CASAA Response to the FDA

[Webby]

Official Response: http://casaa.org/casaa122809.pdf

December 28, 2009
Lawrence Deyton, MD
Director, Center for Tobacco Products
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850-3229

Dear Dr. Deyton:

The Consumer Advocates for Smoke-Free Alternatives Association (CASAA) urges the FDA's Center for Tobacco Products to shift the focus of tobacco control to saving lives. For decades tobacco control laws and smoking cessation treatment efforts have focused on one goal: complete abstinence from nicotine. The Healthy People 2010 smoking prevalence goal was set at 12%. The fact that the number of adult smokers in the US has not decreased, but rather has increased to 46 million (20.6%), leads to an inescapable conclusion: we need a different approach.

If smokers are not quitting, it is not for lack of trying. Millions of smokers find they simply cannot quit smoking, despite multiple attempts and with use of the various FDA-approved cessation products. The success rates for nicotine replacement therapy (NRT) products are abysmal, ranging from 16% to 19% at six weeks, falling to a range of 5% to 10% after therapy stops.

The easy explanation for this phenomenon is "it's an addiction." It's an easy explanation because it allows the medical community, the tobacco control community, and the nonsmoking public to simply blame the victim.

However, for a large percentage of long-term smokers, nicotine abstinence triggers cognitive deficits and mood impairments that negatively impact job performance, relationships, and instrumental activities of daily living. The nicotine abstinence approach forces these smokers to pay for improvements in physical health with their cognitive and emotional health. It is unethical to force such a choice on anyone.

The Tobacco Harm Reduction approach saves lives by encouraging smokers to switch to products that provide nicotine from less harmful sources than tobacco smoking. The World Health Organization has observed, "If a tobacco user can only abstain from smoking through the use of a therapeutic dose of ‘clean’ nicotine, this should be an option. Such products should be made available, and not placed at a marketing disadvantage compared with tobacco products." [1]

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One smoke-free alternative, commonly known as the electronic cigarette, delivers vaporized nicotine. A user survey shows the success rate of this product to be 79% for complete cessation of tobacco cigarette smoking. [2]

CASAA recommends the following actions:

• Make it easy to import Swedish snus which has proven to be much safer than smoking. [4]
• Encourage U.S. tobacco makers to emulate the methods used in Sweden to reduce carcinogens in tobacco. [5]
• Encourage the development and marketing of higher dose versions and long-term use of FDA-approved nicotine products as a replacement for smoking. [6]
• Provide accurate safety information on products so that consumers can make informed choices. [7]

The Comprehensive Smokeless Tobacco Health Education Act of 1986 (Public Law 99-252) required a misleading warning label on smokeless tobacco: "This product is not a safe alternative to cigarettes." Smokers who read the label concluded that switching to smokeless was not going to help one bit, so they might as well keep smoking until they were ready to quit. The warning label has resulted in countless cases of lung disease, heart disease, excess cancers, and premature death.

Section 205 of the “Family Smoking Prevention and Tobacco Control Act” authorizes the FDA to revise warning label statements on smokeless tobacco products. A more accurate label would state, "This product reduces disease risk by 95% when used as an alternative to cigarettes."

Other smoking alternatives should also carry accurate statements about health effects. Electronic cigarettes users who have stopped smoking tobacco report improvement in lung function and markers of cardiovascular risk. [8]

The FDA has an unprecedented opportunity now to work in the best interest of public health: reduce the death and disability caused by the single most dangerous method of taking in nicotine — tobacco smoking. [9]

Sincerely,

Michal Douglas, Chairman

Theresa Whitt, M.D., Medical Consultant

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References:

[1] Sweanor (2000) Is it the nicotine or the tobacco? Bulletin of the World Health Organization, vol.78 no.7, Print version ISSN 0042-9686.

http://www.scielosp.org/scielo.php?s...rm=iso&tlng=en

[2] Heavner (2009) Electronic cigarettes (e-cigarettes) as potential tobacco harm reduction products: Results of an online survey of e-cigarette users. Working Paper.

http://www.tobaccoharmreduction.org/wpapers/011v1.pdf

[3] Sumner, W., Estimating the health consequences of replacing cigarettes with nicotine inhalers. Tobacco Control 2003;12;124-132

http://www.bvsde.paho.org/bvsacd/cd26/tc/v12n2/124.pdf

[4] Gartner (2007) Assessment of Swedish snus for tobacco harm reduction: an epidemiological modelling study. The Lancet, Volume 369, Issue 9578, Pages 2010 - 2014, 16 June 2007.

Assessment of Swedish snus for tobacco harm reduction: an epidemiological modelling study : The Lancet

[5] Connolly (2001). Informational Update Research on Tobacco Specific Nitrosamines (TSNAs) in Oral Snuff and a Request to Tobacco Manufacturers to Voluntarily Set Tolerance Limits For TSNAs in Oral Snuff.

http://smallbusiness.findlaw.com/fin...nuffsstudy.pdf

[6] Etter (2006) Nicotine replacement therapy for long-term smoking cessation: a metaanalysis.Tobacco Control 2006;15:280-285.

Nicotine replacement therapy for long-term smoking cessation: a meta-analysis

[7] Kozlowski (2002) Harm reduction, public health, and human rights: smokers have a right to be informed of significant harm reduction options Nicotine and Tobacco Research. 2002;4 Suppl 2:S55-60.

Harm reduction, public health, and human rights: Smokers have a right to be informed of significant harm reduction options -- Kozlowski 4 (2): S55 -- Nicotine & Tobacco Research

[8] The Electronic Cigarette Petition site.

http://www.thepetitionsite.com/1/kee...ttes-available

[9] Phillips (2009). Debunking the claim that abstinence is usually healthier for smokers than switching to a low-risk alternative, and other observations about anti-tobacco-harmreduction arguments. Harm Reduction Journal 2009, 6:29.

Harm Reduction Journal | Full text | Debunking the claim that abstinence is usually healthier for smokers than switching to a low-risk alternative, and other observations about anti-tobacco-harm-reduction arguments

[Stubby]

Section 205 of the “Family Smoking Prevention and Tobacco Control Act” authorizes the FDA to revise warning label statements on smokeless tobacco products. A more accurate label would state, "This product reduces disease risk by 95% when used as an alternative to cigarettes."

This is the recommendation on page 224 of "A report by the Tobacco Advisory Group of the Royal College of Physicians, October 2007" for a warning label for smokeless tobacco

This product is addictive and may increase your risk of disease. This product is substantially less harmful than cigarettes, but abstaining from tobacco use altogether is the safest course of action

Rolls off the tongue a bit nicer yet very accurate.

[CJsKee]

Excellent letter...way to step up CASAA!

[Vocalek]

This is the recommendation on page 224 of "A report by the Tobacco Advisory Group of the Royal College of Physicians, October 2007" for a warning label for smokeless tobacco

This product is addictive and may increase your risk of disease. This product is substantially less harmful than cigarettes, but abstaining from tobacco use altogether is the safest course of action

Rolls off the tongue a bit nicer yet very accurate.

What the RCP wrote at the time was true, and probably still is true today, but given that the Swedes have managed to make their snus tobacco 99% safer than smoking, what's to say they won't be able someday to conquer that remaining 1%?

Unfortunately, "abstaining from tobacco use altogether" has morphed into the belief that abstaining from nicotine altogether is the safest course of action. I disagree.

It was very unsafe for me to abstain from nicotine althogether. I was a menace driving a car due to visual and short-term memory impairment and I have a sneaking suspicion that many of the suicides that are attributed to Chantix and Zyban are actually triggered by nicotine abstinence. Nicotine has widely recognized anti-depressant properties.

[Thulium]

What the RCP wrote at the time was true, and probably still is true today, but given that the Swedes have managed to make their snus tobacco 99% safer than smoking, what's to say they won't be able someday to conquer that remaining 1%?

Unfortunately, "abstaining from tobacco use altogether" has morphed into the belief that abstaining from nicotine altogether is the safest course of action. I disagree.

It was very unsafe for me to abstain from nicotine althogether. I was a menace driving a car due to visual and short-term memory impairment and I have a sneaking suspicion that many of the suicides that are attributed to Chantix and Zyban are actually triggered by nicotine abstinence. Nicotine has widely recognized anti-depressant properties.

The tricky thing is that "abstaining from tobacco use altogether" may or may not apply to e-cigs. We're still waiting on word from Judge Leon whether e-cigs can be considered a tobacco product or a "nicotine delivery device". I really wish we could simply get a new and more accurate category for "clean" tobacco/nicotine products like e-juice. Since the nicotine and other tobacco ingredients are optional, it seems the most judicious.

In any case, I am completely in favor of the suggested labeling.

[TokenVapor]

..........

[Kamanjah]

Kudos, CASAA!!! Well done!

[JustMeAgain]

Keep up the good work - this is a fabulous letter!

Thank you for all your efforts.

jm

[SudokuGal]

Excellent...thanks!

[ArtAttackTat2]

Awesome and keep fighting the good fight!