FDA issues notice of intent to propose "deeming" regulation by April of 2013 for e-cigarettes and other tobacco products

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Berylanna

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FDA worst nightmare a lawsuit by retail e-liquid Manufactures their attorney Jonathan Emord and Judge Richard J. Leon presiding


We can dream cant we ;)
Not really. They list earlier laws as their authority. A lawsuit will not work if they are obeying the laws and their website makes it clear that Congress gave them loopholes that lets them regulate this whether or not they are being reasonable.

IMO we need to also fight to amend the Family Smoking Prevention and tobacco Control Act to apply only to combustibles, and to proven-harmful chemicals in other products (much like food.)

I'm curious if the apparent difference between Swedish vs. U.S. mouth cancer rates is caused by dirty (fertilizers and pesticides) tobacco, or if it is caused by really bad math.
 

Vocalek

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Not really.

IMO we need to also fight to amend the Family Smoking Prevention and Tobacco Control Act to apply only to combustibles, and to proven-harmful chemicals in other products (much like food.)

I'm curious if the apparent difference between Swedish vs. U.S. mouth cancer rates is caused by dirty (fertilizers and pesticides) tobacco, or if it is caused by really bad math.

Actually, there is no difference now between US and Swedish mouth cancer rates.

Lee PN, Hamling J. Systematic review of the relation between smokeless tobacco and cancer in Europe and North America. BMC Med. 2009 Jul 29;7:36. Review. Systematic review of the relation between smokeless tobacco and cancer in Europe and North America

Eighty-nine studies were identified; 62 US and 18 Scandinavian. Forty-six (52%) controlled for smoking. Random-effects meta-analysis estimates for most sites showed little association. Smoking-adjusted estimates were only significant for oropharyngeal cancer (1.36, CI 1.04–1.77, n = 19) and prostate cancer (1.29, 1.07–1.55, n = 4). The oropharyngeal association disappeared for estimates published since 1990 (1.00, 0.83–1.20, n = 14), for Scandinavia (0.97, 0.68–1.37, n = 7), and for alcohol-adjusted estimates (1.07, 0.84–1.37, n = 10). Any effect of current US products or Scandinavian snuff seems very limited. The prostate cancer data are inadequate for a clear conclusion.

As early as 1998, there was evidence of no increased risk of oral cancer with chewing tobacco.

Bouquot JE, Meckstroth RL. Oral cancer in a tobacco-chewing US population - no apparent increased incidence or mortality, Oral Surgery Oral and Maxillofacial Pathology, 1998, Vol. 86, No. 6. 697-706. Oral cancer... [Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998] - PubMed - NCBI

CONCLUSIONS: The hypothesis was not confirmed by data analysis. West Virginia is the state with the highest per capita consumption of smokeless tobacco, yet it has less oral/pharyngeal cancer than the US average. The authors strongly urge additional and improved epidemiologic evaluation of the oral cancer risk of smokeless tobacco use in US males.

As early as 2004, some honest scientists were calling on the government to stop portraying smokeless tobacco products as being as harmful as smoking.

Levy DT, Mumford EA, Cummings KM, et al, The Relative Risks of a Low-Nitrosamine Smokeless Tobacco Product Compared with Smoking Cigarettes: Estimates of a Panel of Experts, 2004, Cancer Epidemiol Biomarkers Prev, Vol. 13, No. 12, 2035-2042. The Relative Risks of a Low-Nitrosamine Smokeless Tobacco Product Compared with Smoking Cigarettes: Estimates of a Panel of Experts

ABSTRACT: A nine-membered panel of experts was asked to determine expert opinions of mortality risks associated with use of low-nitrosamine smokeless tobacco (LN-SLT) marketed for oral use. A modified Delphi approach was employed. For total Mortality, the estimated median relative risks for individual users of LN-SLT were 9% and 5% of the risk associated with smoking for those ages 35 to 49 and ≥50 years, respectively. Median mortality risks relative to smoking were estimated to be 2% to 3% for lung cancer, 10% for heart disease, and 15% to 30% for oral cancer. Although individual estimates often varied between 0% and 50%, most panel members were confident or very confident of their estimates by the last round of consultation. In comparison with smoking, experts perceive at least a 90% reduction in the relative risk of LN-SLT use. The risks of using LN-SLT products therefore should not be portrayed as comparable with those of smoking cigarettes as has been the practice of some governmental and public health authorities in the past. Importantly, the overall public health impact of LN-SLT will reflect use patterns, its marketing, and governmental regulation of tobacco products.

CONCLUSION: On the narrow question of the relative health risk of LN-SLT products, these results clearly indicate that experts perceive these products to be far less dangerous than conventional cigarettes. Based on the available published scientific literature as of 2003, there seems to be consensus that LN-SLT products pose a substantially lower risk to the user than do conventional cigarettes. This finding raises ethical questions concerning whether it is inappropriate and misleading for government officials or public health experts to characterize smokeless tobacco products as comparably dangerous with Cigarette smoking (29)


Lee PN. Summary of the epidemiological evidence relating snus to health. Regul Toxicol Pharmacol. 2011 Mar;59(2):197-214. Epub 2010 Dec 14. Review. Summary of the epidemiological evide... [Regul Toxicol Pharmacol. 2011] - PubMed - NCBI

Abstract

Interest in snus (Swedish-type moist snuff) as a smoking alternative has increased. This wide-ranging review summarizes evidence relating snus to health and to initiation and cessation of smoking. Meta-analyses are included. After smoking adjustment, snus is unassociated with cancer of the oropharynx (meta-analysis RR 0.97, 95% CI 0.68-1.37), oesophagus (1.10, 0.92-1.33), stomach (0.98, 0.82-1.17), pancreas (1.20, 0.66-2.20), lung (0.71, 0.66-0.76) or other sites, or with heart disease (1.01, 0.91-1.12) or stroke (1.05, 0.95-1.15). No clear associations are evident in never smokers, any possible risk from snus being much less than from smoking. "Snuff-dipper's lesion" does not predict oral cancer. Snus users have increased weight, but diabetes and chronic hypertension seem unaffected. Notwithstanding unconfirmed reports of associations with reduced birthweight, and some other conditions, the evidence provides scant support for any major adverse health effect of snus. Although some claims that snus reduces initiation or encourages quitting are unsoundly based, snus seems not to increase initiation, as indicated by few smokers using snus before starting and current snus use being unassociated with smoking in adults (the association in children probably being due to uncontrolled confounding), and there are no reports that snus discourages quitting.
 

Berylanna

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Thanks for posting that. I was looking through the slides for the testimony given by Legacy's David Abrams and found it a pleasant surprise and rather a change in attitude. I was curious about one of his slides so I tracked down the journal article he referred to and found the full text is available for free.

Exploring Scenarios to Dramatically Reduce Smoking Prevalence: A Simulation Model of the Three-Part Cessation Process

THAT is really interesting. It's a mathematical proof that a big cut on the total number of smokers can ONLY be done by getting older people to quit, based on demographics of trying to quit vs starting.

We can do something with that I bet, because I found a page that says the #1 factor in whether kids start to smoke is....wait for it...

Why do people start smoking? Top 10 reasons | Addiction Blog
1. Family attitudes that condone smoking – Young people who start smoking in their teen years frequently have siblings, parents, grandparents or “broader family” members who smoke. The risk that a person start smoking is often higher if one or both parents smoke.

This means, if flavors actually do attract both young and old people to vaping, then the risk of flavors to young people is LESS than the risk to young people of their parents being unable to switch to vaping!!!!!

(Also, though it has been proven via memos that BT used flavors to try to market to young people, did anybody ever prove that it WORKED?)
 

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(Also, though it has been proven via memos that BT used flavors to try to market to young people, did anybody ever prove that it WORKED?)

I often ask the same question about the alleged "nasty chemicals to make cigarettes more addictive" claim. Taken with the "lied about knowing cigarettes are addictive" claim, one has to wonder why, if they already knew cigarettes were so highly addictive, they would bother to spend millions on "fixing what ain't broke?" And did they actually make them "more addictive" or just deliver the nicotine more efficiently so smokers wouldn't have to expose themselves to as many cigarettes to be "satisfied?" How does one go about making a supposedly highly addictive product more addictive? Nicotine doesn't work like alcohol where higher proof gets you more inebriated. And a higher proof isn't "more addictive" - it just gets you drunk faster with less drinking. Let that bounce around your brains for a bit.

" Not to mention that long-living, addicted customers are better for the bottom line than killing them off by adding nasty chemicals that do nothing and then having to spend millions every year trying to hook children. Seeing with my own eyes the ANTZ lies about e-cigs and the companies trying to hook kids and sell products with "deadly chemicals," I can't help but wonder how many of the ANTZ horror stories about "big, evil tobacco" are just as made up to further their prohibitionist agenda and vilify the industry to make the ANTZ look like public health heroes.

I'd like to see a link to those memos proving BT was targeting children with flavors. Most of the flavored cigarettes I saw were significantly higher priced (I got them occasionally when I had the money) and if the ANTZ are to be believed, kids are more swayed by cost than adults (per their justification for higher taxes.) If BT was really targeting kids, they could have simply made a brand that was cheaper, rather than developing a higher-end line with fairly sophisticated flavors. And the hardest hit by the flavor ban, as far as younger smokers, were the clove cigarette makers, which were mainly imported and not even sold by BT. Not saying BT didn't lie about some things, but which are BT lies vs ANTZ lies about BT to manipulate the public?
 
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Berylanna

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I often ask the same question about the alleged "nasty chemicals to make cigarettes more addictive" claim.

I think I saw ammonia mentioned in that regard somewhere, but I don't have a link.

I'd love it if we could find research to support a slogan that "The single most-effective way to keep kids from starting smoking is
to get their parents, grandparents, coaches, and teachers to stop lighting tobacco on fire!"

Also: "Everytime someone switches to e-cigarettes, XXXX less pounds/year of tobacco smoke goes into the air!"

Cigarette smoke produces 10 times more air pollution than diesel car exhaust Cigarette smoke produces 10 times more air pollution than diesel car exhaust
 

kristin

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Yes, the already naturally present ammonia helps deliver nicotine more efficiently. But do we know that adding a bit more makes cigarettes "more addictive" or is that just ANTZ conjecture along the same lines as "e-cigarettes will addict kids and then they'll graduate to smoking traditional cigarettes?"

There are other studies that show the exact opposite of that diesel fuel claims. In fact, unlike with tobacco smoke, they have actually been able to give rats lung cancer with direct fume exposure in a lab. That claim about SHS is junk, IMO.
 

zeratul734

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Here's my outlook.

If this proposed legislature ends in regulation, the most likely course of action is the following:


Flavored juices will be removed. Tobacco and menthol only. (there is precedent for this in the tobacco industry already)

juice bottles will be removed. Pre-filled cartomizers and other "sealed" devices only. (because they can easily sell the "poisonous unsafe product" line; spilling juice on your hand is NOT good, and there are a lot of idiots who will leave juice where kids can get it). If we are lucky, tanks and sealed tank refills will be available.

There will be a major review of hardware. They will try to look at cartomizer filler, the materials atomizers and tanks are made of, and the safety of batteries and mods. This will drive up prices and knock certain products out.

It will require a financial investment to stay in the industry, because of forced product reviews. This will drive up prices and eliminate smaller shops.



But it's a slippery slope. After this, they will tax it, force more regulations and money from businesses, and all but the largest e-cig shops will fall through the cracks. Eventually, if vaping as we know it today survives, it will be in the same way cigar shops compete with cigarettes being sold at gas stations. It will still be there, but the majority of consumers won't be doing it.
 

zapped

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juice bottles will be removed. Pre-filled cartomizers and other "sealed" devices only. (because they can easily sell the "poisonous unsafe product" line; spilling juice on your hand is NOT good, and there are a lot of idiots who will leave juice where kids can get it). If we are lucky, tanks and sealed tank refills will be available.

Where did you hear the fairy tale about spilling juice on your hand is NOT good? It wont hurt you as long as you wash it off in a reasonable amount of time. Nicotine takes a long time and pretty much constant contact to be absorbed through the skin thats why the patch is designed the way it is.

Ive spilled uncut 100mg nicotine on my hand while attempting DIY (you should always wear gloves and goggles with that high a concentration) and admit to freaking out a bit, mainly based on what Id read on the forums. I washed it off 10 seconds later and Im obviously still alive.
 

zeratul734

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Where did you hear the fairy tale about spilling juice on your hand is NOT good? It wont hurt you as long as you wash it off in a reasonable amount of time. Nicotine takes a long time and pretty much constant contact to be absorbed through the skin thats why the patch is designed the way it is.

Ive spilled uncut 100mg nicotine on my hand while attempting DIY (you should always wear gloves and goggles with that high a concentration) and admit to freaking out a bit, mainly based on what Id read on the forums. I washed it off 10 seconds later and Im obviously still alive.

I've had my share of juice mishaps too, but at some point someone will (at least claim to have) hurt themselves by doing so. Vaping has left the dedicated hobbyist and hit the masses, and some of the masses are just plain dumb and entitled. Plus, if you are uneducated on the issue and the FDA says it's bad, most people's first inclination is to believe them.

Edit: just so we're clear, it would be a real freak situation for someone to be seriously harmed by juice contact with skin. You're probably about as likely to be killed by a meteorite in your living room than from skin contact overdose with vendor nicotine concentrations.
 
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DC2

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I've had my share of juice mishaps too, but at some point someone will (at least claim to have) hurt themselves by doing so. Vaping has left the dedicated hobbyist and hit the masses, and some of the masses are just plain dumb and entitled. Plus, if you are uneducated on the issue and the FDA says it's bad, most people's first inclination is to believe them.

Edit: just so we're clear, it would be a real freak situation for someone to be seriously harmed by juice contact with skin. You're probably about as likely to be killed by a meteorite in your living room than from skin contact overdose with vendor nicotine concentrations.
If the juice were pure nicotine, there could be a serious problem.

But our concentrations are generally no more than 10% which is 100mg strength.
And keep in mind that the nicotine is bound up in PG and/or VG solution, which further delays absorption.

I use 12mg strength, and when I get some on my fingers I am just as likely to lick it off as wipe it off.
:)
 

Berylanna

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I think we need to have a ban against meteorites hitting our houses.

At least where children are present.
Doesn't anyone care about the children?
My favorite wine of all time is called "Cigar Volante" (French for spaceship) and has a true story on the back label about a small town in France that passed a strict law against flying saucers hovering over their vinyards, back in the 1940's.

It is quite clear that this law has been 100% effective. So don't knock what you haven't tried! :blink:
 

FloridaNoob

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I often ask the same question about the alleged "nasty chemicals to make cigarettes more addictive" claim. Taken with the "lied about knowing cigarettes are addictive" claim, one has to wonder why, if they already knew cigarettes were so highly addictive, they would bother to spend millions on "fixing what ain't broke?" And did they actually make them "more addictive" or just deliver the nicotine more efficiently so smokers wouldn't have to expose themselves to as many cigarettes to be "satisfied?" How does one go about making a supposedly highly addictive product more addictive? Nicotine doesn't work like alcohol where higher proof gets you more inebriated. And a higher proof isn't "more addictive" - it just gets you drunk faster with less drinking. Let that bounce around your brains for a bit.

" Not to mention that long-living, addicted customers are better for the bottom line than killing them off by adding nasty chemicals that do nothing and then having to spend millions every year trying to hook children. Seeing with my own eyes the ANTZ lies about e-cigs and the companies trying to hook kids and sell products with "deadly chemicals," I can't help but wonder how many of the ANTZ horror stories about "big, evil tobacco" are just as made up to further their prohibitionist agenda and vilify the industry to make the ANTZ look like public health heroes.

I'd like to see a link to those memos proving BT was targeting children with flavors. Most of the flavored cigarettes I saw were significantly higher priced (I got them occasionally when I had the money) and if the ANTZ are to be believed, kids are more swayed by cost than adults (per their justification for higher taxes.) If BT was really targeting kids, they could have simply made a brand that was cheaper, rather than developing a higher-end line with fairly sophisticated flavors. And the hardest hit by the flavor ban, as far as younger smokers, were the clove cigarette makers, which were mainly imported and not even sold by BT. Not saying BT didn't lie about some things, but which are BT lies vs ANTZ lies about BT to manipulate the public?

I am not sure I can completely agree with you on some of your points. Firstly my counselor actually comes from a generational family of tobacco growers. He was the first not to do it. Anyways he actually confirms that the tobacco grown today is for more potent that that of our "fathers." Nicotine is an anti-depressent, as we all know. So by having a larger dose of any given medicine and having your body get a larger dose of said chemical in your body means your body will want that same larger dose. Those it can/could be more addictive than the original cigerettes we started out on decades ago.

Think along these lines. We know nicotine is addictive. It is probably much easier, at first, to get over the cravings for said addiction if the dosage we are withdrawling from is smaller. We may not be getting more drunk as you want to point out. However, our body is getting used to a larger dosage. Thus their is a larger amount our body craves and a long period of withdrawl.

Think of persons who is on caffine. Their body gets used to the amount of caffine they are taking in and after a time it won't function normal w/o it. Thus a person who drinks 2 pots of coffee will have a hard time getting off of caffine than a person who drinks 2 cups of coffee. Also if one person drinks half caffine coffee they are less likely to be as addicted as someone who drinks expresso.

I think you will agree my example is more in line to effects than yours.
 

Petrodus

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Those opposed to e-cigarettes today are just using "Nicotine" as their talking point
sucking us into the discussion ... It's nothing more than their current distraction
from their true agenda which is simply banning e-cigarettes.

Those opposed to e-cigarettes have waived many flags in the past. Every time we
prove them wrong ... They just find another flag to waive.

It wasn't that long ago ... They were waiving the flag "Save the Children"

Those opposed to e-cigarettes won't publicly admit they
want them banned because they remind them of smoking.

Of course, everyone on the planet knows why the FDA
is opposed to e-cigarettes.
 
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Vocalek

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I am not sure I can completely agree with you on some of your points. Firstly my counselor actually comes from a generational family of tobacco growers. He was the first not to do it. Anyways he actually confirms that the tobacco grown today is for more potent that that of our "fathers." Nicotine is an anti-depressent, as we all know. So by having a larger dose of any given medicine and having your body get a larger dose of said chemical in your body means your body will want that same larger dose. Those it can/could be more addictive than the original cigerettes we started out on decades ago.

Think along these lines. We know nicotine is addictive. It is probably much easier, at first, to get over the cravings for said addiction if the dosage we are withdrawling from is smaller. We may not be getting more drunk as you want to point out. However, our body is getting used to a larger dosage. Thus their is a larger amount our body craves and a long period of withdrawl.

Think of persons who is on caffine. Their body gets used to the amount of caffine they are taking in and after a time it won't function normal w/o it. Thus a person who drinks 2 pots of coffee will have a hard time getting off of caffine than a person who drinks 2 cups of coffee. Also if one person drinks half caffine coffee they are less likely to be as addicted as someone who drinks expresso.

I think you will agree my example is more in line to effects than yours.

The mechanism being discussed here is called "tolerance." It's true that for some drugs such as alcohol and many illicit drugs, tolerance is limitless. This is not true of all substances.

Nicotine is one where it isn't true. Until the advent of "light" cigarettes, most smokers built up to about a pack a day and stayed there for years and years. I stayed at 1 PAD for 20 years. When the surgeon general said "If you can't quit, at least switch to a low tar, low nicotine product." The National Cancer Institute, by the way, is the organization that dreamed up the idea of lights and asked tobacco companies to work on products with reductions in tar and nicotine. The result was the body of the smoker wanted to get the usual amount of nicotine and people smoked more. I was up to 50 B&H Lights within a few months.

Years later when I wanted to reduce my consumption I researched to find the highest nicotine level I could find and did reduce the number of cigs per day. Now I realize this is anecdotal, but I think you will find many similar stories among those who began smoking before 1980.

Here's what the scientists have to say:

A Critique of Nicotine Addiction - Hanan Frenk, Reuven Dar - Google Books

Chronic tolerance to nicotine in humans and... [Nicotine Tob Res. 2002] - PubMed - NCBI

http://jpet.aspetjournals.org/content/296/3/849.full.pdf

The Biology of Nicotine Dependence - CIBA Foundation Symposium - Google Books

Smoking and Dependence
 

zapped

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The mechanism being discussed here is called "tolerance." It's true that for some drugs such as alcohol and many illicit drugs, tolerance is limitless. This is not true of all substances.

Nicotine is one where it isn't true. Until the advent of "light" cigarettes, most smokers built up to about a pack a day and stayed there for years and years. I stayed at 1 PAD for 20 years. When the surgeon general said "If you can't quit, at least switch to a low tar, low nicotine product." The National Cancer Institute, by the way, is the organization that dreamed up the idea of lights and asked tobacco companies to work on products with reductions in tar and nicotine. The result was the body of the smoker wanted to get the usual amount of nicotine and people smoked more. I was up to 50 B&H Lights within a few months.

Years later when I wanted to reduce my consumption I researched to find the highest nicotine level I could find and did reduce the number of cigs per day. Now I realize this is anecdotal, but I think you will find many similar stories among those who began smoking before 1980.

Here's what the scientists have to say:

A Critique of Nicotine Addiction - Hanan Frenk, Reuven Dar - Google Books

Chronic tolerance to nicotine in humans and... [Nicotine Tob Res. 2002] - PubMed - NCBI

http://jpet.aspetjournals.org/content/296/3/849.full.pdf

The Biology of Nicotine Dependence - CIBA Foundation Symposium - Google Books

Smoking and Dependence

Its highly likely that the higher amount of combustibles we inhaled because of switching over to "lights" (I went up to 2 packs a day as well from 1 pack of Marlboro reds) did MORE damage to us than if we had stayed with full flavor.
 
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