CRE Appreciates Its Readership

Each day, hundreds of  individuals  read this Interactive Public Docket on TPSAC.

Readers include, federal agencies, tobacco industry, press,  academics and public health organizations.   One measure of  the degree of readership a website has is its Google ranking.

For example, if you place the term ” tpsac aug 30″ into Google, the  CRE website is the first website displayed–even ahead of the FDA.

Please see

Therefore  you need not hire a law firm or a PR firm to affect government policies, simply comment on a user friendly Interactive Public  Docket.

FDA Domination of the TPSAC Proceeding

Please see this link for the CRE Report to the FDA

From the onset CRE has expressed its concerns regarding FDA  domination of the proceedings. FDA’s actions at the TPSAC meeting on August 30 provide ample justification for CRE’s concerns.

At the August 30 meeting in which a list of harmful constituents was developed:

 FDA selected the outside reviewer.

FDA  paid  the outside reviewer.

FDA developed the criteria for selection.

FDA performed the analysis.

FDA package the material.

FDA presented the material for an up or down vote by the TPSAC.

TPSAC Panel Members Raise Data Quality Concerns

 During the August 30 meeting of the TPSAC Constituents  subcommittee ,   two members raised data quality questions.  The Chair, Dr, Samet asked whether  the criteria for designating constituents as harmful were replicable; Dr. Lauterbach made a similar comment regarding information being disseminated by the FDA with respect to testing guidance.

 The Data Quality Act might well be the only mechanism available to ensure that the FDA does not continue to dominate every facet of the proceeding. To this end, see the CRE statement at the meeting  which is attached below.

CRE Notice to FDA: TPSAC Violates FACA

See the attached memorandum which explains in detail the reasons why the Constitutents Subcommitee is in violation of FACA. Hopefully, FDA will address these issues  administratively so as not to necessiate other corrective actions.

CRE’s objective is to make FDA aware of  its non-compliance with FACA so it will not make the same mistakes when it establshes the menthol subcommittee.

See CRE  coverage in  FDA Week


Sept 27 TPSAC Meeting

On September 27, 2010, the subcommittee will receive a presentation and discuss the timelines and structure of the Tobacco Products Scientific Advisory Committee’s required report to the Secretary of Health and Human Services regarding the impact of use of menthol in cigarettes on the public health”


Is the establishment of this subcommittee FDA’s response to CRE’s continual request to announce that TPSAC is going to write the menthol report and thus not work off an FDA draft?

Is this a new subcommitee analgous to the constituents subcommitee?

How have these members been vetted?

FDA Mulling Ban on Menthol Cigarettes


By Jenifer GoodwinHealthDay Reporter

WEDNESDAY, Aug. 18 (HealthDay News) — With their enticing cool and minty flavor, menthol cigarettes have emerged as one of the most controversial products made by the tobacco industry.

Kids are particularly drawn to them, with nearly 45 percent of smokers aged 12 to 17 using menthol cigarettes, according to a 2009 National Survey on Drug Use and Health. Most black teenaged smokers — and 82.7 percent of black adult smokers — favor menthols, the same survey found.

A menthol mess: Agency probing menthol cigarette risk

Staff Writer Greensboro News Record
Editor’s Note: This article originally gave an incorrect number for menthol cigarette smokers. Among menthol smokers, there are twice as many white smokers as African American smokers. Among African American smokers, however, 75 percent prefer menthol cigarettes.

GREENSBORO — Pierre Lorillard could hardly have imagined that the small tobacco company he started 250 years ago in New York City would ship 36.3 billion cigarettes a year in the 21st century, 87 percent of which would be flavored with menthol.

Skepticism Greets Industry Claims on Menthol Safety

  U.S. tobacco companies have ramped up a campaign to keep menthol cigarettes on the market, but U.S. Food and Drug Administration (FDA) officials are skeptical of claims that menthols are no more harmful than regular cigarettes and want to see more data from the industry.

The Richmond Times-Dispatch reported July 17 that the FDA’s Tobacco Products Scientific Advisory Committee — tasked with recommending whether menthol cigarettes should be further regulated or even banned — took testimony last week from industry officials and advocates for banning menthol on health grounds.

TPSAC Meeting August 30

See Federal Register Notice

Note: In the comments below a reader addresses CRE’s continued concern about who is writing the TPSAC reports. If this were any proceeding other than tobacco, we seriously doubt that FDA could ignore established rules governing the conduct of FACA committees.

It appears that CRE’s continued statements highlighting the need for Committee members, not FDA,  to write TPSAC reports may be  falling on deaf ears.

CRE will explore a more powerful intervention other than  notice and comment.