign that questions the fairness of the Food and Drug Administration’s process of writing regulations to implement the law. Earlier this month, Jim Tozzi, a longtime industry advocate who co-founded a Washington think tank critical of regulation called the Center for Regulatory Effectiveness, launched what he calls an Interactive Public Docket on the tobacco rules.

Comments from the Docket: Menthol No Impact on Start or Quit Rates

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.”

Why Rush to Complete a Report on Menthol? See USA News Week

A Sleeper Provision in the Tobacco Control Act: Section 919 User Fees

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

Questions Raised by Our Readers

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:

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;

New Disclosure Rules Forcing FDA To Broaden Hunt For Panel Experts

Inside Health Policy

New draft guidance expanding conflict of interest disclosure of advisory committee members is continuing to dry up the expert pool, forcing FDA to dramatically step up efforts to recruit experts, FDA officials concede. The agency has also stepped up its process for issuing waivers to the disclosure rules.

Concerns both inside and outside the agency on the challenge of finding scientific experts to serve on advisory panels under the new guidelines appear to have borne out to a degree, Jill Hartzler Warner, acting associate commissioner for special medical programs, told attendees of the Drug Information Association annual meeting this week. She said that the agency has widely broadened its pursuit of potential experts — newly engaging in professional meetings, direct mailings and professional organization listservs to find candidates who will pass the guidance’s threshold.

A Readers Comment on the FDA Request for Guidance on Harmful Constitutents

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.

June 9th, 2010 at 10:55 am

So far, the FDA/CTP have still not been able to tell us what they will do with the data when they get them.

A Message to TPSAC Members

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.

Consensus of Comments To Date In Studies and Concepts Forum

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.”

FDA Tobacco Products Scientific Advisory Shadow Panel

A group of scientists have formed a shadow panel of TPSAC; their website is at this address

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.

SMARTT on Modified Risk

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”).”

Note To Readers: American Council Health and Safety Posts its Report on Menthol

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.

Accolades to the FDA!

 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.”

CNN Health on Menthol

Should menthol cigarettes be banned?

By Amanda Gardner,
June 15, 2010 8:22 a.m. EDT


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.

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.


  • 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

Recent Posts


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

Live from Gaithersburg: June 8 – 9 2010

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.

An Open Letter to TPSAC: Public Peer Review of Studies Identifed by FDA

Members of the Committee:
The FDA has provided the Committee with a number of studies to review.  What is the process the committee is going to use which would allow members of the public to submit comments on the said studies?  Please provide a response in order that we may publish your response on our Interactive Public Docket on this matter.
To this end, we have completed an initial review of one of the studies identified by FDA and have provided  our results to the authors of study.
Will you provide TPSAC not only with FDA studies recommend for their consideration, but also peer reviews supplied by the public?
Jim Tozzi
Center for Regulatory Effectiveness

Governance Forum: Will the Public See Answers FDA Gives In Response to Questions Raised by Committee Members?

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:

…  As I understand, again, the question that was asked we would have to interpret  the responses as any contact with menthol– the use of menthol cigarettes in the last 30 days without  providing information on the proportion of smoking  that was menthol.

Members Statements Forum: Henningfield On Cessation

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:

Recent Posts

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

Data Quality Act: A Formidable Watchdog

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:

Industry Sees Court Rejection Of DOJ Petition Aiding Bid For DQA Review

Proponents of making Data Quality Act (DQA) petitions judicially reviewable claim they received a boost after a federal appeals court rejected the Justice Department’s (DOJ) bid to clarify that a recent ruling did not address the issue, though DQA critics say the DOJ petition reinforces the administration’s position that DQA decisions are not judicially reviewable.