FDA Seeks Comments in Changes to Smokeless Health Warnings
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This is the only step forward FDA has made on tobacco harm reduction since the agency began regulating tobacco products in 2009, and this provides THR advocates with yet another opportunity to submit comments to the FDA pointing out that all smokefree tobacco/nicotine products are far less hazardous alternatives than cigarettes, that millions of smokers in US and Sweden have already switched to smokeless tobacco, and that millions more smokers would be likely to switch if the FDA simply stopped deceiving smokeless tobacco consumers (and the public) to believe that smokeless tobacco is as hazardous as cigarettes.
This is also the first time (that I'm aware of) that FDA has established a docket and invited public comments on something that wasn't required by the FSPTCA. In other words, the FDA has established this docket and invited public comments on smokeless tobacco warnings because RJR, me and others have repeatedly urged the agency to eliminate the "This product is not a safe alternative to cigarettes" mandatory warnings.
Below is an excerpt of my submitted testimony to FDA on Section 918 that urges FDA to eliminate the three inaccurate and misleading mandatory warnings on smokeless tobacco products (I support the newly mandated warning stating that smokeless tobacco is addictive).
Anyone may copy, rephrase, or borrow any information (in my testimony below) and submit it to the FDA's new docket on smokeless tobacco product warnings.
Smokefree Tobacco/Nicotine Products Are Far Less Hazardous Alternatives to Cigarettes
To improve consumer and public health, it is critically important for the FDA to stop protecting cigarettes from market competition by far less hazardous smokefree alternatives, to correct or clarify FDA’s many inaccurate and misleading claims about low risk smokefree tobacco and nicotine alternatives, and to keep all smokefree alternatives legal and affordable for smokers.
>99% of all tobacco attributable mortality and health care costs in the US are caused by repeated inhalation of tobacco smoke, while <1% are caused by the use of noncombustible tobacco and nicotine products. Epidemiological evidence indicates that cigarettes are at least 100 times more hazardous than smokefree nicotine and tobacco products marketed in the US, including smokeless tobacco, electronic cigarettes and NRT products.
While cigarettes and smokefree tobacco products are similarly addictive (i.e. creating daily dependence), published epidemiology research finds that daily cigarette smoking imposes about 100 times greater mortality risks than does daily use of smokefree tobacco products marketed in the U.S. and Sweden. On a continuum of tobacco mortality risk from 1 to 100 (whereby Nicotine Replacement Products are 1 and cigarettes are 100), smokefree tobacco products are below 2.
In 2006, I coauthored a comprehensive evaluation of epidemiology research on smokeless tobacco products, which found that smokeless tobacco products used in the U.S. and Sweden are exponentially less hazardous than cigarette smoking, and recommended that smokers be provided with truthful information about the comparable health risks of different tobacco products and encouraged to switch to smokefree tobacco alternatives if they cannot or don’t want to quit using tobacco.
Tobacco harm reduction: an alternative cessation strategy for inveterate smokers, Brad Rodu and William T Godshall, Harm Reduction Journal 2006, 3:37doi:10.1186/1477-7517-3-37. HRJ | Full text | Tobacco harm reduction: an alternative cessation strategy for inveterate smokers
In 2007, the Royal College of Physicians published a report on the comparable health risks of smokeless tobacco products and cigarettes, that similarly concluded smokeless tobacco products are far less hazardous than cigarettes, and that smokers who cannot or won’t quit tobacco use should be encouraged to switch to smokeless alternatives.
Harm reduction in nicotine addiction; Helping people who can't quit, Royal College of Physicians, 2007.
Publication - Harm reduction in nicotine addiction
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(07)61482-2/fulltext#article_upsell
A comprehensive evaluation of epidemiological research on Swedish snus published in 2007 at http://nzhta.chmeds.ac.nz/publications/smokeless_tobacco.pdf similarly concluded that Swedish snus poses exponentially fewer health risks than cigarettes.
In 2008, the American Association of Public Health Physicians published a white paper at http://www.aaphp.org/Resources/Documents/20081026HarmReductionResolutionAsPassedl.pdft
that evaluated the existing epidemiological research, and similarly concluded that smokeless tobacco products are exponentially less hazardous than cigarettes, and that vast public health gains could be achieved by eliminating the federally required (since 1986) warning on smokeless tobacco products that misleadingly states “This product is not a safe alternative to cigarettes.”
In 2010, the American Association of Public Health Physicians updated the new scientific evidence published since its 2008 white paper at American Association of Public Health Physicians - Tobacco Update
The Tobacco Harm Reduction 2010 yearbook published by TobaccoHarmReduction.org at THR2010. (tobaccoharmreduction.org) similarly evaluated the published research and concluded that the health risks posed by smokeless tobacco products are exponentially fewer than the health risks posed by cigarettes.
At the FDA’s 2010 workshop entitled: Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products; Public Workshop at:
Regulations.gov, many presenters and commenters (including two FDA Tobacco Product Scientific Advisory Committee members) cited the strikingly similar health risk and benefit profiles between Swedish snus and Nicotine Replacement Therapy (NRT) gums and lozenges when recommending FDA approve longterm usage of NRT products (since epidemiology studies on NRT aren’t available because the products have only been on the market for several decades).
A report by the American Council on Science and Health and Brad Rodu The Scientific Foundation for Tobacco Harm Reduction, 2006-2011 at
http://www.harmreductionjournal.com/content/pdf/1477-7517-8-19.pdf evaluated all published studies (during the past five years) on the health risks of smokeless tobacco products, confirmed that they are far less hazardous than cigarettes, and that increasingly more smokers have quit smoking by switching to smokeless tobacco alternatives.
Authors of a published meta analysis of North American and European epidemiological cohort and case-control studies relating any form of cancer to smokeless tobacco use (i.e. 62 US and 18 Scandinavian studies) reported the following results:
“Random-effects meta-analysis estimates for most sites showed little association. Smoking-adjusted estimates were only significant for oropharyngeal cancer (1.36, CI 1.04–1.77, n = 19) and prostate cancer (1.29, 1.07–1.55, n = 4). The oropharyngeal association disappeared for estimates published since 1990 (1.00, 0.83–1.20, n = 14), for Scandinavia (0.97, 0.68–1.37, n = 7), and for alcohol-adjusted estimates (1.07, 0.84–1.37, n = 10). Any effect of current US products or Scandinavian snuff seems very limited. The prostate cancer data are inadequate for a clear conclusion.” and “Smokeless tobacco-attributable deaths would be 1,102 (1.1%) if as many used smokeless tobacco as had smoked, and 2,081 (2.0%) if everyone used smokeless tobacco.”
Systematic review of the relation between smokeless tobacco and cancer in Europe and North America, Peter N Lee and Jan Hamling, BMC Medicine 2009, 7:36doi:10.1186/1741-7015-7-36
BMC Medicine | Full text | Systematic review of the relation between smokeless tobacco and cancer in Europe and North America
Another comprehensive meta analyses of 150 studies on various diseases found no association with snus use and cancer of the oropharynx (meta-analysis RR 0.97, 95% CI 0.68-1.37), oesophagus (1.10, 0.92-1.33), stomach (0.98, 0.82-1.17), pancreas (1.20, 0.66-2.20), lung (0.71, 0.66-0.76) or other sites, or with heart disease (1.01, 0.91-1.12) or stroke (1.05, 0.95-1.15). The author concluded: “Using snus is clearly much safer than smoking. While smoking substantially increases the risk of cancer and cardiovascular diseases, any increase from snus use is undemonstrated, and if it exists is probably about 1% of that from smoking.”
Summary of the epidemiological evidence relating snus to health, Peter N Lee, Regul Toxicol Pharmacol 2011, Mar, 59(2):197-214 Summary of the epidemiological evide... [Regul Toxicol Pharmacol. 2011] - PubMed - NCBI
A previously published and widely reported meta analysis of 11 studies found that snus use was associated with slightly elevated risk of fatal myocardial infarction and fatal stroke, but was NOT associated with all myocardial infarctions or strokes, casting doubt on its findings about fatal heart attacks and strokes.
Use of smokeless tobacco and risk of myocardial infarction and stroke: systematic review with meta-analysis, Paulo Boffetta, Kurt Straif, BMJ 2009; 339:b3060
Use of smokeless tobacco and risk of myocardial infarction and stroke: systematic review with meta-analysis | BMJ
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 is 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 cause 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.”
This is also the first time (that I'm aware of) that FDA has established a docket and invited public comments on something that wasn't required by the FSPTCA. In other words, the FDA has established this docket and invited public comments on smokeless tobacco warnings because RJR, me and others have repeatedly urged the agency to eliminate the "This product is not a safe alternative to cigarettes" mandatory warnings.
Below is an excerpt of my submitted testimony to FDA on Section 918 that urges FDA to eliminate the three inaccurate and misleading mandatory warnings on smokeless tobacco products (I support the newly mandated warning stating that smokeless tobacco is addictive).
Anyone may copy, rephrase, or borrow any information (in my testimony below) and submit it to the FDA's new docket on smokeless tobacco product warnings.
Smokefree Tobacco/Nicotine Products Are Far Less Hazardous Alternatives to Cigarettes
To improve consumer and public health, it is critically important for the FDA to stop protecting cigarettes from market competition by far less hazardous smokefree alternatives, to correct or clarify FDA’s many inaccurate and misleading claims about low risk smokefree tobacco and nicotine alternatives, and to keep all smokefree alternatives legal and affordable for smokers.
>99% of all tobacco attributable mortality and health care costs in the US are caused by repeated inhalation of tobacco smoke, while <1% are caused by the use of noncombustible tobacco and nicotine products. Epidemiological evidence indicates that cigarettes are at least 100 times more hazardous than smokefree nicotine and tobacco products marketed in the US, including smokeless tobacco, electronic cigarettes and NRT products.
While cigarettes and smokefree tobacco products are similarly addictive (i.e. creating daily dependence), published epidemiology research finds that daily cigarette smoking imposes about 100 times greater mortality risks than does daily use of smokefree tobacco products marketed in the U.S. and Sweden. On a continuum of tobacco mortality risk from 1 to 100 (whereby Nicotine Replacement Products are 1 and cigarettes are 100), smokefree tobacco products are below 2.
In 2006, I coauthored a comprehensive evaluation of epidemiology research on smokeless tobacco products, which found that smokeless tobacco products used in the U.S. and Sweden are exponentially less hazardous than cigarette smoking, and recommended that smokers be provided with truthful information about the comparable health risks of different tobacco products and encouraged to switch to smokefree tobacco alternatives if they cannot or don’t want to quit using tobacco.
Tobacco harm reduction: an alternative cessation strategy for inveterate smokers, Brad Rodu and William T Godshall, Harm Reduction Journal 2006, 3:37doi:10.1186/1477-7517-3-37. HRJ | Full text | Tobacco harm reduction: an alternative cessation strategy for inveterate smokers
In 2007, the Royal College of Physicians published a report on the comparable health risks of smokeless tobacco products and cigarettes, that similarly concluded smokeless tobacco products are far less hazardous than cigarettes, and that smokers who cannot or won’t quit tobacco use should be encouraged to switch to smokeless alternatives.
Harm reduction in nicotine addiction; Helping people who can't quit, Royal College of Physicians, 2007.
Publication - Harm reduction in nicotine addiction
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(07)61482-2/fulltext#article_upsell
A comprehensive evaluation of epidemiological research on Swedish snus published in 2007 at http://nzhta.chmeds.ac.nz/publications/smokeless_tobacco.pdf similarly concluded that Swedish snus poses exponentially fewer health risks than cigarettes.
In 2008, the American Association of Public Health Physicians published a white paper at http://www.aaphp.org/Resources/Documents/20081026HarmReductionResolutionAsPassedl.pdft
that evaluated the existing epidemiological research, and similarly concluded that smokeless tobacco products are exponentially less hazardous than cigarettes, and that vast public health gains could be achieved by eliminating the federally required (since 1986) warning on smokeless tobacco products that misleadingly states “This product is not a safe alternative to cigarettes.”
In 2010, the American Association of Public Health Physicians updated the new scientific evidence published since its 2008 white paper at American Association of Public Health Physicians - Tobacco Update
The Tobacco Harm Reduction 2010 yearbook published by TobaccoHarmReduction.org at THR2010. (tobaccoharmreduction.org) similarly evaluated the published research and concluded that the health risks posed by smokeless tobacco products are exponentially fewer than the health risks posed by cigarettes.
At the FDA’s 2010 workshop entitled: Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products; Public Workshop at:
Regulations.gov, many presenters and commenters (including two FDA Tobacco Product Scientific Advisory Committee members) cited the strikingly similar health risk and benefit profiles between Swedish snus and Nicotine Replacement Therapy (NRT) gums and lozenges when recommending FDA approve longterm usage of NRT products (since epidemiology studies on NRT aren’t available because the products have only been on the market for several decades).
A report by the American Council on Science and Health and Brad Rodu The Scientific Foundation for Tobacco Harm Reduction, 2006-2011 at
http://www.harmreductionjournal.com/content/pdf/1477-7517-8-19.pdf evaluated all published studies (during the past five years) on the health risks of smokeless tobacco products, confirmed that they are far less hazardous than cigarettes, and that increasingly more smokers have quit smoking by switching to smokeless tobacco alternatives.
Authors of a published meta analysis of North American and European epidemiological cohort and case-control studies relating any form of cancer to smokeless tobacco use (i.e. 62 US and 18 Scandinavian studies) reported the following results:
“Random-effects meta-analysis estimates for most sites showed little association. Smoking-adjusted estimates were only significant for oropharyngeal cancer (1.36, CI 1.04–1.77, n = 19) and prostate cancer (1.29, 1.07–1.55, n = 4). The oropharyngeal association disappeared for estimates published since 1990 (1.00, 0.83–1.20, n = 14), for Scandinavia (0.97, 0.68–1.37, n = 7), and for alcohol-adjusted estimates (1.07, 0.84–1.37, n = 10). Any effect of current US products or Scandinavian snuff seems very limited. The prostate cancer data are inadequate for a clear conclusion.” and “Smokeless tobacco-attributable deaths would be 1,102 (1.1%) if as many used smokeless tobacco as had smoked, and 2,081 (2.0%) if everyone used smokeless tobacco.”
Systematic review of the relation between smokeless tobacco and cancer in Europe and North America, Peter N Lee and Jan Hamling, BMC Medicine 2009, 7:36doi:10.1186/1741-7015-7-36
BMC Medicine | Full text | Systematic review of the relation between smokeless tobacco and cancer in Europe and North America
Another comprehensive meta analyses of 150 studies on various diseases found no association with snus use and cancer of the oropharynx (meta-analysis RR 0.97, 95% CI 0.68-1.37), oesophagus (1.10, 0.92-1.33), stomach (0.98, 0.82-1.17), pancreas (1.20, 0.66-2.20), lung (0.71, 0.66-0.76) or other sites, or with heart disease (1.01, 0.91-1.12) or stroke (1.05, 0.95-1.15). The author concluded: “Using snus is clearly much safer than smoking. While smoking substantially increases the risk of cancer and cardiovascular diseases, any increase from snus use is undemonstrated, and if it exists is probably about 1% of that from smoking.”
Summary of the epidemiological evidence relating snus to health, Peter N Lee, Regul Toxicol Pharmacol 2011, Mar, 59(2):197-214 Summary of the epidemiological evide... [Regul Toxicol Pharmacol. 2011] - PubMed - NCBI
A previously published and widely reported meta analysis of 11 studies found that snus use was associated with slightly elevated risk of fatal myocardial infarction and fatal stroke, but was NOT associated with all myocardial infarctions or strokes, casting doubt on its findings about fatal heart attacks and strokes.
Use of smokeless tobacco and risk of myocardial infarction and stroke: systematic review with meta-analysis, Paulo Boffetta, Kurt Straif, BMJ 2009; 339:b3060
Use of smokeless tobacco and risk of myocardial infarction and stroke: systematic review with meta-analysis | BMJ
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 is 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 cause 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.”
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- Apr 2, 2009
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There will be an organized campaign by tobacco harm reduction opponents to submit comments to the FDA urging the agency to keep the same deceptive warnings on smokeless tobacco products (as the Tobacco Control Legal Consortium urged many folks to submit comments to RJ Reynolds' Citizens Petition docket urging the FDA to change the intentionally deceptive mandated warning "This product is not a safe alternative to cigarettes" to a warning stating "No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes."
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So ...
Those opposed to harm reduction will submit their lies and junk science
and we submit the truth.
Then the FDA will review everything and since the FDA
is known for truth ... They will, of course, choose to go with
our suggestions.
Those opposed to harm reduction will submit their lies and junk science
and we submit the truth.
Then the FDA will review everything and since the FDA
is known for truth ... They will, of course, choose to go with
our suggestions.
So your advice would be to????
There is a time for cynicism and a time for action. This is certainly a time for action. The misinformation on warning labels on cans of smokeless tobacco has likely contributed to the premature death of millions of smokers who where deceived into believing ST products are just as harmful as smoking. Truthful warnings on smokeless tobacco products would be a major change for the better in the way we approach tobacco products.
My suggestion ??
I'm not making any suggestions...Just posted an opinion based on history.
Nobel cause ... Yes
Faith in the FDA ... Zero
Not all less than favorable observations require
a suggested solution. In this case ... those qualified
should participate in what the FDA is calling for.
We can hope and pray.
Have us submit one message as a group. All of us sign onto that one message, unless we have some disagreement. That could be discussed here, as desired.
Bill's message and cited science work for me.
I'm just curious why more than one of us would be needed to cite the same scientific data if we all are on board with that?
Perhaps this is a question for me to ask of FDA?
I dunno.
- Apr 2, 2009
- 5,171
- 13,288
- 67
Only 10 comments were submitted to the RJ Reynolds' citizen petition docket (that urged FDA to change the "not a safe alternative to cigarettes" warning to "this product presents substantially lower risks to health than cigarettes") at
Regulations.gov
Of the 10 comments, Altria submitted a comment in support of Reynolds' petition, 8 comments submitted by harm reduction opponents opposed Reynolds' petition, and one commenter indicated a lack of support for both the current FDA warning and Reynolds' proposal.
Back in December, the Tobacco Control Legal Consortium issued an alert urging folks to submit comments opposing RJ Reynolds' citizen petition at
http://publichealthlawcenter.org/si...talkingpts-fda-comments-RJR-petition-2012.pdf
Regulations.gov
Of the 10 comments, Altria submitted a comment in support of Reynolds' petition, 8 comments submitted by harm reduction opponents opposed Reynolds' petition, and one commenter indicated a lack of support for both the current FDA warning and Reynolds' proposal.
Back in December, the Tobacco Control Legal Consortium issued an alert urging folks to submit comments opposing RJ Reynolds' citizen petition at
http://publichealthlawcenter.org/si...talkingpts-fda-comments-RJR-petition-2012.pdf
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- Apr 2, 2009
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Jman8 wrote
Because I've submitted very similar comments to the FDA on 8 or 9 different dockets since 2009.
If only one or two people are informing FDA of the truth, the agency doesn't seem to care. But if lots of folks inform the FDA of the truth, the agency is more likely to take corrective action.
That's why it was very important that a half dozen e-cigarette consumers testified at the FDA's Dec 17 hearing, that more than 5,000 e-cigarette consumers submitted comments to FDA, and that nearly 25,000 e-cigarettes have recently signed the online petition to the White House.
Because I've submitted very similar comments to the FDA on 8 or 9 different dockets since 2009.
If only one or two people are informing FDA of the truth, the agency doesn't seem to care. But if lots of folks inform the FDA of the truth, the agency is more likely to take corrective action.
That's why it was very important that a half dozen e-cigarette consumers testified at the FDA's Dec 17 hearing, that more than 5,000 e-cigarette consumers submitted comments to FDA, and that nearly 25,000 e-cigarettes have recently signed the online petition to the White House.
I'd really like the science to speak for itself. If it helps, can I just copy and paste that and present that alone? Or if you have suggestion for something more, I'm willing / listening. My words seem anecdotal to me.
I am working on a CASAA Call to Action for this. As usual, it will provide directions for commenting along with suggestions about what to say. What would be important is for us to be on the same page about how the warnings should be revised (or eliminated if totally untrue.)
The only research that supports the safety of long term use of tobacco/nicotine products has been conducted on smokeless tobacco (ST) products. The research shows that unlike cigarette smoking, ST does not cause cancer, heart attacks, strokes, or lung disease. The existing warning labels hide the truth from smokers.
The only research that supports the safety of long term use of tobacco/nicotine products has been conducted on smokeless tobacco (ST) products. The research shows that unlike cigarette smoking, ST does not cause cancer, heart attacks, strokes, or lung disease. The existing warning labels hide the truth from smokers.
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