An idea for avoiding FDA approval or control

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Myk

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I just have to break my silence and say how delighted I am to learn that the nicotine patch is a tobacco product, as is nicotine gum, nicotine lozenges and the prescription-only nicotine nasal spray. By using nicotine mixed with other chemicals, they become tobacco products -- because, doncha see, the nicotine comes from a tobacco plant! Voila! There was no need for all that clinical trial stuff they went through, or the expensive application and approval process.

Because they contain nicotine, they were all exempt from FDA regulation!

Boy, I bet Big Pharmaceutiful feels stupid now, since the FDA can't regulate tobacco products like the patch, gum, inhaler, nasal spray, lozenges. And if those don't need regulation, then the FDA certainly has no authority over a vial of chemicals that contains some of the exact same drug -- nicotine.

This is comforting news, indeed.
You probably should've kept your silence.

The odds of big pharmaceutical companies extracting nicotine from tobacco plants is just about zero. It's a lot easier and cheaper to synthesize than extract from plants. When extracting pure chemicals from plants you end up with a lot of toxic waste.
They even try to get away from using opiates opting for synthetic versions and pushing them instead of real codeine.

I'm glad you think that the FDA should be in on herbals since many of our modern drugs were synthesized out of herbal remedies like the active ingredient in Valerian is synthesized into being the active ingredient in Valium.
Thankfully you're not the one who makes the rules.

Nicorette is a form of Therapeutic Nicotine. Therapeutic Nicotines reduce the intensity of nicotine withdrawal cravings so you can focus on changing your behavior.
http://www.nicorette.com/Quit_Before_List.aspx
Get that? It's a FORM of nicotine.

The e-liquids are tobacco extract.
If they had a drug FORM of nicotine like Nicotine Water originally had then they would be a "new drug". But they don't, they have a version of nicotine taken from tobacco that is so unrefined that it's easily traced back to tobacco.

It is possible that the form of nicotine was altered during the making of the extract making it not the form of nicotine that is in tobacco.
If that is the case I'm all for the FDA stepping in. But at this point it seems as though they are simply seeing a means to get their hands on a tobacco product and protect the pharmaceutical companies that are in their pocket.
 

TropicalBob

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Sorry, but statements like the last sentence are just a complete turnoff. You know nothing about the FDA, but feel free to impugn the agency and every employee with your group slam of bribery and/or extortion.

As for the rest .. more of the same warped logic I've come to expect from you.

Let's just see how this plays out, shall we? We're both making assumptions: you, that e-liquid is a tobacco product above FDA jurisdiction; me, that e-smoking is drug delivery and is going to be required to get FDA approval.

Ladies and gentlemen, let's get ready to rummmmmble.
 

Myk

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Sorry, but statements like the last sentence are just a complete turnoff. You know nothing about the FDA, but feel free to impugn the agency and every employee with your group slam of bribery and/or extortion.

As for the rest .. more of the same warped logic I've come to expect from you.

Let's just see how this plays out, shall we? We're both making assumptions: you, that e-liquid is a tobacco product above FDA jurisdiction; me, that e-smoking is drug delivery and is going to be required to get FDA approval.

Ladies and gentlemen, let's get ready to rummmmmble.
Why was Zyban approved for tobacco cessation? Have you ever read up on reports about it? Ever tried it? Funny how the UK reports on Zyban were very different than the ones in the US.
Why are there so many class action suits against drugs the FDA approved and yet here they are trying to stop e-cigs with no reason?
Why does the FDA threaten doctors who hand out Xanax which costs pennies a pill and acts instantly for panic disorder but push SSRIs which cost many dollars per pill and take weeks to know if it's the right one for the individual and then coming off them gives worse panic than you had before them?
Why was Chantix approved for nicotine cessation and yet there's a class action going on with it?
I'll believe the FDA isn't selling to the highest bidder as soon as I see other government agencies and officals not doing that same thing and start seeing better results from the FDA testing.

Warped logic is better than the complete lack of logic that comes from you.

My "assumption" is the same one Lacey came up with that you seem to have agreed with until I pointed out it was the one I was making all along.

My non-assumption is that the FDA person who told someone on this forum that as long as it wasn't marketed as NRT it wouldn't be looked at. Come to find out the FDA's definitions clearly says claims to not qualify something as a drug.
The problem comes when you try to get a tobacco product approved as a NRT.

My non-assumption is that Nicotine Water used a drug form of nicotine and was banned. They then came back with a tobacco extract form of nicotine and have not been banned.

If you want to rumble with the FDA you'd better come up with a better plan than the bend over and take it plan you seem to be proposing.
 

burnt

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Jan 30, 2009
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Unfortunately, we had to remove your listing because the following information violates our policy:

Nicotine cartridges are not permitted on eBay and sellers are not permitted to include information regarding where such items can be bought.



We notified members who placed bids on the item that the listing has been canceled.

eBay does not allow members to sell narcotics, steroids, controlled substances, and drug paraphernalia. Drug paraphernalia are items that are designed or primarily intended for making, concealing, or using a controlled substance. eBay also does not permit members to sell any drug that requires a prescription from a medical practitioner such as a doctor, dentist, optometrist, or veterinarian. This is because the sale of these drugs may be prohibited by law, regulated by the government, or harmful to the eBay Community.

For more information on this eBay policy, please visit:

(URL deleted because of forum post restriction)




Please note: violation of this or other eBay policies may result in forfeit of eBay fees on cancelled listings, limits on account privileges and account suspension.

You can review our list of prohibited and restricted items here:
(URL deleted)

Thanks for your understanding.

Sincerely,

eBay Trust and Safety team
 

TropicalBob

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A marketer got a notice from Google today that it will not accept e-smoking devices or liquid for adverts. New policy.

Dear It's a Tobacco Product dude:

The World Health Organization has released a statement that clarifies its position on e-smoking. WHO had a conference last November to consider our practice. A French poster on ecigtest.com got the response, which Kate posted on this forum. Read it and take it to heart. Every point Kate itemizes is TRUE. It follows verbatim:

There is a considered statement from WHO on their current position here - WHO - Marketers of electronic cigarettes should halt unproved therapy claims - *E-Cigtest, the ultimate electronic cigarettes review site and forum* Le site de la cigarette électronique

Their definition is - nicotine delivery system and health product.

These points seem particularly important to me:

... products including the electronic cigarette cannot be supported unless they meet national regulatory criteria for efficacy, safety and quality of a new public health product.

... scientifically rigorous, peer-reviewed studies to substantiate claims for the electronic cigarette as an effective smoking cessation aid. In this respect, WHO does not equate a manufacturer’s undocumented claims of safety or toxicity to peer-review by a science based committee.

... the generation of theoretically adequate safety data by one manufacture is not tantamount to validation of all electronic nicotine delivery devices.

... WHO is not aware of any set of data that establishes the safety of nicotine and/or propylene glycol (in addition to other constituents of the product which are present to confer the claimed cigarette mimicking sensory characteristics) when heated and delivered to the lung. WHO is not convinced of the precise nature and amount of the constituents of the emissions.

... WHO is concerned about the variety and lack of uniformity of these products. [I wonder what the significance of that statement is]

... WHO does not discount the possibility that the electronic cigarette could eventually be regarded as a useful smoking cessation aid. That said, rigorous pharmacokinetic studies, safety and efficacy trials, and review and approval by national authorities which regulate NRTs must be conducted.

... the burden is on product sponsors to satisfy regulatory agencies and to ensure public health institutions that their products are safe (and effective if such claims are made) - not on WHO or regulatory agencies to prove all aspects of potential harm when there is a plausible basis for harm.

... substantiation of smoking cessation and other health claims would include rigorous pharmacokinetic studies, safety and efficacy trials, and review and approval by major drug regulatory authorities of the following types data and studies: (1) the complete listing of ingredients in electronic cigarettes, (2) the effect on smoking cessation of these products compared to NRT and placebo, and (3) adverse effects caused by these products.

... WHO urges its Member States to require manufacturers to provide adequate scientific data in accordance to the criteria set by national regulatory bodies.

... WHO TobReg also recommends that claims for safety relative to cigarettes, health benefits, or claims such as effectiveness as smoking cessation aids or as cigarette substitutes be prohibited until such claims are substantiated with data accepted by scientific organizations and approved by regulatory agencies.

... WHO TobReg strongly recommended that these class of products not be exempted from clean air laws that restriction restrict cigarette smoke exposure (see WHO FCTC, Article 8) until adequate evidence is provided to assure the regulatory authority that use of the product will not expose people to toxic emissions. [How would this effect us? Will we be unable to vape in no smoking areas?]

... Research is needed on the delivery and absorption of nicotine in relation to these devices, both acutely and chronically, in order for regulators to establish the dosage and formulation for regulatory approval.

... This class of products should be regulated as nicotine delivery systems and must meet the scientific, efficacy and safety criteria established by regulatory authorities prior to sale and marketing.

Lemme guess. You're gonna whine and cry about WHO. Do go read the entire post. The above are only highlights, but they serve to shred your silly argument.
 

sherid

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I believe Big Tobacco needs to get involved. They at least have power and are smoker friendly. They are also more and more interested in smokeless options, including some MAJOR buyouts of smokeless tobacco products, Native Spirit tobacco, and the search for smoke free cigarettes (Heatbar, Aeros) Although e cigs do not have tobacco, I believe that BT is constantly looking for new ways to sell smoking in one variation or another. I would imagine that they are paying very close attention to this phenomena and have had discussions of how they might get involved. It would not surprise me at all if we heard an announcement that Phillip Morris had acquired Ruyan, Janty, Njoy, etc. etc. in one big package. I would not want Big Pharma involved because the hate anything that in any way resembles smoking or cigarettes. They would find a way to strip e cigarettes of any pleasure for the smoker.
 

ladybug51

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After reading the interesting conversation and facts so to speak on e-cigtest, I am now concerned and even a bit fearful of my future vaping. What do I do. Buy a thousand dollars of supplies and hoard them and sneak vape? Not to mention learning how to make my own juice.

I'm sure the suppliers, e.g. NJOY, Runyan, etc. are aware of this? Hey, I'm even willing to be a guinea pig in a controlled test study.

My health concern? I know cigarettes were literally killing me. Not WANTING to stop smoking, I chose to vape. If vaping is proven to a severe health issue, wow, which way do I choose to die. Firstly, prove it.

Why is it we can die from what is inside the foods we eat, over time, yet I can have the freedom of vaping taken away from me.

I hope the manufacturers and/or suppliers get with it. This is like buying the cart before the horse as I see it.

Before any door gets closed, I want a warning so I can hoard and sneak.
 
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TropicalBob

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Lacey, you are ignoring the reality of the FDA policy letters and WHO statement. If now is not a time to worry, when is that time? The FDA says clearly these are illegal to sell or market (but okay to own and use). WHO suggests to member nations that these be banned, as they are presently configured.

Several enlightened countries already have full bans in place.

It is NOT okay out there. It's every-man (and woman)-for-himself time. Every new revelation is worse. Play nomenclature games if you must. Shout out that this unproven technology will save lives. You are preaching in a canyon. It's only echos you hear.

But listen carefully to what those who are charged with regulating food and drugs are saying: These are not going to be allowed at some point down the road.

That's cause for worry. I'm not reassured by platitudes and cheerful posts opining that all is well.
 

ZambucaLu

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I tend to still hold onto the belief that if anything gets banned, it will be the nic juice. Afterall, if head shops can legally sell products known to be used with illegal substances that you can actually be arrested for possessing, then I don't see how this can be much different. And who knows....0 nic juice may also end up being legal to sell.

But I'm not worried about it at this point. I have 5 bottles of 36mg liquid sitting here from CT and sometime soon, hope to place another order. This would last me quite some time and with a 2 year shelf life...well...by then I'm sure we'd know what's what legally.

Meanwhile, I stuff my own carts, am working on purchasing devices that use regular batts and am checking into ways of making my own nic. As long as they still sell PG and glycerin, I should be good to go!

Now I see inhalers coming up. Wonder how those will fare with the FDA?

Lu
 

LaceyUnderall

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Lacey, you are ignoring the reality of the FDA policy letters and WHO statement. If now is not a time to worry, when is that time? The FDA says clearly these are illegal to sell or market (but okay to own and use). WHO suggests to member nations that these be banned, as they are presently configured.

Several enlightened countries already have full bans in place.

It is NOT okay out there. It's every-man (and woman)-for-himself time. Every new revelation is worse. Play nomenclature games if you must. Shout out that this unproven technology will save lives. You are preaching in a canyon. It's only echos you hear.

But listen carefully to what those who are charged with regulating food and drugs are saying: These are not going to be allowed at some point down the road.

That's cause for worry. I'm not reassured by platitudes and cheerful posts opining that all is well.

No... I am not ignoring the letters. People have plastered them all over the place. But I read them as they are: "We at the FDA haven't made a decision so we are going to confuse you by saying two opposites in the same letter".

The fact of the matter is is that the electronic cigarette is a vaporizer and vaporizers are legal. The fact of the matter is is that the e-liquid will eventually be regulated. In order for it to be banned, they will have to ban nicotine or PG. The fact of the matter is is that there is enough money to be made by the manufacturers that they will seek approval from either the FDA or BT. Until anyone has clear proof that these are going to be banned, it is all crazy hear say. I have repeatedly asked for proof that these will be banned and NO ONE can come up with anything.

And I have NEVER shouted into the canyon that this unproven technology will save lives.

Also... I think it would behoove the masses if the users stopped sending random emails to the FDA asking them to take a stance. RTV should be doing that for everyone and the suppliers and manufacturers should be doing that for everyone. We all crawled up Jon's ... from SafeCig... but what he is doing is causing far less harm than the swarm of emails coming from random people to the FDA asking the same question over and over and over and over... Eventually, they will get sick of being consumed by emails and will follow suit with a real ruling and your dark premonition will be right.

I simply am attempting to calm the masses because the suppliers are going to be the FIRST ones to know what is happening and everyone will know it as soon as we do. And frankly, the reasons shipments have been stopped is because boxes were marked improperly as "lung apparatus" or "medical device", of which neither is correct. The FDA/customs did exactly what they should have done and that is stop a box that is improperly marked.

There are correct numbers for the shipments and those having their shipments stopped simply have not done their due diligence. Again I ask... Am I the only one with Internet access? If I can find the proper coding, then they can find the proper coding.

UPDATE: And as far as the WHO.... they gave us a hint: DO NOT market these as NRT's. That's all.
 

TropicalBob

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Suffice it to say we see things differently .. except for this:

I think it would behoove the masses if the users stopped sending random emails to the FDA asking them to take a stance. RTV should be doing that for everyone and the suppliers and manufacturers should be doing that for everyone.

Demands for explanation of legal status will just stampede the rush to judgment. Let sellers handle it. Period.

We do disagree on the interpretation of both the FDA and WHO statements. No need to elaborate. It's all here to read.
 

ladybug51

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Lacey, you are ignoring the reality of the FDA policy letters and WHO statement. If now is not a time to worry, when is that time? The FDA says clearly these are illegal to sell or market (but okay to own and use). WHO suggests to member nations that these be banned, as they are presently configured.

Several enlightened countries already have full bans in place.

It is NOT okay out there. It's every-man (and woman)-for-himself time. Every new revelation is worse. Play nomenclature games if you must. Shout out that this unproven technology will save lives. You are preaching in a canyon. It's only echos you hear.

But listen carefully to what those who are charged with regulating food and drugs are saying: These are not going to be allowed at some point down the road.

That's cause for worry. I'm not reassured by platitudes and cheerful posts opining that all is well.

I think your response to Lacey was a little rough TB. Perhaps she hasn't read some of the statements and issues you have and I feel your quote "Play nomenclature games if you must", was not fair. And I do not feel she is playing games or shouting into the canyon.

When you state comments about the reality of all this to others that you feel aren't being realistic to what you feel, you might add what you have read from WHO. WHO - Marketers of electronic cigarettes should halt unproved therapy claims - *E-Cigtest, the ultimate electronic cigarettes review site and forum* Le site de la cigarette électronique She obviously has not read it.

I too feel the way Lacey does. That's why I said I'd be a guinea pig on the testing of the contents. That does not mean I am not concerned. Sometimes things are banned till they are proven. Like being guilty until proven innocent?

And the,"The FDA says clearly these are illegal to sell or market (but okay to own and use)." The but okay to own and use?" ??? Non compus mentis. Just how in the 'h e double hockey sticks does that make sense? So hoard, watch, and wait.

Just my opinion.
 
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TropicalBob

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Note that I really toned down the last response, Bug. I tried to lighten up there. Lacey has every right to see things any way she wants to. I like her. She has spirit!

Sorry to be so rough. It's not optimism that bothers me; it's attempts to skirt reality. Face facts and work with the authorities. Science wins; hope and anecdotes lose.

All sellers need to get to work on what needs to be done for e-cigs to (1) avoid "enforcement action" and (2) be certified as a recognized nicotine delivery device.
 

LaceyUnderall

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Thanks for the defense Bug... but I have read everything and more importantly, I have had actual discussions with actual people, not form letters. I keep saying this on multiple threads and no-one seems to listen. We aren't skirting reality, we are attempting to subside some of these wild attempts to create a false reality.

But TB you are absolutely right on your steps to take forward and there are some of us suppliers who are doing just that. We are just asking that the consumers please have a little patience and gain a little control. We are doing what we can to ensure that everyone gets to continue their e-smoking freely and openly.
 
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