Saturday, June 23, 2012

CASAA Member Meeting Sunday 6-24-12

What: CASAA Member Meeting
Where: GoToWebinar link
When: Jun 24, 7:30 PM - 9:00 PM Eastern


Register Now at: https://www3.gotomeeting.com/register/204379094 


Once registered you will receive an email confirming your registration with information you need to join the Webinar. 


System Requirements 
PC-based attendees 
Required: Windows® 7, Vista, XP or 2003 Server 
Macintosh®-based attendees 
Required: Mac OS® X 10.5 or newer

Thursday, June 21, 2012

NY Legislature OKs ban on e-cigarettes for minors, but not all sales ban


ALBANY, N.Y. 
If Governor Cuomo signs a new bill into law, New York will join Alaska, Idaho, Kansas and Maryland in restricting the sale of e-cigarettes to minors.
Assemblywoman Linda Rosenthal, a Manhattan Democrat, pushed the bill that passed in her house. She said in an AP article that she was "baffled" by a last minute dispute with the Republican-controlled Senate.          
Today, the last day of the legislative session, the Senate passed the bill 60-0.

The passage of S2926B will likely stop the advancement of another e-cigarette bill, S07635, which was introduced just two weeks ago by Republican New York State Senator Kemp Hannon. CASAA had issued a member Call to Action against S07635, which would have banned all sales and advertisement for sale of electronic cigarettes in New York. Such a ban would have left hundreds of thousands of adult e-cigarette users and smokers without means to purchase the devices from businesses located in the state. 
It is unknown why Senator Hannon would suddenly push for a complete ban on a product that most tobacco harm reduction experts agree are a much safer alternative for adult smokers. It is estimated that there are nearly 3 million electronic cigarette users in the U.S., thousands of whom reported in surveys that they have experienced improved health and no significant negative health effects since replacing their traditional cigarettes with the smoke-free devices.
"Instead of benefiting the public health, [banning e-cigarette sales to adult consumers] would force New York e-cigarette users to return to smoking cigarettes or to travel across state lines to buy e-cigarettes from a newly created illicit market,"  stated a letter from CASAA, regarding S07635, to the Senate Rules Committee.                                                              
However, CASAA enthusiastically supported the passage of S02926B and A 9044-B that would ban the sale to minors.  

"Although there is no evidence that e-cigarettes are particularly attractive to minors or that e-cigarette suppliers are marketing to minors," stated a CASAA spokesperson, "of course we support efforts to keep potentially addicting tobacco and nicotine products away from children."

Monday, June 18, 2012

FDA Regulation Could Make E-Cigarettes Less Effective


E-cigarette designs have changed and improved dramatically
since the introduction of the original "cigarette look alikes."
Photo Credit: youtubecommercial on ECF
By
Elaine Keller

In an April 25, 2011 letter to stakeholders, the FDA described its intention to regulate electronic cigarettes (e-cigarettes) “and other tobacco products.” The FDA plans to impose Section 905(j) of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) on e-cigarettes. Specifically, the FDA will consider any product that was not being marketed before February of 2007 a “new tobacco product and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action.”
Translation: The FDA failed to ban e-cigarettes by regulating them as drug-delivery devices, so the Agency has found a way to ban all but the most primitive early models of e-cigarettes by applying a section of the law that is inappropriate for this type of product. Section 905(j) was intended to stop the proliferation of new brands of combusted cigarettes.
Unlike tobacco cigarettes, e-cigarettes are high tech devices. Compare the features and performance of the computers or cell phones being sold five years ago to today’s products. Technology develops at a very rapid pace. The batteries in the 2007 models of e-cigarettes went dead after a couple of hours. Cartridges were poorly constructed and often leaked nicotine-laced liquid onto the user’s skin and even into the user’s mouth. Vapor production was sluggish, and as the liquid levels in the cartridge went down, users needed to inhale more and more strongly to produce vapor.
Researchers at the University of California, Riverside, documented these product deficiencies. [Trtchounian A, Williams M, Talbot P. Conventional and electronic cigarettes (e-cigarettes) have different smoking characteristics. Nicotine Tob Res. 2010 Sep;12(9):905-12. Epub 2010 Jul 19. http://www.ncbi.nlm.nih.gov/pubmed/20644205]
Today’s products are a vast improvement on the original models. Larger and more powerful batteries last all day, and even several days for some users. Modern designs that don’t contain the fibrous filling used in the original products eliminate the need to increase puff intensity as the liquid is used up. Clever inventors have figured out ways to eliminate the leakage that plagued the original products.
More importantly, today’s products are more effective than their predecessors. Many people tried to use the early models of e-cigarettes as a replacement for smoking and were unable to do so, mostly due to inadequate vapor production and inefficient delivery of nicotine.
In order for a product that was not on the market prior to February 2007 to be approved for sale, it must prove that it is “substantially equivalent” to a “grandfathered” product that was being sold. FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.” http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM239021.pdf
“Substantial Equivalence,” according to the Guidance document, means that the new product has the same characteristics as the predicate tobacco product, or has different characteristics and the report submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates the product does not raise different questions of public health.
The FDA defines Characteristics as “the materials, ingredients, design, composition, heating source, or other features of a tobacco product.” So the definition of characteristics is extremely broad, the required proof may be time-consuming and expensive to gather, and the criteria for approval is highly subjective.
How long will it take before there is a government stamp of approval on modern, effective e-cigarette models? Many long-time smokers don’t have any time to waste. The damage has already started and will continue until they find a way to stop inhaling smoke.

Wednesday, June 13, 2012

New York State Call to Action (Ended)


UPDATE: Thanks to the hard work of CASAA members, the New York State Legislature ended their session by passing A9044-B, which bans the sale of e-cigarettes to minors.  A9044-B, which would have senselessly banned sales of e-cigarettes to adults, failed to pass.




New York State Senator Kemp Hannon has proposed Bill S07635  (Linkhttp://open.nysenate.gov/legislation/bill/S7635-2011).
This bill would:
If enacted, prohibit all sales of electronic cigarettes. It amends New York Public Health Law, §1399-11, enacted in August 2000, which prohibited cigarette sellers and common carriers from shipping cigarettes directly to consumers.

The bill was introduced in the Health Committee and may be referred to the Rules Committee which meets daily. Thus it could be sent to the full Senate at any time. So it is urgent that messages be sent to members of the Rules Committee immediately.


NOTE: You do not need to include all of the items listed below, but the first two are vital.

What to say:
1. Let them know that you strongly oppose S07635 that would ban all electronic cigarette sales, but that you do support a ban on sales to minors. Senator Johnson's S02926B (same as A 9044-B introduced by Assemblymember Linda Rosenthal) would appropriately ban sales to minors while keeping the products available to adults as a reduced-risk alternative to smoking.


2. Tell your story on how switching from smoking cigarettes to a far less hazardous alternative product has changed your life. When and why did you start using an e-cigarette? What effect has this had on your smoking of tobacco cigarettes? What has been the effect on your health?


3. Explain that research has consistently shown that virtually all e-cigarette users are using them as a substitute for smoking. The vast majority tried to quit smoking multiple times, using the other methods available and failed.


4. Tell them that there are an estimated 250,000 e-cigarette users in New York. Many, deprived of the ability to purchase e-cigarettes in New York, will return to the far more hazardous act of smoking since tobacco cigarettes will, ironically, continue to be readily available in New York.


5. Tell them that e-cigarettes have been shown to pose so little health risk that it is below what can be measured and no one has even tried to estimate it.
a.     Claims about chemical contamination are vastly overblown. Some of the supposed contaminants occur as such incredibly low levels that they are barely measurable using the most modern instruments.
b.    Pharmaceutical nicotine products like patches and nicotine gum contain about the same quantities of “carcinogens” as a gram of e-cigarette liquid—about 8 nanograms. In contrast, a pack of Marlboro cigarettes contains 126,000 nanograms.
6. Tell them that cigarette lighters and home fires started by smoking tobacco cigarettes cause far more injuries than e-cigarettes have. According to one study, well over a thousand people are injured per year due to defective lighters [news story], and over 1,000 people are killed by fires caused by smoking [FEMA].

7. As for smoking itself, on average, it is estimated that smoking for just a couple of months poses a greater health risk than a lifetime of using a smoke-free nicotine or tobacco product.

6. Direct them to the CASAA.org website for more information.


Please call, write or fax the members of the New York Senate Rules Committee below.

Kemp Hannon (sole sponsor and member of Senate Rules Committee)
hannon@nysenate.gov
The Capitol Room 420
Albany, NY 12247
Phone: 518-455-2200

Chair: Sen. Dean G. Skelos (chairman of Senate Rules Committee)
skelos@nysenate.gov
Legislative Office Building, Room 909
Albany, NY 12247
Phone: (518) 455-3171

James S. Alesi
alesi@nysenate.gov
Room 512, Legislative Office Building
Albany, NY 12247
Phone: (518) 455-2015
Fax: (518) 426-6968


Neil D. Breslin
breslin@nysenate.gov
172 State Street Room 413, Capitol
Albany, NY 12247
Phone: (518) 455-2225

Martin Malavé Dilan
dilan@nysenate.gov
188 State Street Room 903, Legislative Office Building
Albany, NY 12247
Phone: (518) 455-2177
Fax: (518) 426-6947

Thomas K. Duane
duane@nysenate.gov
181 State Street Room 711-B Legislative Office Building
Albany, NY 12247
Phone: (518) 455-2451
Fax: (518) 426-6846

Hugh T. Farley
farley@nysenate.gov
188 State Street Room 711, Legislative Office Building
Albany, NY 12247
Phone: (518) 455-2181
Fax: (518) 455-2271

Charles J. Fuschillo Jr.
fuschill@nysenate.gov
188 State Street Room 609, Legislative Office Building
Albany, NY 12247
Phone: 518-455-3341

Ruth Hassell-Thompson
hassellt@nysenate.gov
188 State Street Room 707 Legislative Office Building
Albany, NY 12247
Phone: (518) 455-2061
Fax: (518) 426-6998

Owen H. Johnson
ojohnson@nysenate.gov
188 State Street Room 913 Legislative Office Building
Albany, NY 12247
Phone: (518) 455-3411
172 State Street Room 905 Legislative Office Building
Albany, NY 12247
Phone: (518) 455-2297
Fax: (518) 426-6874

William J. Larkin Jr.
larkin@nysenate.gov
188 State Street Room 502, Senate Capitol Building
Albany, NY 12247
Phone: (518) 455-2770

Kenneth P. LaValle
lavalle@nysenate.gov
188 State Street Room 806, Legislative Office Building
Albany, NY 12247
Phone: (518) 455-3121
429 Capitol
Albany, NY 12247
Phone: (518) 455-2677

Carl L Marcellino
marcelli@nysenate.gov
188 State Street Room 811, Legislative Office Building
Albany, NY 12247
Phone: (518) 455-2390

George D. Maziarz
maziarz@nysenate.gov
Room 708, Legislative Office Building
Albany, NY 12247
Phone: (518) 455-2024

Velmanette Montgomery
montgome@nysenate.gov
944 Legislative Office Building
Albany, NY 12247
Phone: (518) 455-3451
Fax: (518) 426-6854

Michael F. Nozzolio
nozzolio@nysenate.gov
188 State Street Room 412, Legislative Office Building
Albany, NY 12247
Phone: (518) 455-2366
Fax: (518) 426-6953

Kevin S. Parker
parker@nysenate.gov
188 State Street Room 604, Legislative Office Building
Albany, NY 12247
Phone: (518) 455-2580
Fax: (518) 426-6843

Bill Perkins
perkins@nysenate.gov
188 State Street Room 517, Legislative Office Building
Albany, NY 12247
Phone: 518-455-2441
Fax: 518-426-6809

Stephen M. Saland
saland@nysenate.gov
State Street Room 504 - Capitol
Albany, NY 12247
Phone: 518-455-2411

John L. Sampson
sampson@nysenate.gov
188 State Street Room 907, Legislative Office Building
Albany, NY 12247
Phone: (518) 455-2788
Fax: (518) 426-6806

James L. Seward
seward@nysenate.gov
172 State Street Room 430, Capital
Albany, NY 12247
Phone: 518) 455-3131

Dean G. Skelos
skelos@nysenate.gov
Legislative Office Building, Room 909
Albany, NY 12247
Phone: (518) 455-3171

Malcolm A. Smith
masmith@nysenate.gov
181 State Street Room 808, Legislative Office Building
Albany, NY 12247
Phone: (518) 455-2701
Fax: (518) 455-2816

Andrea Stewart-Cousins
scousins@nysenate.gov
188 State Street Room 615, Legislative Office Building
Albany, NY 12247
Phone: (518) 455-2585
Fax: (518) 426-6811

Wednesday, June 6, 2012

Miami, FL Call to Action

Commissioner Barbara Jordan of the Miami-Dade County Board of County Commissioners has proposed Ordinance No. 120901 (link).


This bill would:
 If enacted, sales of flavored smokeless tobacco products (excluding menthol, mint and wintergreen) would be prohibited and punishable by a $500 fine.

A public hearing will be held on July 10, 2012 at 9:30 A.M. before the Public Safety & Healthcare Administration Committee (instructions for speaking at a public hearing).  CASAA members in the Miami area are strongly encouraged to attend and testify in opposition to the portion of the ordinance that would ban the sale of flavored smokeless tobacco.  Please e-mail us if you can attend!

The proposed ordinance has been portrayed by anti-tobacco groups as a public health measure to protect children from the lure of flavored smokeless tobacco products (news link).  This comes despite Florida's decades old law banning tobacco sales to minors and significantly improved retailer compliance rates.  Furthermore, according to AC Nielsen Scantrak data for 2009 and 2010, sales of non-menthol flavored smokeless products were only approximately 6% of the overall U.S. smokeless market.  There is no evidence that banning this small segment of the smokeless tobacco market will decrease youth tobacco usage.

What to say:
1. Let them know that you oppose banning the sale of flavored smokeless tobacco products.
2. Tell your story on how switching from cigarettes to a far less hazardous smoke-free tobacco product has changed your life.
3. Explain that the smokeless tobacco products have been found to be around 99% less harmful than cigarettes, and that many former adult smokers have quit smoking by switching to less harmful alternatives, including products that contain flavors. discourage smokers from switching to a less harmful alternative.
4. Suggest that instead of banning the sale of flavored smokeless products under the guise of keeping the products out of the hands of children, the Board of Commissioners examine its own tobacco-retailer laws to determine if already existing penalties for selling tobacco to youth need to be strengthened.
5. Tell them that by switching to a smokeless product, you have greatly reduced your health risks.
6. Direct them to the CASAA.org website for more information.


Please call, write or fax the members of the Public Safety & Healthcare Administration Committee below.

    Jose Diaz, Chair
    111 NW 1st Street, Suite 320
    Miami, Florida 33128
    305-375-4343
    Fax 305-372-6109
    district12@miamidade.gov

    Barbara Jordan
    111 NW 1st Street, Suite 220
    Miami, Florida 33128
    305-375-5694
    Fax 305-372-6028
    district1@miamidade.gov

    Sally Heyman
    111 NW 1st Street, Suite 220
    Miami, Florida 33128
    305-375-5128
    Fax 305-372-6179 Fax
    district4@miamidade.gov

    Lynda Bell
    111 NW 1st Street, Suite 220
    Miami, Florida 33128
    305-375-5218
    Fax 305-372-6073
    district8@miamidade.gov

    Javier Souta
    111 NW 1st Street, Suite 320
    Miami, Florida 33128
    305-375-4835
    Fax 305-375-3456
    district10@miamidade.gov

    Esteban Bovo, Jr.
    111 NW 1st Street, Suite 320
    Miami, Florida 33128
    305-375-4831
    Fax 305-375-2011
    district13@miamidade.gov

Comma delimited list:
district12@miamidade.gov, district1@miamidade.gov, district4@miamidade.gov, district8@miamidade.gov, district10@miamidade.gov, district13@miamidade.gov

Semicolon delimited list:

district12@miamidade.gov; district1@miamidade.gov; district4@miamidade.gov; district8@miamidade.gov; district10@miamidade.gov; district13@miamidade.gov

Monday, June 4, 2012

Dr. Polosa Interview On Electronic Cigarettes As Cessation


At this year’s Tobacco Merchants Association annual meeting, Ecig Advanced staff got a chance to speak with Dr. Riccardo Polosa, a Professor at the University of Catania currently researching the use of electronic cigarettes as a smoking cessation device.
Although he’s a bit hesitant to speak on the results of his current study, it sounds like things are looking good for the little device that could.
Click image to open video window

Source: EcigAdvanced.com

Sweden under attack


Christopher Snowdon
The Free Society
Friday June 1, 2012

The EU’s anti-tobacco regulations threaten Sweden’s safe alternative to smoking, reports Chris Snowdon
Like most people outside of Scandinavia, you’ve probably never heard of the product, but the threat of ‘snus’ facing backdoor prohibition was making all the headlines in Sweden last month.

Snus – which simply means ‘snuff’ in Swedish – is finely cut tobacco in a small sachet which Swedes have been placing under their top lip for more than two centuries. The product had largely fallen out of fashion by the 1960s. But when the dangers of smoking became widely understood, consumers started to abandon cigarettes and revert to snus.

This form of smokeless tobacco has been in the prohibitionist firing-line before. Snus was banned by the European Commission in 1992 as a result of fears that oral snuff – especially the infamous ‘Skoal Bandits’ – caused mouth cancer. So popular had the product become with Swedes by this time that securing an opt-out from the ban was a deal-breaker when they joined the EU three years later. The EU duly gave them an exemption and the Swedish referendum went in favour of accession by the narrow margin of 52% to 48%. Numerous studies have since found no association between snus and oral cancer and, in 2001, the European Commission acknowledged that the product is not carcinogenic. Prohibition in the rest of the EU, however, remains in place. [Read More]

CASAA's comment on FDA Draft Guidance for Modified Risk Tobacco Product Applications


The following is the comment letter CASAA has submitted to the FDA. CASAA encourages members to submit their own comments by the end of the day (6/4/12)  at http://www.regulations.gov/?source=govdelivery#!documentDetail;D=FDA-2012-D-0071-0001

Under the FDA's Draft Guidance for MRTP Applications, it would cost any smokeless tobacco manufacturer (and any e-cigarette manufacturer if the agency "deems" they should be regulated by Chapter IX, as the FDA has stated it intends to do) tens of millions of dollars conducting unnecessary research before applying to the FDA to truthfully claim that any of its smokefree tobacco products is less hazardous than cigarettes.


The Consumer Advocates for Smoke-free Alternatives Association (CASAA) is pleased to submit this comment on “Draft Guidance for Industry; Availability: Modified Risk Tobacco Product Applications,” Docket ID: FDA-2012-D-0071, hereinafter referred to as “Draft Guidance.” We are commenting in our capacity as representatives of consumers who use alternatives such as smokeless tobacco, dissolvable tobacco, and e-cigarettes as a partial or complete replacement for smoking. Most of us would not have been able to stop smoking otherwise. Those of us who smoked for decades and have switched to smoke-free alternatives are now enjoying improved health.

The FDA has specifically requested comment on Recommendation 2 in the Institute of Medicine (IOM) report, Scientific Standards for Studies on Modified Risk Tobacco Products (MRTPs). Please note that this recommendation is related to Finding 2, which addresses new products, specifically novel MRTPs. The IOM report maintains there is a minimum range of research domains required to evaluate the effect of (novel) MRTPs on individuals and public health.

Section 3, item (4), of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) requires “flexible enforcement authority to ensure that there is effective oversight” of the development, introduction, and promotion of less harmful tobacco products. This flexibility needs to address the difference between totally new (“novel”) products versus established products that have been in general use for years.

The need to act on existing knowledge about smokeless tobacco

Subjecting established and thoroughly studied low-risk smokeless tobacco products to the entire gamut of new testing described in the IOM report is unnecessary, expensive, and time-consuming, and creates an unacceptable delay in providing factual information to the public about less hazardous alternatives to smoking. A consequence of this delay is that, lacking such information, most American smokers will continue smoking, and millions of smokers will die.

In Table 1, TABLE S-1 Evidence Domains Relevant to an MRTP Application and Examples of Types of Findings, the Epidemiological Class calls for:
·         Clear and consistent evidence of reduction in disease
·         No convincing evidence of offsetting increased risk for other diseases
·         No significant evidence of uptake among nonusers or relapse among former users

The years of epidemiological evidence documented in numerous peer-reviewed scientific journal articles have empirically demonstrated that smokers who switched to Western (U.S. or Swedish style) moist snuff (aka “snus”) have reduced risks for all types of cancers [1,2], cardiovascular disease [3,4], and, other lung disease compared with smoking. (While some commentators have tried to claim there are important differences in health effects between Swedish style products and popular forms of American moist snuff, the science does not actually support this claim. The claim is largely moot, in any case, since the segment of the American market that is likely to make applications has shifted to Swedish-style products.)

There is clear evidence of a positive effect on public health in countries where a substantial proportion of smokers have switched, specifically Sweden (based on decades of data) and more recently Norway [5,6].

Specifically, not only has the prevalence of smoking been reduced in those countries, the overall use of tobacco also continued to decline [7-9].

As we would expect from the reduction in smoking, Norway and Sweden have some of the lowest lung cancer mortality rates in the EU [10], and there have been no observed increases in any disease that is blamed on smokeless tobacco use.




IOM’s recommendation for extensive tests on levels of toxins and carcinogens may be appropriate for novel smoke-free products, where they must stand as a poor substitute for epidemiologic evidence, but it forms a distraction from the wealth of epidemiological evidence for established products. If the epidemiology for the product shows no measurable disease risk, then the chemicals within the product present no risk of disease in that particular form, concentration, and context.

Who can conduct the research?

IOM’s Recommendation 10 calls for the manufacturers to use independent third parties to conduct and oversee research. Where does the IOM suggest that manufacturers find such third parties? The Society for Research on Nicotine and Tobacco has instructed its members to ask their institutions to refuse to conduct research on behalf of tobacco companies. Unless the FDA has the power to force educational institutions or scientific organizations to conduct research on tobacco products, this must not be made a requirement.

Evidence about future behavior

The IOM Report outlines that committee’s opinion of what types of evidence should be gathered. Some of this suggests it is necessary to produce evidence about economic (behavioral) phenomena that will occur in an unknown future, with regard to a relatively new situation. Pseudo-scientists are fond of making pronouncements of certainty about what will happen in novel circumstances. Obstructionists like to use the unavoidable uncertainty to claim it is too risky to allow anything. But policy makers acting in the public interest need to make the best possible evaluation and act on it in spite of the uncertainty. It is impossible to know for sure how low-risk alternatives will affect initiation by nonusers or the proportion of switchers that might have “quit completely” if the MRTP had remained unavailable. While there is no reason to expect that many would-be never smokers will decide to switch to smoking after using a low-risk product, it is again impossible to be certain.

For evidence domains that cannot be directly measured, the FDA’s Guidance document needs to specifically address how those data can and should be gathered, how the results will be measured, and the criteria for success. Those should consist of methods that are possible, consistent with proper scientific modesty (psychic powers and time machines are not options, as is certainty). The FDA should not make the mistake of favoring artificial experiments based on non-natural behavior when trying to understand free economic choices and interactive social behavior; just because a method is optimal for evaluating medicinal drugs and is what the agency is most familiar with does not make it optimal – or even useful at all – in other areas of inquiry.

The FDA also needs to provide direction to sponsors regarding how to collect evidence on the effects of the proposed new product on special populations, particularly non-adults who are legally forbidden from using the products.

The reduction in health risks is clear to any observer

Any product that does not require inhaling smoke or a similar chemical mixture presents little to no risk to lung and airway health in an absolute sense, and certainly not when compared to smoking. Respiratory diseases and cancers of the trachea, lung, and bronchus account for 58% of the CDC’s estimated 390,000 annual deaths attributed to smoking [11]. It is not necessary to acknowledge that the evidence does not support the claim that smoke-free nicotine products cause any mortality risk for adult users to see that there would be a reduction. There is no remotely plausible theory that existing smoke-free products cause other health risks that have anywhere close to the magnitude of risk of lung disease (alone) from smoking. If there were a risk that was 10% of that magnitude from smokeless tobacco, there would be compelling evidence of that. Thus, any rational person who is aware of the existing science must conclude that the product is substantially less hazardous to the individual user than continued smoking. It is also obvious that non-combusted tobacco products do not pose any health risks to bystanders.

Every American standard of ethics says these facts should not be hidden from the public. Moreover, good public policy requires that they be incorporated into MRTPAs.

Inaccurate beliefs cause unfortunate decisions

Research shows that use of alternative tobacco products is strongly related to beliefs about the relative harm of those products [12]. Smokers who correctly believe that health risks of smokeless tobacco use are far lower than smoking are more than four times as likely to be willing to try smokeless tobacco [13]. Users of non-combusted tobacco products are much more likely to switch to smoking if they incorrectly believe that smoking is less likely to cause mouth cancer or dental problems. Thus, the best way to prevent people from experiencing a “gateway” transition to smoking is to make certain they understand that smoking is many times more hazardous than any other way of using tobacco.

Time is of the essence

Completing all the tests specified in the IOM report cannot be accomplished swiftly. Meanwhile, an estimated 1,200 Americans will continue to die each day of smoking-related diseases. While we cannot save the ones who will die tomorrow, we can immediately start saving many of those who would otherwise be doomed to die a few years from now by encouraging them to switch to low-risk alternatives.

The FDA could substantially reduce this death toll by doing one of the following:
  • Design a “fast-track” method of obtaining MRTP approval for established products for which there is ample epidemiological evidence of safety and of consumer acceptability as a replacement for smoking.
  • Provide accurate information to the public about relative risks of each class of tobacco products. This effort might include the following:
    • Revise smokeless tobacco product warning label statements, as permitted in Section 205 of the FSTPCA, to accurately reflect product risks. “This product is not a safe alternative to cigarettes” could be amended to read, “This product is much less hazardous than cigarettes, but not 100% safe.”
    • Revise information on the Center for Tobacco Products website to remove unethically misleading and scientifically incorrect statements such as, “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.” [1-6,10]

Opponents of harm reduction may prefer that smokers continue to smoke until they are ready to “quit completely.” However, this is not in the best interests of public health. For the average smoker, smoking for just a few more months before “quitting completely” causes greater health risk than switching to smokeless tobacco and never quitting it [14].

REFERENCES:

  1. Lee PN, Hamling J. Systematic review of the relation between smokeless tobacco and cancer in Europe and North America. BMC Medicine 2009, 7:36
  2. Nordenvall C, Nilsson PJ, Ye W, Nyrén O. Smoking, snus use and risk of right- and left-sided colon, rectal and anal cancer: a 37-year follow-up study. Int J Cancer. 2011 Jan 1;128(1):157-65. doi: 10.1002/ijc.25305.
  3. Hansson J, Pedersen NL, Galanti MR, Andersson T, Ahlbom A, Hallqvist J, Magnusson C.Use of snus and risk for cardiovascular disease: results from the Swedish Twin Registry. J Intern Med. 2009 Jun;265(6):717-24.
  4. Wennberg P, Eliasson M, Hallmans G, Johansson L, Boman K, Jansson JH. The risk of myocardial infarction and sudden cardiac death amongst snuff users with or without a previous history of smoking. J Intern Med 2007; 262: 360–7.
  5. Foulds J, Ramstrom L, Burke M, Fagerstrom K. Effect of smokeless tobacco (snus) on smoking and public health in Sweden. Tobacco Control 2003;12:349–359.
  6. Lee PN. Summary of the epidemiological evidence relating snus to health. Regul Toxicol Pharmacol. 2011 Mar;59(2):197-214. Epub 2010 Dec 14.
  7. Furberg H, Bulik CM, Lerman C, Lichtenstein P, Pedersen NL, Sullivan PF. Is Swedish snus associated with smoking initiation or smoking cessation? Tob Control. 2005 Dec;14(6):422-4.
  8. Ramström LM, Foulds J.Role of snus in initiation and cessation of tobacco smoking in Sweden. Tob Control. 2006 Jun;15(3):210-4.
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