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

CRE Brazil  reports:

 CRE Note: Every President since Ronald Reagan has instituted a program to review existing regulations and every President since Ronald Reagan has been criticized for both killing regulations and failing to kill  them.  The article that follows demonstrates that the Obama Administration is suffering a similar fate.

 A far more useful approach is for the critics  to present their arguments in a coherent and systematic manner using an Interactive Public Docket (IPD) not controlled by the federal government. One such IPD is available here.

Dan Froomkin   Huffington Post

 The  thirtieth anniversary of OMB’s regulatory review office, OIRA–the Office of Information and Regulatory Affairs,  was celebrated on Friday, May 20^th.  The event was sponsored by Susan Dudley, a former OIRA Administrator,  who presently heads the George Washington University Regulatory Studies Center.

Virtually all former Administrator’s and Deputy Administrators made presentations, including Jim Tozzi, the first Deputy Administrator of OIRA.

The Bureau of National Affairs Reports:

Jim Tozzi, the first deputy administrator of OIRA, said the institution gives a protective shield against the wholesale dismantling of regulatory agencies, which play an integral role in society.

CRE Note:  In the article below the author states:  “Ashley also assured industry representatives that the agency’s decision-making on tobacco regulation would be based on solid scientific evidence.”  Dr. Ashley personally addressed the CRE Data Quality petition; based upon Dr. Ashley’s actions to date CRE  concludes that his actions are going to be science-based.

Richmond Times Dispatch

WILLIAMSBURG —

Some tobacco industry representatives expressed frustration Monday with how the U.S. Food and Drug Administration has handled its regulatory authority over tobacco products so far.

Source: ACSH

CRE  Note:  The establishment of a FDA office dedicated to the regulation of the tobacco industry has generated a cottage industry focused on implementing an  ever increasing volume of regulations. Fortunately none of   the studies submitted can be used by the FDA until which time the FDA determines they are compliant with the Data Quality Act. Those stakeholders interested in addressing the following studies should submit their analyses by posting on the comments section below or providing financial support to CRE to do the same.

Medical News Today

 CRE Note: Rest assured, the release of the TPSAC report on menthol represents the launching point of a contentious debate and a prolonged regulatory review. Well financed anti-menthol groups will flood the regulators with a series of studies aimed at moving the FDA to regulate menthol.  CRE will be responding to these studies to ensure that the resultant regulatory docket is not one-sided.  CRE can not carry this load alone due to constrained resources; our readers are encouraged to post relevant comments in the section below and they  will be used in the preparation of the CRE analyses which will be forwared to the FDA. (Detailed studies can be posted in the Concepts and Studies Discussion Forum)

CRE Note: Mr. Sullum we agree with your point  ” For both practical and moral reasons, I don’t agree that banning menthol cigarettes is a good idea, any more than banning cigarettes in general would be.”  We differ however with your assertion that one action that is not science-based (banning all flavors other than menthol) should be corrected by taking another non-science based action (banning menthol).

 Jacob Sullum | May 9, 2011  Reason Magazine

CRE Note: It would be interesting to compare New Zealand’s risk reduction paradigm compared with that to be used by the FDA.

 Martin Johnston

The Ministry of Health has stated that electronic cigarettes are “far safer” than smoking tobacco.

The statement – made to MPs – has been welcomed by End Smoking trust chairman Dr Murray Laugesen, who is investigating e-cigarettes as a quit-smoking tool.

“End Smoking NZ congratulates the NZ ministry on possibly being the first ministry of health to concede e-cigarettes are safer than smoking.”

Two perspective pieces addressing the menthol cigarette problem appear in today’s New England Journal of Medicine. One, by ACSH advisor and Boston University School of Public Health Professor Dr. Michael Siegel, argues that, by refusing to  recommend clearly that the FDA ban menthol cigarettes, the Tobacco Products Scientific Advisory Committee (TPSAC) contradicted the scientific literature featured in its report and thus failed in its mission to provide a public health solution.

CRE Note: We are publishing the following article to demonstrate the challenge before opponents of the menthol ban;  more specifically the FDA is being bombarded with biased articles which lack a sound science foundation.   Not only does this article neglect to say that the smokers of interest will switch to contraband which has demonstrated adverse health effects  significantly more severe than legal cigarettes but it makes determinative conclusions regarding the impact menthol has on smoking initiation/cessation which is not substantiated by the record. Fortunately because of the considerable traffic on this Interactive Public Docket (IPD) devoted to TPSAC,  rejoinders to these inaccurate statements are being broadcast throughout the web community.

 CRE Note:

 April is Minority Health Month so one can expect a number of articles written on the FDA menthol issue. We print this one because it is representative of a  major argument which is omitted from the proponents of a menthol ban. If one is interested in protecting the health of minorities, then an action should be taken to shield minorities from the onslaught of violence which would occur from organized crime cells operating primarily in their largest markets—minority populated areas– through the sale  of contraband.

 CRE discussed these points in its submission to TPSAC.