Archive for April, 2011

Why we need a ban on menthol cigarettes

29 Apr

 

Editors Note: The proponents of a menthol ban conveniently forget to mention a key recommendation of TPSAC namely: “ Should FDA choose to implement a ban…FDA would need to assess the potential for contraband menthol cigarettes as required by the Act.”.

Continued neglect of this key recommendation suggests that the proponents of ban realize that contraband considerations will dominate the debate since other considerations are  either non-existent or mixed as outlined in the industry report  on menthol.

FDA, as a matter of law, will have to address the fact that contraband cigarettes impose extremely adverse health effects on both  smokers and non-smokers—the unilateral recommendation in the following article is the bow of a  sinking ship.

 
 

FDA to Regulate E-Cigarettes Just Like Tobacco

28 Apr

Editors Note: The regulation of  e-cigarettes will require FDA to develop a harm reduction program that complies with the Data Quality Act and  reviewable by TPSAC.

Agency Will Not Regulate E-Cigarettes Under the Stricter Rules That Apply to Medical Products


By Bill Hendrick
WebMD Health News



April 27, 2011 — The FDA has decided to oversee electronic cigarettes the same way it does tobacco products. The agency will not regulate the vapor-producing devices under the stricter federal rules that apply to medical products.



 
 

On the Call: Lorillard CEO Murray Kessler

27 Apr

Editors Note:  Unlike the statement of Senator Blumenthal the AP story is complete with respect to the TPSAC recommendations”

‘The panel stopped short of recommending an outright ban, saying the FDA should consider other factors, including whether a ban could increase the market for counterfeit and smuggled cigarettes.”

CEO Murray Kessler of Lorillard Inc. — the third-largest U.S. tobacco maker, whose biggest brand, Newport, is the nation’s top-selling menthol cigarette — spoke during a conference call with analysts Tuesday about a report on menthols from a Food and Drug Administration advisory panel.

 
 

FDA wants to get schooled in cigarette making, asks tobacco cos for learning tours

24 Apr

By Michael Felberbaum, The Associated Press – 1 day ago

RICHMOND, Va. — The Food and Drug Administration wants to get schooled in cigarette making.

The federal agency’s 2-year-old Center for Tobacco Products is asking tobacco companies to invite it to tour farms and factories that grow or process tobacco.

It says the visits are meant to help the agency better understand how each step in the process — from field to package — could influence the final product.

The FDA wants to tour large and small cigarette factories, a smokeless tobacco plant, tobacco farms, a rolling-paper factory and a tobacco warehouse.

 
 

Blumenthal Seeks To Ban Menthol Cigarettes

20 Apr

Editors Note:  When a US   Senator  states that  an action to ban menthol cigarettes is based upon on the TPSAC  report,  he  has not read the report in its entirety.  The TPSAC made it clear that no action can be taken on a ban until  the issue of contraband has been addressed.  CRE has an Interactive  Public  Docket entitled  Counterfeit Cigarettes: An Enforcement Forum  which is dedicated to the contraband issue. 

 
 

Plain packs pointless when smoke gets in our eyes

18 Apr

Editors Note: There is considerable data to demonstrate that plain packaging increases contraband.  See Counterfeit Cigarettes: An Enforcement Forum

 

Sydney Morning Hearld

April 17, 2011
 
Cigarettes are another case of the nanny state running rampant.

WHEN the Rudd government’s National Preventative Health Taskforce released a position paper on anti-tobacco measures, they titled it ”Making Smoking History”.

If that was the goal you’d think the government could just ban cigarettes – a clear, bold, unequivocal stance on what it has condemned as a very dangerous and addictive product

 
 

FDA Looks Ahead

15 Apr

Issue Date: CSP Daily News, April 15, 2011

By Linda Abu-Shalback Zid

LAS VEGAS — When it comes to tobacco regulation, Dr. Lawrence Deyton, director of the FDA’s Center for Tobacco Products (CTP), acknowledges that there might be discord on occasion. But as he told retailers and manufacturers at the NATO Show Thursday, communication is an important focus of the CTP, even during those times.

“We want to establish a relationship of good communication and trust,” he said. “We may not always agree on everything. But we can disagree on things, but we don’t need to be disagreeable. And we need to keep communicating with each other about how this is all going, so that we can all learn for each other.”

 
 

Plain packaging may require up to $3.4 billion taxpayer gift annually to big tobacco and film companies

13 Apr

Bad anti-intellectual property laws by State and Federal Parliaments could require taxpayers to gift up to $3.4 billion per year in compensation to film companies and big tobacco for the loss of their trademarks”, Director of the IP and Free Trade Unit at the Institute of Public Affairs, Tim Wilson, said today.

Mr Wilson’s comments follow the release of a new IPA report, Governing in ignorance: Australian governments legislating, without understanding, intellectual property, released today for World Intellectual Property Day.

 
 

Center for Public Integrity Reports on Potential Multi-Billion Dollar Overpayment by Tobacco Companies

12 Apr

The Center for Regulatory Effectiveness has established an Interactive Public Docket dedicated exclusively to the discussion of counterfeit cigarettes.  Counterfeit cigarettes play a crucial role in understanding many tobacco-related public policy issues ranging from a proposed ban on menthol flavoring to overpayment by tobacco companies under the 1998 settlement.

CRE has posted on the Counterfeit Cigarette IPD an article prepared by the Center for Public Integrity on an arbitration hearing to determine the extent of tobacco industry overpayment to states under the 1998 settlement.  As the article explains, the marketshare held by counterfeit cigarettes is one of the issues being considered.  The Center for Public Integrity article may be found here, http://www.thecre.com/cc/?p=134

 
 

Chantix: Why the Black Box Warning is Not Enough and Drug Should Be Removed from the Market

11 Apr

Editor’s Note:  What is the metric to be used to judge anti-smoking therapies?  “Modified Risk” determinations are to apply to the entry of new tobacco products; should the metric being developed by the Institute of  Medicine apply to anti-smoking therapies?

Siegel: Rest of the Story

Yesterday, I called for the removal of Chantix from the market, arguing that the black box warning was not adequate to protect the public from the severe adverse side effects that have been observed with the drug. Today, I explain why it is that the black box warning is not sufficient to protect consumers.

The black box warning for Chantix notes the following: