Anti-Counterfeit Actions Taken in Brazil

CRE Brazil  reports:

May 27
New Rules for Exporting Cigarettes
The Federal Revenue Office established a series of norms to avoid cigarettes exported by Brazilian industries returning to the Country as contraband. Now, products destined to be sent abroad will have a special bar code on their packages which will store all the producer’s data. Companies that make the appropriate changes will be exempt from export taxes which are equivalent to 150% of the market value.Packages of cigarettes sold in Brazil will have to include the following inscription: “For export only – The selling of this product in Brazil is prohibited.” If an inspection catches these products circulating in the national market, they will be considered illegal merchandise resulting in serious fines.

Obama Regulatory Review Announcement Finds Few Fans [VIDEO]: Huffington Post

 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

OIRA’s 30th Anniversary

 The  thirtieth anniversary of OMB’s regulatory review office, OIRA–the Office of Information and Regulatory Affairs,  was celebrated on Friday, May 20th.  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.

FDA seeks tobacco industry input, but some firms frustrated with process

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


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.

Reynolds to Start Smokeless Tobacco Ad Campaign

CRE Note:  FDA needs to  establish guidance which would allow tobacco manufacturers to address claims of “reduced harm”.  FDA awaits the report of the IOM which appears to be in the distant future.


By DAVID KESMODEL    Wall Street Journal

Tobacco giant Reynolds American Inc. is seizing on new antismoking laws in New York City this week to launch an advertising campaign for Camel Snus, its small but growing smokeless brand.

Full-page ads beginning Monday in The Wall Street Journal, USA Today, the New York Daily News and other newspapers will urge smokers to drop their cigarettes for Camel Snus, a type of spitless oral tobacco that comes in pouches.

Menthol controversy keeps smoldering

Source: ACSH

Roswell Park Studies Conclude That Cigarette Packaging Needs To Change

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

“Calls To Ban Menthol Cigarettes, US”: 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)

Do Menthol Cigarettes Taste Too Good to Be Legal?


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

Electronic cigarettes safer than tobacco, says ministry: New Zealand Herald

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.”

NEJM lights up TPSAC’s menthol cigarette evaluation: ACSH

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.

The Threat of Menthol Cigarettes to U.S. Public Health: New England Journal of Medicine

CRE Note:  Dr’s Benowitz and Samet know the menthol issue well because of their leadership role in TPSAC.

What is surprising is the statement: : “The TPSAC, a scientific advisory committee, was not charged with addressing regulatory options and did not have the time or expertise to analyze regulatory scenarios, including any involving inadvertently opening a door for the introduction of contraband menthol cigarettes into the U.S. market”.

 CRE agrees  that the magnitude of contraband is outside  the purview of TPSAC but  a review of the health effects of contraband is  not. CRE provided in written and verbal testimony to TPSAC considerable data from governmental authorities which demonstrated that the health effects of contraband were immense compared to legal cigarettes.

The Ban on Menthol Cigarettes Can Help Close the Health Disparities Gap: Center for American Progress

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.

Menthol does contribute to smoker deaths: The Tennessean

 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.