Contact the FDA - Before December 28th!!

[IdolLurker]

Big Bro - Big Pharma - Big tobacco - can all Kiss mine - time for revolution if we had enough balls..... maybe one day....

I luv your attitude...and they can kiss mine too. A doctor prescribed an Rx for a "fake" cigarette for my daughter when she had an extended stay in the hospital. So what is the diff between Rx for a plastic cig with a nicotine cartridge and the electronic-cigs as far as regulation goes? Like you said Big Pharma and Big tobacco tries to rule. The latest ban is ridiculous...no flavored analogues EXCEPT menthol...yeah right. Gee I wonder why....NOT. They tried to get into the vitamin industry and everyone raised up in arms. Trouble is that smokers have been so beaten down and emotionally abused that they have lost their balls. Don't let them do that to vapers.

Looking forward to giving up the analogues for good. I do want to live with balls (figuratively) LOL!! 8-o

 

[PhiHalcyon]

To Whom It Does Concern,

Prior to the FSPTCA, most nicotine delivery devices were largely unregulated; and, in regards to their safety in use, not regulated at all. In the opposite extreme were a few NRT drug products which took several years and a small fortune to show their safety and effectiveness before being approved to market. Now that the FDA has been given the specific authority to regulate tobacco products, (and thus, all nicotine delivery devices), a regulatory order at the mean between the old extremes can be established.

Rather than seek to maintain the old regulatory order (by construing the tobacco product definition to mean "wholly or primarily" made or derived from tobacco), the FDA should establish a new regulatory order by construing the tobacco product definition to mean "in any part" made or derived from tobacco. Not only is this quite permissible under the FSPTCA, but because this construe would open the door to reduced-harm innovations like the electronic cigarette, it would also better serve the public health.

In choosing the regulatory order that will be established, it is important to note that the segment of the public health that will be most directly affected by the decision will be those who use tobacco products. Thus, the decision between the old regulatory order, and the suggested new regulatory order, that will best serve the interest of public health is the one that best serves the health interests of tobacco users; and this is the one that provides ready access to reduced-harm innovations like the electronic cigarette.

Had Congress intended the tobacco product definition to mean "wholly or primarily" made or derived from tobacco, then not only would it have included language to that effect, but it would have also excluded tobacco product additives from the marketing combination prohibition of Section 201(rr)(4). The fact that it did neither lends credible support to an "in any part" construe of the tobacco product definition, and to Section 201(rr)(4) referring to nothing but fully independent finished products.

The responsible decision by the FDA to now construe the FSPTCA definition of tobacco products to mean "in any part" made or derived from tobacco (and thus establish a new regulatory order) cannot be understood to render the electronic cigarette a tobacco product at the time it was introduced. So, not only is it fitting to deem the electronic cigarette a 'new tobacco product', but it is also fitting that the FDA demand the sort of quality, safety, and consistency that is befitting of an FDA-approved product.

Finally, as the FDA takes measures required to temper an out-of-control electronic cigarette industry, it should not lose sight of the interests of the quarter of a million or so Americans who have managed to completely quit smoking in thanks only to their current and continuing use of the electronic cigarette. For, any actions which would force such a large number of people to return to smoking (even if for only a short period) could be to jeopardize the improvements to their health that have already been realized - while putting a detrimental stain of folly on the FDA's early management of its new role and authority.

Thanks for this opportunity to be heard, and good luck in well-managing the clear-cut course ahead.

 

[Bill Godshall]

Many thanks to all e-cigarette users (and vendors) who submitted comments to the FDA on tobacco regulations, and special thanks to SmokeyJoe for posting the alert at the top of this website for the past week.

Smokefree Pennsylvania submitted the following comments to the FDA yesterday.

- - -

The following are in addition to comments previously submitted by William Godshall and Smokefree Pennsylvania (on September 29, comment tracking number 80a2e4ef) on FDA tobacco regulation.

The FDA should STOP protecting cigarettes from market competition by far less hazardous smokefree tobacco/nicotine products (including electronic cigarettes).

As delineated in Smokefree Pennsylvania’s letters and testimony to U.S. Congress during the past five years, the recently enacted Family Smoking Prevention and Tobacco Control Act protects the deadliest consumer product (i.e. cigarettes) from market competition by far less hazardous smokefree tobacco products.
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Meanwhile, existing FDA policies for electronic cigarettes and nicotine gums, lozenges, skin patches and inhalers also protect cigarettes from many aspects of market competition by these far less hazardous smokefree nicotine alternatives.

Since switching from cigarettes to smokefree tobacco/nicotine products reduces morbidity and mortality risks by nearly as much as quitting all tobacco/nicotine use, the FDA should adopt policies to inform/encourage smokers who are unwilling or not ready to quit using tobacco to switch to smokefree tobacco/nicotine products until they are willing and ready to quit using tobacco.

Based upon published calculations by Karl Fagerstrom, Smokefree Pennsylvania has estimated that the percentage of nicotine consumed in the US from smokefree tobacco/nicotine products has increased from about 10% a decade ago to about 20% in 2009, while the percentage of nicotine consumed from cigarettes has declined from about 90% a decade ago to about 80% in 2009.
The nicotine market: An attempt to estimate the nicotine intake from various sources and the total nicotine consumption in some countries, Karl Fagerstrom, Nicotine & Tobacco Research, Vol. 7, Number 3, pp 343-350, June 2005.

Furthermore, about 90% of the nicotine consumed from smokefree tobacco/nicotine products in the US is now obtained from smokeless tobacco products, while about 10% is now obtained from nicotine gums, lozenges, patches, and electronic cigarettes.

Just as less than half of all nicotine consumed in Sweden is now obtained from smokefree tobacco/nicotine products (primarily snus), less than half of all nicotine consumed in the U.S. could be obtained from smokefree tobacco/nicotine products within the next decade if the FDA adopted policies to truthfully inform smokers that smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes, to allow manufacturers and marketers to truthfully inform smokers that smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes, and to provide other incentives to encourage manufacturers to develop and market smokefree tobacco/nicotine product to smokers as far less hazardous alternatives to cigarettes.

The FDA should propose reasonable and responsible regulations for Electronic Cigarettes and for Electronic Cigarette Liquid to ensure that these products remain legally accessible and less expensive than cigarettes.

Based upon my communications with dozens of electronic cigarette vendors in recent months, it appears that there are now about 200,000 e-cigarette consumers in the U.S., virtually all of whom are either exsmokers or are dual users in the process of switching. E-cigarettes also now appear to be a $200 million dollar per year industry in this country, similar to current sales of nicotine gums, lozenges and patches.

It is crucial that the FDA recognize that every dollar spent on e-cigarettes would otherwise be spent on tobacco cigarettes, and that every dose of nicotine obtained from an e-cigarettes would otherwise be obtained from inhaling hazardous tobacco smoke. That is why the FDA’s ongoing opposition to e-cigarettes primarily protects cigarette markets at the expense of smokers and public health.

The FDA should take seriously statements by e-cigarette users, including the following.

Petition to US FDA with testimonials by thousands of e-cigarette users
http://www.thepetitionsite.com/1/keep-life-saving-electronic-cigarettes-available

Surveys of e-cigarette users
http://www.tobaccoharmreduction.org/wpapers/011v1.pdf
http://www.e-cigarette-forum.com/forum/quitting/6470-e-cig-success-rate.html
http://www.e-cigarette-forum.com/fo...sion/50594-update-analogs-vs-vaping-poll.html
http://www.e-cigarette-forum.com/fo...have-you-been-using-electronic-cigarette.html
http://www.e-cigarette-forum.com/fo...50464-poll-how-long-have-you-been-vaping.html
http://www.e-cigarette-forum.com/fo...2778-myth-e-cigarettes-aimed-non-smokers.html
http://www.e-cigarette-forum.com/fo...nicotine-abstinence-screw-up-your-life-4.html
http://www.e-cigarette-forum.com/forum/health-safety-e-smoking/31195-did-your-lungs-clear-up.html

While Smokefree Pennsylvania’s previously submitted comments encouraged the FDA to propose redefining electronic cigarettes as tobacco products and to reasonably regulate them as such, another option available to the FDA is to propose reasonable and responsible regulations for electronic cigarettes (and electronic cigarette liquid) as drug delivery devices.

It is critically important to note that when then Commissioner David Kessler proposed FDA regulations for tobacco products as drug delivery devices in 1995, he insisted that the FDA had no intention of removing tobacco products from the market (even though the agency has the legal authority to do so for unapproved drug delivery devices) because doing so would be a societal disaster by creating a black market for tobacco products.

Instead of proposing to remove tobacco products from the market in 1995, the FDA wisely proposed reasonable and responsible regulations to reduce tobacco industry marketing and sales to youth. Although the US Supreme Court struck down the tobacco regulations approved by the FDA in 1996 (citing Congressional failure to grant FDA authority to regulate tobacco products), David Kessler’s rationale opposing removal of tobacco products (as drug delivery devices) from the market is even more cogent as it pertains to electronic cigarettes. If it made no sense for the FDA to remove the deadliest consumer products (i.e. cigarettes) from the market, it is absurd for the FDA to now claim that far less hazardous smokefree alternatives to cigarettes (i.e. electronic cigarettes) should be removed from the market simply because the agency has recently declared them to be drug delivery devices.

That is yet another reason why the FDA should propose regulations reasonable and responsible regulations for electronic cigarettes and electronic cigarette liquid (as either drug delivery devices or as tobacco products) to prevent their marketing and sales to youth, to ensure product safety and proper labeling via standards for manufacturers and/or importers, and to display a warning indicating that the products contain nicotine and can be addictive.

Although there is no evidence that electronic cigarettes have been or are marketed to youth (despite claims to contrary by several government officials and other tobacco harm reduction opponents), it would be wise for the FDA to prohibit the sale of electronic cigarettes and electronic cigarette liquid to minors under 18 years, to require the products be kept behind-the-counter at retail stores accessible to youth, to prohibit their advertising in publications with significant youth readership, and to prohibit their promotions via sports sponsorships. But since there is no evidence that flavored e-cigarettes are marketed to or appeal to youth, there is no justification for the FDA to ban flavorings in e-cigarettes or e-cigarette liquid (just as there is no justification for the FDA to ban flavorings in nicotine gums or lozenges).

To ensure product safety and proper labeling of electronic cigarettes and electronic cigarette liquid, the FDA should require product testing by manufacturers and/or importers (similar to those required for tobacco products by the new FDA tobacco law).

Since the nicotine in electronic cigarettes and electronic cigarette liquid can be addictive (which is one of the reasons many smokers have found the products to be desirable substitutes for cigarettes), the FDA should require a warning on e-cigarettes and e-cigarette liquid that informs consumers that the products contain nicotine and can be addictive.

It is critically important for the FDA to understand that the agency’s ongoing efforts to block shipments of e-cigarettes from entering the country have affected only a small percentage of product shipments, nearly all of which have been subsequently reshipped back into the country.

It is also critically important for the FDA to understand that future attempts by the agency to remove e-cigarettes from the market will:
- protect and preserve cigarette markets, revenues and profits,
- encourage thousands of e-cigarette users to switch back to deadly cigarettes,
- discourage millions of smokers from reducing health risks by switching to e-cigarettes,
- create a black market for e-cigarettes, and
- demonstrate that the FDA is more interested in protecting cigarettes than public health.

Feel free to contact me anytime for additional information, clarification, or collaboration in reducing this nation’s leading cause of disease, disability and death.

Since 1990, Smokefree Pennsylvania has advocated policies to reduce tobacco smoke pollution indoors, increase cigarette taxes, reduce tobacco marketing to youth, preserve civil justice remedies for those injured by cigarettes, expand smoking cessation services, and inform smokers that smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes.

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

 

[Bill Godshall]

FYI Below are the comments Smokefree Pennsylvania submitted to the FDA on September 29 (I'm posting these in two separate posts due the length).
- - -

Following are suggested regulatory policies for the FDA to significantly reduce cigarette consumption, tobacco diseases, disabilities and deaths.


Truthfully inform smokers and the public that smokefree tobacco products are far 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. On a continuum of tobacco mortality risk from 1 to 100 (whereby nicotine replacement therapy (NRT) products are 1 and cigarettes are 100), smokefree tobacco products are between 1 and 2. By switching to smokefree tobacco products, cigarette smokers can reduce their health risks nearly as much as by quitting all tobacco/nicotine.
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.
Harm Reduction Journal | Full text | Tobacco harm reduction: an alternative cessation strategy for inveterate smokers
Harm reduction in nicotine addiction; Helping people who can't quit, Royal College of Physicians, 2007.
http://www.rcplondon.ac.uk/pubs/contents/e226ee0c-ccef-4dba-b62f-86f046371dfb.pdf

Millions of smokers 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 denialists 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 smokefree tobacco products to help them quit smoking cigarettes, and 6.4% (i.e., 1.63 million) of males who currently smoked indicated using smokefree tobacco 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 smokefree tobacco product users in Houston, Atlanta, and Florida (who were interviewed outside retail stores after purchasing SLT) found that 37% of smokefree tobacco 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 smokefree tobacco users said YES (including 11% of those under age 35 and 27% of those 35 years or older). These findings were consistent in the three different survey locations. Interestingly, 62% of respondents who used both SLT and cigarettes reported that SLT 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 smokeless tobacco users reported being former cigarette smokers, and the 1998 NHIS found that 31.1% of SLT 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.

A study of 1226 male high school baseball players in California found that 33% of the 184 current smokefree tobacco product users were former cigarette smokers.
Walsh MM, Ellison J, Hilton J, et al, Spit (smokeless) tobacco use by high school baseball athletes in California, Tobacco Control 2000;9(Suppl II):ii32-ii39 (Summer). Search Results

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. Wiley InterScience :: Session Cookies

A study of 51 female and 59 male SLT 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 SLT 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 recent study found that 72% of an estimated 359,000 US smokers who switched to smokefree tobacco 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 smokefree tobacco products commonly sold in the U.S., snus and is spitfree, contains fewer nitrosamines, and has not been found to be associated with mouth cancer.
Effect of smokeless tobacco (snus) on public health in Sweden, Foulds J, Ramstrom L, Burke M, Fagerstom K, Tobacco Control, 2003, Vol 12, 349-359. Sign In
Smokeless tobacco use and increased cardiovascular mortality among Swedish construction workers. Bolinder G, Alfredsson L, Englund A, et al., Am J Public Health 1994, Volume 84, 399-404.
Smoking tobacco, oral snuff and alcohol in the etiology of squamous cell carcinoma of the head and neck. A population based case-referent study in Sweden. Lewin F, Norell SE, Johansson H, et al, 1998, Cancer, Vol. 82, 1367-1375.
Oral snuff, smoking habits and alcohol consumption in relation to oral cancer evaluated in a Swedish case-control study, Schildt E-B, Eriksson M, Hardell L, Magnusson A, 1998, International Journal of Cancer, Vol. 77, 341-346.

When a large national sample of Swedish ex-smokers was asked about how they succeeded in quitting, 50% stated that they had stopped without help, 33% said they used snuff, and 17% said they had used some form of NRT.
Smokeless Tobacco and Cardiovascular Disease, Asplund, K, Progress in Cardiovascular Diseases, Vol. 45, No 5, (March/April) 2003, 383-394.

Another survey of more than 6,700 Swedes found that more than 25% of male cigarette smokers indicated they had switched to snus. The survey also found that snus was more effective than NRT products as a smoking cessation aid.
Role of snus in initiation and cessation of tobacco smoking in Sweden, Ramström and Foulds Tob Control.2006; 15: 210-214. 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, recently 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

Many tobacco manufacturers in the U.S. have recently began marketing snus products.
Since there is no evidence that snus or other low nitrosamine smokefree tobacco products are associated with oral cancer, the FDA should eliminate the mandatory warning from snus and other low nitrosamine smokefree tobacco products stating “This product may cause mouth cancer.”



Most smokers wrongly believe smokefree tobacco is as hazardous as cigarettes

While smokefree tobacco 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 smokeless tobacco 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.
Smokers' beliefs about the relative safety of other tobacco products: Findings from the ITC Collaboration - Nicotine & Tobacco Research

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 smokefree tobacco 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 smokefree tobacco.
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 smokeless tobacco 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.
Harm perception of nicotine products in college freshmen - Nicotine & Tobacco Research

A survey of more than 2,000 adult U.S. smokers found that only 10.7% correctly agreed that smokefree tobacco 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.

Not only does the FDA (and other public health agencies) have an ethical duty to truthfully inform smokers that smokefree tobacco products are less hazardous alternatives to cigarettes, but smokers have a human right to be truthfully informed of that potentially life saving information.
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

Another reason the FDA should truthfully inform smokers and the public that smokefree tobacco products are far less hazardous alternatives to cigarettes is because the recently filed lawsuit claiming that certain provisions of the new FDA law violate the 1st amendment rights of tobacco companies could very well result in court rulings upholding the right of tobacco companies to truthfully state (especially in noncommercial speech) that smokefree tobacco products are less hazardous alternatives to cigarettes.
Commonwealth Brands et al v U.S.A. et al
http://static.mgnetwork.com/rtd/pdfs/complaint.pdf
Tobacco Blow Back, Challenging the Marlboro/Congress marketing cartel.
The Wall Street Journal editorial, September 14, 2009
Big Tobacco Challenges New Regulations - WSJ.com
It's Not All Smoke. The Washington Post editorial, September 14, 2009
It's Not All Smoke - washingtonpost.com

Therefore, the FDA should require an additional warning label on all cigarette packages to inform smokers that “Smokefree tobacco and nicotine products are less hazardous alternatives to cigarettes.”

The FDA should eliminate the grossly misleading mandatory warning on all smokefree tobacco products stating “This product is not a safe alternative to cigarettes,” which Title II, Section 204 of the new FDA tobacco law requires to be made even larger.

The FDA also should publish consumer information materials revealing the comparable health risks of different tobacco/nicotine products.


Educate smokers and the public about light, ultralight, mild and low-tar cigarettes.

The previously mentioned survey of 36,012 young adults entering the U.S. Air Force also found that an overwhelming majority of smokers (77%), ex-smokers (72%) and never smokers (73%) inaccurately believed that switching to a low-tar/nicotine cigarette would reduce health risks of smoking.
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.

The same survey found that the overwhelming majority of males, females, nonsmokers, smokers and ex-smokers thought that switching from regular cigarettes to low-tar cigarettes conferred a greater risk reduction than switching from cigarettes to smokeless tobacco. This finding is especially alarming considering that a majority of smokers have already switched to light or ultralight cigarettes in an attempt to reduce their health risks.

Another survey found that 35% and 40% of college freshmen incorrectly believe that light and ultra-light cigarettes (respectively) are less hazardous than other cigarettes. Harm perception of nicotine products in college freshmen, Smith SY, Curbow B, Stillman FA, Nicotine Tob Res. 2007 Sep;9(9):977-82.
Harm perception of nicotine products in college freshmen - Nicotine & Tobacco Research

The FTC method for testing cigarette emission yields (aka the Cambridge Filter Method) is inaccurate and unreliable, as most smokers who switch to so-called low-tar, light or ultralight cigarettes simply change their smoke inhalation patterns in order to attain similar doses of nicotine, usually by inhaling the smoke longer and deeper, by inhaling more puffs or smoking more cigarettes, and/or by covering the vent holes near the cigarette filter.

Furthermore, a recent study by leading international experts (1) concluded that NO cigarette emission testing regime (including the FTC method) accurately measures human exposure, and that none should be relied upon for establishing government regulatory standards.
Revising the machine smoking regime for cigarette emissions: implications for tobacco control policy, Hammond D, Wiebel F, Kozlowski LT, et al, Tobacco Control 2007;16:8-14.
Revising the machine smoking regime for cigarette emissions: implications for tobacco control policy

As such, the FDA should establish different regulatory criteria for cigarette manufacturers to make “reduced exposure” claims about cigarettes (than for smokefree tobacco product manufacturers to make about smokefree tobacco products).

Also, the FDA should not propose cigarette emission standards, as doing so is unlikely to reduce the health risks of cigarettes, while misleading smokers and the public to believe that the FDA cigarette emission standards make cigarettes less hazardous.

Although the FDA tobacco law requires the removal of terms Light, Ultralight, Mild and Low-Tar as cigarette descriptors, most smokers will continue to inaccurately believe that those brands are less hazardous than other cigarettes. As such, the FDA should require a mandatory warning on all cigarette packages stating “There is no such thing as a safer cigarette, as all cigarettes are similarly hazardous.”

 

[Bill Godshall]

Below is the second of three parts of Smokefree Pennsylvania's comments submitted to the FDA on September 29 (dealing with NRT products).
- - -

Allow smokefree nicotine products to fairly compete against cigarettes

The FDA should quickly approve NY State Health Commissioner Richard Daines’ petition (submitted in January, 2008) to (1) modify warning labels on nicotine replacement therapy (NRT) products (i.e. gums, lozenges, patches) to inform smokers that NRT products are far less hazardous than cigarettes (2) allow nicotine products to be sold in less expensive daily dose units: and (3) allow nicotine products to be sold in all stores that sell cigarettes.
Requesting Expansion of Availability of Nicotine Replacement Therapy to Consumers who use Tobacco
Regulations.gov

A recently published study found that only one-third of smokers and exsmokers surveyed correctly believed that NRT products were less hazardous than cigarettes.
Perceived safety and efficacy of nicotine replacement therapies among US smokers and ex-smokers: relationship with use and compliance, Shiffman, Saul; Ferguson, Stuart; Rohay, Jeffrey; Gitchell, Joseph; Addiction, Volume 103, Number 8, August 2008, pp. 1371-1378(8),
IngentaConnect Perceived safety and efficacy of nicotine replacement therapies a...

Another survey found that 19%, 24% and 53% of college freshmen incorrectly believe that nicotine skin patches, gum and inhalers (respectively) are 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.
Harm perception of nicotine products in college freshmen - Nicotine & Tobacco Research

A 2001 survey of more than 1,000 adult U.S. smokers found that 53% incorrectly believed nicotine causes cancer and 14% didn’t know, which may also help explain why many smokers overestimate the health risks of SLT products.
Cummings KM, Hyland A, Giovino G, et al. Are smokers adequately informed about the health risks of smoking and medicinal nicotine? Nicotine & Tobacco Research, 2004.

A similar problem exists in the U.K., where recent research found that 69% of smokers believe NRT products are as harmful as cigarettes. Only 14% of those smokers planned to use NRT during their next quit attempt, while 38% of the smokers who indicated that NRT products are less harmful than cigarettes planned to use NRT.
Nicotine Misconceptions in UK Smoking. Research undertaken by TNS. August 2004, Presented at the UK National Smoking Cessation Conference in June 2005. 22% Of General Practitioners Think Nicotine In Stop Smoking Products As Harmful As Cigarettes

This lack of accurate information may not be easy to overcome, as research also has found that 22% of general practitioners in the U.K. worried that NRT products are as harmful as cigarettes, with over 40% confirming they believed these products may cause cardiovascular disease, stroke (40%), and lung cancer (25%).
Perceived safety of nicotine replacement products among general practitioners in the UK: impact on utilisation. Presentation by David Halpin at the British Thoracic Society Winter meeting, 7-9 December 2005. 22% Of General Practitioners Think Nicotine In Stop Smoking Products As Harmful As Cigarettes

Meanwhile, 60% of U.S. smokers surveyed believe that NRT products are too expensive.
Cigarettes U.S. consumer intelligence, Mintel International Group Ltd., April, 2004.

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: b1024 -- BMJ

While supposedly double-blind clinical trials have found that NRT products double the chances of quitting when compared to using a placebo, skepticism has been raised about the accuracy and reliability of these studies, since it is likely that many participants who were assigned to placebos realized they were not getting nicotine.
The blind spot in the nicotine replacement therapy literature: Assessment of the double-blind in clinical trials, Mooney M, White T, Hatsukami D, Addictive Behaviors, 2004 Vol. 29, 673-684. http://whyquit.com/studies/NRT_Blinding_Failures.pdf
Precessation treatment with nicotine patch significantly increases abstinence rates relative to conventional treatment, Jed E. Rose, Joseph E. Herskovic, Frederique M. Behm and Eric C. Westman, Nicotine & Tobacco Research 2009 11(9):1067-1075; doi:10.1093/ntr/ntp103.
Precessation treatment with nicotine patch significantly increases abstinence rates relative to conventional treatment -- Rose et al. 11 (9): 1067 -- Nicotine & Tobacco Research

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 cessati... [Addiction. 1993] - PubMed result
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.

Meanwhile, 42% of U.S. smokers surveyed agreed with the statement “there are currently no smoking cessation products that will truly help you quit”.
Cigarettes U.S. consumer intelligence, Mintel International Group Ltd., April, 2004.

Another 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.
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

Although NRT products are not very effective as smoking cessation aids, they are effective as less hazardous temporary or long term alternatives to cigarettes. The FDA should provide this information on all NRT product packages (as package warnings currently urge users to use NRT products for just 10-12 weeks).

To encourage greater usage of NRT products, the United Kingdom recently liberalized its NRT regulations. The new guidelines allow NRT use by patients with cardiovascular disease, by confirmed smokers ages 12 to 17, by pregnant smokers, by those who concurrently use other NRT products, and by those who continue to smoke. NRT can now also be prescribed for up to nine months if patients need it beyond the initial eight to twelve weeks.
Nicotine Replacement Therapy, Guidance for Health Professionals on changes in the Licensing Arrangements for Nicotine Replacement Therapy, ASH, London, December 2005.
http://www.ash.org.uk/html/cessation/Smoking reduction/NRT051229.pdf

 

[Bill Godshall]

Below is the third of three parts of Smokefree Pennsylvania's comments submitted to the FDA on September 29 (this part includes lots of stuff on e-cigarettes).
- - -

Electronic Cigarettes

The FDA should redefine and reclassify electronic cigarettes as tobacco products (instead of combination drug-delivery devices) and reasonably regulate them as such to allow current electronic cigarette users and 45 million cigarette smokers access to these less hazardous alternatives to cigarettes, to resolve ongoing litigation against the FDA by Smoking Everywhere and NJoy, to prohibit electronic cigarette sales to minors, and to establish reasonable manufacturing standards for the products.

The FDA’s July 22rd press conference and related documents irresponsibly misrepresented much existing evidence about electronic cigarettes in an attempt to scare electronic cigarette users and the public alike, to encourage electronic cigarette users to switch back to far deadlier cigarettes, and to prevent millions of cigarette smokers from switching to these far less hazardous alternatives. FDA and Public Health Experts Warn About Electronic Cigarettes
FDA Warns of Health Risks Posed by E-Cigarettes
Concerns Voiced by the Public Health Experts About Electronic Cigarettes
http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM173405.pdf

The FDA failed to reveal that electronic cigarettes contain virtually none of the 5,000+ contaminants found in cigarette smoke, and failed to identify levels of carcinogens found in the agency’s laboratory test of 19 sample products. http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

The FDA also intentionally ignored other laboratory tests (including some that I had previously sent to the agency) finding that electronic cigarettes had similar trace levels of carcinogens that are in FDA approved and heavily advertised NRT products.
http://www.starscientific.com/404/stepanov tsna in.pdf
http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf
http://www.healthnz.co.nz/DublinEcigBenchtopHandout.pdf
http://www.healthnz.co.nz/ecig_effect-2.pdf
The migration of tobacco-specific nitrosamines int... [Food Chem Toxicol. 1990] - PubMed result

A subsequent laboratory test also found that electronic cigarettes pose very few if any health risks to users, and pose far fewer risks than cigarettes.
http://www.njoythefreedom.com/contactcommerce/images/press_releases/Response to the FDA Summary.pdf

The FDA also intentionally ignored testimonials by thousands of electronic cigarette users stating that the products had helped them quit smoking cigarettes.
http://www.thepetitionsite.com/1...ettes- available
E Cigarette Comments
http://www.e-cigarette-forum.com/forum/

An invited guest (Jonathan Winickoff) at the FDA press conference accused (without providing any evidence) electronic cigarette companies of target marketing their products to youth. In fact, no evidence exists indicating that any youth or nonsmoker has ever become a regular user of electronic cigarettes.

I had previously delineated many of these points to the FDA in my May 1st letter to the agency at: Smokefree Letter to FDA

Had the FDA truly desired to prevent electronic cigarettes to youth and ensure reasonable manufacturing and marketing standards for electronic cigarettes, the agency could/would have joined with me and other health advocates in urging Congress to amend the FDA tobacco legislation to define electronic cigarettes as a new category of tobacco product.

Unfortunately, FDA officials irresponsibly chose to mislead the public (at the press conference) to believe that even trace levels of carcinogens pose significant health hazards, despite the fact that many foods, cosmetics, drugs and medical devices contain carcinogens (and that carcinogens are naturally occurring in the environment).
Nitrosamines, JA Cotruvo, RJ Bull, J Crook, M WhittakerWateReuse Foundation 06-004, Nitrosamine DBPs in water (and food)
Regulations.gov fdmsp...contentType=pdf
Estimates of nitrates, nitrites and nitrosamines in food items and alcoholic beverages by the National Birth Defects Prevention Study calculated serving size
PubMed Central, : Nutr J. 2009; 8: 16. Published online 2009 April 6. doi: 10.1186/1475-2891-8-16.
Nitrosamines in many food products and beer:
Volatile Nitrosamines in Food
Development of a Food Database of Nitrosamines, Heterocyclic Amines, and Polycyclic Aromatic Hydrocarbons
Development of a Food Database of Nitrosamines, Heterocyclic Amines, and Polycyclic Aromatic Hydrocarbons -- Jakszyn et al. 134 (8): 2011 -- Journal of Nutrition
Nitrosamines in cosmetics
Campaign for Safe Cosmetics : Nitrosamines
Presence and release of nitrosamines from children’s balloons
http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_q_148.pdf

The FDA Press Release http://www.fda.gov/NewsEvents/Ne...s/ ucm173222.htm also stated "The U.S. Food and Drug Administration today announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in ANTIFREEZE." But according to wikipedia, diethylene glycol Diethylene glycol - Wikipedia, the free encyclopedia is not in antifreeze, but rather it is ethylene glycol Ethylene glycol - Wikipedia, the free encyclopedia

Altria also has reported that diethylene glycol comprises up to .3% of a cigarette's total weight.
Non-Tobacco Ingredients - Philip Morris USA

The FDA has an ethical duty to correct and clarify the misinformation and scare mongering it presented about electronic cigarettes to the news media, and the agency should redefine and reasonably regulate electronic cigarettes as tobacco products.




Limits and concerns about FDA regulations to reduce youth tobacco use

It is critically important to note that (due largely to smokefree workplace laws, the 1998 Master Settlement Agreement, and tobacco tax increases) daily and past month use of cigarettes has declined significantly among youth. Since 1996, daily cigarette smoking has declined by 71% among 8th graders, by 68% among 10th graders, and by 49% among 12th graders. Similarly, smoking during the past month has declined by 68% among 8th graders, by 60% among 10th graders, and by 40% among 12th graders.
Trends in Prevalence of Use of Cigarettes in Grades 8, 10 and 12, Monitoring the Future, 2008
http://www.monitoringthefuture.org/data/08data/pr08cig1.pdf

Meanwhile, daily and past month use of smokeless tobacco by youth also has declined significantly during the past decade.
Trends in Prevalence of Use of Smokeless Tobacco in Grades 8, 10 and 12, Monitoring the Future, 2008 http://www.monitoringthefuture.org/data/08data/pr08cig4.pdf

Since Section 906(d)(3)(A)(ii) of the FDA tobacco laws prohibits the FDA from banning tobacco sales and marketing 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 cigarettes from 18 year olds).

Since the new FDA tobacco law prohibits the FDA from banning tobacco sales at any category of retailers, and prohibits the FDA from establishing tobacco retailer fees, it is unlikely that any FDA regulation could substantially reduce the approximately 500,000 tobacco retailers nationwide.

Since the US Supreme Court has ruled that tobacco companies have a 1st amendment right to advertise their products to adult customers within 1,000 feet of schools, parks and playgrounds (even if youth are influenced by the ads), it is unlikely that additional FDA regulations to reduce tobacco advertising that may appeal to youth.
Lorilllard v Reilly, SCOTUS, 2001 http://www.megalaw.com/fed/opinions/00-596.pdf

Thus, it is imperative that the public not be misled to believe that the FDA (or FDA tobacco regulations) has or can significantly reduce youth tobacco use. This is important because many advocates of the FDA tobacco legislation have misleadingly claimed that reducing youth tobacco use was/is/should be the primary purpose of the law, and because FDA and other federal government officials have made similar claims in recent months.

Just last week, FDA officials outrageously and irresponsibly misled the public to believe that the recently implemented ban on certain flavorings in cigarettes would protect youth from cigarette companies, and would reduce smoking among youth. In fact, none of those so-called candy flavored cigarettes have been marketed by any cigarette company for several years (due to a settlement with State Attorneys General), while clove cigarettes accounted for just .2% of the cigarette market and are smoked by very few youth.

If the FDA continues to mislead the public to believe that the new law (or subsequent regulations) has reduced youth tobacco use, it will be far more difficult for public health advocates to advocate for local, state and other federal tobacco policy changes (e.g. cigarette tax hikes, increasing the minimum age for cigarette sales, tobacco retailer licensure laws) that can significantly reduce youth tobacco use.

Instead of taking credit for the work of others to reduce cigarette consumption, the FDA should collaborate with public health advocates to further reduce cigarette consumption.


Menthol Cigarettes

The FDA should not ban menthol cigarettes, because doing so would create a huge black market for these cigarettes, especially in African American communities that already suffer disproportionately from violence, incarcerations and other problems caused by other drug prohibition laws. In contrast to claims that menthol cigarettes are more addictive and more commonly smoked by youth (than non menthol cigarettes), the nationwide market share for menthol cigarettes fluctuated between 25% - 29% from 1973 to 2005, while dropping to just 20% in 2006.
Federal Trade Commission Cigarette Report For 2006, Table 7.
http://www.ftc.gov/os/2009/08/090812cigarettereport.pdf

Flavorings in other tobacco products

Sugars and other flavorings have been used the manufacture of cigars and smokefree tobacco products for hundreds of years, and there is no credible evidence that youth are more likely to begin using these products compared to other tobacco products. But if the FDA proposes banning flavorings in other tobacco products, it should be consistent and also ban flavoring additives in NRT products (e.g. Commit cappuccino, cherry and mint).
Commit Lozenge ? Stop Smoking Lozenges


Since 1990, Smokefree Pennsylvania has advocated policies to reduce tobacco smoke pollution indoors, increase cigarette taxes, reduce tobacco marketing to youth, preserve civil justice remedies for those injured by cigarettes, expand smoking cessation services, and inform smokers that smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes.

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

 

[Bill Godshall]

Sorry for the multiple postings of my comments to the FDA (several times when I tried to post them they didn't appear or I was informed that I had to wait 30 seconds before posting again). Thanks to SmokeyJoe for deleting my duplicate postings, as I haven't figured out how to do that.

 

[PhiHalcyon]

As an addendum to my original comment and advice, I submit the following additional comment:

The logic of preaching abstinence (while not allowing risk-reducing products to be readily obtainable) has already been rightly refuted. Thus, there is no need to repeat this error in the case of nicotine use.

Just like some people will engage in premarital sex, some people will engage in nicotine use. And just as it was short-sighted and irresponsible to preach abstinence from premarital sex without making birth control and condoms available to those who do not abstain, it would be no less irresponsible and short-sighted to preach abstinence from nicotine use without making reduced-harm/low-risk nicotine delivery products available to those who do not, or cannot, abstain. Therefore, the wise, sane, and responsible goal for the FDA to embrace and adopt is to make low-risk nicotine use (like protected sex) just as easy to practice and engage in as high-risk nicotine use (or unprotected sex).

Just as impeding the availability of birth control and condoms to those who engage in premarital sex would be a dereliction of duty (even if such products were feared to increase the number of people who engage in premarital sex), so would impeding the availability of reduced-harm/low-risk nicotine delivery products to users of nicotine be a dereliction of duty (even if such products were feared to increase the number of people who will choose to use nicotine). For, just as the greatest dangers to health in engaging in premarital sex are in having unprotected sex, the greatest dangers to health in engaging in nicotine use are in using traditional high-risk tobacco products to get it.

Therefore, let the FDA prove itself worthy of the duty that has been entrusted to it by a) construing the definition of tobacco products to mean "in any part" made or derived from tobacco, and b) regulating all nicotine delivery products (that are intended to be used as reduced-harm/low-risk alternatives to the use of traditional/high-risk tobacco products) as tobacco products. For, an "in any part" construe of the tobacco product definition would preclude a "physically-combined" construe of Section 201(rr)(4) - making all reduced-harm/low-risk nicotine delivery products able to be regulated as tobacco products; and if the reduced-harm/low-risk nicotine delivery products of the FDA-Era are to effectively compete in the marketplace with traditional high-risk nicotine delivery products, then they need to be subject to the same burdens, expense, and standards of approval as traditional high-risk nicotine delivery products.

As a final thought, I would like to point out the fact that if the fight to have the FDA regulate tobacco products does not result in the FDA striving to make reduced-harm/low-risk nicotine delivery products readily available to those who use nicotine (for the purpose of dramatically reducing the harm that is caused by nicotine use via traditional tobacco products), then winning that fight will have been in vain.

Thanks again for the opportunity to be heard.

 

[Tanner S Hyde]

"The latest ban is ridiculous...no flavored analogues EXCEPT menthol...."

Is that why all those nifty camel tins with orange and crap went away?? GRRRRR Those were awesome.. but hell, not as awesome as the cali-orange juice i got anyway