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

The Supplement consists of one Editorial, three Commentaries and eleven Research Reports.

The objectivity of the articles differs substantially; one of the Commentaries could be classified as puffery and elements of the Editorial are on the edge.  CRE has not reviewed the Research Reports in detail, but CRE has reviewed the most significant initiation/cessation studies identified by FDA.

Editors  Note:  Puffery as a legal term refers to promotional statements and claims that express subjective rather than objective views, such that no reasonable person would take them literally. Puffery serves to “puff up” an exaggerated image of what is being described and is especially featured in testimonials .

Yesterday, November 24,  Medical News Today  published an article with the title “Menthol Cigarette Smokers Find It Much Harder To Give Up”.

Was the aforementioned conclusion based on recent clinical trials of menthol?  No, the article was written based upon  a Supplement to the December 2010 edition of  Addiction.

In its November 18 testimony  to TPSAC,   CRE stated that ATF had recently published the following  statements regarding contraband tobacco:

 “contraband cigarettes are more likely to be sold to underage persons than legitimate product.”

 “The trafficking in counterfeit and contraband tobacco products also poses a serious  health risk to our society. There are no standards of production in counterfeit product.  This allows for such things as biological or chemical contamination of the product.”

Months ago, CRE concluded that:

 1.  Out of all the studies cited by the FDA regarding the health effects of menthol that the only end points of any potential significance dealt with smoking initiation/ cessation.

2.  The initiation/cessation studies identified by FDA could not be used by the FDA because they failed to meet the standards of the Data Quality Act.

Lorillard Inc., trying to stop the U.S. government from outlawing its Newport cigarettes, will tell a Food and Drug Administration panel tomorrow that banning the mint flavor will create a black market for menthol brands.

The Greensboro, North Carolina-based producer has joined other U.S. cigarette companies this year in telling an FDA advisory panel that most scientific evidence shows menthol cigarettes to be no more dangerous than regular ones. Lorillard now plans to argue that banning menthol would push smokers to regular varieties and create a black market for menthol ones.

Editors  Note:   The article  below  demonstrates  that  whatever one’s views are on smoking,  it is clear that FDA is going to resort to extreme measures  to regulate the tobacco industry.   To date CRE has covered the actions of  TPSAC;  the action described below was not reviewed by TPSAC.

In a like manner, whatever one’s views are on TPSAC,  it is the  body duly constituted to inject sound science into decision-making.  Menthol on its own  is a very significant issue;  however if future  FDA  actions are to be guided by the action described below,  now  it  is  even more  important   that the  TPSAC  review of  menthol  establish  the precedent  that the regulation of  the tobacco industry is to be science based.

November 10, 2010 | Business Wire, Inc.

WASHINGTON–(BUSINESS WIRE)– U.S. Department of Health and Human Services today unveiled a new comprehensive tobacco control strategy that includes proposed new bolder health warnings on cigarette packages and advertisements. Once final, these health warnings on cigarettes and in cigarette advertisements will be the most significant change in more than 25 years. These actions are part of a broader strategy that will help tobacco users quit and prevent children from starting.

FOR IMMEDIATE RELEASE

CRE filed comments on the Bureau of Alcohol, Tobacco, Firearms, and Explosives’ proposed rule to counter the smuggling and sale of contraband cigarettes and smokeless tobacco.  Key points raised by ATF in their NPRM were:

    1.   Cigarette smuggling profits fund terrorism and other deadly criminal groups.

    2.   Counterfeit cigarettes pose health hazards over and above those of genuine cigarettes.

    3.   Illegal cigarette trafficking makes it easier for children to smoke.

CRE’s comments informed the ATF about the contemplated ban on menthol cigarettes and noted that, “if enacted, a ban would create enormous demand for contraband menthol cigarettes, a product preferred by over 18 million people, or one-third of adult cigarette smokers.