FDA may soon propose regulation that could ban many/most e-cigarette products, eliminate many/most companies

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TrueNews

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Dec 1, 2012
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Your right we need to stick to our topic, forgive me, for 3 lousy hours of sleep. :vapor: will try and educate myself about the important legis stuff now!

Health is important Lisa Belle - The rest can wait a while.

Plus - you don't function well when sleep deprived.

Catch some zzzzee's - it will all look better and be a lot clearer then.
 

Vocalek

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I wonder if Health and Ageing publish anywhere their thinking behind the changes they make to such standards (perhaps an explanation). It would be interesting to know whether influences had come more from the Pharmaceutical or tobacco industry. Nothing like recommending states and territories align their legislation to ensure smokers are kept on the NRT/Smoking merry-go-round and removing the ability for someones to persue an effective harm minimization strategy when dealing with their own health problem.

In the US, government agencies are required to publish proposed regulations in the Federal Register and invite the public to make comments. Usually there is a minimum of 60 days allowed for submitting comments.

Nevertheless, the government seems to be quite adroit at issuing a report that ignores the vast majority of the content of the comments.
 

Vocalek

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In a slide from my presentation at that hearing coming up on Monday, I display the lung cancer mortality rates for females and males, comparing Sweden to the U.S. These are deaths per 100,000 population.

Females 18.6 v. 39.0
Males 33.6 v. 63.0

My accompanying comment is as follows:
These statistics speak for themselves. Also, research shows that switching to smokeless tobacco reduces cardiovascular, cancer, and lung disease risks and lowers mortality rates. If CDER can implement a fast track process for previously known, unproven, innovative smoking cessation pharmaceutical products, the Center for Tobacco Products should be implementing a fast-track “modified risk tobacco product” approval process for the smokeless tobacco products that have a proven beneficial effect at the population level.

Instead, the CTP has issued guidance for the MRTP approval process that will cost millions and take years. If cutting lung cancer mortality in half isn’t considered modifying risk, I’d like to know what is. Why should research be forced to start at the most basic level on products that are proven to be less hazardous at the population level? How many lives will be lost before the FDA tells smokers the truth?
 

NorthOfAtlanta

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In a slide from my presentation at that hearing coming up on Monday, I display the lung cancer mortality rates for females and males, comparing Sweden to the U.S. These are deaths per 100,000 population.

Females 18.6 v. 39.0
Males 33.6 v. 63.0

My accompanying comment is as follows:

I think we all know that the FDA and the alphabet organizations are going to preach quit or die until the Big Pharma money teat is cut off.

:glare::2c:;)
 

TrueNews

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Dec 1, 2012
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I think we all know that the FDA and the alphabet organizations are going to preach quit or die until the Big Pharma money teat is cut off.

That is a summation and a half for someones' presentation, I hope you get plagiarised :)

I keep visualising the looks on the F@#$ing Dumb A$$es faces, if someone actually said that, and can't stop smiling.

Good Luck for Monday Guys.
 
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MarVp

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Jul 10, 2011
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Guess what - I found it - and it makes interesting reading.

TGA - Reasons for Change to the 2011 legislation (Detailed reasons about Nicotine start on page 72)
http://www.tga.gov.au/pdf/scheduling/scheduling-decisions-1108-interim-a.pdf

On first reading, I was very cynical that they had just removed the loophole in schedule 2, but on reading the 'Reasons for Change to the 2011 legislation' I am now, not so sure.
(As this is getting a slightly off topic, for FDA matters, see the sticky-'Official Documents and Resource Information' on aussievapers for the whole post and info)

Yes TrueNews, very interesting reading. Even though it might be getting a bit off topic, I am not entirely sure, and I think our American friends might find some value when reading pages 70 - 76 of the document, as it shows the basic mechanism those in such health policy offices use to skew terminology, such that it fits the models they are trying to achieve. I'll just post this perspective and then come and find you on Aussie Vapers and say hi!

What I found interesting was their discussion around the Nicotine Inhaler and how they could get it to join the scheduling exemptions allowed to other NRT products that absorb nicotine through the mouth (the gums etc). They tout that the NRT inhaler device allows for most of the absorption of nicotine to be in the mouth and only about 5% makes it into the lungs. They further propose that they need to re-define the name of the device from inhaler to inhalator to make this distinction clearer. What is amazing is that (on p75) they out-right discuss that they are trying to distance the NRT inhaler from e-cigarettes and make a big assumption (based on no good science) that they believe the primary absorption of nicotine when using an e-cigarette would be through the lungs. I have heard differently here and was always under the assumption that e-cigarettes deliver the vast majority of the nicotine to the mouth and I am sure there are a few studies out there that back that up. Empirical evidence shows this too as you do not get the fast large spikes in nicotine from using an e-cig as you do with smoking, rather more of a slow even curve, as might suggest you are absorbing the nicotine in the mouth.

So, what to do here. They are basically trying to push NRT inhalers and cigarettes in the direction of not requiring scheduling (like the gums) and anything that does not fit their terminology to be classified under schedule 7, which effectively means illegal. (no looking at the positive outcomes electronic Nicotine delivery devices have been having over almost a 10 year period - which was another argument they touted to back the safety of NRT inhalers). Brings me to the confusing terminology which has evolved within the vaping community and what people actually call these things we use. They are not cigarettes as far as I can tell. They have been called that because that is what they are replacing. Calling them Personal Vaporizers is also confusing, as the general public don't have a clue what you mean and it allows misinformation to be delivered about the mechanism of Nicotine absorption being primarily of the lungs (as was seen on p75). Thinking about what the correct terminology should be when referring to electronic cigarettes in a medical setting (and to be talking their language as such) I'd have thought a more accurate description of our electronic nicotine delivery devices could be the Electronic Inhalator, also know as the e-halator. I for one might start referring to them as such. Below I have put the terminology in some context for you all to have some fun with...

Officer: Hi there son, I believe you are standing in a smoking section and that device you are using is not a cigarette, hookah, pipe or b_ng. You must know the state frowns on people using Nicotine delivery products which have not been given exemptions in schedule 7, like tobacco prepared and packed to be en-kindled into fine particles, tar and 4000 chemicals which reach the bottom of your lungs when inhaled has.

Patron: Don't be alarmed sir. I am just using my e-halator which delivers Nicotine to my oromucosal regions, enabling me to resist the temptations of lighting up a product that was sure to kill me had I continued its use.
 
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TrueNews

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What I found interesting was their discussion around the Nicotine Inhaler and how they could get it to join the scheduling exemptions allowed to other NRT products that absorb nicotine through the mouth (the gums etc). They tout that the NRT inhaler device allows for most of the absorption of nicotine to be in the mouth and only about 5% makes it into the lungs.

Brilliant MarVp, name change from Inhaler to Inhalator, I totally missed the significance.

Unfortunately, the situation only seems to get worse.

From my reading of the Poisons Standard, Nicotine is now classed in the schedules as:
4. Pharmacy Prescription Only
6. Animal Care (less than 3% strength)
7. Commercial and Industrial use Only

The Therapeutic Goods Administration of Australia personal importation scheme, does not appear to allow any importation of schedule 4 items without a doctors prescription. (Therapeutic good blockade)

In other words - Nicotine appears to be effectively banned in Australia, unless we can prove the absorbtion method for 'Vaping'.

Our American friends are going to be very busy for the next couple of days so I am sending you a PM (see your inbox - I hope it works).

We definately need to work on this together MarVp and there are a few guys on 'aussievapers' that are cluey as well.
The guy I really want to wake up over there (which is the real reason I joined) is ironically named "soundasleep" - he is/started 'smokescreen'.

When the FDA stuff is over I am sure that CASAA will help us out as well.
 
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Brotolemaeus

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I am relatively new to the entire fact that legislation was even being considered. I've read through most of the thread, but I just don't have the background most of you have at this point. What is a realistic opinion on how things are going? Are e-cigs going to be banned? Massively taxed and available only behind a counter and ID checker? Or, will it go the route of nicotine gum where I can just buy it in walgreens and online?
 

DC2

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I am relatively new to the entire fact that legislation was even being considered. I've read through most of the thread, but I just don't have the background most of you have at this point. What is a realistic opinion on how things are going? Are e-cigs going to be banned? Massively taxed and available only behind a counter and ID checker? Or, will it go the route of nicotine gum where I can just buy it in walgreens and online?
We really have no idea at this point, and will just have to wait and see.

The only one I know of who has even a reasonable clue would be Bill Godshall.
Maybe he will chime in with his opinion.
 

francky5591

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Dec 14, 2012
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In Europe we are taking the same way, a few people are going to decide what we have to do in order to stay in the legality.
They issued a recent proposition which will be a regulation of the tobacco and assimilated other stuff (like the Swedish snus)
As for e-cigarettes, they are planning to allow only e-liquids that would not exceed 4mg/ml of nicotine. This proposition will be adopted by the European commission in 2014, and applied in 2015-2016.
What I think about that is, the more time goes on and the more we're ressembling what was described in Orwell's book "1984".
We've got to associate and federate, and let people listen to us, or if we don't, all we'll have to do is bow head and be good slaves.
 
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Lisa Belle

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Not good news! We do need to Federate and we do need to be a voice that can't be ignored! The addiction to nicotine is the most mis-understood of all addictions and the FDA approved treatments so ineffective. Only a QUIT OR DIE message for the past 50 years, the profiteering from smoking related diseases is more significant than ever in dollars and cents, as the biggest over the age of 50 population ever to grace the planet at the same time ages. Profits soar in healthcare and in smoking related healthcare, especially. It is the only addiction where it's victims or addicts are treated more inhumanely than any other of addicted groups, such as alcoholics/drug addicts, food addicts. We all know this... so a commonality needs to be acceptable to everyone and anyone that feels nicotine is and should be a legal substance used for pleasure, health benefits or for any reason acceptable as long as it is respectful and un-harmful.
 

Vocalek

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Hark! I see a loophole in Aussieville.

From my reading of the Poisons Standard, Nicotine is now classed in the schedules as:
4. Pharmacy Prescription Only
6. Animal Care (less than 3% strength)
7. Commercial and Industrial use Only

Most of us use liquid at 24 mg / ml or less. This is the equivalent of 2.4% nicotine in the solution. Three percent strength is 30 mg / ml of nicotine. Are we not animals, rather than plants? Are we not caring for ourselves by refraining from inhaling products of combustion?

Bottles should be labeled referring to the % of nicotine in the solution, not mg of nicotine (technically speaking, this is actually mg per ml)/. The absolute quantity of nicotine in milligrams varies depending on the quantity of liquid in a container. For example, if you were using a cartridge that holds 1 ml and filled it up with liquid at 1.6% strength, the cartridge would be holding a total of 16 mg of nicotine. Once you vaporize half of the liquid, the cartridge now contains only 8 mg of nicotine, but the remaining .5 ml of liquid remains at 1.6% strength (which is the same as 16 mg per ml.)
 
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MarVp

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Jul 10, 2011
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Hi Vocalek,

Hark! I see a loophole in Aussieville.

RE: Schedule 6 - Animal Care (less than 3% strength)

Are we not animals, rather than plants? Are we not caring for ourselves by refraining from inhaling products of combustion?

You might be onto something there! Besides, my cat has a pretty heavy Cigar habit and its time he switched to the e-cigs I reckon :)

Yeah, not sure what this all means for us. I believe the documents Health and Aging produce are for reference only and still need to be enacted by the various states and territories, so it would be up to them to make changes. Not sure though and I might need to do a bit of research (TrueNews might know).

Another thing... Regarding Schedule 7. I'm not sure what they mean by "domestic" or "domestic garden" use (things schedule 7 can't be used for). I wasn't planning on using my e-liquid for cleaning the kitchen, even when after that pine-fresh smell! :)
 
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TrueNews

Full Member
Dec 1, 2012
54
55
Perth, Australia
In Europe we are taking the same way, a few people are going to decide what we have to do in order to stay in the legality.
They issued a recent proposition which will be a regulation of the tobacco and assimilated other stuff (like the Swedish snus)
As for e-cigarettes, they are planning to allow only e-liquids that would not exceed 4mg/ml of nicotine. This proposition will be adopted by the European commission in 2014, and applied in 2015-2016.
What I think about that is, the more time goes on and the more we're ressembling what was described in Orwell's book "1984".
We've got to associate and federate, and let people listen to us, or if we don't, all we'll have to do is bow head and be good slaves.

4mg/ml would be less than a Nicorette Inhalator (15mg) - get a friendly MEP involved Francky, that way it will be 2036 by the time they apply any regulation.

I think the UK legislation at present is 72mg/ml and Greece, from memory, is around 36mg/ml.
 

TrueNews

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Dec 1, 2012
54
55
Perth, Australia
Hark! I see a loophole in Aussieville.



Most of us use liquid at 24 mg / ml or less. This is the equivalent of 2.4% nicotine in the solution. Three percent strength is 30 mg / ml of nicotine. Are we not animals, rather than plants? Are we not caring for ourselves by refraining from inhaling products of combustion?

Bottles should be labeled referring to the % of nicotine in the solution, not mg of nicotine (technically speaking, this is actually mg per ml)/. The absolute quantity of nicotine in milligrams varies depending on the quantity of liquid in a container. For example, if you were using a cartridge that holds 1 ml and filled it up with liquid at 1.6% strength, the cartridge would be holding a total of 16 mg of nicotine. Once you vaporize half of the liquid, the cartridge now contains only 8 mg of nicotine, but the remaining .5 ml of liquid remains at 1.6% strength (which is the same as 16 mg per ml.)

Spot On Vocalek

The potential problem might be: (and it is only a potential problem at the moment - We can still import Nicotine)

1: Getting Nicotine solution >3%, and labelled 'For Animal Use Only' through Customs. (post any legislation)
2. Affixing a label with 12 point sans serif font, stating 'For Animal Use Only', to the Dogs Carto :)


PS.
How did you go with the FDA - tried to watch on the Adobe viewer but way too laggy here - 3 seconds of play and 10 seconds of pause.
 

TrueNews

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Dec 1, 2012
54
55
Perth, Australia
Yeah, not sure what this all means for us. I believe the documents Health and Aging produce are for reference only and still need to be enacted by the various states and territories, so it would be up to them to make changes. Not sure though and I might need to do a bit of research (TrueNews might know).

Another thing... Regarding Schedule 7. I'm not sure what they mean by "domestic" or "domestic garden" use (things schedule 7 can't be used for). I wasn't planning on using my e-liquid for cleaning the kitchen, even when after that pine-fresh smell! :)

AGHHHH - Just lost a 2 page reply to you, so this will be a precis - (Site keeps logging me out whilst I am typing).

In essence:

Schedule 7 (Dangerous Poison) - "Domesic Use' has 'Human' under its' Definitions.
Schedule 6 (Animal Use Only) Maybe, worth exploring, but the only 'Animal Use' I can find so far is Big Pharma and Big Tobacco doing research on the poor little things
Schedule 4 (Pharmacy Only Medicine) is the weak link.
Oramucosal, Therapeutic Good and Therapeutic Use are the key terms.

1. We need help to prove that Nicotine absorbtion by 'Vaping' is primarily via the 'Oralmucosa' (Buccal Mucosa, Sublingual. Pharynx, upper respitory tract etc - Anything but the Lungs - If we can prove this then nicotine for vaping would be 'unscheduled')
I have peer some reviewed research on Inhalers that shows minor absorbtion via the lungs which we could use as ammo.

2. Therapeutic Good is governed by the TGA (Therapeutic Goods Administration) Therapeutic Use is not, (Therapeutic means anything that causes a physiological or phsycological change - eg, my Hydro Therapy Spa has a therapeutic use, but is NOT a therapeutic good)

Can anyone help with studies on Nicotine absorbtion by 'Vaping' - PLEASE
 
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