Monday, January 21, 2013

CASAA submits comments to the FDA

The Family Smoking Prevention and Tobacco Control Act (Tobacco Act) was structured to regulate cigarettes, smokeless tobacco, and “roll your own” under a newly created Center for Tobacco Products (CTP) and to continue regulation of so-called “Nicotine Replacement Products” (NRPs) products and other drugs to treat “tobacco addiction” under the Center for Drug Evaluation and Research (CDER.) http://www.govtrack.us/congress/bills/111/hr1256/text  

Sec. 918(b) of the FSPTCA requires the Secretary to submit a report to congress “that examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine-based products and treatments) to better achieve, in a manner that best protects and promotes the public health--
(A) total abstinence from tobacco use;
(B) reductions in consumption of tobacco; and
(C) reductions in the harm associated with continued tobacco use.”

Currently e-cigarettes are not regulated under either the CTP or CDER, but the CTP has announced that it intends to issue a deeming regulation that would bring e-cigarettes and other tobacco products under the Agency’s regulatory authority.

The FDA held a public hearing on Section 918 on Monday, December 17, 2012. Many THR advocates testified. See: http://www.e-cigarette-forum.com/forum/legislation-news/361023-more-details-analysis-fdas-december-17-hearing.html

The FDA will use the testimony that was given at the December 17 hearing, plus the written comments submitted by January 16, 2013 as input for the report to Congress required by the Tobacco Act. CASAA encouraged members to submit written comments. This resulted in over 5,300 comments made by CASAA members and other concerned citizens. 


Below are CASAA's submitted comments regarding FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence:


FDA Document ID: FDA-2012-N-1148-0011
Your Comment Tracking Number: 1jx-8359-2oya


The Consumer Advocates for Smoke-free Alternatives Association (CASAA) submits these comments as additional information to our testimony delivered at the December 17, 2012 public meeting that was held to solicit input for a report the Food and Drug Administration ("FDA") will submit to Congress in accordance with Section 918(b)(1) of the Federal Food, Drug, and Cosmetic Act ("FDCA").

The FDA and consumers share a common goal of reducing the prevalence of diseases and deaths caused by smoking. This can only be accomplished by finding ways to encourage and facilitate smoking cessation.

As CASAA’s slide presentation at the December 17, 2012 public meeting pointed out, the 2007 report by Tobacco Advisory Group of the Royal College of Physicians1 explained that nicotine abstinence is unworkable for some smokers—especially those who are self-medicating underlying conditions that impair their cognitive and/or emotional health. Some smokers will never be able to give up all use of nicotine.

We know that the most significant health problems associated with tobacco use are in connection with smoking. The use of smokeless tobacco and nicotine in non-combusted forms are inherently less dangerous than smoking. The practice of Tobacco Harm Reduction, encouraging substitution of low-risk alternative nicotine delivery mechanisms for smoking, could save millions of lives.

Consumers, however, have not seen any evidence that the FDA’s Center for Tobacco Products (CTP) is willing to consider any method for smoking cessation other than complete nicotine abstinence. Many of CASAA’s members were early adopters of the innovative products known as electronic cigarettes (e-cigarettes). We were thrilled that after years of struggling to stop inhaling smoke, we finally found something that worked.

To our great surprise, in 2008 we learned that the FDA was causing incoming shipments of electronic cigarettes to be seized. At first we thought that we could count on help from those organizations that had been nagging us for years to quit. In our naivety, we thought they would be happy that we finally found a way to a healthier lifestyle. We were shocked and appalled when we learned that the American Cancer Society wasn’t interested in helping us avoid cancer, that the American Lung Association wasn’t interested in our improved lung health, that the American Heart Association didn’t care that we had reduced our risks of heart attacks and strokes, and that Campaign for Tobacco-free Kids didn’t care that we reduced the exposure to smoke of our children and were modeling abstinence from smoking. Instead, those organizations colluded to bring pressure on the FDA to ban e-cigarettes.

FDA’s propaganda campaign against E-cigarettes

The FDA demonstrated its prejudice against e-cigarettes (and its lack of concern for the health and well-being of consumers who use them) by greatly exaggerating and sensationalizing the significance of findings in lab tests of 18 samples of two brands of e-cigarettes in 2009. (We do not believe it is a coincidence that the only two brands of e-cigarettes the FDA chose to analyze were manufactured by the two companies that had filed suit against the FDA.) In fact the FDA’s cleverly-worded press release gave the impression that e-cigarettes were more likely to trigger cancer or poison users than continued smoking.2

Tobacco-specific Nitrosamines (TSNAs) were referred to as “carcinogens” in the press release with no mention being made that the same “carcinogens” are present in FDA-approved NRT products in roughly equivalent amounts and are present in tobacco smoke in quantities thousands of times higher. Withholding this vital information is a lie by omission.

In that same press statement, completely unfounded suspicions were stated as though they were proven facts. There was not (and still is not) a shred of evidence to support the FDA's assertion in that press release that, “These products are marketed and sold to young people.” In fact, according to surveys, it is clear that e-cigarettes are aimed at adult smokers to be used as an alternative to inhaling smoke. (For example, see a survey conducted by smoking-cessation researchers and specialists Jean-Fran├žois Etter and Chris Bullen.3 The mean age of the 3587 participants was 41 years. In another survey with 2,217 participants conducted by CASAA, 50.9% were between the ages of 30 and 50 years. Another 24.7% were over the age of 50. 4)

The press release indicated that the FDA viewed the availability of pleasant flavors, such as chocolate and mint, as proof that the manufacturers and vendors of e-cigarettes were targeting their products to children. In actual fact, however, adults don’t eschew products that taste good. To the contrary, the pleasant flavors play an important role in the acceptability of the products as a substitute for smoking by the adult consumers of the products. In CASAA’s survey, 55% of the 2,168 respondents indicated that pleasant flavors are moderately, very, or extremely influential in their continued use of e-cigarettes, and 51.9% use such flavors regularly, often, or always.

In short, it appeared that the U.S. Government was essentially telling smokers, “It’s safer for you to just keep smoking.” Furthermore, by making an unsupported and unwarranted accusation of target marketing to minors, the FDA engaged in blatant propaganda to poison the court of public opinion against e-cigarettes.

The FDA web page “E-Cigarettes: Questions and Answers” continues the fiction that e-cigarettes lead children to use of real tobacco products, again without a scintilla of evidence: “Experts have also raised concerns that the marketing of products such as e-cigarettes can increase nicotine addiction among young people and may lead kids to try other tobacco products. Visit FDA’s Electronic Cigarettes webpage for additional information.”5

Scientific research does not support the validity of FDA’s concern about e-cigarettes addicting young people. Vansickel and Eissenberg assessed the abuse liability of e-cigarettes and found, “Electronic cigarettes can deliver clinically significant amounts of nicotine and reduce cigarette abstinence symptoms and appear to have lower potential for abuse relative to traditional tobacco cigarettes, at least under certain laboratory conditions.”6 To date, no research has contradicted that finding.

The “E-cigarette Questions and Answers” page also demonstrates that FDA has no idea about the make-up of e-cigarette consumers and what experiences they have been through. The last Q&A on the page advises smokers to use FDA-approved products “to reduce their dependence on nicotine.” The FDA appears to be unaware that the smokers most drawn to e-cigarettes are those for whom the government-approved products and methods—all of which ultimately require complete abstinence from nicotine--failed to work, despite numerous attempts.

The FDA appears to be unaware that the smokers most drawn to e-cigarettes are those for whom the government-approved products and methods—all of which ultimately require complete abstinence from nicotine—failed to work, despite numerous attempts or who simply decided that they would rather smoke than give up nicotine.

Tobacco Control Act provisions for harm reduction

Many provisions in the Tobacco Control Act were written to prevent the proliferation of hazardous combusted tobacco cigarettes. They were not written for the purpose of preventing low-risk alternatives from being brought to market. In fact, the Tobacco Control Act recognizes the need for Tobacco Harm Reduction in two sections of the act.

Section 918 calls for a report that examines how best to regulate, promote, and encourage the development of innovative products and treatments that lead not only to total abstinence, but also to reductions in consumption of tobacco, and reductions in the harm associated by continued tobacco use. E-cigarettes are the epitome of an innovative product and use of e-cigarettes has led to reductions in smoking as well as smoking cessation.7 8 9 10 11

In view of the fact that smokers are developing debilitating diseases and dying on a daily basis, the law recognized that time is of the essence. Section 918 calls for the Agency to consider fast track research and approval of innovative products.

Section 911 specifically addresses Modified Risk Tobacco Products. The law states, “The term ‘modified risk tobacco product’ means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.” In subsection ‘(l) Implementing Regulations or Guidance-, the law calls upon the Secretary to “issue regulations or guidance (or any combination thereof) on the scientific evidence required for assessment and ongoing review of modified risk tobacco products.”

Consumers are concerned that the FDA will propose regulations that will, in effect, thwart Congress' clear intent that the concepts of Tobacco Harm Reduction be embraced.

No evidence that FDA wants to implement harm reduction

FDA’s 50-page Guidance for Industry: Modified Risk Tobacco Product Applications12 describes a process that appears to be quite time-consuming as well as expensive. Consumers believe that the FDA has made the process needlessly complex and it will have the result of undermining the goals of Tobacco Harm Reduction in favor of continuing to require total nicotine abstinence.

The Guidance makes no mention of providing a way to “fast track” promising products. For example, it completely ignores Sec. 911(2) SPECIAL RULE FOR CERTAIN PRODUCTS that allows for the Secretary to approve a product for marketing when “the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies.”

One section of the Tobacco Control Act would allow the FDA to apply the provisions of the law appropriately to different circumstances.
SEC. 5. SEVERABILITY.
If any provision of this division, of the amendments made by this division, or of the regulations promulgated under this division (or under such amendments), or the application of any such provision to any person or circumstance is held to be invalid, the remainder of this division, such amendments and such regulations, and the application of such provisions to any other person or circumstance shall not be affected and shall continue to be enforced to the fullest extent possible.
Judging from the totally negative information about e-cigarettes posted on the FDA’s web site, consumers have seen no indication that the FDA intends to permit, much less encourage, continued marketing of these life-saving products.

FDA’s deeming announcement

FDA’s announcement, “Regulation of E-Cigarettes and Other Tobacco Products,”13 signed by CTP Director Lawrence Deyton and CDER Director Janet Woodcock, cites several provisions of the law that the Agency intends to apply to “other tobacco products” (including e-cigarettes):
Section 201(rr)(4), for example, prohibits the marketing of a “tobacco product” in combination with any other article or product regulated under the FD&C Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement).
This is disturbing, as it indicates that the FDA may continue its efforts to ban e-cigarettes by using the argument that e-cigarette liquid is being delivered in combination with a battery and atomizer.
The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”
Registration, product listing, ingredient listing, and good manufacturing requirements are reasonable controls. However, most e-cigarette companies are small businesses that cannot afford the level of user fees levied on huge corporations. The mention of premarket review requirements for “new tobacco products” sends up a red flag.
“Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent. FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.”
These provisions of the Tobacco Control Act were written to prevent the proliferation of hazardous combusted tobacco cigarettes. In view of the fact that e-cigarettes are not combusted and are innovative products likely to be much less hazardous, applying these inappropriate controls would have the effect of outlawing all except for the first primitive models which had leaky cartridges, batteries that died too quickly, and other quality control issues.14

Nothing within the deeming announcement even hints at the idea that the CTP will be tailoring regulations to fit these innovative products. Applying them all exactly as written would decimate the e-cigarette industry. The effect on consumers would be devastating, creating a public health crisis instead of helping to solve one.

Recommendations for report to Congress

Not all smokers want to“quit completely” (i.e., give up the beneficial effects of nicotine), but many would like to reduce their odds of developing a smoking-related disease. The harm reduction mechanisms in the Tobacco Control Act were intended to provide help for smokers such as these.

Encourage switching: The report should recommend that the Department of Health and Human Services be directed to take steps to encourage smokers who will not choose abstinence over smoking to switch to a non-combusted product. Switching to a non-smoked method of nicotine delivery will improve public health by reducing exposure to the harmful elements in smoke, thereby reducing the prevalence of smoking-related diseases. This should be reflected on the web sites of all Agencies under the DHHS.

Require accurate communication: Agencies entrusted with public health responsibilities should present complete and accurate information to the public. Congress should require the Department of Health and Human Services to correct all web pages that present inaccurate and/or misleading health information, starting with the most egregious misinformation on a page titled “Tobacco Products: Health Fraud. 15

The “Health Fraud” page 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.

There is overwhelming epidemiologic and other evidence that using smokeless tobacco products rather than smoking reduces the risk of disease. On October 26, 2010, the FDA held a Public Workshop on Risks and Benefits of Long-term Use of Nicotine Replacement Therapy (NRT). Dr. Neal Benowitz presented a summary of the health effects of using smokeless tobacco (ST). Extrapolating from ST studies, he addressed questions of nicotine safety. He reported that that is no evidence that ST use causes or promotes cancer, that nicotine may slightly increase the risk of MI and stroke (but if so, risks are far lower than from cigarette smoking), but that nicotine may increase the risk of pre-eclampsia and preterm birth.16

If the FDA is willing to extrapolate this evidence to provide assurance that long-term use of NRT is not particularly harmful and certainly is less harmful than smoking, there is no reason why this evidence should not be applied to the use of ST (after all, this is where the evidence came from in the first place) and to the use of other smoke-free delivery mechanisms for nicotine such as ecigarettes.

Although there are more tobacco users among adults in Sweden, the Lung Cancer Mortality Rages (LCMR) in the US are nearly twice as high. Swedish men have LCMR of 33.6 per 100,000. American men have LCMR of 63.6 per 100,000. The LCMR for Swedish women is 18.6 per 100,000, while American women have an LCMR of 39 per 100,000.

Studies of ST use in Sweden, Norway, and the US clearly show a lower risk of all smoking-related diseases among ST users.

The “Health Fraud” page also states: Claiming less harm or reduced risk of disease from using tobacco products misleads consumers to think that these products are safe to use.

Alternative products don’t need to be 100% safe. They only need to be somewhat less hazardous than continuing to smoke. Refusing to acknowledge that non-combusted sources of nicotine are lower in risk misleads consumers to think that if all products are equally hazardous, they might as well continue to smoke. It is unacceptable for the FDA to mislead consumers. Consumers are entitled to accurate information about the relative risks of various tobacco and nicotine-containing products so that they can make informed decisions.

Hardware is not tobacco: The report to Congress should note that the FDA is ill-equipped to regulate a high-tech product such as electronic cigarette hardware. High-tech products are never ideal when they are first brought to market. Such products evolve rapidly in response to feedback from consumers. Many of the products now being mass-manufactured were the result of consumers experimenting with product improvements. These products are still evolving and improving, and it would be in the best interests of public health to allow these improvements to continue.

In contrast, the products regulated by the FDA are expected to remain exactly the same, year after year. New Product Approval guidance issued by CTP indicates that any product change, even a minor one, triggers the need for new rounds of testing and stacks of paperwork.

Acknowledge current regulatory controls: The report to Congress needs to acknowledge that electronic cigarettes are already being regulated by the U.S. Department of Transportation (DOT) and the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). The DOT is regulating the safe transport of the lithium ion batteries used in e-cigarettes. CFSAN regulate the safety of the liquids used in e-cigarette. The law requires all companies that produce products for human consumption to register their facility and operations with the U.S. Food & Drugs Administration pursuant to Section 305 of the Bioterrorism Act of 2002, P.L. 107-188. Further, all information pertaining to a company's address and nature of business must be current with FDA at all times.

In addition, a group of small and medium-sized vendors have recently established testing and mixing standards that will be rolled out in 2013. These regulations are not onerous but would still protect public health.17

Overseas facilities: Now that FDA’s authority has been expanded by the Food Safety Modernization Act (FSMA), the Agency will be able to apply the same manufacturing and safety standards to foreign labs that supply e-liquid as are currently required of e-liquid manufacturers based in the U.S. under P.L. 107-188.

MRTP approval problems: The MRTP process outlined by CTP appears to be a dead end for ecigarettes. It isn’t designed to be “fast track.” Also, there’s a Catch-22 in the process. Tobacco companies cannot submit a product for MRTP consideration without having conducted numerous types of testing including clinical trials. The Institute of Medicine recommended that third parties conduct testing. However, nearly all of the entities that conduct clinical trials for pharmaceutical companies have adopted policies against accepting any funding from tobacco companies.

If the FDA simply declares e-cigarettes to be a tobacco product without substantial tailoring of regulations, e-cigarette companies also will be hamstrung when it comes to proving that their products are lower in risk than continued smoking. Despite the fact that the definition of “tobacco product” could be gerrymandered to include e-cigarettes while excluding pharmaceutical nicotine products, the fact is that e-cigarettes are not made of and do not contain tobacco. It is doubtful whether any innovative product could meet MRTP approval requirements.

Additional concerns about regulation of e-cigarettes

There is a growing body of scientific evidence showing that e-cigarettes are being used effectively as a partial or complete replacement for smoked tobacco cigarettes. The evidence shows that smokers who switch to e-cigarettes (even if only partially) are seeing improvements in their physical health commensurate with having reduced or stopped intake of tobacco smoke.

Consumers want to see this phenomenon continue and expand, to help save the lives of as many smokers as possible. Toward that end, consumers respectfully request to be included in the regulatory process.

We are concerned that, lacking accurate information, the FDA will propose regulations that will work to destroy the effectiveness of the products. In its public communications, the Agency has mentioned several unfounded allegations against e-cigarette companies and against the products themselves.

Consumers need the opportunity to express their needs and e-cigarette companies need the opportunity to respond to the concerns of “public health experts.” Regulations should be based on verified facts and adequate data to show that a problem exists, as well as a scientifically conducted risk-benefit analysis of proposed solutions. An optimum solution can only be reached if all affected stakeholders are allowed to participate in the dialog, and there is no stakeholder with a greater interest in this process than the consumer.

Without significant involvement from all stakeholders (including consumers), it is all but inevitable that bad decisions will be made. For example, the European Union has proposed a regulation to limit nicotine strength of e-cigarette liquid to 4 mg / ml, with no more than 2 mg present in a cartridge. Perhaps the EU is under the impression that there is a one-to-one correspondence of a cartridge with a single tobacco cigarette. Vaporizing a milliliter of ecigarette liquid typically requires 200-300 puffs, representing replacement of an entire pack of cigarettes. This would not be sufficient nicotine to serve as an acceptable substitute for smoking for more than a tiny fraction of smokers. If the EU implements this restriction, the outcome will
be the relapse of many former smokers and/or the emergence of a completely unregulated black market to meet the needs of consumers.

E-cigarettes are not a pharmaceutical product, because they are not intended to treat a disease or condition. Despite the fact that the definition of “tobacco product” could be stretched (very broadly) to include e-cigarettes, the fact is that e-cigarettes are not made of and do not contain tobacco. They are not known to carry any greater risk of harm than pharmaceutical nicotine products.

The FDA appears to be trying to use the Tobacco Control Act as a bludgeon to kill off the products, when its harm reduction provisions could be used as a tool to save lives. On the FDA’s web page, What We Do, after describing the FDA’s responsibility for medicines and foods, tobacco is given a vary narrow target. “FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.” 18

Again, the FDA perpetuates the fiction that all tobacco products are equally harmful by making the target “tobacco use” rather than “smoking.” But what is even more disturbing is that the FDA intends to help only minors, apparently leaving current smokers to quit or die. Sadly, millions of lives have already been lost because the government insists on obfuscating the fact that smokeless tobacco products have a significantly lower risk profile than smoking. E-cigarettes are an innovation that could save millions of lives by serving as an extremely low risk substitute for smoking.

The FDA needs to show that it values the lives and health of humans of all ages. A more appropriate mission statement would be “FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect public health by providing prompt approval of low-risk innovative products and modified risk tobacco products that can facilitate smoking cessation.”

Respectfully submitted,

Elaine D. Keller, President
The Consumer Advocates for Smoke-free Alternatives Association
8094 Rolling Rd, #100
Springfield, VA 22153
(202) 241-9117
http://casaa.org
ekeller@casaa.org


SOURCES
1 Tobacco Advisory Group of the Royal College of Physicians, October 2007. Harm reduction in nicotine addiction: Helping people who can't quit. ISBN 978-1-86016-319-7
2 http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm173222.htm
3 Etter JF, Bullen C. Electronic cigarette: users profile, utilization, satisfaction and perceived efficacy. Addiction, 106: 2017–2028.
4 Consumer Advocates for Smoke-free Alterantives Association (CASAA), E-cigarette consumer survey, 2010. https://www.surveymonkey.com/sr.aspx?sm=HrpzL8PN5cP366RWhWvCTjggiZM_2b8yQJHfwE9UXRNhE_3d
5 http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm225210.htm
6 Vansickel AR, Weaver MF, Eissenberg T. Clinical laboratory assessment of the abuse liability of an electronic cigarette. Addiction. 2012 Jan 9.
7 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 crossover trial. Tob Control. 2010 Apr;19(2):98-103. http://www.healthnz.co.nz/2010%20Bullen%20ECig.pdf
8 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. http://www.endsmoking.org.nz/IJCMecigsDepressionJuly2011.pdf
9 Darredeau C, Campbell M, Temporale K, et al. Subjective and reinforcing effects of electronic cigarettes in male and female smokers. 12th annual meeting of the Society for Research on Nicotine and Tobacco Europe. Bath, UK, 2010. https://secure2.symphonyem.co.uk/CMS/UserDocuments/899/Cathy%20Book1-121%20.pdf
10 Dawkins L, Turner J, Hasna S, Soar K. The electronic-cigarette: Effects on desire to smoke, withdrawal
symptoms and cognition. Addict Behav. 2012 Aug;37(8):970-3. http://www.ncbi.nlm.nih.gov/pubmed/22503574
11 Polosa R, Caponnetto P, Morjaria J B, Papale G, Campagna D, Russo C: Effect of an Electronic Nicotine Delivery Device (e-Cigarette) on Smoking Reduction and Cessation: A Prospective 6-Month Pilot Study. BMC Public Health 2011, 11:786. http://www.biomedcentral.com/content/pdf/1471-2458-11-786.pdf
12 http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM297751.pdf
13 http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm
14 Trtchounian A, Talbot P. Electronic nicotine delivery systems: is there a need for regulation? Tob Control. 2011 Jan;20(1):47-52. doi: 10.1136/tc.2010.037259. Epub 2010 Dec 7. http://www.ncbi.nlm.nih.gov/pubmed/21139013
15 http://www.fda.gov/TobaccoProducts/ResourcesforYou/ucm255658.htm
16 http://www.fda.gov/downloads/Drugs/NewsEvents/UCM232147.pdf
17 http://www.aemsa.org/


ATTACHMENTS
CASAA Attachment A – ST Pancreatic Cancer Risk
Bertuccio 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 Jun;22(6):1420-6. doi: 10.1093/annonc/mdq613. Epub 2011 Jan 18.
Conclusion: This collaborative analysis provides evidence that cigar smoking is
associated with an excess risk of pancreatic cancer, while no significant association
emerged for pipe smoking and smokeless tobacco use.
CASAA Attachment B – Depression Prevents Cessation
Weinberger AH, Mazure CM, Morlett A, McKee SA. Two Decades of Smoking
Cessation Treatment Research on Smokers with Depression: 1990-2010. Nicotine Tob
Res. 2012 Oct 25.
Conclusion: Although attention to the relationship of depression and smoking cessation
outcomes has increased over the past 20 years, little information exists to inform a
treatment approach for smokers with Current Major Depressive Disorder, Dysthymia, and
Minor Depression.
CASAA Attachment C – Promise of Nicotine Inhalation Devices
Caldwell B, Sumner W, Crane J. A systematic review of nicotine by inhalation: is there a
role for the inhaled route? Nicotine Tob Res. 2012 Oct;14(10):1127-39. Epub 2012 Feb
29.
Results: The pharmacokinetic profiles of portable nicotine inhalers were inferior to
smoking, but among commercially available products, electronic cigarettes are currently
the most promising.
CASAA Attachment D – FDA Tests on E-Cigarettes
Whelan E. FDA smokescreen on e-cigarettes. Washington Times, 2009 Aug 6.
Conclusion: Cigarette smoking remains the leading cause of preventable disease and
death in the United States today. Any alternative acceptable to addicted smokers should
be taken seriously. Instead of condemning the e-cigarette, the FDA should be sponsoring
studies to evaluate its safety and efficacy -- leaving it on the market in the interim.
Consumer Advocates for Smoke-free Alternatives Association FDA-2012-N-1148
January 16, 2013 Page 12 of 12
CASAA Attachment E – Bullen-Etter Survey
Etter JF, Bullen C. Electronic cigarette: users profile, utilization, satisfaction and
perceived efficacy. Addiction, 106: 2017–2028.
Conclusions. E-cigarettes were used much as people would use nicotine replacement
medications: by former smokers to avoid relapse or as an aid to cut down or quit
smoking. Further research should evaluate the safety and efficacy of e-cigarettes for
administration of nicotine and other substances, and for quitting and relapse prevention.
CASAA Attachment F – Smokeless Tobacco Safety
Benowitz N. 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. 2010 Oct 26.
So, my reading of the smokeless tobacco literature is that there is no evidence that
nicotine per se causes or promotes cancer. Nicotine might slightly increase the risk of
myocardial infarction and stroke. If so, the risks are far lower than those of cigarette
smoking. Nicotine does likely have adverse effects on reproduction, including increasing
the risk of preeclampsia and pre-term birth.
CASAA Attachment G – Scientific Foundations for THR
Rodu B. The scientific foundation for tobacco harm reduction, 2006-2011. Harm
Reduction Journal 2011, 8:19.
Applying harm reduction principles to public health policies on tobacco/nicotine is more
than simply a rational and humane policy. It is more than a pragmatic response to a
market that is, anyway, already in the process of undergoing significant changes. It has
the potential to lead to one of the greatest public health breakthroughs in human history
by fundamentally changing the forecast of a billion cigarette-caused deaths this century.
CASAA Attachment H – Chronic Disease Mortality ST Users
Accortt NA, Waterbor JW, Beall C, Howard G. Chronic disease mortality in a cohort of
smokeless tobacco users. Am J Epidemiol. 2002 Oct 15;156(8):730-7.
The mortality experience of smokeless tobacco users was not significantly greater than
that of non-tobacco users and was appreciably less than that of cigarette smokers.

3 comments:

Duster6524 said...

LOVE IT!!!
This is a PERFECT follow up to the testimony given at the hearing!
Keep up the good fight!
Mark Pillion

Shasta Vape said...

Thank you Elaine for all you do!! You have wonderful people around you to help with all the research involved, kudos to them as well!!!

Teresa Haas said...

I am a 49 year old woman who has smoked for 30 plus years. I have acute asthma and COPD. Smoking cigarettes was KILLING ME. I just started with the e-cigarette a week ago and already have noticed a DRASTIC improvement in my ability to BREATHE. For those that don't (for some reason) understand, breathing is IMPORTANT! In this past week, I have gone from using my "rescue" inhaler 5-6 times per day to just once or twice. That tells me my lungs are working better. I also have not had to use my oxygen at all this past week. HOW can this be as harmful to me as smoking? I honestly believe that the use of the electronic cigarettes is a LIFE SAVER to me! I know my energy levels are greatly improved. My outlook on LIFE is greatly improved. I feel I can now look forward to getting back to LIVING like I once did. I can now look forward to living long enough to not only see my grandchildren but have the lung capacity to ENJOY and HAVE FUN with them!

Thank you for the fight you are putting up for our rights to CHOOSE.