FDA and bait and switch- letter to manufacturers

 http://www.tveca.com/PDF/fda-letter.pdf

Is a link to the marvelous letter sent to elecronic cigarette and juice manufacturers.  Quoting the Tobaccolawblog from the the law firm of Troutman and Sanders  http://www.tobaccolawblog.com/  :
"The letters note that FDA has authority under the Tobacco Control Act to assert jurisdiction over e-cigarettes, and that FDA intends to do so by issuing appropriate regulations.
The letters request information regarding the following issues:

• Customer complaints and “adverse event issues.”
• Reports of “consumer misuse.”
• Descriptions of product labeling.
• Systems in place to review customer complaints and adverse events."

Based on the information requested, it appears that FDA’s letters may have been prompted by a report earlier this year of an e-cigarette exploding in a man’s mouth.

It appears that the FDA is continuing to tally data to produce a case for strict regulation and safety is an issue.  There is no mention of any material in these letters pertaining to the positive effects or reports venders are receiving.

Sad that there is only Big Tobacco and Pharma (pharmaceutical companies who make NRT's- nicotine replacement therapies) interests with the money to lobby the FDA.

very sad

Of course Vermont not banning internet sales of ecigarettes- priceless.

For the truth about tobacco harm reduction- there is the one and only CASAA-The Consumer Advocates for Smoke-free Alternatives Association  casaa.org.

Inernet Bans in Vermont; Maybe the Domino Effect Was Real

A note from my heart on H 747

In a State that has Bernie Sanders as a Senator, a true Progressive Party member, and a history of individualism and of course Ethan Allen and Ben and Jerry's, it is hard to imagine that this state would be the first to criminalize the freedom of God fearing Vermont residents for attempting to stop smoking.

I have never been told that I was able to express my thoughts and opinions in a paragraph or two, so I hope that my lengthy diatribe is not out of line. The common good is my passion and the loss of freedom and especially the hardships of this time and its effects on the hard working men and women have made that passion more fervent.

There are many facets to any subject and the most important, in my opinion, is that there is a need to protect those that have not reached the age of consent without causing harm to those of the age of consent. I fully support the Vermont actions to remove tobacco and tobacco products from the hands of children. They are our most precious resource. To never start is to never have to stop.

Bill H 747 addresses that issue well from the standpoint of protecting the child. I wish 56 years ago that such was the case for myself and others of my generation. Smoking in my youth was the water bottle of this era. Nearly everywhere was tobacco and smokers. At 12 or 13 I started and by 25 knew I needed to quit. The advent of replacement therapies gave me hope, as quitting was impossible. I had tried every agent used from gums, patches and medication therapies along with counseling. A month or two after ending the prescribed regimens; relapse.

In 2010 I was introduced to vaping, a simple means of obtaining nicotine (which I literally have been exposed to since conception). The content of the vapor is similar to FDA patches when looking at the residual carcinogenic compounds that are ingested. I have not smoked a cigarette since the first day I vaped and am actually vaping solutions that are near zero nicotine. Smoking is a behavior that is biological and psychological. That is where the 50-75 percent of smokers who keep relapsing when trying to quit fail. Nicotine free for 2 months and then smoke again is counter to any intellectual process. Vaping has improved my health, stamina and dramatically changed my life.

This is not to say that nicotine replacement therapies that are marketed have no place in society, it is not to say that smokeless tobacco does not have a place in society- it is only to say that they did not work for this person.

I do not live in Vermont, but I entertained doing my residency in Burlington when I graduated from UNC-Chapel Hill. The visit was wonderful and people delightful and progressive. If it were not for my wife's pregnancy and a desire to be near family, I would have accepted that position.

I am a retired, ex-smoking physician who has elected to go back to school to teach High School Physics and Biology. I should have known better than to start smoking but in the sixties and seventies that was the norm.

As I am returning to teach it is very apparent that children and adolescents are not developmentally able to make decisions wisely. The millions of people who have successfully stopped inhaling tobacco smoke through vaping are freeing themselves from the 4000 chemicals that include at least 50 carcinogens (nicotine not one of them) and changing, through grassroots efforts, the options for tobacco users. Unfortunately the ending of internet sales will drastically hamper the effort toward harm reduction. We know 400,000 people will die from cancer of the lung each year. Vaping has been quoted by the Boston University Department of Public Health as 98% safer than smoking. It requires credit cards, is costly and there is no evidence that adolescents are using vaping to get their nicotine.

On the other hand the expanse of your state makes vender available personal vaping devices and the liquids unfeasible to most. Internet sale elimination will make citizens that are only attempting to find a potentially safer (and legal) avenue for either use or cessation criminals. It seems counterproductive to a medical mind to block this when prescription medications that are lethal are dropped on front porches daily by health insurance companies and the VA. Internet access is essential for people like me who live in rural areas (I am in New Mexico) and inflict their greatest harm on those of the lower and middle income groups who would have to cross borders and spend their money in other states, when they could order from Vermont Vapers for example.

I urge you and your committee to stand tall and defend those who cannot make decisions and make it criminal to sell or buy any nicotine, alcohol or prescription medication for a minor. I also urge that you allow adults of age to have the ability to engage in a life changing means of tobacco harm reduction that presently requires internet and mail order for its availability.

The only jobs that will be enhanced, in my opinion, are those of the jails that will be filled with good citizens who found a way to stop smoking and postal box sales in towns outside the Vermont borders.

Please keep hope alive for those who have found it by not eliminating internet and mail order sales. People will go back to smoking and the chemical and particulate smoke that carries with it the morbidity of cigarettes will increase health costs and decrease the quality of the life of the citizens of Vermont.

Please keep the statutes that penalize those that would introduce any nicotine product to youth. This is wise and essential. To ban internet availability is to mimic prohibition and can only deter a more hopeful lifestyle.

For more information go to cassa.org.

Thank you,

John Connell, M.D. (and future educator)

Please veto HB 245 Utah Governor Gary R. Herbert

"Some men see things as they are and ask “Why?”.  I dream things that never were and ask, “Why not?" –Robert F. Kennedy.  (Paraphrasing his brother JFK).

Don’t ask me why I smoked because I really have no good reason.  I started in the sixties when everyone smoked and the thought that cigarettes might be harmful was being undermined by the tobacco lobby and glamorous jingles that I can remember to this day.  Don’t tell me I made a conscious choice to start, I was nine years old.  Don’t tell me that I was following the crowd; most of my peers didn’t smoke. Don’t tell me I was stupid, I skipped two grades and was taking college classes at 15.  RFK was prophetic, the answer is in looking at history and postulating from what is known, then going a step further into the unknown.  What if I never had a chance to make the decision?

My parents both smoked 10 years prior to my birth, so the germ cells from which I was eventually conceived were bathed in nicotine; my conception to birth was a nicotine sea as my mother smoked heavily.  I was breast fed and lived in a small house with two active smokers.  We know that nicotine evokes distinct changes in the brain, in the body and causes dependence.  I have never been successfully free of nicotine.  But I have been free of smoke.   Nicotine patches and gums did something, as I have 10 of my 45 years since the first cigarette smoke free through those agents.  They did not work because there was always something missing.  I could wean myself down to a quarter strip of a 2 mg gum- but never any further.  Why not? Because I stop being able to think clearly and my attention span is absent. I would go six months free of smoke then fall again into the lue haze.

I found e-cigarettes quite by accident, a co-worker switched at first to avoid having to take smoke breaks as vaping was allowed in the workplace.  The only awareness the rest of the center noted was he smelled better, as did his office.  I ordered them in Dec. 2010 and have not smoked a cigarette since.  My doctor visit six months later led to a discussion of how my weight, blood pressure and pulmonary function were dramatically better.  I simply told him I was off cigarettes.  I saw him last week and again and am now on no blood pressure medications and no inhalers.  I told him about the e-cigarette and being a physician expected a lecture.  He just smiled and said, my wife started those 6 weeks ago, small world.

Interestingly, before I retired to enter into teaching, I was a psychiatrist and addictionologist.  Smoking has three main features.  The first is addiction and withdrawal, the second is what some call pleasurable but I call self-medication of mood and attention span problems and the third the behavior of smoking and the physical nature of the act.  It explains a great deal to me.

E-cigarettes are vapor producing agents that contain the equivalent level of carcinogens as a patch or gum.  Both felt lower than any level dangerous per the FDA.  There is no evidence of any risk higher than that of the official nicotine replacement therapies.  But most important, there is no smoke.  Vapor produce a mist, like a kettle produces steam.  Tobacco burns and chemically emits at least 4000 compounds, 40 of which are carcinogens.  A cloth put over the spout of a kettle dampens and dries to a show no residue.  Put your mouth to a tissue and blow out smoke from a cigarette- brown residue that does not go away.

So let us dream and ask ourselves- exposed to nicotine all his life and probably for 10 years prior to conception, why would a person like me not be helped by this product.  And since it is the particulate smoke that lingers in the bronchioles in a maelstrom of carcinogenic material, how is an e-cigarette not a better and more appropriate choice? 

Associating vaping with smoking is comparing Utah Basketball to European Rugby.  They have a ball, but that is about the only association. 

Ban e-cigarette sales to minors, there isn’t much interest anyway.  Ban smoking, as an ex-smoker I am in awe of the pungent and lingering odors.  But vaping has not been shown to be an entry drug to smoking, it is not the evil empire of tobacco- it is an exit from the tobacco smoking habit.  Vapor is rapidly dissipating and not smoke.

And since it was not developed by a Pharmaceutical Company or Big Tobacco, those lobbies oppose them because they were a grass root industry that has formed to help millions across the globe and are more interested in the empathic elimination of smoking, harm reduction and choice.

When we dream of what is not obvious, find a solution and experience the amazing heath changes, we ask “Why not”.  When we see there are no toxins and no particulate smoke, we ask “Why not”.  When we see it is again American (borrowed from China) ingenuity and the American people seeking a solution to a problem that works for many more than FDA approved replacements, it is then we ask why, why eliminate a product that is less toxic to all.  The presence of vapers in public is an enticement for smokers to be exposed to a possible and most probably less harmful agent.  Like me they just might try it.  With Boston’s Department of Health stating they are 98-99% less toxic than cigarettes, think of the gains.

And the thought of being segregated with smokers in a designated area, is this not placing me in a harmful and toxic environment, the exact point the bill is attempting to free others of experiencing?

Equating vapor and smoke is not science and is not accurate, and accuracy is what leadership is all about.  Dream, be leaders and ask, as RFK did- WHY NOT?

ECIGS OCCUPY WALL STREET

[italics my own]

This article was gleaned from the internet and is unfortunately typical of the focus that is being exaggerated with little proof that a concern, other than the general moral dilemma of minors accessing electronic cigarettes, that is more emotion than reality. In a Wall Street Journal Article Mike Esterl this is unfortunately again the litany of the electronic cigarette foes that is eschewed.

 E-Cigarettes Draw Fire From Legislators -- Limits Sought on Nicotine-Mist Devices; Users Say They Eliminate Secondhand Smoke and Help Break Tobacco Addiction

  2 March 2012


There's no smoke, but there's plenty of fire.

A growing number of states are taking aim at electronic cigarettes in the absence of federal regulations, intensifying a public-health debate over the fast-growing alternative to traditional cigarettes.

Lawmakers in more than half a dozen states from Arizona to New York have introduced legislation this year that would prohibit the sale of e-cigarettes to minors. Bills in Alabama, Kentucky, Mississippi and Utah would extend smoking bans in public areas to include e-cigarettes, and politicians in other states have proposed special taxes and halting Internet sales.            


[Interesting the point made regarding taxes and bans. A comment in the Utah house included You Tube as one of their sources for information.]

The activity comes as more Americans turn to the battery-powered tubes, which turn nicotine-laced liquid into a vapor mist that is inhaled. Annual sales of e-cigarettes in the U.S. have grown to between $250 million and $500 million since arriving from China five years ago, according to industry estimates. That still represents a sliver of the roughly $100 billion U.S. tobacco market.

A survey by the Centers for Disease Control and Prevention indicated 2.7% of U.S. adults had tried e-cigarettes by 2010, up from 0.6% a year earlier.

Anti-smoking groups seeking tight regulations on e-cigarettes say not enough is known about their health effects and that scientific studies are scant. They also say e-cigarettes are more likely to attract youth because they come in flavors like chocolate, cherry and pina colada.


[Anti-smoking groups are quite aware of the scant evidence of any direct harm from electronic cigarettes.  They are quite aware of the dangers of combustible tobacco and the difference between the two, yet do not see the risk/benefit ratios for reduction of harm.  4000+ chemicals are produced in the combustion of tobacco, 50-60 of them known carcinogens.  Nicotine is not one of the carcinogens.  Nicotine is a plant alkaloid, where are the ban tomato and eggplant outcries as they are nicotine sources?  The FDA approved smoking cessation patches and gums contain trace levels of carcinogens at about the same of slightly higher that of e-liquids.  Words are everything!  Look at this line from a Nature article (1) http://www.nature.com/nrc/journal/v3/n10/fig_tab/nrc1190_F1.html

Nicotine and carcinogens can also bind directly to some cellular receptors, leading to activation of the serine threonine kinase AKT (also known as protein kinase B), protein kinase A (PKA) and other factors. This, in turn, can result in decreased apoptosis, increased angiogenesis and increased cell transformation. Tobacco products also contain tumor promoters and co-carcinogens, which could activate protein kinase C (PKC), activator protein 1 (AP1) or other factors, thereby enhancing carcinogenesis. 


[Bias is the inclusion of personal views, agendas and sometimes the unconscious inference of association. Note the paragraph starts with, "Nicotine and carcinogens..., association with words but not data.  The carcinogens are in the combustible products of smoking, vaping is not smoke. In the diagram associated with the above link the figure gives the implied message that nicotine becomes the carcinogen.  Nicotine should be replaced by the word smoke.  Back to the article.]

In 2009, the Food and Drug Administration warned that e-cigarettes may pose health risks after its laboratory analysis of samples detected carcinogens and toxic chemicals. The agency said in April it planned to regulate e-cigarettes as a tobacco product, but it has yet to issue its proposal. It could be several more months or even years before federal rules are implemented.

"It's a very serious and important issue. We obviously need to learn more about potential health benefits and risks of novel products," said Lawrence Deyton, director of the FDA's Center for Tobacco Products. He added the agency is moving "expeditiously" to propose e-cigarette regulations.

[Again the vials of 2009, with trace amounts of diacetyl (within the FDA's) own standards.  This is never left out of any article that needs to associate electronic cigarettes with cancer.  No further studies have been done and the trace carcinogens are again in league with the FDA approved replacement agents.  Can we move on to science.  One shot analysis is not scientific research or following the scientific method]


E-cigarette users -- so-called vapers -- and some health experts are urging regulators to tread lightly. They say e-cigarettes help nicotine addicts quit more harmful traditional cigarettes, which release most of the toxins that cause disease through combustion, and eliminate the problem of secondhand smoke.

"We finally found something that worked; we quit smoking, and they want to ban it," said Elaine Keller, president of the nonprofit Consumer Advocates for Smoke-Free Alternatives Association, a consumer group that has received funding from e-cigarette companies but is mainly supported by e-cigarette users.

"To put some sort of major obstacle in the way of its use would be really unfortunate," said Michael Siegel, a professor at Boston University School of Public Health. 

[Slight breath of fresh air, and even quotes CASAA]

Dr. Siegel said inhaling propylene glycol, a respiratory irritant found in e-cigarettes, represents a major health concern. But he also noted the FDA's initial 2009 test and more than a dozen industry-commissioned lab studies indicate e-cigarettes have far fewer carcinogens or toxins and at far lower levels than traditional cigarettes, which are linked to an estimated 443,000 deaths a year.

Even e-cigarette companies support some regulation of an industry that has sprouted hundreds of start-up brands but still lacks standardized oversight. Although a growing number of brands such as NJOY and blu Cigs can be found at major retailers like 7-Eleven, Walgreens and Wall-Mart, many are sold exclusively over the Internet. Since they aren't taxed like traditional cigarettes, e-cigarettes can cost half as much, according to some estimates.

While they support age restrictions, the companies say their products shouldn't be cordoned off like traditional cigarettes or taxed at similar rates.

"We don't believe they are analogous in terms of their impact on society," said Craig Weiss, president of Scottsdale, Ariz.-based Sottera Inc., which owns the NJOY brand.

Lawmakers in Hawaii have moved to ban the sale of e-cigarettes to minors. But they backtracked last month on taxing the products at the same rate as traditional cigarettes after receiving more than 1,000 written submissions, many from e-cigarette users opposing the measure.

In Vermont, state Rep. Bill Frank has introduced a bill that would ban the sale of e-cigarettes to those under 18 years of age and make Internet-based sales punishable by up to five years of imprisonment. "If you're going to get kids hooked on nicotine, they're going to be smoking," Mr. Frank, a Democrat, said.

[And that's the fact Jack!  Mr. Frank appears to have implied the e-cigarette is an entry level agent.  We as of yet have seen evidence that the e-cigarette is an attractant of the youth (even pina colada).  But under 18 or 19 consumption is not supported by venders or those that have switched]

Senators in Utah are weighing a House-approved bill that would extend bans on smoking in public areas to e-cigarettes. New Jersey already has such a law in place, as do some cities, including Boston and Seattle. Many anti-smoking groups say e-cigarettes, which often look like traditional cigarettes, spark confusion in nonsmoking areas, undermining bans.

[Undermining bans.... why is it always a way to circumvent cigarette use. Bias]

"I would rather err on the side of caution," said state Rep. Susan Westrom, a Democrat who sponsored a similar bill in Kentucky, a major tobacco producer. She thinks too little is still known about e-cigarettes.

[And of course since there are significant issues with the multitude of personal stories that are evident in people who could not stop the known carcinogenic cigarette and have switched to e-cigarettes- and reported significant improvements in their self perception of their health.  Err to caution- 400,000 deaths per year and no significant change with billions of dollars that go to Pharma for replacement therapies... insanity defined in a new way, ban a promising agent that may help.  70% of smokers want to quit... many cannot.  Many do with e-cigarettes, some to abstinence, some to no nicotine vaping. Nice article, at least it included 2 paragraphs from real experts]