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.
Stay tuned!
What’s the beef CRE? Doesn’t FDA have regulatory authority?? Maybe this is the “new, improved FDA” actually regulating — for once!
Tracker:
FDA has the authority to issue regulations if the said regulations comply with the Data Quality Act. The actions identified above by CRE demonstrate that the FDA is ignoring the statute. Our “beef” as a regulatory watchdog is they must comply with the law.
CRE
Tracker,
Thank you for your question.
The problem is that the Center for Tobacco Products (CTP) does not have the expertise to do the job correctly. What is needed is a bottoms-up, scientifically rigorous identification and quantification of the hazardous and potentially hazardous constituents in tobacco and tobacco smoke that is done with the best chemistry and toxicological tools available. The CTP is not doing such studies or using studies in the peer-reviewed literature. CTP is not even using basic toxicological principles. The CTP is using the WHO Framework Convention for Tobacco Control playbook. Other FDA centers have some of the best scientific talent in their disciplines. Where is the top scientific talent at the CTP?
Can DHHS exempt the Center for the Tobacco Products from the DQA? Can DHHS change the wording in its “Guidelines for Ensuring the Quality of Information
Disseminated to the Public” to exempt briefing mateials and background information given to TPSAC members? CRE needs to check this out as DHHS apparently does not want to have the DQA apply to CTP and TPSAC.