I sent the following testimony to the Philadelphia Board of Health today.
City of Philadelphia Board of Health’s Proposed Regulations Regarding Tobacco and Cigarette Informational Signs
August 29, 2011
Testimony
by
William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
FAX 351-5881
smokefree@compuserve.com
Executive Summary
Upon careful analysis, I strongly encourage the Board of Health to reject the proposed Regulations Regarding Tobacco and Cigarette Informational Signs because the proposed Cigarette Informational Signs and the proposed Non-Cigarette Informational Signs that address other smoked tobacco products almost certainly violate the preemption clause of the Federal Cigarette Labeling and Advertising Act, and because smokers, smokeless tobacco consumers and the public already greatly overestimate the known health risks of smokeless tobacco products.
If the Board of Health desires to avoid a federal lawsuit while also informing tobacco consumers and the public about the known health risks of different tobacco products, I encourage the Board of Health to require the Department of Public Health to truthfully inform smokers (via educational materials and messages) that:
- Smokeless tobacco products are far less hazardous alternatives to cigarettes,
- Switching to smokeless tobacco products reduces smoker’s health risks nearly as much as quitting all tobacco use, and
- Millions of smokers have already switched to far less hazardous smokeless tobacco products.
About Smokefree Pennsylvania
Since 1990, Smokefree Pennsylvania has advocated federal, state, local and organizational policies to reduce tobacco smoke pollution indoors, increase cigarette tax rates, reduce tobacco marketing to youth, preserve civil justice remedies for those injured by cigarette smoking, fund tobacco education and smoking cessation programs, inform smokers that smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes, and in 2007 I convinced US Senator Mike Enzi to amend the Family Smoking Prevention and Tobacco Control Act (FSPTCA) to require color graphic warnings on the front of all cigarette packages.
For conflict of interest disclosure, neither William Godshall nor Smokefree Pennsylvania have ever received any direct or indirect funding from any tobacco, drug or electronic cigarette company.
Federal Cigarette Labeling and Advertising Act Preempts
Regulations Regarding Tobacco and Cigarette Informational Signs
Although the proposed Cigarette Informational Signs could further educate smokers and the public about the enormous and many different health risks attributable to cigarette smoking, Section 1334(b) of the Federal Cigarette Labeling and Advertising Act (FCLAA) at
United States Code: Title 15,1334. Preemption | LII / Legal Information Institute
preempts (i.e. prohibits) state (and local) governments from requiring signs “based on smoking and health” “with respect to the advertising or promotion of any cigarettes”.
Last year, federal Judge Jed Rakoff struck down a similar New York City law
Antismoking Poster Law in New York City Is Struck Down - NYTimes.com requiring cigarette retailers to display similar informational signs about the health risks of smoking. Although New York City is appealing Judge Rakoff’s ruling, the appeal is highly unlikely to succeed. Judge Rakoff’s 13 page decision is attached to the e-mail submitting this testimony.
Since the FCLAA almost certainly preempts state and local laws that require cigarette retailers to inform smokers and the public about the health risks of smoking cigarettes (or any other tobacco product), the Board of Health should reject its proposed Regulations Regarding Tobacco and Cigarette Informational Signs.
Smokeless Tobacco Products Pose Very Few Health Risks and are
Exponentially 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 Nicotine Replacement Products are 1 and cigarettes are 100), smokefree tobacco products are below 2.
Nearly five years ago, I coauthored the most 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.
http://www.rcplondon.ac.uk/pubs/contents/e226ee0c-ccef-4dba-b62f-86f046371dfb.pdf
Tobacco smoking, harm reduction, and nicotine product regulation : The Lancet
A recently updated 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 evaluating all published studies (during the past five years) on the health risks of smokeless tobacco products, confirming that they are far less hazardous than cigarettes, and that increasingly more smokers have quit smoking by switching to smokeless tobacco alternatives.
At the FDA’s 2010 workshop entitled: Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products; Public Workshop, 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)
Regulations.gov.
Authors of a recently 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.”
“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
BioMed Central | Full text | Systematic review of the relation between smokeless tobacco and cancer in Europe and North America
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 -- Boffetta and Straif 339 -- bmj.com
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
Millions of smokers have switched to smokefree tobacco products
Switching from cigarettes to smokefree tobacco products has been occurring in the U.S. and in Sweden for many decades, and isn’t an unproven theory (as some harm reduction opponents claim).
The 1986 nationwide Adult Use of Tobacco Survey (AUTS), conducted by the CDC Office on Smoking and Health, found that 7% (i.e., 1.67 million) of male ex-smokers indicated they had used smokeless tobacco (ST) products to help them quit smoking cigarettes, and 6.4% (i.e., 1.63 million) of males who currently smoked indicated using ST to help them quit smoking. In comparison, just 1.7% of male ex-smokers (i.e., 404,600) and 2.4% of males who currently smoked (i.e., 609,000) indicated using organized programs to help them quit smoking cigarettes.
Smokeless Tobacco Use in the United States: The Adult Use of Tobacco Surveys, Novotny, Pierce, Fiore & Davis, NCI Monograph 8, 25-29, NIH, U.S. DHHS, 1989.
A 1984 Philip Morris market research survey of 489 adult male ST product users in Houston, Atlanta, and Florida (who were interviewed outside retail stores after purchasing ST) found that 37% of ST users stated they were former cigarette smokers (including 22% of those under age 35 and 50% of those 35 years or older). The survey also found that, in response to the question, “Did you start using smokeless/chewing tobacco as a replacement for cigarettes, that is, when you stopped smoking cigarettes, or not?” 20% of ST users said YES. These findings were consistent in the three different survey locations. Interestingly, 62% of respondents who used both ST and cigarettes reported that ST was “more enjoyable” than cigarettes.
Smokeless Tobacco Study – Atlanta/Florida, Philip Morris USA Marketing Research Department Report, Miller K,
Marketing Research Department Report Smokeless Tobacco Study - Atlanta / Florida
The 1991 NHIS found that 33.3% (i.e., 1.75 million) of U.S. adult ST users reported being former cigarette smokers, and the 1998 NHIS found that 31.1% of ST users reported being former cigarette smokers. The 1998 NHIS found that 5.8% of daily snuff users reported quitting smoking cigarettes within the past year, that daily snuff users were 3.2 times more likely to report being former cigarette smokers than were never snuff users who had smoked, and that daily snuff users were 4.2 times more likely to have quit smoking in the past year than were never snuff users who had smoked.
Use of Smokeless Tobacco Among Adults – United States, 1991, Morbidity and Mortality Weekly Report, Vol 42, No 14, 263-266, April 16, 1993, CDC, U.S. DHHS.
Use of Smokeless Tobacco Among Adults -- United States, 1991
Tomar S, Snuff Use and Smoking in US Men: Implications for Harm Reduction, American Journal of Preventive Medicine, 2002, Vol. 23, No. 3, 143-149.
The 1987 NHIS found that, among 23-to-34 year old U.S. males, those who had smoked cigarettes and then subsequently used snuff were 2.1 times more likely to have quit smoking than were cigarette-only users.
Most smokeless tobacco use is not a causal gateway to cigarettes: using order of product use to evaluate causation in a national US sample, Kozlowski L, O’Connor, Edwards BQ, Flaherty BP, Addiction, 2003, Vol. 98, 1077-1085.
http://www.blackwell-synergy.com/links/doi/10.1046/j.1360-0443.2003.00460.x/abs
A study of 51 female and 59 male ST users (in the Northwestern U.S.), in which 98% of females and 90% of males were either current or former cigarette smokers, found that 52% of females and 59% of males responded affirmatively when asked whether they used ST in place of cigarettes while quitting smoking.
A comparison of male and female smokeless tobacco use, Cohen-Smith D, Severson H, Nicotine & Tobacco Research, 1999, Vol. 1, 211-218.
Another study found that 72% of an estimated 359,000 U.S. smokers who switched to ST products on their last smoking cessation attempt successfully quit smoking.
Switching to smokefree tobacco as a smoking cessation method: evidence from the 2000 National Health Interview Survey, Brad Rodu and Carl V Phillips, Harm Reduction Journal 2008, 5:18doi:10.1186/1477-7517-5-18.
http://www.harmreductionjournal.com/content/pdf/1477-7517-5-18.pdf
In Sweden, moist oral snuff is called snus. Unlike moist oral snuff commonly used in the U.S., snus is pasteurized, not fermented, and stored in refrigerators from the time of manufacture until sold at retail. Also in contrast to most ST products commonly sold in the U.S. (except for dissolvable ST products), snus is spitfree, contains fewer nitrosamines, and has not been found to be associated with mouth cancer.
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.
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Smokeless tobacco use and increased cardiovascular mortality among Swedish construction workers. Bolinder G, Alfredsson L, Englund A, et al., Am J Public Health 1994, Volume 84, 399-404.
Smoking tobacco, oral snuff and alcohol in the etiology of squamous cell carcinoma of the head and neck. A population based case-referent study in Sweden. Lewin F, Norell SE, Johansson H, et al, 1998, Cancer, Vol. 82, 1367-1375.
Oral snuff, smoking habits and alcohol consumption in relation to oral cancer evaluated in a Swedish case-control study, Schildt E-B, Eriksson M, Hardell L, Magnusson A, 1998, International Journal of Cancer, Vol. 77, 341-346.
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.
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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.
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An international panel of seven experts, using the Delphi approach, estimated that an additional 10% of cigarette smokers would quit over five years if all smokefree tobacco products in the U.S. were required to be low-nitrosamine products and if those products were accompanied by a warning label that stated: “This product is addictive and may increase your risk of disease. This product is substantially less harmful than cigarettes, but abstaining from tobacco use altogether is the safest course of action.”
The potential impact of a low-nitrosamine smokeless tobacco product on cigarette smoking in the United States: Estimates of a panel of experts, Levy D, Mumford E, Cummings KM, et al. ,Addictive Behaviors, Nov. 2005.
http://www.ascribe.org/cgi-in/behold.pl?ascribeid=20051114.171444&time=07 42 PST&year=2005&public=1
Authors of a recent survey of Norwegian men who were either former or current smokers reported: “In a regression model in which education, number of previous attempts to quit smoking, perception of risk, and age were controlled for, the odds ratio (OR) for reporting total abstinence at the time of the survey was significantly higher for those who had used varenicline (OR = 4.95, p < .006) and snus (OR = 2.68, p < .001) compared with those who had used nicotine chewing gum (reference OR = 1).” and “Compared with medicinal nicotine products, snus and varenicline increased the probability of quitting smoking completely”.
The use of snus for quitting smoking compared with medicinal products, Karl Erik Lund, Ann McNeill, Janne Scheffels, Nicotine Tob Res (2010) doi: 10.1093/ntr/ntq105
The use of snus for quitting smoking compared with medicinal products
The Vast Majority of Smokers Inaccurately Believe that
Smokeless Tobacco Products are as Hazardous as Cigarettes
While ST products are far less hazardous alternatives to cigarettes, a recent survey of more than 13,000 cigarette smokers in the US, Canada, UK and Australia found that only 13% correctly believed that ST products are less hazardous than cigarettes.
Smokers' beliefs about the relative safety of other tobacco products: Findings from the ITC Collaboration, Richard J. O'Connor; Ann McNeill; Ron Borland; David Hammond; Bill King; Christian Boudreau; K. Michael Cummings, Nicotine & Tobacco Research, Volume 9, Issue 10 October 2007, pages 1033-1042.
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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.
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A survey of more than 2,000 adult U.S. smokers found that only 10.7% correctly agreed that ST products are less hazardous than cigarettes, while 82.9% incorrectly disagreed.
Smoker Awareness of and Beliefs About Supposedly Less-Harmful Tobacco Products, O’Conner RJ, Hyland A, Giovino G, et al, American Journal of Preventive Medicine, 2005, Vol. 29, No. 2, 85-90.
In yet another survey, when asked if they believed that chewing tobacco is just as likely to cause cancer as smoking cigarettes, 82% of U.S. smokers incorrectly agreed.
Informing Consumers about the Relative Health Risks of Different Nicotine Delivery Products, presentation by K. Michael Cummings at the National Conference on Tobacco or Health, New Orleans, LA, November 2001.
The reason for this lack of knowledge is largely due to the 1986 Comprehensive Smokeless Tobacco Education Act, which required three rotating warnings on all smokeless tobacco products (i.e. This product is not a safe alternative to cigarettes. This
product may can mouth cancer. This product may cause gum disease and tooth loss.)
The FSPTCA now requires even large warnings on smokeless tobacco products and advertisements.
Authors of a study that evaluated 316 English language websites (none of which were tobacco companies) that contained health risk information about cigarettes and smokeless tobacco use concluded: “The risk from ST is widely conflated with the risk from cigarettes on websites that provide health advice and information. Almost every website had statements that played up the health risks from ST without caveat, making it difficult for consumers to recognize the huge contrast with cigarettes. The quantitative claims of health risks from ST were very often beyond a worst-case-scenario interpretation of the scientific literature. A large portion of websites directly stated or implied that the risks from ST and cigarettes are similar.”
You might as well smoke; the misleading and harmful public message about smokeless tobacco, Carl V Phillips, Constance Wang, Brian Guenzel,
BMC Public Health 2005, 5:31doi:10.1186/1471-2458-5-31
BioMed Central | Full text | You might as well smoke; the misleading and harmful public message about smokeless tobacco
Smokers have a Human Right to be Truthfully Informed that Smokeless Tobacco Products are Far Less Hazardous Alternatives to Cigarettes
Just as sexually active individuals have a human right to be informed that condoms can reduce risks of pregnancy and STD transmission, and just as ...... addicts have a right to be informed that clean needles can reduce risks of HIV, hepatitis and other blood borne diseases, cigarette smokers have a human right to be truthfully informed that ST products are far less hazardous alternatives than cigarettes.
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.
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Public Health Officials have an Ethical Duty to Truthfully Inform Smokers that Smokeless Tobacco Products are Far Less Hazardous Alternatives
Just as the US Public Health Service had an ethical duty to inform black syphilis sufferers in the notorious Tuskeegee 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.
No Evidence Smokeless Tobacco is a Gateway to Cigarette Smoking
Authors of a recently published analysis of NSDUH data concluded that: “Smokeless Tobacco (ST) use has played virtually no role in smoking initiation among White men and boys, the demographic groups among which ST use is most prevalent. There is evidence that, compared with cigarette initiators, ST initiators are significantly less likely to smoke.”
Evidence against a gateway from smokeless tobacco use to smoking, Brad Rodu and Philip Cole, Nicotine Tob Res (2010) 12 (5): 530-534. doi: 10.1093/ntr/ntq033
Evidence against a gateway from smokeless tobacco use to smoking
Using most of the same data, a 2009 SAMHSA report found that, among US residents who had used both cigarettes and smokeless tobacco products in their lifetime, 65.5% used cigarettes prior to smokeless tobacco use, and 31.8% used smokeless tobacco prior to cigarette usage.
Substance Abuse and Mental Health Services Administration, Office of Applied Studies. (February 19, 2009). The NSDUH Report: Smokeless Tobacco Use, Initiation, and Relationship to Cigarette Smoking: 2002 to 2007. Rockville, MD.
Smokeless Tobacco Use, Initiation, and Relationship to Cigarette Smoking: 2002 to 2007
The Overwhelming Majority of NRT Users Switch Back to Cigarettes
A meta-analysis found that an average of just 7% of those using over-the-counter NRT products remained cigarette free after six months, a 93% relapse rate.
A meta-analysis of the efficacy of over-the-counter nicotine replacement, Hughes JR, Shiffman S, Callas P, Zhang Z, Tobacco Control, 2003, Vol. 12, 21-27.
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Another recent meta-analysis also found that 7% of NRT remain cigarette free after six months, and that just 2% remain cigarette free after 20 months (a 98% relapse rate).
Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis, David Moore, Paul Aveyard, Martin Connock, Dechao Wang, Anne Fry-Smith, Pelham Barton, BMJ 2009;338:b1024
Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis -- Moore et al. 338 -- bmj.com
A meta analysis of seven placebo controlled randomised controlled trials involving different NRT products found that just 6.75% of those receiving NRT had quit smoking after six months. While this may have been twice the quit rate compared to placebo, it represents a 93.25% failure rate for smoking cessation, and clearly indicates that smokers need additional and alternative methods of reducing the health risk of cigarette smoking.
Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis, David Moore, Paul Aveyard, Martin Connock, Dechao Wang, Ann Fry-Smith, Pelham Burton, BMJ 2009; 338:b1024
ScienceDirect - Addictive Behaviors : Adolescents' self-reported reasons for using nicotine replacement therapy products: A population-based study
While supposedly double-blind clinical trials have found that NRT products double the chances of quitting when compared to using a placebo, skepticism has been raised about the accuracy and reliability of these studies, since it is likely that many participants who were assigned to placebos realized they were not getting nicotine.
The blind spot in the nicotine replacement therapy literature: Assessment of the double-blind in clinical trials, Mooney M, White T, Hatsukami D, Addictive Behaviors, 2004 Vol. 29, 673-684.
http://whyquit.com/studies/NRT_Blinding_Failures.pdf
Precessation treatment with nicotine patch significantly increases abstinence rates relative to conventional treatment, Jed E. Rose, Joseph E. Herskovic, Frederique M. Behm and Eric C. Westman, Nicotine & Tobacco Research 2009 11(9):1067-1075; doi:10.1093/ntr/ntp103.
Precessation treatment with nicotine patch significantly increases abstinence rates relative to conventional treatment
Skin patches appear to be ineffective smoking cessation aids for those who fail to quit smoking during their first use of NRT, as two published studies on the use of NRT skin patches to quit smoking after an initial failure with NRT found six-month smoking cessation rates of 0% and 1.4%, respectively.
Recycling with nicotine patches in smoking cessation. Tonnesen P, Norregaard J, Sawe U, Simonsen K, Addiction. 1993 Apr;88(4):533-9.
Recycling with nicotine patches in smoking cessation. [Addiction. 1993] - PubMed - NCBI
Double blind trial of repeated treatment with transdermal nicotine for relapsed smokers. Gourlay SG, Forbes Q, Marriner T, et al. British Medical Journal, 1995, Vol. 311, No 7001 363-366.
A survey of 500 U.S. smokers found only 16% agreed that NRT helps people quit smoking.
Attitudes toward nicotine replacement therapy in smokers and ex-smokers in the general public. Etter JF, Perneger TV, Clinical Pharmocol Therapy 2001 Volume 69, 175-83.
An estimated 36.6% of current nicotine gum users have consumed the product for longer than six months, indicating that long-term nicotine maintenance can occur with NRT gum, just as can occur with smokefree tobacco products.
Persistent use of nicotine replacement therapy: analysis of actual purchase patterns in a population based sample, Shiffman S, Hughes JR, Pillitteri JL, Burton SL, Tobacco Control, Vol. 12, 310-316, 2003.
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Summary
The City of Philadelphia Board of Health should reject its proposed Regulations Regarding Tobacco and Cigarette Informational Signs because the proposed Cigarette Informational Signs and the proposed Non-Cigarette Informational Signs that address other smoked tobacco products almost certainly violate the preemption clause of the Federal Cigarette Labeling and Advertising Act, and because smokers, smokeless tobacco consumers and the public already greatly overestimate the known health risks of smokeless tobacco products.
If the Board of Health desires to avoid a federal lawsuit while also informing tobacco consumers and the public about the known health risks of different tobacco products, I encourage the Board of Health to require the Department of Public Health to truthfully inform smokers (via educational materials and messages) that:
- Smokeless tobacco products are far less hazardous alternatives to cigarettes,
- Switching to smokeless tobacco products reduces smoker’s health risks nearly as much as quitting all tobacco use, and
- Millions of smokers have already switched to far less hazardous smokeless tobacco products.
