CASAA Call to Action! Submit Written Comments – Sec. 918 of Tobacco Act

[Bill Godshall]

Testimony Part 2.

A study found that Star’s Ariva and Stonewall dissolvable tobacco products contained far lower levels of tobacco specific nitrosamines than various American moist snuff products and several Swedish snus products, and that nitrosamine levels in Star’s Ariva and Stonewall were just slightly higher than nitrosamine levels in GlaxoSmithKline’s Nicorette gum and Nicoderm CQ skin patch.
tobacco-specific nitrosamines in new tobacco products, Irina Stepanov, Joni Jensen, Dorothy Hatsukami, Stepehen S. Hecht, Nicotine and Tobacco Research Volume 8, Number 2 (April 2006) 309-313.
http://www.starscientific.com/404/stepanov tsna in.pdf


Another study evaluating plasma nicotine levels, heart rates, and reduction in cigarette cravings following use of Star’s Ariva dissolvable tobacco product were very similar to those following use of GlaxoSmithKline’s Commit dissolvable nicotine product. Meanwhile, participants reported that Star’s Ariva tasted better than GSK’s Commit.
Evaluating the Acute Effects of Oral, Non-combustible Potential Reduced Exposure Products Marketed to Smokers, Caroline O Cobb, Michael F Weaver, Thomas Eissenberg, Tob Control doi:10.1136/tc.2008.028993
http://static.mgnetwork.com/rtd/pdfs/20090712_toba.pdf

The daily inhalation of tobacco smoke causes more than 99% of tobacco attributable mortality in the US Annual Smoking-Attributable Mortality, Years of Potential Life Lost, and Productivity Losses --- United States, 1997--2001 and more than 99% of all tobacco attributable healthcare costs. Meanwhile, the evidence indicates that the use of smokefree tobacco/nicotine products causes less than than 1% of tobacco attributable mortality and healthcare costs.

But while ST products are far less hazardous alternatives to cigarettes, a recent survey of more than 13,000 cigarette smokers in the US, Canada, UK and Australia found that only 13% correctly believed that ST products are less hazardous than cigarettes.
Smokers' beliefs about the relative safety of other tobacco products: Findings from the ITC Collaboration, Richard J. O'Connor; Ann McNeill; Ron Borland; David Hammond; Bill King; Christian Boudreau; K. Michael Cummings, Nicotine & Tobacco Research, Volume 9, Issue 10 October 2007, pages 1033-1042.
http://www.informaworld.com/smpp/content~content=a783052257~db=all~order=page

A 2000 survey of 36,012 young adults entering the U.S. Air Force found that 75% of males and 81% of females incorrectly believed that switching from cigarettes to ST products would not result in any risk reduction, while another 16% of males and 13% of females incorrectly believed that only a small risk reduction would occur. Only 2% of males and 1% of females correctly thought that a large risk reduction would occur by switching from cigarettes to ST.
Modified Tobacco Use and Lifestyle Change in Risk-Reducing Beliefs About Smoking, Haddock CK, Lando H, Klesges RC, et al, American Journal of Preventive Medicine, 2004 Vol. 27, No. 1, 35-41.

Another survey found that 89% of college freshmen incorrectly believe that ST is just as or more harmful than cigarettes.
Harm perception of nicotine products in college freshmen, Smith SY, Curbow B, Stillman FA, Nicotine Tob Res. 2007 Sep;9(9):977-82.
http://www.informaworld.com/smpp/content~content=a781712955~db=all~tab=content~order=page

A survey of more than 2,000 adult U.S. smokers found that only 10.7% correctly agreed that ST products are less hazardous than cigarettes, while 82.9% incorrectly disagreed.
Smoker Awareness of and Beliefs About Supposedly Less-Harmful Tobacco Products, O’Conner RJ, Hyland A, Giovino G, et al, American Journal of Preventive Medicine, 2005, Vol. 29, No. 2, 85-90.

In yet another survey, when asked if they believed that chewing tobacco is just as likely to cause cancer as smoking cigarettes, 82% of U.S. smokers incorrectly agreed.
Informing Consumers about the Relative Health Risks of Different Nicotine Delivery Products, presentation by K. Michael Cummings at the National Conference on Tobacco or Health, New Orleans, LA, November 2001.

Another study published in 2011 at http://www.harmreductionjournal.com/content/pdf/1477-7517-8-21.pdf similarly found that 5 of 6 smokers in the US inaccurately believe that smokeless tobacco products are just as hazardous as cigarettes.



A key reason for this lack of knowledge about the morbidity and mortality risks of smokeless tobacco products the 1986 Comprehensive Smokeless Tobacco Education Act, which required three rotating warnings on all smokeless tobacco products (i.e. This product is not a safe alternative to cigarettes. This product may can mouth cancer. This product may cause gum disease and tooth loss.)

Authors of a study that evaluated 316 English language websites (none of which were tobacco companies) that contained health risk information about cigarettes and smokeless tobacco use concluded: “The risk from ST is widely conflated with the risk from cigarettes on websites that provide health advice and information. Almost every website had statements that played up the health risks from ST without caveat, making it difficult for consumers to recognize the huge contrast with cigarettes. The quantitative claims of health risks from ST were very often beyond a worst-case-scenario interpretation of the scientific literature. A large portion of websites directly stated or implied that the risks from ST and cigarettes are similar.”
You might as well smoke; the misleading and harmful public message about smokeless tobacco, Carl V Phillips, Constance Wang, Brian Guenzel,
BMC Public Health 2005, 5:31doi:10.1186/1471-2458-5-31
BMC Public Health | Full text | You might as well smoke; the misleading and harmful public message about smokeless tobacco

Considering the published research confirms that smokeless tobacco products are far less hazardous than cigarettes, the FDA should eliminate the currently mandated warning label on smokeless tobacco products that deceptively states “This product is not a safe alternative to cigarettes,” and replace it with the warning proposed by RJ Reynolds in a Citizens Petition to the FDA (or a similar one) that truthfully states “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”

Considering the published research confirming that smokeless tobacco products pose far fewer oral cancer risks than cigarettes, and that snus poses no oral cancer risk, the FDA should propose a regulation to eliminate the currently mandated warning label on smokeless tobacco products that misleading or inaccurately states “This product may cause mouth cancer.”

A 2008 meta analysis of smokeless tobacco use and periodontal diseases at
BMC Oral Health | Full text | Systematic review of the relation between smokeless tobacco and non-neoplastic oral diseases in Europe and the United States and another 2011 study at Periodontal disease in relation to smokin... [J Clin Periodontol. 2011] - PubMed - NCBI found that Swedish snus poses far fewer risks of periodontal disease and tooth loss than are posed by cigarette smoking, and poses risks far more similar to those found in never-tobacco-users.

Therefore, the FDA also should propose a regulation to eliminate the inaccurate but currently mandatory warning on smokeless tobacco products that states: “This product may cause gum disease and tooth loss.”

Since the FSPTCA required even larger warnings on smokeless tobacco products and advertisements (that did the 1986 Comprehensive Smokeless Tobacco Education Act), it is critically important for the FDA propose a regulation to eliminate these misleading mandatory warnings on smokeless tobacco products.



Most Smokers Inaccurately Believe that Smokeless Tobacco Products
Are as Hazardous as Cigarettes

While ST products are far less hazardous alternatives to cigarettes, a recent survey of more than 13,000 cigarette smokers in the US, Canada, UK and Australia found that only 13% correctly believed that ST products are less hazardous than cigarettes.
Smokers' beliefs about the relative safety of other tobacco products: Findings from the ITC Collaboration, Richard J. O'Connor; Ann McNeill; Ron Borland; David Hammond; Bill King; Christian Boudreau; K. Michael Cummings, Nicotine & Tobacco Research, Volume 9, Issue 10 October 2007, pages 1033-1042.
http://www.informaworld.com/smpp/content~content=a783052257~db=all~order=page

A 2000 survey of 36,012 young adults entering the U.S. Air Force found that 75% of males and 81% of females incorrectly believed that switching from cigarettes to ST products would not result in any risk reduction, while another 16% of males and 13% of females incorrectly believed that only a small risk reduction would occur. Only 2% of males and 1% of females correctly thought that a large risk reduction would occur by switching from cigarettes to ST.
Modified Tobacco Use and Lifestyle Change in Risk-Reducing Beliefs About Smoking, Haddock CK, Lando H, Klesges RC, et al, American Journal of Preventive Medicine, 2004 Vol. 27, No. 1, 35-41.

Another survey found that 89% of college freshmen incorrectly believe that ST is just as or more harmful than cigarettes.
Harm perception of nicotine products in college freshmen, Smith SY, Curbow B, Stillman FA, Nicotine Tob Res. 2007 Sep;9(9):977-82.
http://www.informaworld.com/smpp/content~content=a781712955~db=all~tab=content~order=page

A survey of more than 2,000 adult U.S. smokers found that only 10.7% correctly agreed that ST products are less hazardous than cigarettes, while 82.9% incorrectly disagreed.
Smoker Awareness of and Beliefs About Supposedly Less-Harmful Tobacco Products, O’Conner RJ, Hyland A, Giovino G, et al, American Journal of Preventive Medicine, 2005, Vol. 29, No. 2, 85-90.

In yet another survey, when asked if they believed that chewing tobacco is just as likely to cause cancer as smoking cigarettes, 82% of U.S. smokers incorrectly agreed.
Informing Consumers about the Relative Health Risks of Different Nicotine Delivery Products, presentation by K. Michael Cummings at the National Conference on Tobacco or Health, New Orleans, LA, November 2001.

The reason for this lack of knowledge is largely due to the 1986 Comprehensive Smokeless Tobacco Education Act, which required three rotating warnings on all smokeless tobacco products (i.e. This product is not a safe alternative to cigarettes. This
product may can mouth cancer. This product may cause gum disease and tooth loss.)
The FSPTCA requires even large warnings on smokeless tobacco products and advertisements.

Authors of a study that evaluated 316 English language websites (none of which were tobacco companies) that contained health risk information about cigarettes and smokeless tobacco use concluded: “The risk from ST is widely conflated with the risk from cigarettes on websites that provide health advice and information. Almost every website had statements that played up the health risks from ST without caveat, making it difficult for consumers to recognize the huge contrast with cigarettes. The quantitative claims of health risks from ST were very often beyond a worst-case-scenario interpretation of the scientific literature. A large portion of websites directly stated or implied that the risks from ST and cigarettes are similar.”
You might as well smoke; the misleading and harmful public message about smokeless tobacco, Carl V Phillips, Constance Wang, Brian Guenzel, BMC Public Health 2005, 5:31doi:10.1186/1471-2458-5-31
BMC Public Health | Full text | You might as well smoke; the misleading and harmful public message about smokeless tobacco
No Evidence Smokeless Tobacco Products are Gateway to Cigarette Smoking

Authors of a recently published analysis of NSDUH data concluded that: “Smokeless Tobacco (ST) use has played virtually no role in smoking initiation among White men and boys, the demographic groups among which ST use is most prevalent. There is evidence that, compared with cigarette initiators, ST initiators are significantly less likely to smoke.”
Evidence against a gateway from smokeless tobacco use to smoking, Brad Rodu and Philip Cole, Nicotine Tob Res (2010) 12 (5): 530-534. doi: 10.1093/ntr/ntq033
Evidence against a gateway from smokeless tobacco use to smoking

Using most of the same data, a 2009 SAMHSA report found that, among US residents who had used both cigarettes and smokeless tobacco products in their lifetime, 65.5% used cigarettes prior to smokeless tobacco use, and 31.8% used smokeless tobacco prior to cigarette usage.
Substance Abuse and Mental Health Services Administration, Office of Applied Studies. (February 19, 2009). The NSDUH Report: Smokeless Tobacco Use, Initiation, and Relationship to Cigarette Smoking: 2002 to 2007. Rockville, MD.
Smokeless Tobacco Use, Initiation, and Relationship to Cigarette Smoking: 2002 to 2007

 

[Bill Godshall]

Testimony Part 3.



Millions of Smokers in the US, Sweden and Norway Have Already Switched to Smokefree Tobacco/Nicotine Products

Switching from cigarettes to smokefree tobacco products has been occurring in the U.S. and in Sweden for many decades, and isn’t an unproven theory (as some harm reduction opponents claim).

The 1986 nationwide Adult Use of Tobacco Survey (AUTS), conducted by the CDC Office on Smoking and Health, found that 7% (i.e., 1.67 million) of male ex-smokers indicated they had used smokeless tobacco (ST) products to help them quit smoking cigarettes, and 6.4% (i.e., 1.63 million) of males who currently smoked indicated using ST to help them quit smoking. In comparison, just 1.7% of male ex-smokers (i.e., 404,600) and 2.4% of males who currently smoked (i.e., 609,000) indicated using organized programs to help them quit smoking cigarettes.
Smokeless Tobacco Use in the United States: The Adult Use of Tobacco Surveys, Novotny, Pierce, Fiore & Davis, NCI Monograph 8, 25-29, NIH, U.S. DHHS, 1989.

A 1984 Philip Morris market research survey of 489 adult male ST product users in Houston, Atlanta, and Florida (who were interviewed outside retail stores after purchasing ST) found that 37% of ST users stated they were former cigarette smokers (including 22% of those under age 35 and 50% of those 35 years or older). The survey also found that, in response to the question, “Did you start using smokeless/chewing tobacco as a replacement for cigarettes, that is, when you stopped smoking cigarettes, or not?” 20% of ST users said YES. These findings were consistent in the three different survey locations. Interestingly, 62% of respondents who used both ST and cigarettes reported that ST was “more enjoyable” than cigarettes.
Smokeless Tobacco Study – Atlanta/Florida, Philip Morris USA Marketing Research Department Report, Miller K, Marketing Research Department Report Smokeless Tobacco Study - Atlanta / Florida


The 1991 NHIS found that 33.3% (i.e., 1.75 million) of U.S. adult ST users reported being former cigarette smokers, and the 1998 NHIS found that 31.1% of ST users reported being former cigarette smokers. The 1998 NHIS found that 5.8% of daily snuff users reported quitting smoking cigarettes within the past year, that daily snuff users were 3.2 times more likely to report being former cigarette smokers than were never snuff users who had smoked, and that daily snuff users were 4.2 times more likely to have quit smoking in the past year than were never snuff users who had smoked.
Use of Smokeless Tobacco Among Adults – United States, 1991, Morbidity and Mortality Weekly Report, Vol 42, No 14, 263-266, April 16, 1993, CDC, U.S. DHHS. Use of Smokeless Tobacco Among Adults -- United States, 1991
Tomar S, Snuff Use and Smoking in US Men: Implications for Harm Reduction, American Journal of Preventive Medicine, 2002, Vol. 23, No. 3, 143-149.

The 1987 NHIS found that, among 23-to-34 year old U.S. males, those who had smoked cigarettes and then subsequently used snuff were 2.1 times more likely to have quit smoking than were cigarette-only users.
Most smokeless tobacco use is not a causal gateway to cigarettes: using order of product use to evaluate causation in a national US sample, Kozlowski L, O’Connor, Edwards BQ, Flaherty BP, Addiction, 2003, Vol. 98, 1077-1085. http://www.blackwell-synergy.com/links/doi/10.1046/j.1360-0443.2003.00460.x/abs

A study of 51 female and 59 male ST users (in the Northwestern U.S.), in which 98% of females and 90% of males were either current or former cigarette smokers, found that 52% of females and 59% of males responded affirmatively when asked whether they used ST in place of cigarettes while quitting smoking.
A comparison of male and female smokeless tobacco use, Cohen-Smith D, Severson H, Nicotine & Tobacco Research, 1999, Vol. 1, 211-218.

Another study found that 72% of an estimated 359,000 U.S. smokers who switched to ST products on their last smoking cessation attempt successfully quit smoking.
Switching to smokefree tobacco as a smoking cessation method: evidence from the 2000 National Health Interview Survey, Brad Rodu and Carl V Phillips, Harm Reduction Journal 2008, 5:18doi:10.1186/1477-7517-5-18. http://www.harmreductionjournal.com/content/pdf/1477-7517-5-18.pdf

In Sweden, moist oral snuff is called snus. Unlike moist oral snuff commonly used in the U.S., snus is pasteurized, not fermented, and stored in refrigerators from the time of manufacture until sold at retail. Also in contrast to most ST products commonly sold in the U.S. (except for dissolvable ST products), snus is spitfree, contains fewer nitrosamines, and has not been found to be associated with mouth cancer. In 2003, Foulds et al found that snus posed exponentially fewer health risks than cigarettes, and that many Swedish smokers had quit smoking by switching to snus.
Effect of smokeless tobacco (snus) on public health in Sweden, Foulds J, Ramstrom L, Burke M, Fagerstom K, Tobacco Control, 2003, Vol 12, 349-359. http://tc.bmjjournals.com/cgi/content/full/12/4/349

When a large national sample of Swedish ex-smokers was asked about how they succeeded in quitting, 50% stated that they had stopped without help, 33% said they used snuff, and 17% said they had used some form of NRT.
Smokeless Tobacco and Cardiovascular Disease, Asplund, K, Progress in Cardiovascular Diseases, Vol. 45, No 5, (March/April) 2003, 383-394.

Another survey of more than 6,700 Swedes found that more than 25% of male cigarette smokers indicated they had switched to snus. The survey also found that snus was more effective than NRT products as a smoking cessation aid.
Role of snus in initiation and cessation of tobacco smoking in Sweden, Ramström and Foulds Tob Control.2006; 15: 210-214. http://tobaccocontrol.bmj.com/cgi/content/full/15/3/210




Largely due to smokers switching to snus, the male cigarette smoking rate in Sweden dropped from 40% in 1976 to just 15% in 2002, while snus use among Swedish men increased from 10% to 23%. Due to this decline in smoking, male lung cancer rates in Sweden are the lowest in Europe, while Sweden’s oral cancer rate has fallen during the last 20 years as snus use sharply increased.
Effect of smokeless tobacco (snus) on public health in Sweden, Foulds J, Ramstrom L, Burke M, Fagerstom K, Tobacco Control, 2003, Vol 12, 349-359. http://tc.bmjjournals.com/cgi/content/full/12/4/349

An international panel of seven experts, using the Delphi approach, estimated that an additional 10% of cigarette smokers would quit over five years if all smokefree tobacco products in the U.S. were required to be low-nitrosamine products and if those products were accompanied by a warning label that stated: “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.”
The potential impact of a low-nitrosamine smokeless tobacco product on cigarette smoking in the United States: Estimates of a panel of experts, Levy D, Mumford E, Cummings KM, et al. ,Addictive Behaviors, Nov. 2005. http://www.ascribe.org/cgi-in/behold.pl?ascribeid=20051114.171444&time=07 42 PST&year=2005&public=1

Authors of a recent survey of Norwegian men who were either former or current smokers reported: “In a regression model in which education, number of previous attempts to quit smoking, perception of risk, and age were controlled for, the odds ratio (OR) for reporting total abstinence at the time of the survey was significantly higher for those who had used varenicline (OR = 4.95, p < .006) and snus (OR = 2.68, p < .001) compared with those who had used nicotine chewing gum (reference OR = 1).” and “Compared with medicinal nicotine products, snus and varenicline increased the probability of quitting smoking completely”.
The use of snus for quitting smoking compared with medicinal products, Karl Erik Lund, Ann McNeill, Janne Scheffels, Nicotine Tob Res (2010) doi: 10.1093/ntr/ntq105
The use of snus for quitting smoking compared with medicinal products

A 2011 study at Changing patterns of tobacco use in a middle-aged population similarly confirmed that many Swedish male and female smokers have switched to snus, that very few snus users switched to cigarettes, and that dual usage isn’t very prevalant but rather primarily serves as a transition period for smokers as they switch to snus. Amazingly, however, the authors of this study misinterpreted their own data by concluding “The increase in snus use is being paralleled by a slight increase in dual use and the smoking prevalence does not seem to be influenced by snus.”


Electronic Cigarettes also are Far Less Hazardous Alternatives to Cigarettes, and Have Helped More Than a Million Smokers Quit Smoking

Published surveys and sales data indicate at least a million smokers have quit smoking or sharply reduced their cigarette consumption by switching to or substituting smokefree e-cigarettes. To date, there is no evidence that e-cigarette usage has harmed anyone, which is logical since the products emit a tiny amount of vaporized nicotine (similar to nicotine inhalers that are marketed as smoking cessation aids) and water vapor. Of the dozen plus laboratory tests conducted on e-cigarettes, only one (conducted by the FDA in 2009) found a trace (and well below toxic) level of one so-called toxic chemical in just one of eighteen samples tested, and levels of nitrosamines in e-cigarettes are nearly identical to those in nicotine gums and patches. Despite truthful marketing claims by many e-cigarette companies that the products are less hazardous than cigarettes, there is no evidence that youth or non tobacco users have become regular users of e-cigarettes.
http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf
http://www.starscientific.com/404/stepanov tsna in.pdf
http://www.casaa.org/resources/lab.asp
http://www.hsph.harvard.edu/centers-institutes/population-development/files/article.jphp.pdf
http://www.jstage.jst.go.jp/article/seikatsueisei/55/1/55_59/_article
Effect of a nicotine free inhalator as part of a smoking cessation program
http://ectoh.org/documents/3B.5 Ett...ation satisfaction and perceived efficacy.pdf
Interviews With
'It's Not the Addiction that Kills People, It's the Smoke' - The Takeaway
Electronic Cigarettes
Electronic cigarettes (e-cigs): views of af... [Int J Clin Pract. 2011] - PubMed - NCBI
http://www.scirp.org/journal/PaperInformation.aspx?paperID=6134&publishStatus=2
http://www.sciencedirect.com/science/article/pii/S0300483X11002095
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http://www.casaa.org/news/article.asp?articleID=197&l=a&p=
Behavioural Insights Team annual update | Cabinet Office

Former FDA Commissioner David Kessler has also acknowledged the benefits of smokeless tobacco, dissolvables and e-cigarettes as less hazardous alternatives for cigarette smokers at http://www.westport-news.com/busine...-Commissioner-talks-about-tobacco-1735433.php by stating "there's no doubt that in terms of risk of death there are some advantages to that substitution."

E-cigarettes also have been found to contain/emit similar or lower levels of nicotine than nicotine gums and lozenges at
http://www.healthnz.co.nz/2010 Bullen ECig.pdf
http://www.e-cigarette-forum.com/fo...eissenberg-study-vindicates-e-cigarettes.html

This indicates that e-cigarettes emit enough nicotine to satisfy the cravings of smokers, but may not emit enough nicotine to addict nonsmokers. Several published surveys have confirmed that e-cigarettes satisfy the cravings of smokers, and provide many health benefits to users who switched from cigarettes.
Sign In
http://www.biomedcentral.com/content/pdf/1471-2458-10-231.pdf
THR2010. (tobaccoharmreduction.org) (see chapter 9)

Other public health organizations that have extensively studied e-cigarettes have also endorsed their use by smokers, including The American Association of Public Health Physicians at Regulations.gov and the American Council on Science and Health at Blog.

On July 22, 2009, in an attempt to justify the agency’s unwarranted and unlawful import ban on e-cigarettes, then FDA Deputy Commissioner Josh Sharfstein held a press conference where the agency’s laboratory test findings on e-cigarettes were misrepresented to scare the public, and where invited guests falsely claimed the products were target marketed to youth.
http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM173405.pdf

The FDA also issued a press release and a webpage PDF on July 22, 2009 (that have been cited by hundreds of other e-cigarette prohibitionists and propagandists, and by thousands of news reports) containing the same or similar false and misleading claims.
FDA Warns of Health Risks Posed by E-Cigarettes
http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM173430.pdf

But even after the FDA concurred with Judge Leon’s ruling prohibiting FDA from banning e-cigarettes as unapproved drugs, the FDA has refused to correct or clarify its inaccurate and misleading claims about e-cigarettes. Even worse, the agency has issued even more misleading claims about e-cigarettes.

And yet, e-cigarette sales continue to skyrocket and should surpass NRT sales next year, whose sales have remained stagnant at $1 billion annually for the past decade.

The FDA has repeatedly stated its intent to propose a “deeming” regulation to apply Chapter IX of the FSPTCA to e-cigarettes. But Sections 905 and 910 would ban all e-cigarettes, and other provisions of Chapter IX would also decimate the e-cigarette industry, protect cigarette markets and otherwise threaten public health.

Based upon this and other evidence, the FDA should never again attempt to ban electronic cigarettes, and should keep electronic cigarettes and ALL other smokefree tobacco/nicotine products legally accessible and affordable for smokers.


Smokers Have a Human Right to Truthful Health Risk Information and Access to Less Hazardous Alternatives

Government health agencies (including the FDA) have an ethical duty to truthfully inform smokers that smokefree tobacco products are less hazardous alternatives to cigarettes. Similarly, smokers have a human right to be truthfully informed that smokefree tobacco products are far less hazardous alternatives than cigarettes, and legal and affordable access to these products.
Harm reduction, public health, and human rights: Smokers have a right to be informed of significant harm reduction options, Kozlowski L, Nicotine & Tobacco Research, S55-S60, 2002. http://ash.org.uk/html/regulation/pdfs/hr_kozlowski.pdf
First Tell The Truth, A Dialogue on Human Rights, Deception, and the Use of Smokeless Tobacco as a Substitute for Cigarettes, Kozlowski L, Tob Control,12:34-36, 2003. Search Results


Public Health Officials and Agencies have an Ethical Duty to Inform Smokers and the Public that Smokefree Tobacco/Nicotine Products are Far Less Hazardous Alternatives to Cigarettes

Just as the US Public Health Service had an ethical duty to inform black syphilis sufferers in the notorious Tuskegee Study that there were effective treatments for syphilis, public health officials have an ethical duty to truthfully inform smokers that ST products are less hazardous alternatives to cigarettes. To intentionally deceive smokers and the public about health risks of smokeless tobacco products is public health malpractice.

FDA (and other DHHS agencies) Should Correct or Clarify Their False and Misleading Fear Mongering Claims About Smokefree Tobacco/Nicotine Products

It is extremely important that FDA stop misleading smokers and the public about the health/safety risk/benefit profiles of smokeless tobacco, electronic cigarettes and other smokefree tobacco products.

After I provided similar oral testimony at several FDA public meetings, and submitted similar written comments to several related FDA dockets, the FDA created a webpage about Section 911 of the FSPTCA entitled “Health Fraud” that falsely claims
“To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products.”
Health Fraud

The FDA should correct or clarify that false claim IMMEDIATELY.

Considering the scientific and empirical evidence in this testimony (and elsewhere),
the FDA also should:

- acknowledge that long term use of nicotine poses negligible if any disease risks,

- acknowledge that all smokefree tobacco/nicotine products (including NRT, smokeless tobacco and electronic cigarettes) are far less hazardous alternatives to cigarettes,

- acknowledge that millions of cigarette smokers have already quit smoking and/or sharply reduced cigarette consumption by switching to e-cigarettes, smokeless tobacco products and/or NRT, and

- correct/clarify all of the false, misleading and fear mongering propaganda about the health risks of smokeless tobacco products, electronic cigarettes and other smokefree tobacco/nicotine products at all of the following FDA and DHHS websites:

Health Fraud
http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM173430.pdf http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM173405.pdf
FDA Warns of Health Risks Posed by E-Cigarettes
Electronic Cigarettes | BeTobaccoFree.gov
Smoked Tobacco Products | BeTobaccoFree.gov
Tobacco and Nicotine | BeTobaccoFree.gov
http://betobaccofree.hhs.gov/about-tobacco/smokeles- tobacco/index.html
Smokeless Tobacco and Your Health | BeTobaccoFree.gov
Tobacco and Nicotine | BeTobaccoFree.gov

 

[Bill Godshall]

Of the 5,365 comments that were submitted, I'm pretty certain that more than 5,000 were submitted by vapers.

So will the FDA acknowlege, accommodate and embrace this, and the testimony and evidence provided by 2/3rds of testifiers at the 12/17/12 public hearing, into the agency's policies and its mandated report to Congress?

Or will Obama's FDA continue to threaten the lives of smokers and vapers by proposing the prohibitionist "deeming" regulation and by continuing to misrepresent the scientific and empirical evidence, demonize e-cigarettes and other smokefree tobacco alternatives, preach abstinence-only, and hawk FDA approved drugs to treat "tobacco dependence"?

 

[Petrodus]

Of the 5,365 comments that were submitted, I'm pretty certain that more than 5,000 were submitted by vapers.

So will the FDA acknowledge, accommodate and embrace this, and the testimony and evidence provided by 2/3rds of testifiers at the 12/17/12 public hearing, into the agency's policies and its mandated report to Congress?

Or will Obama's FDA continue to threaten the lives of smokers and vapers by proposing the prohibitionist "deeming" regulation and by continuing to misrepresent the scientific and empirical evidence, demonize e-cigarettes and other smokefree tobacco alternatives, preach abstinence-only, and hawk FDA approved drugs to treat "tobacco dependence"?

I have zero confidence in the "Regulator and Chief's" FDA.

 

[2coils]

If these regulations DO turn out to be utterly ridiculous as we believe they will, do we have recourse after the fact?? From all that I have read, I was under the impression that Congress wanted to "fast track" innovative products. Its obvious the FDA isnt going to comply. Can we go to court over this? Can they be held accountable for their biased decisions? Someone please elaborate?

 

[FloridaNoob]

I am sure the next step will be the courts. As has been the case since the FDA started trying to ban PV devices several years ago. Hopefully the same defeats will keep happening to the FDA.

 

[DC2]

If these regulations DO turn out to be utterly ridiculous as we believe they will, do we have recourse after the fact?? From all that I have read, I was under the impression that Congress wanted to "fast track" innovative products. Its obvious the FDA isnt going to comply. Can we go to court over this? Can they be held accountable for their biased decisions? Someone please elaborate?

Bill Godshall has indicated in the past that if the FDA issues "deeming" regulations, there are people prepared to file lawsuits...
http://www.e-cigarette-forum.com/fo...acco-products-released-today.html#post4790722
http://www.e-cigarette-forum.com/fo...ata-misrepresenting-evidence.html#post6982918
http://www.e-cigarette-forum.com/fo...-approves-deeming-regulation.html#post5785843
http://www.e-cigarette-forum.com/fo...kes-new-report-press-release.html#post6857867

No further details have been made available as far as I know.

 

[Petrodus]

I'm sure the possibility of lawsuits
will keep the FDA awake at night.


The FDA is a Federal Agency
Tax payers pay their legal expenses.

 

[Fiamma]

Of the 5,365 comments that were submitted, I'm pretty certain that more than 5,000 were submitted by vapers.

So will the FDA acknowlege, accommodate and embrace this, and the testimony and evidence provided by 2/3rds of testifiers at the 12/17/12 public hearing, into the agency's policies and its mandated report to Congress?

Or will Obama's FDA continue to threaten the lives of smokers and vapers by proposing the prohibitionist "deeming" regulation and by continuing to misrepresent the scientific and empirical evidence, demonize e-cigarettes and other smokefree tobacco alternatives, preach abstinence-only, and hawk FDA approved drugs to treat "tobacco dependence"?

I don't think the FDA will recant their positions on Smokeless Tobacco in any form. They have lied far too long now to do an about face voluntarily. They will have to be compelled to do so and the courts are probably the only hope for that. The question is, who will sue?

If the deeming comes down in the Blu/Njoy format only, the companies invested in that format will be the winners and they would not. I doubt that any other US e cig companies have that kind of cash.

We must keep the pressure up on our elected representatives in any and all locations to support our position on Smokeless Tobacco in all its forms, be it e cigs, snus, dissolvables, snuff or chew. The FDA must be brought to heel and only the Congress can effectively do that. After all the President is in favor of the FDA's position and does not appear to mind that they are pathological liars.

 

[2coils]

Bill Godshall has indicated in the past that if the FDA issues "deeming" regulations, there are people prepared to file lawsuits...
http://www.e-cigarette-forum.com/fo...acco-products-released-today.html#post4790722
http://www.e-cigarette-forum.com/fo...ata-misrepresenting-evidence.html#post6982918
http://www.e-cigarette-forum.com/fo...-approves-deeming-regulation.html#post5785843
http://www.e-cigarette-forum.com/fo...kes-new-report-press-release.html#post6857867

No further details have been made available as far as I know.

Thanks for everyone's input. DC2 thank you for the links, I really appreciate them. I definately dont want to get too political,but, Are we saying the OVER-REGULATING DEMOCRATS have something to do with this nonsene. If so shame on them. For some reason I recall Obama seen smoking a cig. If so, shame on him for not helping!! I joined CASAA and started small donations. I will also become a supporting member here soon. Also trying to get the word out to everyone I know about this. I am glad to fight for this anyway I can!!!

 

[Fiamma]

Thanks for everyone's input. DC2 thank you for the links, I really appreciate them. I definately dont want to get too political,but, Are we saying the OVER-REGULATING DEMOCRATS have something to do with this nonsene. If so shame on them. For some reason I recall Obama seen smoking a cig. If so, shame on him for not helping!! I joined CASAA and started small donations. I will also become a supporting member here soon. Also trying to get the word out to everyone I know about this. I am glad to fight for this anyway I can!!!

Good for you 2coils We need a million more like you !!

 

[2coils]

Good for you 2coils We need a million more like you !!

Thanks for the kind words but not necessary. I just want the folks down here in Legislation Land to know they have another person joining the fight!!