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

thestarpress.com

WARNING: Reading this newspaper might cause paper cuts. Or, for Web users — WARNING: Reading this page might cause eye strain. We doubt those warnings would cause many readers to stop using Star Press products.

If this sounds silly, then one has to question the efficacy of the government forcing cigarette makers to slap graphic photos on their packages starting in 2012. The Food and Drug Administration has approved nine new warnings to rotate on cigarette packs. They will be printed on the entire top half, front and back, of the packaging. The new warnings also must constitute 20 percent of any cigarette advertising, and will include a number for a stop-smoking hotline.

The Center for Regulatory Effectiveness provided testimony to the FDA in support of advancing effective harm reduction strategies.  Specifically, CRE advised the agency to state, as an overarching principle, that the marketing of modifiable risk tobacco products will be permitted when it is reasonably clear that:

1.  The new product will not be more harmful than existing products; and

2.  There is a reasonable scientific basis indicating the new product has the potential to reduce the risk of adverse health effects from consumption of tobacco products.

CRE’s complete testimony is attached below.

FDA is to be complimented for having an extensive outreach program to address the implementation of the agency’s  Modified Risk Tobacco Products (MRTP) program.

In FDA’s words:

FDA is: announcing a public workshop to obtain input on specific issues associated with the scientific evaluation of modified risk tobacco product (MRTP) applications.

 The FDA Workshop affords all stakeholders the opportunity to have an input into this important deliberative process. The Workshop is on August 25 and 26^th the  FDA Conference Center in Silver Spring.

The public is given the opportunity to speak on August 25 beginning at 11:00 AM.

Editors Note: As we expected, the FDA is going to be deluged by studies conducted by organizations in support of a menthol ban.  The study described below is only one such study.  The authors of the current study agree with CRE on one point; that the earlier studies on iniatition/cessation were mixed at best. However,the authors go on to state that they have the  silver bullet study–the study of all studies on menthol.

To that claim, CRE will allow  the late trumpeter  Harry James  ( the editors’ icon)  and Helen Forrest to  respond, http://www.youtube.com/watch?v=MA2hk_CIZeo

Consumeraffairs.com

CSP/Tobacco E-News Exclusive:
NATO executive director updates industry on tobacco legislation, regulations

By Linda Abu-Shalback Zid

ROSEMONT, Ill. — “It has been a very active year, both legislatively and with FDA tobacco regulations,” Thomas Briant, executive director of the National Association of Tobacco Outlets (NATO) told participants at the CSP 8th Annual Tobacco Category Review Meeting.

Briant then outlined some of the more recent legislative highlights:

Taxation. Out of 18 states that proposed cigarette and tobacco tax increases, only Vermont and Connecticut adopted higher cigarette and OTP tax rates, Briant informed retailers.

The Hearld Scotland

  9 Aug 2011

• DIRTY HABIT: Money made from selling black market tobacco and cigarettes, like those seized at a Glasgow market, is ploughed straight back into criminal activities, the authorities say. Picture: Mark Gibson

Now, in Scotland, cigarettes are increasingly linked to organised crime through the black market, according to a new survey.

More than one in 10 cigarettes smoked in some parts of the country were sold illegally, figures published yesterday suggest.

 In an August 8 letter, attached hereto, to Dr. Deyton of the Center for Tobacco Products, CRE explains in detail the reasons that the FDA peer review fails to comply with the peer review guidelines mandated by the Data Quality Act.

CRE concludes that the FDA must take the following actions to come into compliance:

1.  The agency must inform the public of how it can comment on the peer review plan and must consider any public comments.

CSP Daily News

Don’t “throttle permissible speech in cradle,” tobacco company lawyer argues

CINCINNATI — The free-speech rights of tobacco companies are improperly restricted by a federal law giving the U.S. Food & Drug Administration (FDA) the power to impose graphic warnings about the dangers of smoking and regulate how tobacco companies market and advertise their products, an attorney for the tobacco companies argued Wednesday.

According to an Associated Press report, Noel Francisco, a lawyer for R.J. Reynolds Co., told a three-judge panel from the 6th U.S. Circuit Court of Appeals on Wednesday that the Family Smoking Prevention & Tobacco Control Act is so sweeping that it stops companies from making statements that are true and not misleading.

The federal agency can now limit tobacco marketing, ban some ingredients, mandate big, graphic labels and outlaw some flavored cigarettes. And the largest tobacco companies are paying state governments billions of dollars a year under a lawsuit settlement covering health care and smoking cessation programs.

Irish  Central

Electronic cigarettes have been removed from the shelves of Irish pharmacies due to concerns about the safety of the products.

The device allows people to smoke in areas where tobacco is banned and were invented by a
Chinese pharmacist. They offer the sensation of smoking but have no tobacco or tar. However concerns were expressed that the cigarettes could contain harmful chemicals.

The EU must now establish if the device can be classified as a medical or tobacco products

 FDA has released the transcript of the July 21 TPSAC meeting. CRE has reproduced the Tozzi presentation, attached hereto,  and the Hennigfield criticism:

Tozzi

“The fact that the FDA and TPSAC continually, for whatever reason, refuse not to address the adverse impacts of counterfeit tobacco I think puts a cloud over this proceeding because, as in a point that I will make, there are a lot of proceedings around the world that address this particular issue.”

“Initially we were going to look solely at contraband but as we got into the record we saw very clearly that in our mind a huge and very important issue is the one associated with the health effects of these cigarettes”