Class Action Against the FDA

[DarthVapr]

I also read that they are studying nicotine now as a possible medication to help alzheimer's patients and parkinson's sufferers as well as helping schizophrenics.

Absolutely correct, HeatherC.

While it is true that nicotine has some negative side-effects, it is not the nicotine that causes the vast majority of health problems associated with smoking. In fact, according to the scientific and medical community, nicotine, without the other 4,000 chemicals in cigarette smoke, has many potential therapeutic and medicinal properties:

Nicotine's mood-altering effects are different by report: in particular it is both a stimulant and a relaxant.[31] First causing a release of glucose from the liver and epinephrine (adrenaline) from the adrenal medulla, it causes stimulation. Users report feelings of relaxation, sharpness, calmness, and alertness.[32] By reducing the appetite and raising the metabolism, some smokers may lose weight as a consequence.[33][34]

When a cigarette is smoked, nicotine-rich blood passes from the lungs to the brain within seven seconds and immediately stimulates the release of many chemical messengers including acetylcholine, norepinephrine, epinephrine, vasopressin, arginine, dopamine, autocrine agents, and beta-endorphin.[35] This release of neurotransmitters and hormones is responsible for most of nicotine's effects. Nicotine appears to enhance concentration[36] and memory due to the increase of acetylcholine. It also appears to enhance alertness due to the increases of acetylcholine and norepinephrine. Arousal is increased by the increase of norepinephrine. Pain is reduced by the increases of acetylcholine and beta-endorphin. Anxiety is reduced by the increase of beta-endorphin. Nicotine also extends the duration of positive effects of dopamine[37] and increases sensitivity in brain reward systems.[38] Most cigarettes (in the smoke inhaled) contain 1 to 3 milligrams of nicotine.[39]

Source: Wikipedia, the free encyclopedia
​

And studies show that nicotine may be an important source of treatment for a variety of illnesses and conditions.

Video – Dr Paul Newhouse, Professor of Psychiatry at the University of Vermont.

According to the American Academy of Neurology, mild cognitive impairment is a precursor to Alzheimer's disease. It may seem strange that nicotine could have a "good" side, but Paul Newhouse, M.D., from the University of Vermont, says indeed, it does. He says, "Nicotine can improve learning. It can improve attentional performance. It can improve visual performance. It can improve sustained attention over time."

THE PROMISE OF NICOTINE: Researchers like Dr. Newhouse across the country are finding that nicotine may benefit more than just Alzheimer's disease and dementia. They're also finding beneficial effects for people with Parkinson's disease, ADHD, Tourette syndrome and more. In a study on Parkinson's disease, Dr. Newhouse found nicotine improved both cognitive and motor performance. Recent research by Dr. Newhouse's colleagues at UVM suggests there also may be a specific role for nicotinic stimulation for both children and adults with ADHD.

Source: WCHS TV / ABC News
​

Many people think nicotine causes cancer, or other diseases. But “Just the opposite is true,” says Dr. Virginia Reichert, Lead investigator for the North Shore-Long Island Jewish Health System in Great Neck, New York. “Nicotine does not cause cancer, . . . It’s the cigarette smoke that contains carcinogens, neurotoxins and other toxins.”

 

[DarthVapr]

Not only that, but we have proof that they were cruising the e-cig forums and reading about people using 100mg liquid, making their own and mods blowing up on people.

Another reason why we caution people about saying stupid stuff on the forums - they WILL use it against us if they can!

I'd like to see that documentation. I believe it 100%. That stuff they accept as Gospel, but anyone that says that vaping helped them quit smoking is totally ignored. Typical of these mental midgets. (Yeah, you! You, staring into your computer screen at the FDA, scribbling your little notes. I'm taking about you! ESADAH!)

 

[thephoenix]

gotta be honest...curious about a throat hit of a 100mg nicotine mix...

 

[Danyulc]

I can't believe anybody would even smoke 100mg mix. Without graduating up to that level you are asking for serious trouble/illness.

All the references I have heard of relating to 100mg involve using it to increase the nicotine level of liquid without nicotine or that which has too low a level for the user. Not saying that somebody hasn't tried to use 100mg straight out of the bottle, but, that person(s) represents the minority of users.

Agreed though, people should refrain from talking about their foolish adventures in nicotine abuse. Nobody here condones it. In addition the higher the nicotine level the harder it is to practice gradual nicotine cessation.

BTW, You're too funny Darthvapr. I used to play WoW, but, I got tired of it. I really should sell my uber account though, lol. Maybe post in the trade forum and get ecig supplies, hehe. You're right though, Starcraft II is gonna be sweet! Skipped the multiplayer beta because I've always sucked at those kind of mp games. Actually at all mp games, lol.

-Danyulc

 

[DarthVapr]

gotta be honest...curious about a throat hit of a 100mg nicotine mix...

I'm not. Sounds like drinking Clorox, but they say that's how Joe Cocker got his distinctive voice. Maybe vaping cat piss.

 

[Gandy]

Well i know I quit smoking for a month only because of my e cig and I feel, breath, taste and smell a lot better.

 

[DarthVapr]

Last year the FDA sent a letter to General Mills with the following statement:

Unapproved New Drug

Based on claims made on your product's label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease.
​

Below is the Action Alert Level of contamination for a container of ground black pepper:

PEPPER, GROUND

Insect filth (AOAC 972.40) Average of 475 or more insect fragments per 50 grams

Rodent filth (AOAC 972.40) Average of 2 or more rodent hairs per 50 grams

DEFECT SOURCE: Insect fragments - post harvest and/or processing insect infestation, Rodent hair - post harvest and/or processing contamination with animal hair or excreta

SIGNIFICANCE: Aesthetic
​

Okay, this is the level at which the FDA has a problem with the contamination. Below that is not a problem for them. I have a 4 ounce can of black pepper, that's 113 grams.

So, should I conclude that there may be (probably will be?) 950 insect fragments, and an average of 4 rodent hairs? And they just lump rodent "excreta" in with the hair. I don't like that. Does that mean an average of two hairs and two turds?

And nowhere on the package label does it list these ingredients. Maybe the manufacturer just forgot, or couldn't figure out the % of the minimum daily requirements of bug parts, rat hair and excreta. Or maybe the bug parts, rat hair and turds have medicinal value, but haven't been submitted to the FDA's New Drug Application process which, as we've seen with Cheerios, can get you a stern letter from the FDA.

My message to the FDA - Stay away from my propylene glycol, flavorings, and nicotine, and spend some time getting the bug parts, rat hair and turds out of my condiments and food, especially the three primary food groups, popcorn, potato chips and pizza.

 

[Vocalek]

Yes while very true that nicotine is the "drug" in tobacco, the three doctors I've talked to...including my GP and a Cardiologist agree that while nicotine is addictive it does basically the same thing that caffeine does increasing the heartrate and blood pressure while increasing dopamine production in the brain and releasing endorphines(adrenaline)
I also read that they are studying nicotine now as a possible medication to help alzheimer's patients and parkinson's sufferers as well as helping schizophrenics.

The real danger in tobacco smoking is the carbon monoxide and the around 4000 other chemicals that appear in cigarette smoke including the 50 some identified as carcinogens.
The fact that I'm not breathing those toxic chemicals and neither is my son is enuff for me to vape not smoke anymore!!

SOOO to sum up keep telling others about your successes...keep telling your doctor how much better you feel....keep your children safe....KEEP VAPING and I would definately be willing to be part of a class action suit if they ban or make illegal the ecig.

Comment on blood pressure and heart rate:

When the Alphabet Soup Gang mentions that nicotine "increases blood pressure," they always leave out a very important clarifier: "temporarily." The average Joan thinks that "increases blood pressure" means "causes hypertension." Hypertension is a condition characterized by chronic and sustained higher blood pressure readings.

Yes, a dose of nicotine increases blood pressure and heart rate temporarily, just like caffeine, and just like that doctor-recommended activity--exercise!

Nicotine does not cause hypertension. In fact, quite a few studies have documented an increase in the rate of hypertension among folks who achieved smoking cessation when compared with continuing smokers in the same study. This leads to the hypothesis that perhaps nicotine is protective, to some extent, against hypertension.

 

[kristin]

Last year the FDA sent a letter to General Mills with the following statement:

Unapproved New Drug

Based on claims made on your product's label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of
​

And it amazes me how many things are sold that simply have "These statements have not been evaluated/approved by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease" and they are left on the market without question.

I was just watching a commercial for Focus Factor (a memory enhancement suppliment) and they had that in tiny print. This product also carries a warning that it is highly dangerous to small children - a poison if swallowed - due to high concentrations of iron.

Someone please explain how something like this is so different from e-cigs??

It's too bad the original e-cig distributors didn't have the forethought to put on the FDA disclaimer. It wouldn't have stopped the FDA from trying the same crap, but it sure would have helped the e-cig argument, had they covered their arses.

 

[D103]

A little off topic - but it does relate to the FDA. For anyone interested...or anyone who runs up against the propylene glycol BS, check out PARI Pharma and their EFlow nebulizer technology. If you look into this there is a lot of information about this technology and the multiple ways in which this is being utilized, eg. inhaled chemotherapy, inhalation therapies for patients with cystic fibrosis and chronic bronchitis as well as other chronic pulmonary disorders. There is a whole host of medications being delivered through this nebulizer/inhaled technique and it takes a bit of reading but if you wade through the explanation of the technology it explains that the medication is aerosolized into tiny particles and then inhaled into the lungs and it is a far more effective and safer delivery system. In order for the medication to be aerosolized they use a "cosolvent" which is necessary for the process to work - and guess what they use (FDA approved) as the cosolvent - propylene glycol. Some of the applications even utilize "flavorings" as well. Again, so much for the FDA claims that "...we don't yet know what the effects of inhaling propylene glycol are, blah, blah, blah...."

 

[markarich159]

And it amazes me how many things are sold that simply have "These statements have not been evaluated/approved by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease" and they are left on the market without question.

I was just watching a commercial for Focus Factor (a memory enhancement suppliment) and they had that in tiny print. This product also carries a warning that it is highly dangerous to small children - a poison if swallowed - due to high concentrations of iron.

Someone please explain how something like this is so different from e-cigs??

It's too bad the original e-cig distributors didn't have the forethought to put on the FDA disclaimer. It wouldn't have stopped the FDA from trying the same crap, but it sure would have helped the e-cig argument, had they covered their arses.

That Statement was a result of an act passed by Congress called the Dietary Supplement Health and Education Act of 1994. I don't have the time or the energy to go into detail on how or why the act was passed right now, but I explain it, in some detail, in the middle of this post:

http://www.e-cigarette-forum.com/forum/diy-e-liquid/52669-pg-vg-labeling-purity-please-read.html

The reason that statement is not applicable, at this time, to e-cigs is that e-cigs do not fall into the dietary supplement/natural product/health food product category., The FDA is still insisting they are an unapproved drug/device combo.

 

[DarthVapr]

A little off topic - but it does relate to the FDA. For anyone interested...or anyone who runs up against the propylene glycol BS, check out PARI Pharma and their EFlow nebulizer technology. If you look into this there is a lot of information about this technology and the multiple ways in which this is being utilized, eg. inhaled chemotherapy, inhalation therapies for patients with cystic fibrosis and chronic bronchitis as well as other chronic pulmonary disorders.
---snip---
Some of the applications even utilize "flavorings" as well. Again, so much for the FDA claims that "...we don't yet know what the effects of inhaling propylene glycol are, blah, blah, blah...."

You are so right. I found a page that has both summaries of many studies into the inhalation of vaporized propylene glycol, and links to the source of the summaries. Apparently, since the page is on the VaporsClub website, the link won't work. I guess you'll have to search for it the hard way. The heading is: "Research Results from studies on Propylene Glycol" (PG) [Can't we all just work together?]

Anyway, here is one summary, of the research findings of the Environmental Protection Agency relating to Propylene Glycol inhalation:

"General Toxicity Observations
Upon reviewing the available toxicity information, the Agency has concluded that there are no endpoints of concern for oral, dermal, or inhalation exposure to propylene glycol and dipropylene glycol. This conclusion is based on the results of toxicity testing of propylene glycol and dipropylene glycol in which dose levels near or above testing limits (as established in the OPPTS 870 series harmonized test guidelines) were employed in experimental animal studies and no significant toxicity observed."

"Carcinogenicity Classification
A review of the available data has shown propylene glycol and dipropylene glycol to be negative for carcinogenicity in studies conducted up to the testing limit doses established by the Agency; therefore, no further carcinogenic analysis is required."
​

http://www.epa.gov/oppsrrd1/reregistration/REDs/propylene_glycol_red.pdf
​

The full page has many more such scientific findings. We have all the documentation we need to convince anyone with an IQ above their shoe size that the FDA is lying outright.

 

[DarthVapr]

Here is the abstract of a research paper on tobacco harm reduction that really simplifies our argument, and includes electronic cigarettes:

Nicotine is so desirable to many people that when they are given only the options of consuming nicotine by smoking, with its high health costs, and not consuming nicotine at all, many opt for the former. Few smokers realize that there is a third choice: non-combustion nicotine sources, such as smokeless tobacco, electronic cigarettes, or pharmaceutical nicotine, which eliminate almost all the risk while still allowing consumption of nicotine. Widespread dissemination of misleading health claims is used to prevent smokers from learning about this lifesaving option, and to discourage opinion leaders from telling smokers the truth. One common misleading claim is a risk-risk comparison that has not before been quantified: A smoker who would have eventually quit nicotine entirely, but learns the truth about low-risk alternatives, might switch to an alternative instead of quitting entirely, and thus might suffer a net increase in health risk. While this has mathematical face validity, a simple calculation of the tradeoff -- switching to lifelong low-risk nicotine use versus continuing to smoke until quitting -- shows that such net health costs are extremely unlikely and of trivial maximum magnitude. In particular, for the average smoker, smoking for just one more month before quitting causes greater health risk than switching to a low-risk nicotine source and never quitting it. Thus, discouraging a smoker, even one who would have quit entirely, from switching to a low-risk alternative is almost certainly more likely to kill him than it is to save him. Similarly, a strategy of waiting for better anti-smoking tools to be developed, rather than encouraging immediate tobacco harm reduction using current options, kills more smokers every month than it could possibly ever save.
​

Carl V Phillips
University of Alberta, School of Public Health, 8215 112 St Suite 215, Edmonton, AB, T6G 2L9, Canada

author email

corresponding author email
Harm Reduction Journal 2009, 6:29doi:10.1186/1477-7517-6-29
The electronic version of this article is the complete one and can be found online at: Harm Reduction Journal | Full text | Debunking the claim that abstinence is usually healthier for smokers than switching to a low-risk alternative, and other observations about anti-tobacco-harm-reduction arguments
Received: 2 July 2009 Accepted: 3 November 2009 Published: 3 November 2009 © 2009 Phillips; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

 

[kristin]

fair enough.

would be nice to see a list of who's doing what though...

Ask and ye shall receive!

http://www.e-cigarette-forum.com/fo...2186-se-vs-fda-discussion-22.html#post1572810

 

[markarich159]

"General Toxicity Observations

Upon reviewing the available toxicity information, the Agency has concluded that there are no endpoints of concern for oral, dermal, or inhalation exposure to propylene glycol and dipropylene glycol. This conclusion is based on the results of toxicity testing of propylene glycol and dipropylene glycol in which dose levels near or above testing limits (as established in the OPPTS 870 series harmonized test guidelines) were employed in experimental animal studies and no significant toxicity observed."

​

​

Darth, do you happen to have any info regarding the MAC(minimum alveolar concentration) that the OPPTS 870 series uses to establish it's inhalation toxicity level? It would go quite a long way to see if the level coincides with any clinically documented e-cig alveolar concentrations currently available through peer-reviewable studies. If so could you post them. Thanks

 

[DarthVapr]

[/INDENT]Darth, do you happen to have any info regarding the MAC(minimum alveolar concentration) that the OPPTS 870 series uses to establish it's inhalation toxicity level? It would go quite a long way to see if the level coincides with any clinically documented e-cig alveolar concentrations currently available through peer-reviewable studies. If so could you post them. Thanks

I found the " Health Effects Test Guidelines OPPTS 870-1300 Acute Inhalation Toxicity. EPA. 712–C–98–193."

(b) Purpose. Determination of acute toxicity is usually an initial step
in the assessment and evaluation of the toxic characteristics of a substance that may be inhaled such as a gas, volatile substance, or aerosol/particle. It provides information on health hazards likely to arise from short-term exposure by the inhalation route. Data from an acute study may serve as a basis for classification and labeling. It is traditionally a step in establishing a dosage regimen in subchronic and other studies and may provide initial information on the mode of toxic action of a substance. An evaluation of acute toxicity data should include the relationship, if any, between the animals’ exposure to the test substance and the incidence and severity of all abnormalities, including behavioral and clinical abnormalities, the reversibility of observed abnormalities, gross lesions, body weight changes, effects on mortality, and any other toxic effects.
​

It's way above my head, but if that's what you're looking for the link on the EPA's website for the document is:

http://iccvam.niehs.nih.gov/SuppDocs/FedDocs/EPA/EPA-870-1300.pdf

Does this help? And if it does, can you explain what it means?
---------------
May The Vapor Be With You

 

[rothenbj]

Okay DV, I can see we're in need of an activist writer to research and expose the little-known business and political relationships between US corporations, certain government agencies and "health" organizations in their concerted effort to control the world supply of nicotine among a small group of businesses, thus eliminating all competition.

Know any writers up to the task?

 

[kristin]

It's all in the Tobacco Harm Reduction Yearbook!
THR2010. (tobaccoharmreduction.org)

Another good one is Velvet Glove, Iron Fist by Chris Snowden.

 

[rothenbj]

It's all in the Tobacco Harm Reduction Yearbook!
THR2010. (tobaccoharmreduction.org)

Another good one is Velvet Glove, Iron Fist by Chris Snowden.

I was just yanking on DV, he'll know what I'm talking about.

 

[DarthVapr]

I was just yanking on DV, he'll know what I'm talking about.

Only the Shadow knows! The secret is in the documentation. Right?

Hey, I've got my own abbreviation, like the CIA, the DEA, and the FD . . . no, forget that one. How about the EPA! Cool.
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Beware the Dark Side of the Vapor!