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

[Vocalek]

CASAA's submissions were in the form of PDF documents.

Here is the contents of the first file, which is the cover letter. The Appendices A - P are separate PDF documents. I did not have access to the full text of Appendix O, so that is linked as the last item in the cover letter.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
U.S. Food and Drug Administration
Center for tobacco Products
9200 Corporate Blvd
Rockville, MD 20850

Subject: Docket No. FDA-2011-N-0443, Modified Risk tobacco Products

The Consumer Advocates for Smoke-free Alternatives Association (CASAA) urges the U.S. Food and Drug Administration (FDA) to approve all Modified Risk tobacco Product applications for smokeless tobacco products and permit manufacturers to truthfully claim the product is a significantly less hazardous alternative to cigarettes.

Warning labels currently mandated on all smokeless product lead the public to believe that smokeless tobacco products are just as hazardous as cigarettes, pose a greater risk for mouth cancer than cigarettes, and pose a greater risk for gum disease and tooth loss than cigarettes, when the opposite is true. CASAA also urges the FDA to propose regulations to eliminate the inaccurate and misleading warning labels

The FDA should not require smokefree tobacco product manufacturers to conduct expensive studies to prove safety, when there is a plethora of peer-reviewed scientific literature documenting the positive effects on the health of smokers who switched to snus. There is an emerging body of evidence showing similar positive health effects on smokers who switch to electronic cigarettes.

Even if every nonsmoker in America suddenly began using smoke-free products, any potential population-level health risk increase has already been offset by the 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.

Concern about addiction is misplaced when lung disease, cardiovascular disease, and cancers are much more important concerns. This issue should not be about profits or politics. Millions of lives are at stake.

Very truly yours,

Theresa A. Whitt, MD
CASAA Medical Advisor

Elaine D. Keller
CASAA Vice President

CASAA is a non-profit organization that works to ensure the availability of reduced harm alternatives to smoking and to provide smokers and non-smokers alike with truthful information about such alternatives.

APPENDICES:

A. Some Smokers Will Never Be Able to Quit

Royal College of Physicians. Harm reduction in nicotine addiction: helping people who can't quit. A report by the Tobacco Advisory Group of the Royal College of Physicians. London: RCP 2007.

B. Time Course and Severity of Smoking Withdrawal

Piasecki TM, Fiore MC, Baker TB. Profiles in Discouragement: Two Studies of Variability in the Time Course of Smoking Withdrawal Symptoms. J Abnorm Psychol. 1998 May;107(2):238-51

C. Smoking as a Multi-Purpose Coping Mechanism

Hughes JR. Why does smoking so often produce dependence? A somewhat different view. Tob Control. 2001 Mar;10(1):62-4.

D. Snus Provides Evidence of Long-Term Safety of Nicotine Use

Benowitz NL. Smokeless Tobacco and Disease: Evidence Related to Long-term Safety of Nicotine. Presentation at FDA Public Workshop: Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products. October 26, 2010.

E. CASAA Urges FDA to Streamline MRTP Approval Process

Keller ED. Consumer Advocates for Smoke-free Alternatives Association. Testimony at FDA Public Workshop, Modified Risk Tobacco Products. August 25, 2011.

F. Use of Snus Increases Probability of Quitting

Lund, K.E., et al. The use of snus for quitting smoking compared with medicinal products. Nicotine Tobacco Research, 2010 August; 12(8): 817-822.

G. Health Risks of Snus Much Lower Than Smoking

Roth HD, Roth AB, Liu X. Health Risks of Smoking Compared to Swedish Snus. Inhalation Toxicology, 17:741–748, 2005/

H. Swedish Miracle Works in Norway, Too

Lund KE, Schellels J, McNeill A. The association between use of snus and quit rates for smoking: results from seven Norwegian cross-sectional studies. 2011 Jan;106(1):162-167.

I. Incorrect Safety Information Discourages Adoption of Effective Cessation Techniques

Ramström L. Commentary on Lund et al. (2011): Consolidating the evidence on effectiveness of snus for smoking cessation – implications for public health. Addiction. 2011 Jan;106(1):168-9.

J. One of the Greatest Public Health Breakthroughs in Human History

Rodu B. The scientific foundation for tobacco harm reduction, 2006-2011. Harm Reduction Journal 2011, 8:19.

K. E-Cigarettes Suppress Symptoms Without Adverse Effects

Vansickel AR, Cobb CO, Weaver MF, Eissenberg TE. A clinical laboratory model for evaluating the acute effects of electronic "cigarettes": nicotine delivery profile and cardiovascular and subjective effects. Cancer Epidemiol Biomarkers Prev. 2010 Aug;19(8):1945-53. Epub 2010 Jul 20.

L. E-Cigarette Pharmaconetic Profile More Like Inhalator Than Tobacco Cigarette

Bullen C, C, McRobbie H, Thornley S, Glover M, Lin R, Laugesen M. Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial. Tob Control. 2010 Apr;19(2):98-103.

M. E-Cigarette Helps Smokers with Depression

Caponnetto P, Polosa R, Auditore R, Russo C, Campagna D. Smoking Cessation with E-Cigarettes in Smokers with a Documented History of Depression and Recurring Relapses. International Journal of Clinical Medicine, 2011, 2, 281-284.

N. User Survey Show E-Cigarettes Help Those Who Kept Relapsing

Etter JF, Bullen C. Electronic cigarette users profile, utilization, satisfaction and perceived efficacy. Addiction 2011 DOI: 10.1111/j.1360-0443.2011.03505.x.

O. Survey Shows 78% of E-Cigarette Users No Longer Smoke

Foulds J, Veldheer S, Berg A. Electronic cigarettes (e-cigs): views of aficionados and clinical/public health perspectives. International Journal of Clinical Practice, 2011; DOI: 10.1111/j.1742-1241.2011.02751.x

P. E-Cigarettes Show Tremendous Promise in Fight Against Morbidity and Mortality

Khan Z, Siegel M. Electronic cigarettes as a harm reduction strategy for tobacco control: A step forward or a repeat of past mistakes? Journal of Public Health Policy advance online publication 9 December 2010; doi: 10.1057/jphp.2010.41.

Q. Dual User Smoke Fewer Cigarettes, More Likely to Cease Smoking

Frost-Pineda K, Appleton S, Fisher M, Fox K, Gaworski CL. Does dual use jeopardize the potential role of smokeless tobacco in harm reduction? Nicotine Tob Res. 2010 Nov;12(11):1055-67. Epub 2010 Sep 16. Does dual use jeopardize the potential role... [Nicotine Tob Res. 2010] - PubMed - NCBI

 

[Placebo Effect]

Great job Bill and Elaine

 

[DC2]

CASAA's submissions were in the form of PDF documents.

R. E-Cigarettes are marketed to young people and act as a gateway to real cigarettes.

Oh, I'm sorry, I couldn't find a damn thing that even suggests these absurd conclusions have any basis in fact or reality.
Unfortunately, therefore, I can not provide any links or attachments.

 

[Vocalek]

Here is a great example of a stupid, stupid comment: Regulations.gov

And here is another: View attachment Comment-ACS-ALA-AHA-CTFK.pdf

Hard as it may be for some of us to comprehend, the American Cancer Society, American Lung Association, American Heart Association, and Campaign for Tobacco Free Kids would prefer that millions continue smoking, rather than allow smokers to learn that there are much less hazardous ways of obtaining nicoitne.

These groups claim they want to protect public health, and they keep citing the "light cigarette fiasco" as their justification. They ignore the fact that there are decades of research to support the assertion that snus is less hazardous than smoking. They continue to pretend that this research doesn't exist and to pretend that tobacco companies are evil empires that want to make false safety claims as a way to make a buck.

BTW: Many people don't realize that it was not the tobacco companies' idea to develop "light" cigarettes. The National Cancer Institute suggested that they find ways to reduce the "tar and nicotine", and the tobacco companies complied. It was the US surgeon general that urged smokers who could not quit to at least switch to a cigarette that reduced "tar and nicotine".

Notice the pairing of "tar and nicotine". Tar is harmful, nicotine much less so. The two are mechanically paired due to the fact that the nicotine is delivered to the body via droplets of tar. If you reduce the tar delivery, you automatically reduce the delivered nicotine.

The reason "light" cigarettes turned out to be no less harmful than non-light cigarettes is that smokers unconsciously compensated for the reduction in nicotine by either smoking more cigarettes, or inhaling more deeply.

There were no decades of research behind the "light" cigarettes to show that they reduced harm. Urged on by the U.S. government itself, tobacco companies plowed ahead in all ignorance and reaped a storm of grief and blame in the process.

 

[rothenbj]

There were no decades of research behind RIP/FSC requirements in cigarette paper either. Who knows the implications of inhaling those additional chemicals for decades. I know they immediately bothered me enough to look for an alternative to smoking. Will the ?non-profit?"health" associations claim any damage was the fault of the irresponsible tobacco industry years from now?

 

[Bill Godshall]

Joel Nitzkin submitted the following comments to FDA on MRTP applications on behalf of the American Association of Public Health Physicians (AAPHP).


FDA Should Approve MRTP Applications by Smoke-free Products

Summary: FDA should approve Modified Risk Tobacco Product (MRTP) applications by smoke-free products requesting such designation on the basis of the nature of the product, and without the need for any form of additional epidemiologic or human exposure research. This should be done for two reasons. The first is the overwhelming scientific evidence that such products, as a class, present a risk of fatality less than 1% the risk posed by cigarettes. The second is the ethical principle that FDA in its statements and requirements should be truthful and not mislead the public. The case against such approval is based entirely on questions surrounding the initiation of tobacco/nicotine use by children and teens. Here there have been fears and unsubstantiated allegations that such approval would substantially increase the numbers of teens initiating tobacco/nicotine use and/or serve as a gateway to cigarette smoking. The available evidence indicates that neither allegation would be true. FDA, in collaboration with others in the tobacco control community could virtually assure that current smokers could enjoy the benefits of a tobacco harm reduction program without adversely impacting teens if the tobacco harm reduction message is paired with universal prohibition of the sale of all tobacco and nicotine delivery products to teens and health education relative to the harms of nicotine addiction.

Risk posed by Smoke-free tobacco products: Older studies determined that the risk posed by smoke-free tobacco products is less than 10% of the risk posed by cigarettes, and likely, less than 1%.1-4 More recent reviews5-11 provide relative risks for cancer and cardiovascular diseases that are in the lower end of this range. While smoke-free tobacco products have “unacceptable cancer risk” according to toxicological assessments.12 such risk has not been detectable in more recent epidemiologic studies.

Smoke-free as a Gateway to Smoking: Critics of tobacco harm reduction believe that it will lead to increased teenage smokeless tobacco use, which will function as a “gateway” to smoking.13 However, there is no evidence for this concern in Sweden, where smokeless tobacco use has been high for many decades. A 2008 study of 3,000 adolescents from the Stockholm area by Galanti et al. found that “the majority of tobacco users (70%) started by smoking cigarettes” and “the proportion of adolescent smoking prevalence attributable to a potential induction effect of snus is likely small.”14 That same year the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks concluded that “The Swedish data…do not support the hypothesis that…snus is a gateway to future smoking.”15

In the U.S. teenagers who use smokeless tobacco are more likely than non-users to subsequently smoke.16,17 However, other American studies have concluded that smokeless tobacco is not a gateway to smoking among teenagers.18-20 OConnor et al. commented that “Continued evasion of the [harm reduction] issue based on claims that smokeless tobacco can cause smoking seems, to us, to be an unethical violation of the human right to honest, health-relevant information.”19

The major benefits of smoking, as seen by teens, include a rite of passage to adulthood – a way to “be grown up,” a way to be popular, glamorous, sexy, charming, tough, independent, and strong; and a way to feel at ease in a group or crowd.21 These themes are unlikely to apply to products such as snus and dissolvables, which are invisible to others while in use. They also seem unlikely to apply to the e-cigarettes which teens are likely to see as overly expensive and only an imitation of “real” cigarettes.

Thus, it seems unlikely that a well managed THR initiative would attract teens who otherwise would not initiate tobacco/nicotine use.


References

1. Royal College of Physicians of London, 2002, Protecting Smokers, Saving Lives <<http://www.rcplondon.ac.uk/pubs/books/protsmokers/index.asp> London> (Accessed 6 January 2009).
2. Levy D, Mumford E, Cummings K, et al. The relative risks of a low-nitrosamine smokeless tobacco product compared with smoking cigarettes; estimates of a panel of experts. Cancer Epidemiol Biomarkers Prev 2004;13:2035-42.
3. Phillips C, Sargent C, Rabiu D, Rodu B. Calculating the comparative mortality risk from smokeless tobacco vs. smoking. Am. J. Epidemiol. 2006;163(S189).
4. Nitzkin JL, Rodu B, 2008, 26 October, AAPHP Resolution and White Paper: The Case for Harm Reduction for Control of Tobacco-Related Illness and Death, in AAPHP Tobacco Issues <http://www.aaphp.org/special/joelstobac/20081026HarmReductionResolutionAsPassed1.pdf> (Accessed 3 August 2010).
5. Lee PN, Hamlin J, 2009, 29 July, Systematic Review of the Relation Between Smokeless Tobacco and Cancer in Europe and North America. BioMed Center Medicine;7(36), literature review <http://www.biomedcentral.com/1741-7015/7/36/abstract> (Accessed 17 August 2010).
6. Lee PN. Circulatory disease and smokeless tobacco in Western populations: A review of the evidence. Int. J. Epidemiol. 2007;36:789-804.
7. Boffetta P, Straif K. Use of smokeless tobacco and risk of myocardial infarction and stroke: Systematic review with meta-analysis. Br. Med. J. 2009 18 August;339(b3060):doi: 10.1136/bmj.b3060.
8. Lee P, Hamling J. The relation between smokeless tobacco and cancer in Northern Europe and North America. A commentary on differences between the conclusions reached by two recent reviews. BioMed Center Cancer 2009;9:256.
9. Piano MR, Benowitz NL, FitzGerald GA, Corbridge S, Heath J, Hahn E et al., 2010, 14 September, Impact of Smokeless Tobacco Products on Cardiovascular Disease: Implications for Policy, Prevention, and Treatment. Circulation;122, A Policy Statement from the American Heart Association <<http://circ.ahajournals.org/cgi/content/abstract/CIR.0b013e3181f432c3v1>> (Accessed 14 September 2010).
10. Rodu B, Nitzkin JL, 2010, 28 June, Update on the Scientific Status of Tobacco Harm Reduction, 2008-2010 Prepared for the American Association of Public Health Physicians, in Tobacco Issues Page on Http://Www.Aaphp.Org Web Site, Update to October 2008 AAPHP White Paper on Tobacco Harm Reduction <http://www.aaphp.org/special/joelstobac/2010/harmredcnupdatejuly2010.html> (Accessed 8 July 2010).
11. Bertuccio P, La Vecchia C, Silverman D, Petersen G, Bracci P, et al. Cigar and pipe smoking, smokeless tobacco use and pancreatic cancer: An analysis from the International Pancreatic Cancer Case-Control Consortium (PanC4). Ann. Oncol. 2011 18 January.
12. Yusuf O, Connolly G. Applying toxicological risk assessment principles to constituents of smokeless tobacco products; implications for product regulation. Tob. Control 2010 5/October.
13. Tomar S, Fox B, Severson H. Is smokeless tobacco use an appropriate public health strategy for reducing societal harm from cigarette smoking? Int J Environ Res Public Health 2009;6:10-24.
14. Galanti M, Rosendahl I, Wickholm S. The development of tobacco use in adolescence among "snus users" and "cigarette starters": An analysis of the Swedish "BROMS" cohort. Nicotine & Tobacco Research 2008;10:315-23.
15. Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), 2008, 6/February <http://ec.europa.eu/health/ph_risk/committees/04_scenihr-o-013.pdf> (Accessed 16/June 2011).
16. Tomar S. Is use of smokeless tobacco a risk factor for cigarette smoking? Nicotine & Tobacco Research 2003;5:561-9.
17. Severson H, Forrester K, Biglan A. Use of smokeless tobacco is a risk factor for cigarette smoking. Nicotine & Tobacco Research 2007;9:1331-7.
18. Timberlake D, Huh J, Lakon C. Use of propensity score matching in evaluating smokeless tobacco as a gateway to smoking. Nicotine & Tobacco Research 2009;11:455-62.
19. O'Connor R, Kozlowski L, Flaherty B, Edwards B. Most smokeless tobacco use does not cause cigarette smoking: Results from the 2000 National Household Suirvey on Drug Abuse. Addict Behav 2005;30:325-36.
20. Rodu B, Cole P. Evidence against a gateway from smokeless tobacco use to smoking. Nicotine & Tobacco Research 2010;12:530-4.
21. Centers for Disease Control and Prevention, 1998, MediaSharp, Print guide with DVDs and related materials <CDC - MediaSharp Guide and Modules - Smoking & Tobacco Use Atlanta, GA> (Accessed 10 August 2011).

 

[D103]

Excellent work Elaine, Bill and Dr. Whitt.

 

[Bill Godshall]

The American Council on Science and Health properly criticized CTFK/ACS/AHA/ALA/APHA for submitting irrational and unscientific comments to the FDA regarding MRTP applications at
Tobacco industry’s infamous past shouldn’t dictate smokeless tobacco’s hopeful future > Facts & Fears > ACSH