Right To Vape

Tobacco Issues

After three years of diligent policy-related work, the AAPHP Tobacco Control Task Force finds itself in the unexpected position of being a major advocate for the widespread use of electronic cigarettes, and in favor of adding a harm reduction component to current tobacco control programming based on informing actual and potential users of tobacco products of the relative risk profiles of each type of product, compared to conventional cigarettes.
It’s important to note that neither I nor AAPHP have received or anticipate receipt of any financial support from any electronic cigarette enterprise, any other tobacco-related enterprise, or any pharmaceutical enterprise. The time, energy and costs we have incurred in pursuit of the E-cigarette issue are all based on our perception that the requested reclassification could pave the way to a harm reduction initiative that, in turn, with FDA oversight, could result in rapid and substantial reductions in tobacco-related illness and death without increasing the numbers of teens initiating nicotine use.
With all this in mind, and after being invited to do so by top level FDA leadership, I, on behalf of the AAPHP task force have submitted two Citizen Petitions to FDA relative to reclassification of E-cigarettes from “drug-device combinations” to “tobacco product.”
To learn more about how we developed this policy stance, and the action we are now taking, please check out the two-page “Lessons Learned” summary of all this, and the petition-related documents posted today.
Joel L. Nitzkin, MD, MPH, DPA
Chair, AAPHP Tobacco Control Task Force
jln-md@mindspring.com or jln@jln-md.com 
February 11, 2010

E-cigarette Petitions to FDA February 10, 2010
The petition related documents consist of a one page summary, the text of the two petitions, and the tables of contents for the three sets of attachments. The 303 pages of attachments are presented in the form of 3 “A” files, 3 “B” files and a single “C” file. These can be downloaded as .pdf files.

The petitions, but not the attachments are accessible and available for comment on the www.regulations.gov web site. To access the petitions there, go to www.regulations.gov and type in the docket number in the Keyword field.  The docket number for the petition to reclassify is FDA-2010-P-0095-0001. The docket number for the petition regarding the press conference is FDA-2010-P-0093-001.

Dr. Mark Clanton served the director of the United States National Cancer Institute, National Institutes of Health, as deputy director from 2004 to 2006.  His NCI leadership portfolio included NCI’s offices, centers and divisions focused on cancer prevention, cancer control, international cancer control, and health services research.

http://www.hsph.harvard.edu/alumni/alumni-council/mark-clanton/index.html

Dr. Gregory Connolly

Connolly added: "This is a great example of how science can be used to protect the health of children, the most vulnerable among us, from public health enemy number one -- tobacco."

http://www.healthnews-stat.com/?id=166&keys=Harvard-smoking-Reynolds


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   This article is part of the Tobacco portal on Sourcewatch funded from 2006 - 2009 by the American Legacy Foundation. Help expose the truth about the tobacco industry.
Tobacco additives: Cigarette engineering and nicotine addiction, by Clive Bates (Action on Smoking and Health, London), Dr. Martin Jarvis (Imperial Cancer Research Fund, London) and Dr. Gregory Connolly (Massachusetts Tobacco Control Program, Boston). July 14, 1999.
Summary of published paper:
This paper draws on tobacco industry documents to explore the public health ramifications of, and effect on human smoking behavior of the some 600+ potential additives used in cigarettes. Which cigarettes incorporate which additives from among this list is known only to the individual tobacco companies; the information is not public. The report finds that most of the additives are not necessary and few were used before 1970. The report seeks to raise concerns that there is need for increased regulatory scrutiny to tobacco additives. Authors found that
   • Additives are used to make cigarettes that provide high levels of "free" nicotine, which increases the addictive "kick" of the nicotine. Ammonium compounds can fulfill this role by raising the alkalinity of smoke.
   • Additives are used to make cigarettes more "attractive" and "palatable," and that this is a cause for concern.
   • Sweeteners and chocolate may help make cigarettes more palatable to children and first time users; Eugenol and menthol numb the throat so the smoker cannot feel the smoke's aggravating effects.
   • Additives such as cocoa may be used to dilate the airways allowing the smoke an easier and deeper passage into the lungs exposing the body to more nicotine and higher levels of tar.
   • Some additives are toxic or addictive in their own right or in combination, and when additives are burned, new products of combustion are formed and these may be toxic or pharmacologically active.
   • Additives are used to mask the smell and visibility of side-stream smoke, making it harder for people to protect themselves and undermining claims that smoking is anti-social without at the same time reducing the health risks of passive smoking.
The authors argue that a new regulatory framework is needed regarding cigarette additives, that that it should incorporate better disclosure, that more information about additives should be made public, that regulators should be free to challenge any additive, and the burden of proof should be placed on manufacturers to prove an additive is safe.


http://www.sourcewatch.org/index.php?title=Tobacco_additives:_Cigarette_engineering_and_nicotine_addiction

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Dr. Connolly has embarked on a crusade against the use of smokeless tobacco. In 1986 he spoke to the Kansas City Royals - at the team's request - at spring training. This spring, sponsored by the American Cancer Institute and the American Dental Association, he was invited by seven more teams. He still keeps in touch with some players and trainers.

http://www.nytimes.com/1987/07/06/sports/sports-world-specials-sticky-situation.html?pagewanted=1

Did You Know? Menthol is used to hook young smokers
Tobacco companies manipulate the amount of menthol in cigarettes to make those first few puffs more palatable to young smokers, U.S. researchers said in a finding that could fuel support for more tobacco regulation.
“Menthol stimulates the cooling receptors in the lung and oral pharynx,” said Dr. Gregory Connolly of the … [বাকিটুকু পড়ুন]

http://health.evergreenbangla.com/2008/07/

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Connolly said tobacco companies use mild menthol cigarettes to target younger smokers and stronger menthol flavors for established smokers.

"Menthol helps the nicotine go down," Connolly said in a telephone interview but he added that too much menthol is hard for new smokers to tolerate.

http://www.iol.co.za/index.php?art_id=iol1216362801214M534

Karen DeLeeuw, MSW

On behalf of the Tobacco Control Resource Council, thank you for the opportunity to provide comments on the proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling. As the organization representing State Tobacco Control Program Managers, we strongly support the coverage of tobacco cessation counseling services under Medicare.

 http://www.cms.hhs.gov/mcd/publiccomment_popup.asp?comment_id=891

"So people are getting a busy signal. But we're asking people to be patient. We're not going to run out of patches. It's an ongoing program that will be available a week from now, a month from now, a year from now," said Karen Deleeuw, with the Tobacco Education and Prevention Partnership.

http://www.thedenverchannel.com/health/5739295/detail.html

Dr. Neal Benowitz, nicotine and addiction specialist at University of California, San Francisco;

In addition, Dr. Benowitz has carried out important research on the role of smoking in atherosclerosis, or "hardening of the arteries," and on the absorption of nicotine through the skin via nicotine patches. Smoking can affect what happens to lipids in the blood and the stress on the heart and blood vessels, according to Dr. Benowitz.
He also notes that "blood clotting is a major link between cigarette smoking and heart attack. However, our data suggest that it is not nicotine but something else in cigarettes that causes the clotting," he adds.


http://www.drugabuse.gov/NIDA_Notes/NNVol10N4/NicResearch.html
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Statement of Committee Composition
Disclosure of Conflict of Interest: Dr. Neal Benowitz

To meet the need for this expertise and experience, Dr. Neal Benowitz is proposed for appointment to the committee even though we have concluded that he has a conflict of interest because he owns stock of more than de minimis value in two pharmaceutical companies that manufacture nicotine replacement therapies.

http://www8.nationalacademies.org/cp/CommitteeView.aspx?key=48896

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AWARD NEWS RELEASE   
February 15, 2006
UCSF PROFESSOR NEAL BENOWITZ TO RECEIVE
OSCAR B. HUNTER MEMORIAL AWARD IN THERAPEUTICS
American Society for Clinical Pharmacology and Therapeutics
Will Honor Dr. Neal Benowitz at its Annual Meeting in Baltimore
(Alexandria, VA) — Neal Benowitz, MD a professor at University of California, San Francisco will be recognized at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting this March. Dr. Benowitz will be presented with the 2006 Oscar B. Hunter Memorial Award in Therapeutics. The Oscar B. Hunter Memorial Award in Therapeutics honors individual scientists for their outstanding contributions in drug research, patient care and teaching.
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https://www.ascpt.org/newsroom/pr021506.cfm

He was a paid consultant to nicotine patch manufacturers? A scientific editor of the 1988 Surgeon General's report on smoking. He is also an expert on the effects of nicotine. He testified for the Plaintiffs in Kotler (NY) suit in 1990 (Boston Globe 2/21/90). Benowitz testified that: "a smoker's addiction to nicotine resembles some characteristics found in cocaine and heroin users".

Benowitz testified that: "a smoker's addiction to nicotine resembles some characteristics found in cocaine and heroin users". "Virtually all" people who smoke a pack-a-day over a period of a year or two, develop a dependency to nicotine. When smokers try to quit, they experience "acute withdrawal symptoms". Benowitz acknowledged that millions of people have quit smoking and the vast majority have stopped on their own. Benowitz also said that nicotine doesn't impair smokers cognitive abilities to understand the effects of smoking or impair their ability to make decisions. While people insist they smoke because they enjoy it, they wouldn't like it if they weren't dependent on it. You need nicotine to feel normal . . . This is drug-driven behavior. Like heroin and cocaine, nicotine prompts psychoactive changes in the brain. It is difficult to stop using and provokes a high relapse rate among those who try to quit. Benowitz also said that in its pure form, nicotine is poisonous and has been used as an insecticide. For smokers, nicotine can act as a stimulant, to help concentrate, and as a tranquilizer, to help relieve stress, per Benowitz (Boston Glove 2/21/90)

http://tobaccodocuments.org/profiles/people/benowitz_neal.html
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Nicotine Safety and Toxicity (Hardcover)
~ Neal L. Benowitz (Editor) "Nicotine, the main determinant of tobacco use and addiction, is now available as a medication to assist smoking cessation and is being evaluated as a..." (more)
Key Phrases: special intervention participants, vapor inhaler, abuse liability testing, Lung Health Study, New York, British Journal (more...)
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SUPERIOR COURT OF THE STATE OF CALIFORNIA
2 FOR THE COUNTY OF LOS ANGELES
3 DEPARTMENT 308 HON. CHARLES MC COY, JUDGE
4 RICHARD BOEKEN, )
5 PLAINTIFF, )
6 )
) CASE NO. BC226593
7 VS. )
)
8 PHILIP MORRIS, )
INCORPORATED, A )
9 CORPORATION; INTERNATIONAL )
HOUSE OF PANCAKES )
10 INCORPORATED, A )
CORPORATION.

REPORTER'S DAILY TRANSCRIPT OF PROCEEDINGS
14 FRIDAY, APRIL  6TH, 2001

(Testomony startes on page 1892)

(Page 1912)

OTHER THINGS THAT ARE IMPORTANT,
8 ONE IS AS YOU MENTIONED BEFORE, ON A PUFF TO PUFF
9 BASIS, BECAUSE YOU GET AN EFFECT IN 10 OR 15
10 SECONDS, YOU CAN WHAT'S CALLED TITRATE, YOU CAN
11 ADJUST THE DOSE TO GET JUST THE DOSE THAT YOU WANT.

Page 1913 bottom

Q. AND IS IT MUCH MORE ADDICTIVE
17 BECAUSE, FROM THE TIME THE PERSON DOES SOMETHING TO
18 THE TIME OF THE HIT, THE HIGH, THE REACTION, IT'S
19 QUICKER?
20 A. IT'S QUICKER AND YOU CAN JUST
21 TITRATE HOW MUCH EFFECT YOU WANT.
22 Q. NOW, YOU HAVE SAID THAT TWICE BUT
23 WHEN YOU SAY YOU CAN TITRATE THE EFFECTS YOU WANT,
24 THAT ISN'T EXACTLY IN THE KIND OF TERMS WE USE
25 EVERY DAY.
26 PLEASE SAY THAT DIFFERENTLY.
27 A. WELL, IF YOU HAVE, SAY, THERE'S A
28 CERTAIN AMOUNT OF NICOTINE THAT MAKES YOU FEEL

(Page 1914)

1 GREAT OR HELPS YOU CONCENTRATE DOING YOUR JOB OR
2 HELPS YOU DEAL WITH STRESS, WHATEVER YOU ARE TRYING
3 TO SMOKE FOR, I WILL TALK ABOUT THAT IN A FEW
4 MINUTES, THAT MAY REQUIRE A CERTAIN AMOUNT OF
5 NICOTINE IN YOUR BRAIN TO DO THAT.
6 BUT AFTER EACH PUFF YOUR BRAIN CAN
7 REGISTER HOW MUCH NICOTINE YOU GOT THERE.
8 AND THE NEXT PUFF YOU CAN TAKE A
9 BIGGER PUFF OR A SMALLER PUFF, THIS IS AUTOMATIC,
10 YOUR BODY JUST DOES IT UNCONSCIOUSLY, TO GET THE
11 AMOUNT OF NICOTINE. AND THEN YOU CAN SMOKE A
12 CIGARETTE DEEPLY, YOU CAN SMOKE IT NOT SO DEEPLY.
13 YOU CAN PUT IT OUT SOONER OR LATER.
14 BY DOING ALL THOSE THINGS, YOU CAN
15 GET WHATEVER AMOUNT OF NICOTINE DOSE YOUR BRAIN
16 WANTS.
17 Q. SOMETIMES IN TODAY'S CURRENT WORLD,
18 I SEE WORKERS GOING OUTSIDE OF A BUILDING, IT
19 DOESN'T HAVE TO BE A WORKER, IT COULD BE A JUROR OR
20 IT COULD BE ANYONE, SOMEONE GOES OUTSIDE OF A
21 BUILDING TO HAVE A PUFF OF A CIGARETTE AND I
22 SOMETIMES NOTICE THAT WHEN I GET OUTSIDE, THE FIRST
23 COUPLE OF HITS OF ONE OF THESE IS BIG ONES LIKE
24 THAT (INDICATING).
25 DOES THAT PLAY INTO WHAT YOU WERE
26 SAYING?
27 A. YEAH, THAT'S EXACTLY RIGHT.
28 WE DID RESEARCH THAT I PUBLISHED

(Read page 1914 and 1915  interesting reading)

http://www.tobacco.neu.edu/box/boekenbox/Boeken%20Trial%20Transcript/1864-1966_040601AM_UydessBenowitzDirect.PDF
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March/April 1996

In 1994, Dr. Henningfield and Dr. Neal Benowitz, a NIDA-funded researcher at the University of California at San Francisco, published an article in The New England Journal of Medicine that proposed a national strategy for reducing nicotine levels in cigarettes over a period of 10 to 15 years, eventually reaching a level that is "essentially nonaddictive." With levels that low, there would not be enough nicotine in cigarettes to support addiction, said the researchers.

http://www.nida.nih.gov/NIDA_Notes/NNVol11N2/henningfield.html

FDA names tobacco panel, sets first meeting

Chairing the committee is Dr. Jonathan Samet, director of the University of Southern California's Institute for Global Health and former director of the Institute for Global Tobacco Control at Johns Hopkins University.

The other members announced Monday are:

- Dr. Neal Benowitz, nicotine and addiction specialist at University of California, San Francisco;

- Dr. Mark Clanton, chief medical officer for American Cancer Society;

- Dr. Gregory Connolly, professor at Harvard University School of Public Health and tobacco control expert;

- Karen DeLeeuw, director of Center for Healthy Living and Chronic Disease Prevention at Colorado Department of Public Health and Environment;

- Dorothy Hatsukami, director of University of Minnesota Transdisciplinary Tobacco Use Research Center;

- Dr. Patricia Nez Henderson, vice president of Black Hills Center for American Indian Health;

- Jack Henningfield, vice president of research and health policy for consumer health company Pinney Associates; and

- Melanie Wakefield, director of Centre for Behavioural Research in Cancer at Cancer Council Victoria, a nonprofit in Australia.