Urge FDA to approve smokefree MRTP applications, comment deadline Fri, Sept 23; Stan Glantz submits comments opposing MRTP applications and products

[Bill Godshall]

Tomorrow is the deadline for submitting public comments to the FDA regarding Modified Risk tobacco Product applications per Section 911 of the FSPTCA.

Please send a comment to the FDA urging the agency to "approve all MRTP applications by smokefreee tobacco products to truthfully inform smokers that the product is a far less hazardous alternative to cigarettes."

Also, please urge the FDA to "not require smokefree tobacco product manufacturers to conduct expensive studies on their truthful claim's impact on nonusers of tobacco products because the enormous health benefits that have accrued to the several million smokers who already switched to smokeless tobacco and to the estimated million smokers who switched to e-cigarettes have already offset any potential health risk increase even if every non-tobacco-user in America began using these smokefree tobacco products (because smokefree products are at least 99% less hazardous than cigarettes)."

Please note that Section 911 of the FSPTCA (i.e MRTP provisions) currently only applies to cigarettes, cigarette tobacco, RYO and smokeless tobacco products, but the FDA has stated its intent to propose a regulation to apply Chapter IX of the FSPTCA (including Sec. 911) to e-cigarettes and e-liquid.

To submit comments, please see
http://www.fda.gov/TobaccoProducts/NewsEvents/ucm259201.htm
and then go to
Regulations.gov
and click on the "submit your comment" icon.

To view the archived webcast of August 25/26 FDA MRTP workshop, go to
http://www.fda.gov/TobaccoProducts/NewsEvents/ucm259201.htm#Archived_Webcast
Of the five webcasts, the second one (Aug 25, 9:30-12) contains the most tobacco harm reduction speakers.

My presentation is at
http://www.casaa.org/news/article.asp?articleID=195&l=a&p=
Scott Ballin's slide show is at:
http://www.e-cigarette-forum.com/forum/legislation-news/216496-fda-host-modified-risk-tobacco-product-workshop-dc-aug-25-26-free-registration-still-being-accepted-6.html#post4011712
CRE's Jim Tozzi's presentation is at
http://www.thecre.com/tpsac/wp-content/uploads/2011/08/ModifiedRiskTPsJJTtestimony.pdf
CASAA's Elaine Keller's presentation is at
http://www.casaa.org/files/CASAA_Modified_Risk_2011_08_25.pdf
Lars Ramstrom's presentation is at:
http://www.casaa.org/files/Ramstrom-presentation-FDA-Workshop.pdf
ACSH's Gil Ross's slides are at:
http://www.e-cigarette-forum.com/forum/legislation-news/216496-fda-host-modified-risk-tobacco-product-workshop-dc-aug-25-26-free-registration-still-being-accepted-7.html#post4018765


Yesterday, Stan Glantz submitted a comment urging FDA to reject MRTP applications (including for smokeless tobacco products to truthfully claim they are less hazardous than cigarettes) because of misleading claims made by cigarette companies several decades ago (about the health risks of low tar/light cigarettes even though NCI, ACS and other health agencies and group had made similar misleading claims).

In another attempt to prevent smokers from reducing cigarette consumption and health risks and from being truthfully informed that smokeless tobacco is far less hazardous than cigarettes, Glantz also urged the FDA to reject any MRTP application for smokeless products if the product shares the same brand name as a cigarette (e.g. Marlboro, Camel).

Glantz also cited his junk science article that grossly exaggerated the known health risks of snus and dual usage of snus by cigarette smokers (as they transition from cigarettes to snus) to falsely claim that public health would be further harmed if smokers were truthully informed that snus is less hazardous than cigarettes.

The full text of Stan Glantz' comments to FDA are posted at:
https://tobacco.ucsf.edu/submission...on-modified-risk-tobacco-product-applications

 

[DC2]

I'm not sure what to put for "Organization Name" and "Submitter's Representative".

 

[Xaria]

Bump for answer to DC. What would the category be also?

 

[rothenbj]

Talk about the pot calling the kettle black. As a spokesman for an industry that has insured their future success by buying support from the whole health industry, to the media to the Federal government (and everything in between) in the name of the public's good, I'm starting to believe the tobacco industry's lies pale in comparison. The billions made on selling products that have a success rate of somewhere around 2% after 20 months doesn't sound like much more than the placebo effect of snake oil.

 

[Placebo Effect]

DC2, you can just write 'N/A'

I submitted a quick comment as an individual

In light of the enormous evidence showing that all smoke-free tobacco products are 98-99% less hazardous than smoking cigarettes, I strongly urge the FDA to approve MRTP applications for these products. TPSAC members have repeatedly heard and read public comments which cite an overwhelming amount of scientific data to support the proposition that these products fall far, far below cigarettes on the risk continuum. TPSAC should not allow fearmongering tactics by prohibitionist 'public health' groups to cloud clearly established facts.

No public health purpose will be served by forcing the manufacturers of smoke-free tobacco products to fund millions of dollars worth of studies to tell TPSAC what we already know -- any modern American smokeless tobacco product is significantly less hazardous than cigarettes, and a smoker who switches to any of these products is greatly reducing his or her risk of suffering from tobacco-related disease or death.

 

[Placebo Effect]

Bump for answer to DC. What would the category be also?

You can select 'Individual' under Category.

rothenbj, please consider submitting a comment of your own. TPSAC members need to know that there is an active community who cares about these issues.

 

[frisco]

I just posted a comment. This whole thing is so absurd!

 

[Bill Godshall]

frisco wrote

This whole thing is so absurd!

This is yet another excellent opportunity (provided by the FDA) for tobacco harm reduction advocates to inform and influence knowledge, attitudes and policies at FDA.

But to prevail, tobacco harm reduction advocates need to submit more supportive comments of smokefree MRTP applications than tobacco harm reduction opponents submit urging FDA to reject smokefree MRTP applications (or make their approval very costly and take many years).

 

[DC2]

I still haven't figured out how to see the comments.

 

[Placebo Effect]

I still haven't figured out how to see the comments.

None of the public submissions (except for a single irrelevant submission) are viewable yet. I believe it takes a couple days or more for the submissions to show up.

 

[Spazmelda]

I'm confused by this. I haven't read it thoroughly as I have a 4 year old right next to me giving a play by play of the worm he is playing with. Kind of hard to concentrate on convoluted wording...

Someone help me out here. So, FDA is saying that MRTP manufacturers have to prove that they are less harmful than conventional tobacco products by a myriad of methods, but then they must also show that their marketing does not lead consumers to believe that the products are less harmful than other tobacco products?!? What's the point of going through all the testing to show that they are less harmful if you then have to ensure that you don't lead people to believe that they are less harmful?

What am I misreading here?

 

[Bill Godshall]

The FDA just sent this notice:

The docket for public comment on the scientific evaluation of modified risk tobacco product (MRTP) applications closes at midnight tonight.

 

[Bill Godshall]

Spazmelda wrote:

Someone help me out here. So, FDA is saying that MRTP manufacturers have to prove that they are less harmful than conventional tobacco products by a myriad of methods, but then they must also show that their marketing does not lead consumers to believe that the products are less harmful than other tobacco products?!?

The second provision you cited "they must also show that their marketing does not lead consumers to believe that the products are less harmful than other tobacco products" only applies to "reduced exposure claims", not to "modified risk claims".

 

[Spazmelda]

Spazmelda wrote:



The second provision you cited "they must also show that their marketing does not lead consumers to believe that the products are less harmful than other tobacco products" only applies to "reduced exposure claims", not to "modified risk claims".

Oh, okay. Thanks!

 

[Bill Godshall]

Still two hours to submit comments to FDA.

 

[Bill Godshall]

I just submitted 20 pages of written comments to the FDA regarding Modified Risk Tobacco Product applications.
Due to its length, I'll post portions of it below and in the next two postings.


Public Comments to FDA on
Modified Risk Tobacco Product Applications

September 23, 2011

by
William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
FAX 351-5881
smokefree@compuserve.com

Oral Comments Presented August 25 at FDA MRTP Workshop

I’m Bill Godshall, founder and executive director of Smokefree Pennsylvania, a nonprofit organization that since 1990 has been advocating local, state and federal policies to reduce indoor tobacco smoke pollution, reduce tobacco marketing to youth, hold cigarette companies accountable, increase cigarette tax rates, fund tobacco education and smoking cessation services, inform smokers that all smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes, and in 2007 I convinced Senator Mike Enzi to amend the FSPTCA to require picture warnings on cigarette packs.

For disclosure, neither Smokefree Pennsylvania nor I have ever received any direct or indirect funding from any tobacco, drug or electronic cigarette company or trade association.

It is important to recognize that Section 911 and other provisions of Chapter IX of the FSPTCA only apply to: cigarettes, cigarette tobacco, RYO tobacco and smokeless tobacco products. Although the FDA has stated that it intends to propose a regulation to apply Chapter IX to all currently unregulated tobacco products, Section 911 does not apply to small cigars, large cigars, pipe tobacco, hookah/shisha tobacco, electronic cigarettes, e-liquid, tobacco skin cream, tobacco water and at least two dissolvable tobacco products.

Thus, there appear to be three different types of MRTP applications that tobacco companies might submit to the FDA:
- comparing a smokeless tobacco product to cigarettes,
- comparing a cigarette to other cigarettes, and
- comparing a smokeless product to other smokeless products.

Since there no scientific evidence indicating that any type of cigarette is less hazardous than other cigarettes, and since there is insufficient evidence indicating that any type of smokeless tobacco product is less hazardous than other smokeless tobacco products used in the US, the FDA should require additional studies for MRTP applications seeking to claim that one cigarette is less hazardous than another and for those seeking to claim that one smokeless product is less hazardous than another.

In sharp contrast, a growing body of scientific evidence has found that daily use of smokefree tobacco products marketed in the US and Sweden pose about 99% fewer mortality risks than cigarettes, and that switching to a smokefree tobacco product reduces a smoker’s mortality risks nearly as much as quitting all tobacco/nicotine. Nonsmokers are also exposed to less tobacco smoke when smokers switch to smokeless tobacco. In fact, NRT and smokeless tobacco products have very similar health risk and benefit profiles.

Since >99% of all tobacco attributable deaths and healthcare costs in the US are caused by the repeated inhalation of tobacco smoke, and that <1% are caused by smokeless tobacco products, it is vitally important for the FDA to publicly acknowledge the exponential differences of risk between cigarettes and smokeless tobacco, and to take this into account when considering criteria for evaluating MRTP applications.

Even in the absence of reduced risk marketing claims, population surveys found that several million smokers have already switched to smokeless tobacco products, despite numerous surveys finding that most smokers inaccurately believe smokeless products are as hazardous as cigarettes. So smokeless tobacco products have already saved more lives (of smokers) than could be offset even if every American non tobacco user begins to use smokeless tobacco. Besides, federal and state laws, and the 1998 MSA, already prohibit the marketing of smokeless tobacco products to youth.

The questions posed by the FDA to presenters of this conference inaccurately presume that there is no evidence that smokeless tobacco products are less hazardous than cigarettes.

If the FDA desires further evidence that the marketing of smokeless tobacco to smokers as less hazardous alternatives won’t harm public health, the agency should consider that e-cigarettes have been marketed to smokers as less hazardous alternatives for several years. As a result, smokers who switched now account for virtually all e-cigarette consumers, there is no evidence youth or non tobacco users have began using e-cigarettes, and surveys of e-cigarette consumers have found that nearly all perceive significant health benefits from switching to e-cigarettes, and that most had previously failed to quit smoking by using FDA approved smoking cessation products.

In sum, there is no justification for FDA to require any new studies for the approval of MRTP applications seeking to claim that a smokeless tobacco product is less hazardous than cigarettes. Any regulation requiring smokeless tobacco companies to conduct additional studies to make that claim is tantamount to a “truth tax”.

Just as ...... addicts and the public have a right to be truthfully informed that methadone, clean needles and condoms can reduce risks of transmitting and contracting HIV, hepatitis and other diseases, tobacco consumers (and the public) have a human right to be truthfully informed that smokeless tobacco products are far less hazardous alternatives to cigarettes.

Just as the US Public Health Service had an ethical duty to inform black syphilis patients in the infamous Tuskeegee Study that effective syphilis treatments were available, the FDA and public health agencies have an ethical duty to truthfully inform tobacco consumers that smokeless tobacco is far less hazardous than cigarettes.

But since 1986 when Congress enacted the Comprehensive Smokeless Tobacco Education Act, public health agencies have intentionally mislead the public to believe that smokeless tobacco is just as hazardous as smoking cigarettes, which has discouraged tens of millions of smokers from switching to smokeless, and has encouraged smokeless users to switch to far more hazardous cigarettes.

Despite repeated assertions that the FDA will rely upon scientific evidence, the FDA’s webpage about Section 911 that is ironically titled “Health Fraud” falsely states “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."

Although the FDA has stated that it will comply with Judge Richard Leon’s ruling that e-cigarettes are tobacco products, the FDA hasn’t clarified or corrected any of Josh Sharfstein’s prohibitionist fear mongering propaganda about e-cigarettes. The FDA’s website still contains inaccurate and misleading information about the risks and benefits of e-cigarettes, false claims that e-cigarettes are marketed to youth, and false claims that e-cigarettes are unapproved drug devices, which continue to be cited in news stories and by prohibitionists to continue deceiving the public.

The FDA also has invited many abstinence-only tobacco prohibitionists to its staff, its TPSAC and to present at this workshop, while inviting very few, if any, harm reduction advocates or tobacco consumers.

It was wrong for cigarette companies to mislead the public about the health risks of cigarettes for decades. But it is far worse for the FDA, health agencies, organizations and/or professionals to mislead the public about the comparable health risks of cigarettes and noncombustible tobacco products.

As long as the FDA and heath agencies continue to misrepresent the health risks of smokefree tobacco products, the public will justifiably continue to distrust the FDA on other critically important public health issues.

Ironically, at the FDA’s 2010 scientific workshop titled “Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products”, there appeared to be a consensus that longterm use of NRT poses very few if any health risks because longterm use of Swedish snus poses very few if any health risks. I strongly suggest the FDA review presentations and discussions at that conference.
Additional comments on MRTP Applications

Legal and Regulatory Scope of Section 911 of the Family Smoking Prevention and Tobacco Control Act (FSPTCA)

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 derived from tobaccco and intended for human consumption can be marketed as a tobacco product (as long as the manufacturer or importer make no therapeutic claims) as defined in Title I Section 101(rr)(1) of the FSPTCA at http://frwebgate.access.gpo.gov/cgi...=111_cong_public_laws&docid=f:publ031.111.pdf.

But as stipulated in Section 901(b) of the FSPTCA, Chapter IX (including Section 911) of the FSPTCA now only applies “to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products” although the FDA has the authority to apply some/many/all provisions of Chapter IX to other tobacco products, and the agency has stated its intent to propose a regulation (in the future) to propose a regulation that would apply Chapter IX provisions to all presently unregulated tobacco products Regulation of E-Cigarettes and Other Tobacco Products.

So at this time, Chapter IX provisions (including Section 911) of the FSPTCA do not apply to small cigars, large cigars, pipe tobacco, hookah/shisha tobacco, electronic cigarettes (e-cigarettes), e-liquid, tobacco skin cream, tobacco water and at least the two dissolvable tobacco products, with the two latter products exempted per FDA’s March, 2011 letter to Star Scientific, Inc. informing the company that Chapter IX didn’t apply to Ariva-BDL or to Stonewall-BDL (presumably because they don’t meet the definition of a smokeless tobacco product) cited at
Two tobacco products free of FDA oversight | JournalNow.com.

Since Chapter IX doesn’t apply to many different types of tobacco products, since Chapter IX may not apply to some/many/most/all other dissolvable tobacco products, since new products that resemble FDA approved Nicotine Replacement Therapy (NRT) products can now be lawfully marketed as tobacco products (without being subject to Chapter IX), and since the FDA has stated its intent to propose a regulation to apply Chapter IX to currently unregulated tobacco products, the FDA would be wise to consider the applicability of ALL tobacco and NRT products that are currently on the market, as well as those that could be potentially developed and marketed in the future when researching, considering and developing criteria for approving different types of potential MRTP applications that may be submitted in future years.

It is critically important that the FDA truthfully inform the public about the provisions in Section 911 of the FSPTCA. Unfortunately, the FDA now posts grossly misleading information about Sections 911, 902 & 903 of the FSPTCA on its webpage ironically entitled “Heath Fraud” at: Health Fraud
that confuses readers to believe that these sections of the FSPTCA apply to ALL tobacco products by stating: “Claiming less harm or reduced risk of disease from using tobacco products misleads consumers to think that these products are safe to use. FDA considers these kinds of claims to be health fraud. These kinds of claims can only be made after scientific evidence to support them has been submitted to FDA, and FDA has issued an order permitting their marketing use.”

Also on that same webpage, the FDA’s answer to its own question “What is Tobacco-Related Health Fraud?” deceptively states: “False or misleading claims in the promotion, advertising, distribution or sale of tobacco products, including suggestions that a tobacco product is safer, less harmful, contains a reduced level or is free of a harmful substance, or presents a lower risk of tobacco-related disease compared to other tobacco products.” The FDA should correct those misleading statements.

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.
Publication - Harm reduction in nicotine addiction
Tobacco smoking, harm reduction, and nicotine product regulation : The Lancet

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 simply 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 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.

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.” 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
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 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 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

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 attribatable mortality and healthcare costs.

On a scale of mortality risk from 1 to 100, on which NRT products are 1 and cigarettes are 100, smokeless tobacco products are between 1 and 2. Smokers who switch to smokefree tobacco/nicotine products reduce their health risks nearly as much as smokers who quit all tobacco/nicotine usage. Besides, usage of smokefree tobacco products poses no known risks for nonusers because they emit ZERO smoke.

In light of this recently published research demonstrating that smokeless tobacco products are far less hazardous than cigarettes and pose far fewer oral cancer risks than cigarettes, the FDA should propose a regulation to eliminate the currently mandated warning labels on smokeless tobacco products that misleading state “This product is not a safe alternative to cigarettes,” and “This product may cause mouth cancer.”

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

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

 

[Bill Godshall]

Millions of smokers in the US, Sweden and Norway have already 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. 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. Sign In

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. Sign In

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. Sign In

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

Figure 1 from this study is reproduced on pages 11 and 12.

 

[Bill Godshall]

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.
An Error Occurred Setting Your User Cookie

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.
An Error Occurred Setting Your User Cookie

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.

A recently published study in 2011 at http://www.harmreductionjournal.com/...-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.

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.)
Since the FSPTCA now requires even larger warnings on smokeless tobacco products and advertisements, it is critically important for the FDA propose a regulation to eliminate these misleading mandatory warnings on smokeless tobacco products.

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

It is extremely important that FDA truthfully inform all tobacco consumers and the public about the vastly different health risks and benefits of different types of tobacco products. Unfortunately, the FDA, like many other government health agencies, is presently misrepresenting the health risks of different products by falsely claiming:
“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.” at Health Fraud, the webpage entitled “Health Fraud”. The FDA needs to correct that webpage ASAP.

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. Search Results

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 Tuskegee Study that there were effective treatments for syphilis, public health officials have an ethical duty to truthfully inform smokers that ST products are less hazardous alternatives to cigarettes. To intentionally deceive smokers and the public about health risks of smokeless tobacco products is public health malpractice.

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
http://ntr.oxfordjournals.org/content/12/5/530.short

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

Smokeless Tobacco Products Pose Very Little Risk of
Accidental Child Ingestion

A recently published article, which has been widely publicized by abstinence-only advocates who oppose tobacco harm reduction, alleged that dissolvable tobacco products (which the author’s repeatedly referred to as candy-like) are potentially toxic to children and that thousands of cases of ingestion of tobacco products has been reported.
Unintentional Child Poisonings Through Ingestion of Conventional and Novel Tobacco Products, Gregory N Connolly, Patricia Richter, Alfred Aleguas Jr, Terry Pechacek, Stephen Stanfill, Hilbert Albert, Pediatrics 2009-2835.
http://pediatrics.aappublications.or...-2835.abstract

In rebutting the alarmist claims made in the Connolly et al article, Brad Rodu revealed that, according to the 2008 report of the American Association of Poison Control Centers, all types of tobacco products only accounted for 1% of all reported exposures to non-pharmaceutical agents of all kinds in children less than 6 years of age, and that smokeless tobacco products accounted for just 15% of the reported tobacco exposures.
Poisoning Public Health Issues, Brad Rodu, Tobacco Truth, April 19, 2010
Tobacco Truth: Poisoning Public Health Issues

A recently published study at ScienceDirect - Regulatory Toxicology and Pharmacology : Frequency and outcomes of accidental ingestion of tobacco products in young children
evaluated twenty-seven years of annual reports by American Association of Poison Control Centers (AAPCC) for occurrence and outcomes associated with accidental ingestion events involving tobacco and pharmaceutical nicotine products among young children. In sharp contrast to the alarmist claims by Connolly et al (cited above), the author of this far more comprehensive review concluded: “The rate of major, non-fatal, outcomes was <0.1%. Data from AAPCC reports and other sources indicate the frequency of accidental poisoning events is relatively low for tobacco products compared with other products such as drugs, dietary supplements, cleaning products, and personal care products. These findings, along with those for pharmaceutical nicotine products, are consistent with published case reports and reviews, indicating that the frequency and severity of outcomes associated with accidental ingestion of tobacco products by young children appear to be relatively low. However, adults should keep tobacco products out of the reach of children.”

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. Sign In

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.
http://ntr.oxfordjournals.org/cgi/co...bstract/ntp103

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. Sign In

Dissolvable nicotine lozenges marketed by GlaxoSmithKline as smoking cessation aids (formerly called Commit and now called Nicorette) have been available in different flavorings, including cherry, mint and formerly cappuccino.
Nicorette Lozenge - Nicotine Lozenge | To Help You Quit
NEW! Nicorette mini Lozenge | Nicotine Lozenges To Help You Quit Smoking
Ironically (or not), critics of flavored tobacco products that receive funding from drug companies have remained silent about strikingly similar flavored NRT products.

This extensive research indicates that the more than 95% of smokers who have used NRT products (to quit smoking) relapse back to cigarettes, that subsequent attempts to quit by using NRT virtually always fail, and that smokers should be provided truthful information about, and legal and affordable access to, other types of smokefree tobacco/nicotine products.

Marketing of tobacco products to minors violates the 1998 Master Settlement Agreement, laws in all 50 states, and the FSPTCA

Although some anti-tobacco activists continue to publicly accuse tobacco companies of target marketing tobacco products to youth (including dissolvable tobacco products), it is critically important to note that marketing tobacco products to minors violates the 1998 Master Settlement Agreement, statutes in all 50 states, and the FSPTCA.

During the Senate HELP Committee markup of the FSPTCA in 2009, Senators Sherrod Brown and Jeff Merkley (when proposing the amendment to require the FDA to study dissolvable tobacco products) repeatedly accused RJ Reynolds of target marketing the company’s new dissolvable tobacco products (i.e. Camel Orbs, Strips and Sticks) to minors. But no evidence was provided indicating that Reynolds (or any other tobacco company) was marketing their tobacco products to minors.

Similar unsubstantiated allegations were made against Star back in 2001/2002 when Citizens Petitions urged the FDA to ban Star’s Ariva and Stonewall dissolvable tobacco products. In the past decade, no evidence has been provided indicating that youth use Ariva or Stonewall, or that Star markets its products to minors.

All three of the 2001/2002 Citizen Petitions urging the FDA to ban Star’s Ariva and Stonewall also repeatedly referred to the products as “candy like” in an attempt to deceive the agency and the public to believe that Star was marketing to youth. A decade later, and the same false “candy like” references to dissolvable tobacco products has been repeated by those who accuse tobacco companies of marketing the products to minors.

Instead of repeating unsubstantiated accusations to the media, anyone who has any evidence that any tobacco products are being illegally marketed to youth should notify the State AG, State Health Department and/or FDA for enforcement or other remedial action.

Referring to any tobacco product as “candy” or “candy-like” can only encourage youth to use these products, which raises serious concerns about the true motives of those who call tobacco products “candy” or “candy-like’. But that’s precisely what many anti tobacco activists have done, including Karla Sneegas from the Indiana Dept. of Health, as well as in an article recently coauthored by FDA’s Lawrence Deyton.

At the July TPSAC meeting, Neal Benowitz repeatedly cited the results of a 2010 junk science push-poll at http://www.healthyyouthva.org/documents/Meltdown.pdf that showed prearranged photographs of similar looking candy and tobacco products/packages to youth (the latter of which most youth had never heard of or seen before), and then asked the youth if they believed the tobacco products looked like candy and if they might want to try using them. The grossly misleading VA Foundation for Healthy Youth's press release publicizing the manufactured results of this push-poll is at: http://www.healthyyouthva.org/docume...el_May2010.pdf
and a subsequent newspaper article (that repeated the push-poll’s unscientific findings) entitled “Many teens mistook smokeless tobacco products for candy” is at:
Many teens mistook smokeless tobacco products for candy | Richmond Times-Dispatch

Since Section 906(d)(3)(A)(ii) of the FDA tobacco laws prohibits the FDA from banning tobacco sales to 18 year olds (the vast majority of whom are 12th grade high school students), it is doubtful that any amount or type of FDA tobacco regulation can substantially reduce tobacco use among 12th graders (or underclass peers/siblings who obtain tobacco from 18 year olds).

Although some surveys indicate that youth usage of smokeless tobacco products has increased slightly during the past several years, it is likely that many new youth smokeless users are also cigarette smokers who desire smokefree alternatives to cigarettes. While many anti tobacco extremists have falsely claimed that smokers who also use smokefree tobacco products increase their risks, dual usage of smokeless tobacco and cigarettes is a necessary prerequisite (that can last several weeks, months or years) for cigarette smokers to switch to less hazardous smokefree alternatives, which sharply reduces their tobacco attributable disease and death risks.

Interestingly, a newly published survey of 14-18 year old adolescents in Finland found that 10% had used NRT products, and that most users were daily smokers. The reasons for NRT use were just try (56%), to quit (33%) and smoking not possible (24%). Adolescents’ self-reported reasons for using nicotine replacement therapy products: A population-based study, Susanna Raisamo, David Doku, Arja Rimpela, Addictive Behaviors Volume 36, Issue 9, September 2011, 945-947.
ScienceDirect - Addictive Behaviors : Adolescents' self-reported reasons for using nicotine replacement therapy products: A population-based study

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

Although electronic cigarettes (e-cigarettes) are not currently subject to Section 911’s MRTP provisions, approximately one million smokers have quit smoking or sharply reduced their cigarette consumption by switching to or substituting smokefree e-cigarettes. To date, there is no evidence that e-cigarette usage has harmed anyone, which is logical since the products emit a tiny amount of vaporized nicotine (similar to nicotine inhalers that are marketed as smoking cessation aids) and water vapor. Of the dozen plus laboratory tests conducted on e-cigarettes, only one (conducted by the FDA in 2009) found a trace (and well below toxic) level of one so-called toxic chemical in just one of eighteen samples tested, and levels of nitrosamines in e-cigarettes are nearly identical to those in nicotine gums and patches. And despite marketing claims by many e-cigarette companies that the products are less hazardous than cigarettes, there is no evidence that e-cigarettes are used by youth or non-tobacco-users.
http://www.healthnz.co.nz/RuyanCartr...t30-Oct-08.pdf
http://www.starscientific.com/404/st...0tsna in.pdf
CASAA.org
http://www.hsph.harvard.edu/centers-...ticle.jphp.pdf
SEIKATSUEISEI : Vol. 55 (2011) , No. 1 p.59-64
Effect of a nicotine free inhalator as part of a smoking cessation program
http://ectoh.org/documents/3B.5 Et...20efficacy.pdf
http://ntr.oxfordjournals.org/conten...95WzUwnLNO6Er9
'It's Not the Addiction that Kills People, It's the Smoke' - The Takeaway
Electronic Cigarettes
Electronic cigarettes (e-cigs): views of af... [Int J Clin Pract. 2011] - PubMed - NCBI
http://www.scirp.org/journal/PaperIn...ublishStatus=2
ScienceDirect - Toxicology : Non-clinical safety and pharmacokinetic evaluations of propylene glycol aerosol in Sprague-Dawley rats and Beagle dogs
Taylor & Francis Online :: ANALYSIS OF ELECTRONIC CIGARETTE CARTRIDGES, REFILL SOLUTIONS, AND SMOKE FOR NICOTINE AND NICOTINE RELATED IMPURITIES - Journal of Liquid Chromatography & Related Technologies - Volume 34, Issue 14
CASAA.org
Behavioural Insight Team annual update | Cabinet Office

Former FDA Commissioner David Kessler has also acknowledged the benefits of smokeless tobacco, dissolvables and e-cigarettes as less hazardous alternatives for cigarette smokers at Q&A: Former FDA Commissioner talks about tobacco - Westport News by stating "there's no doubt that in terms of risk of death there are some advantages to that substitution."

E-cigarettes also have been found to contain/emit similar or lower levels of nicotine than nicotine gums and lozenges
http://www.healthnz.co.nz/2010 Bullen ECig.pdf
http://www.e-cigarette-forum.com/for...igarettes.html
This indicates that e-cigarettes emit enough nicotine to satisfy the cravings of smokers, but may not emit enough nicotine to addict nonsmokers. Several published surveys have confirmed that e-cigarettes satisfy the cravings of smokers, and provide many health benefits to users who switched from cigarettes.
Sign In
http://www.biomedcentral.com/content...458-10-231.pdf
THR2010. (tobaccoharmreduction.org) (see chapter 9)

Other public health organizations that have extensively studied e-cigarettes have also endorsed their use by smokers, including The American Association of Public Health Physicians at Regulations.gov and the American Council on Science and Health at NEJM editorial: e-cigarette users should resume smoking for their own good > Facts & Fears > ACSH.

Unfortunately, after stating it would comply with Judge Richard Leon's court ruling at Regulation of E-Cigarettes and Other Tobacco Products , FDA webpages continue to falsely claim that e-cigarettes are unapproved drug devices, continue to misrepresent the health risks and benefits, and continue to falsely claim that e-cigarettes are marketed to children via legally defective 2009/2010 agency documents, including former FDA Deputy Commissioner Josh Sharfstein’s July 22, 2009 press conference materials and the agency's gross misrepresentation of its own laboratory report findings on SE & NJOY e-cigarettes products Electronic Cigarettes.

The FDA should take corrective action to eliminate all of the agency’s inaccurate and misleading claims about e-cigarettes, and issue a correction/clarification to the public.

 

[Bill Godshall]

I just deleted a duplicate copy of my FDA comments that mysteriously appeared here.

 

[Bill Godshall]

Not sure why duplicate copies of my FDA comments were mysteriously posted here, but I deleted the duplicates.