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The following comments by William T. Godshall, MPH, and Smokefree Pennsylvania are submitted to the Food and Drug Administration (FDA) tobacco Product Scientific Advisory Committee (TPSAC) for its January 18-20, 2012 meeting and its forthcoming study and report on dissolvable tobacco products. Submitted January 3, 2012.
Legal and Regulatory Scope of Dissolvable tobacco Products
Pursuant to Judge Richard Leon’s ruling in the Sottera, Inc v FDA at https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54 and the FDA’s April, 25, 2011 statement agreeing to comply with Judge Leon’s ruling at
Regulation of E-Cigarettes and Other Tobacco Products any product containing nicotine that is intended for human consumption can be marketed as a tobacco product as long as the manufacturer or importer makes no therapeutic claim.
Therefore, the TPSAC should consider ALL dissolvable tobacco and nicotine products, including Nicotine Replacement Therapy (NRT) products, in its forthcoming study and report on dissolvable tobacco products.
Since the FDA notified Star Scientific, Inc. in March, 2011 that Chapter IX of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) http://frwebgate.access.gpo.gov/cgi...=111_cong_public_laws&docid=f:publ031.111.pdf doesn’t apply to two of the company’s dissolvable tobacco products [Ariva-BDL and Stonewall-BDL] (presumably because they don’t meet the definition of a smokeless tobacco product)
Two tobacco products free of FDA oversight | JournalNow.com, since dissolvable nicotine products also probably don’t meet the definition of a smokeless tobacco product, and because other dissolvable tobacco products may not meet the definition of a smokeless tobacco product, it would be wise for the TPSAC to realize that Chapter IX of the FSPTCA may not apply to some/many/most/all dissolvable tobacco products.
Dissolvable Tobacco Products are Similar to Dissolvable NRT Products
At the FDA’s 2010 workshop entitled: Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products; Public Workshop
Regulations.gov
many presenters and commenters (including two TPSAC members) cited the similarities between Swedish snus and NRT products in suggesting that Swedish snus studies be considered for evaluating the long term risks and benefits of NRT usage (since longterm studies on NRT aren’t available because the products have only been on the market for several decades).
Since dissolvable tobacco products have been on the market for the past decade, and since these products also closely resemble Swedish snus, the TPSAC should also consider research on Swedish snus in evaluating dissolvable tobacco products.
A 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 (Appendix A)
Another 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 (Appendix B)
Another more recent study by Stepanov et al similarly found that new dissolvable tobacco products marketed by RJ Reynolds (i.e. Camel Orbs, Strips and Sticks) contain very low levels of tobacco specific nitrosamines, while nicotine levels vary.
Monitoring Tobacco-Specific N-Nitrosamines and Nicotine in Novel Marlboro and Camel Smokeless Tobacco Products: Findings From Round 1 of the New Product Watch;
Irena Stepanov et al, Nicotine & Tobacco Research, doi10.1093/ntr/ntr209
(Appendix C)
Dissolvable tobacco products appear to be even more similar to dissolvable NRT lozenges than they are to Swedish Snus. In their 2001 Citizen Petition urging the FDA declare and regulate Star’s Ariva as a drug (instead of as a tobacco product), the National Center for Tobacco Free Kids (CTFK), American Cancer Society (ACS), American Heart Association (AHA), American Legacy Foundation (ALF) and others argued that Star’s Ariva was strikingly similar to NRT products that are approved by the FDA to be marketed as smoking cessation aids.
ALL Smokefree Tobacco Products Marketed in the U.S. and Sweden are Far Less Hazardous Alternatives to Cigarettes
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 NRT products are 1 and cigarettes are 100), smokefree tobacco products are below 2.
Nearly five years, two comprehensive evaluations of epidemiology research confirmed that smokeless tobacco products 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 (Appendix D)
Harm reduction in nicotine addiction; Helping people who can't quit, Royal College of Physicians, 2007.
http://www.rcplondon.ac.uk/pubs/contents/e226ee0c-ccef-4dba-b62f-86f046371dfb.pdf
Brad Rodu recently wrote an updated review of the scientific evidence for tobacco harm reduction published from 2006 to 2011, which corroborates and provides significantly more evidence that smokeless tobacco products in America and Sweden are far less hazardous than cigarettes, and that many smokers have quit smoking or have significantly reduced cigarette consumption by substituting smokefree tobacco alternatives.
The scientific foundation for tobacco harm reduction, 2006-2011; Brad Rodu, Harm Reduction Journal 2011, 8:19.
http://www.harmreductionjournal.com/content/pdf/1477-7517-8-19.pdf (Appendix E)
Authors of a recent comprehensive 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.”
“Some meta-analyses suggest a possible effect for oesophagus, pancreas, larynx and kidney cancer, but other cancers show no effect of smokeless tobacco. Any possible effects are not evident in Scandinavia. Of 142,205 smoking-related male US cancer deaths in 2005, 104,737 are smoking-attributable. 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
A previous meta analysis of smokeless tobacco similarly found that the use of smokeless tobacco products pose far fewer cancer risks than does cigarette smoking.
Smokeless tobacco and cancer, Boffetta P, Hecht S, Gray N, Gupta P, Straif K, Lancet Oncol, 2008 Jul;9(7):667-75.
Smokeless tobacco and cancer. [Lancet Oncol. 2008] - PubMed - NCBI
Another recently published 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 meta analysis of 11 studies found that snus use was associated with slightly elevated risk of fatal myocardial infarction and fatal stroke, but wasn’t 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
Legal and Regulatory Scope of Dissolvable tobacco Products
Pursuant to Judge Richard Leon’s ruling in the Sottera, Inc v FDA at https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54 and the FDA’s April, 25, 2011 statement agreeing to comply with Judge Leon’s ruling at
Regulation of E-Cigarettes and Other Tobacco Products any product containing nicotine that is intended for human consumption can be marketed as a tobacco product as long as the manufacturer or importer makes no therapeutic claim.
Therefore, the TPSAC should consider ALL dissolvable tobacco and nicotine products, including Nicotine Replacement Therapy (NRT) products, in its forthcoming study and report on dissolvable tobacco products.
Since the FDA notified Star Scientific, Inc. in March, 2011 that Chapter IX of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) http://frwebgate.access.gpo.gov/cgi...=111_cong_public_laws&docid=f:publ031.111.pdf doesn’t apply to two of the company’s dissolvable tobacco products [Ariva-BDL and Stonewall-BDL] (presumably because they don’t meet the definition of a smokeless tobacco product)
Two tobacco products free of FDA oversight | JournalNow.com, since dissolvable nicotine products also probably don’t meet the definition of a smokeless tobacco product, and because other dissolvable tobacco products may not meet the definition of a smokeless tobacco product, it would be wise for the TPSAC to realize that Chapter IX of the FSPTCA may not apply to some/many/most/all dissolvable tobacco products.
Dissolvable Tobacco Products are Similar to Dissolvable NRT Products
At the FDA’s 2010 workshop entitled: Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products; Public Workshop
Regulations.gov
many presenters and commenters (including two TPSAC members) cited the similarities between Swedish snus and NRT products in suggesting that Swedish snus studies be considered for evaluating the long term risks and benefits of NRT usage (since longterm studies on NRT aren’t available because the products have only been on the market for several decades).
Since dissolvable tobacco products have been on the market for the past decade, and since these products also closely resemble Swedish snus, the TPSAC should also consider research on Swedish snus in evaluating dissolvable tobacco products.
A 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 (Appendix A)
Another 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 (Appendix B)
Another more recent study by Stepanov et al similarly found that new dissolvable tobacco products marketed by RJ Reynolds (i.e. Camel Orbs, Strips and Sticks) contain very low levels of tobacco specific nitrosamines, while nicotine levels vary.
Monitoring Tobacco-Specific N-Nitrosamines and Nicotine in Novel Marlboro and Camel Smokeless Tobacco Products: Findings From Round 1 of the New Product Watch;
Irena Stepanov et al, Nicotine & Tobacco Research, doi10.1093/ntr/ntr209
(Appendix C)
Dissolvable tobacco products appear to be even more similar to dissolvable NRT lozenges than they are to Swedish Snus. In their 2001 Citizen Petition urging the FDA declare and regulate Star’s Ariva as a drug (instead of as a tobacco product), the National Center for Tobacco Free Kids (CTFK), American Cancer Society (ACS), American Heart Association (AHA), American Legacy Foundation (ALF) and others argued that Star’s Ariva was strikingly similar to NRT products that are approved by the FDA to be marketed as smoking cessation aids.
ALL Smokefree Tobacco Products Marketed in the U.S. and Sweden are Far Less Hazardous Alternatives to Cigarettes
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 NRT products are 1 and cigarettes are 100), smokefree tobacco products are below 2.
Nearly five years, two comprehensive evaluations of epidemiology research confirmed that smokeless tobacco products 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 (Appendix D)
Harm reduction in nicotine addiction; Helping people who can't quit, Royal College of Physicians, 2007.
http://www.rcplondon.ac.uk/pubs/contents/e226ee0c-ccef-4dba-b62f-86f046371dfb.pdf
Brad Rodu recently wrote an updated review of the scientific evidence for tobacco harm reduction published from 2006 to 2011, which corroborates and provides significantly more evidence that smokeless tobacco products in America and Sweden are far less hazardous than cigarettes, and that many smokers have quit smoking or have significantly reduced cigarette consumption by substituting smokefree tobacco alternatives.
The scientific foundation for tobacco harm reduction, 2006-2011; Brad Rodu, Harm Reduction Journal 2011, 8:19.
http://www.harmreductionjournal.com/content/pdf/1477-7517-8-19.pdf (Appendix E)
Authors of a recent comprehensive 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.”
“Some meta-analyses suggest a possible effect for oesophagus, pancreas, larynx and kidney cancer, but other cancers show no effect of smokeless tobacco. Any possible effects are not evident in Scandinavia. Of 142,205 smoking-related male US cancer deaths in 2005, 104,737 are smoking-attributable. 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
A previous meta analysis of smokeless tobacco similarly found that the use of smokeless tobacco products pose far fewer cancer risks than does cigarette smoking.
Smokeless tobacco and cancer, Boffetta P, Hecht S, Gray N, Gupta P, Straif K, Lancet Oncol, 2008 Jul;9(7):667-75.
Smokeless tobacco and cancer. [Lancet Oncol. 2008] - PubMed - NCBI
Another recently published 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 meta analysis of 11 studies found that snus use was associated with slightly elevated risk of fatal myocardial infarction and fatal stroke, but wasn’t 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