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.
CRE has expressed its concern in numerous statements to TPSAC, all of which are documented on this website. However since the issue is tobacco, FDA has determined that existing rules for fair play need not apply.
Unfortunately it appears that the procedures used in the Consitutents subcomittee will establish the precedent for the procedures to be used in the Menthol subcommittee which meets September 27. It was for this reason that CRE recommended that the menthol committee include one or more mathematical statisticians, with no ties to the public health community, to examine the initiation/cessation studies.
Fortunately, the Data Quality Act provides a mechanism for ensuring that the information used by federal agencies is objective an unbiased.