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

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  http://www.google.com:80/search?hl=en&source=hp&q=tpsac+aug+30&btnG=Google+Search&aq=f&aqi=&aql=&oq=&gs_rfai=CkWnG1Ql9TNWVDo7EM4O98dEEAAAAqgQFT9AxhaU

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.

Please see this link for the CRE Report to the FDA  http://www.thecre.com/tpsac/?p=485

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.

 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.

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

“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”

  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.

See Federal Register Notice  http://edocket.access.gpo.gov/2010/pdf/2010-19283.pdf

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.