An idea for avoiding FDA approval or control

[LaceyUnderall]

In my research this morning, I think I may have found where the e-cigs fit. My suggestion is that we look into the rules and regulations of becoming a Homeopathic or Allopathic drug.

Why? The Homeopathic drugs are submitted to HPCUS. Now, with NicoWater, they were given trouble by the FDA and reforumulated their nicotine concentration to be below 4 mg per dose which drops them into the homeopathic category. We have calculated our dosage lists based on the manufacturers info and the High Nicotine carts fall under 4 mg per dose... actually well under. And technically, as the no nicotine has no nicotine, it doesn't need to be regulated at all.

With homeopathic drugs, you present to HPCUS as you would to the FDA, but you need two clinical trials and samples. (Of which we will be able to provide with the Auckland study and Dr. Lio?) The process is shorter and faster.

Allopathic drugs go through the FDA, but are not held to the same restrictive process as an NRT/NDP.

I thought I would put this out there so others could help me on my lead. We all talk of where does the e-cig fit. Either way, we DO NOT want to be lumped into the NRT/NDP category. Here is a link to the HPCUS website for anyone who is interested. Register  |  Login  |  Edit Acco

Here is another interesting note: FDA doesn't have control of tobacco, however, their formula looks kind of like this - "Device" = tobacco = nicotine-delivery device but tobacco does not = class of device. Yep... that's the FDA for you.

 

[RatInDaHat]

very intriguing find lacy. You might be on to something.

 

[TropicalBob]

If you are right, you're the new hero of the e-smoking world, Lacey. Nicotine is a drug, all right, and we consume it that way. Separated from tobacco, it's a "new drug" and recreational use of it hasn't been approved. But it's relatively benign at our levels of use and its desired actions on us are mental, making us confident, relaxed -- just like some concoctions, including aromatherapy and even herbal stuff, sold with such claims.

If there's a fight on presentation, it will be what constitutes a "dose". And if Nicowater and others are a guide, a "dose" is a cartridge or a vial, not a puff or single inhalation. This fight could lead to 4mg or 2mg (extremely low to me) carts. I'm not interested at that point. But .. if a dose is a typical 15-puff "cigarette break" session, then we would fall well under that 4mg limit.

Congrats on finding this trail. It's worth someone like Ludo pursuing for us.

 

[LaceyUnderall]

We are in the process of re-writing our horrible Changlish manual and we gathered dosing info from several different sources and this is what we came up with:

A. High = .054 mg of nicotine per puff. 14 puffs = 1 dose. .756 mg nicotine per dose.
B. Medium = .042 mg of nicotine per puff. 14 puffs = 1 dose. .588 mg nicotine per dose.
C. Low = .033 mg of nicotine per puff. 14 puffs = 1 dose. .462 mg nicotine per dose.
D. Zero

Well under 4mg.

Does that seem reasonable?

 

[Kate]

Vapers don't tend to stick with 14 puffs so a dose could be an all day session. Saying it's the amount of time taken to smoke a cig doesn't make people dose themselves like that.

 

[LaceyUnderall]

Ignoring puff counts: another shortcoming of the Federal Trade Commission cigarette testing programme -- Kozlowski et al. 17 (1): i6 -- Tobacco Control - and this is just an example, I will look for more... 14 was based on several manufacturers numbers...

Even refining the math to 7 puffs per cigarette (which is about what I am puffing per need and about what I got out of a smoke... but I won't go test it )

A. High = .054 mg of nicotine per puff. 7 puffs = 1 dose. .378 mg nicotine per dose.
B. Medium = .042 mg of nicotine per puff. 7 puffs = 1 dose. .294 mg nicotine per dose.
C. Low = .033 mg of nicotine per puff. 7 puffs = 1 dose. .231 mg nicotine per dose.

Each cartridge prefilled = 6 doses = 2.268 for the high so you are way under 4 even for the entire cartridge.

Dosing info is important. We will have to come up with something that can be agreed upon in order to move forward with any regulation in any form.

 

[TropicalBob]

The dose measurement is critical. To be fair to all parties, it should be a comparison to the dose delivered from a single real cigarette. How many puffs does the average smoker take with a real cigarette? Answer: 14 to 15. That's a dose of nicotine.

There must be agreement on what a dose constitutes, despite variables that can be argued, or this will get nowhere.

 

[Kate]

But this isn't smoking. How can we argue that fourteen puffs is a dose when we don't measure fourteen puffs in practice?

How many snus is a dose?

How many cigars is a dose?

How many puffs on an NRT inhaler is a dose?

What is a dose from an NRT patch?

What is a dose and how much of it are we getting? What strength eliquid does everyone use? How often do they puff? How much nic is absorbed from a puff (and don't quote Dr Laugesen because his figures are not stable).

 

[LaceyUnderall]

And that is why I included the study done by the anti-smoking campaign. If they see cigarettes as being 7.8 puffs (on average), then by their own study we are submitting to their numbers.

I am talking strictly e-cigs here. If someone else wants to take on the others, that's great and I will share my findings.

However, you do make a good point and I will evaluate all of the different doses, what studies have been done and are there any common threads between them.

But a dose needs to be determined for each item. It is my estimation that if we present anything to the FDA, HPCUS, or a Doctor for that matter, they are going to want to know what the dose is since those are the numbers they think in. I also know this to be true of other health commissions like The Ministry of Health New Zealand and Health Canada.

Even though the advil bottle says take two per six hours, that doesn't mean that everyone is going to follow it. However, if someone takes 8 in a hour and gets sick and tries to sue, then they will have a problem since they chose to overdose themselves.

Kate - I do see the point that this isn't smoking... but it is. It is a smoking alternative, especially with the e-cig. I use mine just like I would a cigarette and I don't call it going for a vape, I call it going for a smoke. If we don't want to be classified as an NRT, then we have to keep to the "smoking" side of the argument. With everything I have read, it is far safer and easier to be lumped into the tobacco side than the pharm side. (Neither of which we fit... hence the homeopathic or allopathic idea)

 

[malyden]

Ok.. isn't a 'dose' whatever the manufacter says it is? Just because your suppose to take 2 asprin doesn't mean that you don't take 3 or 4.

 

[LaceyUnderall]

Ok.. isn't a 'dose' whatever the manufacter says it is? Just because your suppose to take 2 asprin doesn't mean that you don't take 3 or 4.

Exactly. When the manufacturers are getting in line for their approval, they have to provide what is in it etc and they formulate their drug based on what is acceptable and will pass through regulation easily. I can take 2 asprin and nothing.

It also allows for a shield of protection for the manufacturer. You took 4? Well the bottle clearly states that you should only take 2. You chose to take more than suggested. Sorry. It's harsh, but true.

So we can set the guidelines (with the manu's) and if someone wants to sit and vape all day... that's their right to do so.

 

[Kate]

Lacey, we are going to have to be NRT one day, it's the only way we're going to get away with persuading millions of smokers to quit. When you use your device to create vapour to inhale you are not smoking. You may think you're smoking but legally and scientifically that is not accurate. We are not going to be approved as tobacco probably and there is no other category once we are defined than medical. It's going to be NRT and safety tests or nothing in my view.

Lets assume a dose is 1mg, that's what we get from an average cigarette apparently.

If I drip two drops of 18mg eliquid and vape for five minutes with it I am getting a dose of around 1.8mg, almost twice as much as a cig in five minutes.

 

[Lithium1330]

..It is a smoking alternative, especially with the e-cig. I use mine just like I would a cigarette and I don't call it going for a vape, I call it going for a smoke. If we don't want to be classified as an NRT, then we have to keep to the "smoking" side of the argument. With everything I have read, it is far safer and easier to be lumped into the tobacco side than the pharm side. (Neither of which we fit... hence the homeopathic or allopathic idea)

Then we gonna fall into the anti-smoker's war and eventually they gonna make us go outside to "smoke" and taxes will be 120% on the product.

We are not smoking either, if you want to call things for their tachnical name then this devices are in fact vaporizers, remember vaporizers are NOT banned even when they tried to ban them.

"It is a personal vaporizer used for Homeopathic substances and it can be used without nicotine for aromatherapy or inhalotherapy, period" what do you say? o yeah: I rest my case Mister FDA's officer.

 

[LaceyUnderall]

And as long as you are under 4 mg, you can still be considered a homeopathic drug instead of an NRT. Under homeopathic you can make claims such as: Healthier alternative. Under homeopathic you cannot make claims that it is a cessation device.

Am I wrong? I thought the WHO warned us not to market these as cessation devices? From what I have read and found, they have given us a ***huge*** hint on the direction we should go.

Either way, this is just day one of my idea. Anything I find, I will of course post as I want this to work for us all.... For many of us... it has too. And finding ways to get around and avoid the FDA is simply going to bite us in the .... We will find ourselves without our beloved vaping devices of all kinds and we will find ourselves in societies where cigarettes are banned... period.

And... as far as persuading millions to quit... that is not my goal. My goal is to offer smokers an alternative to smoking tobacco. One thing I have learned from all of my "quits" is that I am a smoker. It runs deep through my family history and well... I like it. So why should I have to be anything but? Quitting tobacco is just a bonus.

 

[TropicalBob]

Kate, all of those are known. How many snus is a dose? 1 and it varies from 3mg to 15mg; How many cigars is a dose? 1 and it varies by brand and type, but it's all known; How many puffs on an NRT inhaler is a dose? Not measured by puffs, but by unit = 10mg for 8-hour use; What is a dose from an NRT patch? 1 for 12-hour use, nicotine varies by patch strength.

I do see the point that this isn't smoking... but it is. It is a smoking alternative, especially with the e-cig. I use mine just like I would a cigarette and I don't call it going for a vape, I call it going for a smoke. If we don't want to be classified as an NRT, then we have to keep to the "smoking" side of the argument.

This is quite correct. THIS IS SMOKING. Not smoking tobacco. This is not even a tobacco product. But it's smoking to virtually everyone. We can play the pretend-it-isn't game all day, but it's smoking stuff to the world. It's not vaping. It's e-SMOKING.

A dose from use of an e-cig must be defined as equal to a dose from smoking a single cigarette. Yes, people use them in varied ways. That goes for cigs, cigars and snus, too. The only important item is dose. Varied real-world use doesn't matter in government tests. It's all machine testing. Focus only on dose.

 

[TropicalBob]

Lacey, we are going to have to be NRT one day, it's the only way we're going to get away with persuading millions of smokers to quit.

If that's true, e-smoking is dead. Finished. Erect the tombstone. We will never be NRT and the process alone will take these off the market for years and assure our beloved Big Pharmaceutical and Big Tobacco of hearings to oppose these dangerous devices for addicts. We have been and must remain a cigarette alternative, nothing else, with no further claims made.

 

[Lithium1330]

Does the word Smoking comes from the word Smoke? maybe for the public it is smoking but legally it is NOT, if there is NO smoke, how can it be smoking???? it is like if you said that water is any liquid that wets your hand, NOT every liquid is water, NOT everything that looks like smoke is smoke, there is also vapor and vapor looks like smoke but it is NOT.

 

[LaceyUnderall]

"It is a personal vaporizer used for Homeopathic substances and it can be used without nicotine for aromatherapy or inhalotherapy."

Great statement. Brilliant.

Then we gonna fall into the anti-smoker's war and eventually they gonna make us go outside to "smoke" and taxes will be 120% on the product.

We are already on their radar. I have run into several far fringe anti-smokers and introduced this too them and at first glance, they are o.k. with this. It seems "reasonable".

As far as taxes, taxes are what they are. Unfortunately, we get studies telling us that "a study was done and voters in Florida have spoken! They would approve a $1 increase on cigarettes." 1000 people were surveyed by phone. Hardly a sampling. E-cigs have the ability to change the smokers stance and actually give a voice to a group of people who are being shuffled into the streets like dogs.

The taxes on cigarettes will always be there. There's taxes on booze. It's right and it helps the country. But I think there is going to be an evening up before that gets going further... And it's a "fat tax" and we already saw it rise up in Mississippi legislature.

We are not smoking either, if you want to call things for their tachnical name then this devices are in fact vaporizers, remember vaporizers are NOT banned even when they tried to ban them.

And let's talk about vaping. It comes from vap - That which is vapid, insipid, or lifeless; especially, the lifeless part of liquor or wine. How is the action of a vaporizer vaping? If you "smoke a joint", that isn't tobacco. So what is that called? (aside from the slang... )

But we shouldn't be arguing the device because it comes down to the liquid. It's not the pipe, it's what is in the pipe. And our pipes, vaporizers, smoking machines, have nicotine liquid in them. That liquid is yet to be regulated... the vaporizers have already been tried by the judge.

We do not want to be associated with the Tobacco Industry and we don't want to be in with Pharms. Both have laid their paths and well... do you really want to be a part of either?

Nicotine has effects stronger than caffeine, but it isn't the same as coke, ...., etc. Our solution needs to be reclassified and this goes to RTV from an organizational perspective: To keep it's users healthy so the anti campaigns cannot fight against you.

And... scene.

Sorry for the rant.

 

[LaceyUnderall]

Ok... apparently while I was putting kid to bed... TB said it all. Sorry for the "duplicate" post.

 

[Lithium1330]

Does not vaping comes from vapor? well... I really don't know where english words come from, anyway what I absolutely know is that vaporizers are not banned and that everything with CIGARETTE or SMOKE on it is A LOT MORE hard to defend, what we do want? defend the words? or defend the fact that taking nicotine from vapor is better than burn it up and inhale the smoke?