FDA comment deadline tonight for smokeless tobacco warnings

[Bill Godshall]

Tonight is the deadline for submitting comments to FDA suggesting improvements for smokeless tobacco product warnings.
Regulations.gov


Please urge FDA to eliminate the three false and misleading fear mongering warnings that have been required on smokeless tobacco products since 1986 (for the reasons provided below).

"This product is not a safe alternative to cigarettes."
Has deceived Americans to inaccurately believe smokeless tobacco products are as hazardous as cigarettes, even though scientific evidence indicates that smokeless products are 99% less hazardous than cigarettes.

"This product can cause mouth cancer."
Has deceived Americans to inaccurately believe smokeless tobacco products are the leading cause of mouth cancer in men, even though scientific evidence indicates that smoking is a far greater risk factor for mouth cancer, causing 75% of male mouth cancer deaths in the US.

"This product can cause gum disease and tooth loss."
There is no scientific evidence that smokeless tobacco causes tooth loss, or gum disease (which is a layman's term for periodontal disease).


Another recently required warning on smokeless tobacco products (required in 2009) should be kept because it correctly states
"Smokeless tobacco is addictive."

 

[Fiamma]

Tonight is the deadline for submitting comments to FDA suggesting improvements for smokeless tobacco product warnings.
Regulations.gov


Please urge FDA to eliminate the three false and misleading fear mongering warnings that have been required on smokeless tobacco products since 1986 (for the reasons provided below).

"This product is not a safe alternative to cigarettes."
Has deceived Americans to inaccurately believe smokeless tobacco products are as hazardous as cigarettes, even though scientific evidence indicates that smokeless products are 99% less hazardous than cigarettes.

"This product can cause mouth cancer."
Has deceived Americans to inaccurately believe smokeless tobacco products are the leading cause of mouth cancer in men, even though scientific evidence indicates that smoking is a far greater risk factor for mouth cancer, causing 75% of male mouth cancer deaths in the US.

"This product can cause gum disease and tooth loss."
There is no scientific evidence that smokeless tobacco causes tooth loss, while "gum disease" isn't actually a disease.


Another recently required warning on smokeless tobacco products (required in 2009) should be kept because it correctly states
"Smokeless tobacco is addictive."

Comments in.

 

[Bill Godshall]

My comments submitted to FDA are below. [Comment Tracking Number: 1jx-84jc-9jmj] Others are encouraged to copy, excerpt and/or paraphrase my comments, and send them to FDA's docket before Midnite tonight.


Food and Drug Administration

[Docket ID: FDA-2012-N-1032]

Smokeless Tobacco Product Warning Statements; Request for Comments and Scientific Evidence

April 1, 2013

Comments Submitted
by
William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
FAX 351-5881
SMOKEFREE@COMPUSERVE.COM

William T. Godshall, MPH is founder and executive director of Smokefree Pennsylvania, a nonprofit organization that since 1990 has been advocating local, state and federal policies to ban smoking in workplaces, reduce tobacco marketing to youth, hold cigarette companies accountable in civil litigation, increase cigarette tax rates, fund tobacco education and smoking cessation services, inform smokers that smokefree tobacco/ nicotine products are far less hazardous alternatives to cigarettes, and ensure that smokefree alternatives remain legal and affordable to smokers. In 2007, we convinced Sen. Mike Enzi to amend to FSPTCA to require graphic warnings on cigarette packs.

For disclosure, neither William Godshall nor Smokefree Pennsylvania has received any funding from any tobacco company or trade association.

Executive Summary

Based upon extensive and consistent scientific evidence, Smokefree Pennsylvania strongly urges the FDA to eliminate three mandatory warnings on smokeless tobacco packages because they are false and/or misleading fear mongering propaganda.
“This product is not a safe alternative to cigarettes.”
“This product can cause mouth cancer.”
“This product can cause gum disease and tooth loss.”

Since the vast majority of Americans inaccurately believe that smokeless tobacco is as hazardous as cigarettes, the FDA should require a new warning like or similar to one proposed by RJ Reynolds in a Citizens Petition to the FDA that truthfully states: “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”

Since smokeless tobacco can cause daily dependence, Smokefree Pennsylvania urges the FDA to keep the FSPTCA required warning that states: “Smokeless tobacco is addictive.”


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 by correcting or simply eliminating three warnings on smokeless tobacco products that were mandated by Congress in the 1986 Comprehensive Smokeless Tobacco Education Act, and were mandated again by the 2009 FSPTCA.

More than 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 comprehensive 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 studies published between 2006 and 2011 on the health risks of smokeless tobacco products, confirmed that smokeless tobacco products marketed in the US and Sweden are far less hazardous than cigarettes, and pose negligible risks of mouth cancer.

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 vast majority of Americans inaccurately believe smokeless tobacco products are just as hazardous as cigarettes.

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 smokeless tobacco (ST) products are far less hazardous alternatives to cigarettes, a 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 propose a regulation to eliminate the currently mandated warning label on smokeless tobacco products that deceptively states “This product is not a safe alternative to cigarettes,” and require a new warning like the one proposed by RJ Reynolds in a Citizens Petition to the FDA that truthfully states “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”

 

[Bill Godshall]

Comment to FDA (Part II)


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 can cause mouth cancer.”

A 2008 meta analysis of smokeless tobacco use and periodontal diseases at
http://www.biomedcentral.com/1472-6831/8/13 and another 2011 study at http://www.ncbi.nlm.nih.gov/pubmed/21762421 found that Swedish snus poses far fewer risks of periodontal disease and tooth loss than are posed by cigarette smoking, and that snus poses risks far more similar to those found in never-tobacco-users.

A comprehensive literature search for research on smokeless tobacco use and tooth loss found no published studies, indicating there is no evidence smokeless tobacco use can cause tooth loss..

Therefore, the FDA also should propose a regulation to eliminate the 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 inaccurate and misleading mandatory warnings on smokeless tobacco products.


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 many tobacco harm reduction opponents continue to falsely 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, http://tobaccodocuments.org/pm/2045600026-0045.html


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. http://www.cdc.gov/mmwr/preview/mmwrhtml/00020232.htm
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
http://ntr.oxfordjournals.org/content/early/2010/07/09/ntr.ntq105.full.pdf+html

A 2011 study at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3118776/?tool=pubmed 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.”

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. http://tc.bmjjournals.com/cgi/searc...nce&author1=&fulltext=&volume=12&firstpage=34


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 inhumane and unethical public health malpractice.

FDA (and other DHHS agencies) Should Correct or Clarify ALL 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.”
http://www.fda.gov/TobaccoProducts/ResourcesforYou/ucm255658.htm

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

http://www.fda.gov/TobaccoProducts/ResourcesforYou/ucm255658.htm
http://betobaccofree.hhs.gov/about-tobacco/Smoked-Tobacco-Products/index.html
http://betobaccofree.hhs.gov/about-tobacco/tobacco-and-nicotine/index.html
http://betobaccofree.hhs.gov/about-tobacco/smokeles- tobacco/index.html
http://betobaccofree.hhs.gov/health-effects/smokeless-health/index.html
http://betobaccofree.hhs.gov/about-tobacco/tobacco-and-nicotine/index.html

 

[RosaJ]

Thank you again Bill for posting and also allowing us to copy your comment. My comment number is 1jx-84je-7e08.

 

[Paulette]

Bill, thank you again and again and again for all you do for us and others that use other smokeless tobacco products.

Speaking (via e-mail) with a female vendor the other day about all you do for us, she said: "I love Bill Godshall and I want to have his baby." Needless to say, I laughed right out loud with no one home!

 

[Vocalek]

CASAA's comment:

The Consumer Advocates for Smoke-free Alternatives Association (CASAA) submits the following comment on Docket FDA–2012–N–1032, Smokeless Tobacco Product Warning Statements: Request for Comments and Scientific Evidence.

The most fundamental tenet of health ethics -- that individuals have a right to informed autonomous choices about their own health -- requires allowing such choices. The use of appropriate warning labels furthers that goal. By contrast, the use of manipulation or disinformation under the guise of providing information or legitimate warnings is contrary to the public interest and is grossly unethical. Even if manipulating consumer behavior is considered an acceptable policy goal, doing so by misleading consumers absolutely cannot be justified.

Thus, it is our position that for any warning label to be ethical and in the public interest, it must move consumers closer to an understanding of the scientific truth. An ostensible warning that is designed to move consumers further from such understanding is a gross violation of health ethics and the public trust.

For purposes of this statement, we focus on the proven low-risk forms of smokeless tobacco, Swedish-style moist snuff (typically identified by the Swedish word, snus), American-style moist snuff, and American-style chewing tobacco. Collectively we refer to these as “ST.” We do not attempt to address rare niche products (e.g., dry oral snuff, nasal snuff) for which there is not such clear evidence and which are of minor importance for tobacco harm reduction.

Conditions that must be met by any warning label
There are two conditions that are most important for any ST warning labels: They must be honest and they must not discourage smokers from switching to these much lower risk products.

The requirement of honesty is both a moral and legal obligation of US government agencies. Honesty does not merely mean that a statement can be interpreted in a way that is literally true; it is very easy for someone who wants to lie to do so without writing any statement that is absolutely literally false. Honesty means that the message communicated to most readers is a truthful one. Three of the current four warning statements are not honest. By exaggerating the level of risk associated with use of ST, the government discourages smokers from switching to ST, but also fails to convey the equally important message that switching from ST to smoking will greatly increase health risks.

Misleading current warning labels
The current warnings that ST “can cause mouth cancer” and “can cause gum disease” could be considered literally true because, given what we know about ST and these diseases, is possible to envision a way in which they can cause cancer. That makes these statements literally true in the liar’s sense of “true.”

However the epidemiologic research on modern American smokeless tobacco products, taken as a whole (i.e., not cherry-picked to find the occasional outlier result) does not support the claim that ST causes these diseases. Moreover, it actively supports the conclusion that if it does cause these diseases, it does so at a trivial rate.

The statements are clearly intended to convey the influential and scary message that ST “has been shown to cause these diseases at a nontrivial rate, and therefore it stands a nontrivial chance of causing them in you.”

In fact, the Swedish government acted to remove the oral cancer warning from smokeless tobacco because it agreed that the evidence did not support the claim. While it is popular among non-experts to assert that American ST poses higher oral cancer risk than Swedish ST, there is actually no scientific evidence to support that claim. When anti-ST activists want to mislead people into thinking otherwise, they appeal to a single study from the 1970s of an odd form of US tobacco (the dry oral snuff that used to be somewhat popular in rural Appalachia), but even if that old result was accurate, it has no relevance to today’s products.

Considerably more troubling, however, is the current warning, “This product is not a safe alternative to cigarettes.” Since nothing under the sun is “safe” -- anything poses some chance of causing a bad outcome -- this is literally true. It would be equally true to say that using pharmaceutical products or eating apples is not a "safe" alternative to cigarettes. But, once again, this statement is true only in the liar’s sense: The average person reads that statement as saying “ST is about as harmful as cigarettes.” Extensive research on people’s perceptions confirms this. Therefore this message is the worst offender when it comes to (i) discouraging smokers from switching to this much less hazardous alternative and (ii) doing nothing to discourage ST users from taking up smoking.

Non-helpful warning label
(We do not consider the “addictive” warning to be either false or true since the word “addictive” has no accepted definition in either science or medicine. Rather, it has “I know it when I see it” type definitions that are necessarily idiosyncratic. As such, we believe that it is inappropriate to use this word in any formal claim in any context, just as it would be inappropriate to use an equally vague and subjective claim like “this product will make you ugly." But since this message may not convey a clearly false message to most readers, unlike the other three, we find it less objectionable.)

Given how grossly misleading the current warning labels are, it is quite clear that, from the perspectives of improving public health and the ethics of our government’s behavior, eliminating all warning labels would represent an improvement over the current messages.

Assessment of warning labels
The measure of the accuracy and propriety of a warning label is whether it moves consumers’ understanding closer to the scientific truth and provides information to allow consumers to make informed decisions. It is not whether the warning manipulates people into behaving the way a particular political faction wants them to behave -- in particular whether it simply increases the perception of the health risks from the products and thus reduces consumption. FDA’s warning labels on drugs, as with all safety warnings on machinery and equipment and all manner of other warnings, are not designed to minimize the interest in using the products by anyone under any circumstances. If there were popular will to try to prevent any American from using ST under any circumstances, we would have a ban on the products. The proper measure of a warning label is not whether it tends to substitute for that non-existent ban, but whether it generates accurate knowledge about, and rational consideration of, the risks.

Suggested warning labels
Though the elimination of the warning labels would be a huge improvement by any legitimate measure, we realize that is not a possibility. In fact, there are several ways in which the warning labels could actually be more honest and health-promoting than the absence of warnings.

The most important feature of honest and health-promoting warning labels is an explicit comparison to the risk from smoking. Warning labels are supposed to inform people about something they do not know. Currently, popular perception of the health risk from ST is that it is orders of magnitude higher than what the science shows the actual risk to be. Thus any label that tends to increase the perceived risk is further misleading people rather than warning them.

The warning labels concerning mouth cancer and gum disease/tooth loss could more accurately portray the health risks if they were changed as follows:

“WARNING: Cigarette smoking is more likely to cause mouth cancer than this product.”

“WARNING: Cigarette smoking is more likely to cause gum disease and tooth loss than this product.”

The “not a safe alternative” label could be made less likely to discourage smokers from switching to ST and more likely to discourage ST users from switching to cigarettes. Changing the wording as follows might accomplish this as well as convey a more accurate assessment of safety:
“WARNING: Although lower in risk than cigarettes, this product is not 100% safe.
The FDA’s warning labels on prescription drugs that are controlled substances, ostensibly due to abuse potential, do not use the word “addictive.” For example: WARNING: Methylphenidate can be habit-forming. There is no reason to use stronger language on the warning labels for tobacco products. The revised label would read as follows:

“WARNING: Smokeless tobacco may be habit-forming.”

Respectfully submitted,


Carl V. Phillips, PhD, Science Director
The Consumer Advocates for Smoke-free Alternatives Association
Washington DC Area Office
8094 Rolling Rd. #200
Springfield VA 22153
(202) 241-9117

List of Attachments: Evidence that current ST warning labels may be hazardous to health

Attachment 1: Lund & Scheffels 2012

“Harm reduction with respect to tobacco use implies informing the public about less harmful tobacco or nicotine products and working toward increased use of safer tobacco or nicotine products at the expense of the more hazardous alternatives.”

Lund I, Scheffels J. Perceptions of the relative harmfulness of snus among Norwegian general practitioners and their effect on the tendency to recommend snus in smoking cessation. Nicotine Tob Res. 2012 Feb;14(2):169-75.

Attachment 2: Lund 2012

“Conclusion: Devising a way to inform smokers about the risk continuum of tobacco products could be an important research priority in countries where snus is allowed to compete with cigarettes for market share.”

Lund KE. Association Between Willingness to Use Snus to Quit Smoking and Perception of Relative Risk Between Snus and Cigarettes. Nicotine Tob Res. 2012 Oct;14(10):1221-8.

Attachment 3: Lee & Hamling 2009

“Conclusion: An increased risk of oropharyngeal cancer is evident most clearly for past smokeless tobacco use in the USA, but not for Scandinavian snuff. Effects of smokeless tobacco use on other cancers are not clearly demonstrated. Risk from modern products is much less than for smoking.”

Lee PN, Hamling J. Systematic review of the relation between smokeless tobacco and cancer in Europe and North America. BMC Medicine 2009, 7:36.

Attachment 4: Benowitz 2010

“The lack of increase in common cancers in lifelong ST users indicates that nicotine is not a general cancer promoter.”

Benowitz NL. Smokeless Tobacco and Disease: Evidence Related to Long-term Safety of Nicotine. FDA Workshop: Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products. 2010 Oct 16.

Attachment 5: Phillips et al 2005

“RESULTS: We found that when any substantive information about the risk from ST is given, the risk is almost universally conflated with the risk from cigarettes. Accurate comparative risk information was quite rare, provided by only a handful of websites, all appearing low in our search results (i.e., of low popularity and thus unlikely to be found by someone searching for information). About 1/3 of the websites, including various authoritative entities, explicitly claimed that ST is as bad as or worse than cigarettes.”

Phillips CV, Wang C, Guenzel B.You might as well smoke; the misleading and harmful public message about smokeless tobacco. BMC Public Health. 2005 Apr 5;5:31.

Attachment 6: Foulds et al 2003

“Conclusions: Snus availability in Sweden appears to have contributed to the unusually low rates of smoking among Swedish men by helping them transfer to a notably less harmful form of nicotine dependence.”

Foulds J, Ramstrom L, Burke M, Fagerström K. Effect of smokeless tobacco (snus) on smoking and public health in Sweden. Tob Control. 2003 Dec;12(4).