Vape is saved. Deeming dead?
Oliver Kershaw July 28, 2017
In a somewhat extraordinary and unexpected development Scott Gottlieb, the newly appointed head of FDA, has announced that the submission deadline for PMTAs is to be delayed until 2022.
This is a de-facto endorsement of the vaping industry and heads off the cataclysmic demise that was set in motion by the previous administration.
The grandfathering date from last year is not changed, so new products may not be introduced to the market, although it’s unclear what enforcement there is likely to be on that front.
This delay comes as part of a comprehensive anti-smoking plan which also involves the (controversial) denicotinisation of tobacco cigarettes which will start in 2021. In reality, this could be transformative for the vape industry, as smokers move to vape products to get their nicotine which is no longer available from smoking.
My intel suggests that the FDA’s interim focus will be on underage sales and “kid-centric” flavors, although it’s not clear in practice how the latter will manifest. The rulemaking process for setting standards for characterizing flavors will take at least three years.
In any case, this is huge news for vapers and for the vaping industry. Thousands will rest much easier tonight knowing that this life-saving movement can continue to grow and help fulfill the mission of the coercion-free end of smoking.
The full press release is available here the full speech is available here
It makes a lot of sense to target the nicotine in tobacco as that is what gets people hooked. Although I suspect it will apply equally to vaping and they will start setting low nic limits for juice. The big concern for vaping is the focus on flavourings and the public consultation process to decide how to make nicotine less attractive to kids. That looks to be heading towards flavouring bans a la San Fran. Disaster for juice companies, although DIYers will still be able to source flavours.
The other thing is whether this will survive the mid-terms and the expected swing back to the Dems. If they regain control of the house, who knows what will happen. Still, it's a welcome reprieve for the whole industry. It wasn't entirely unexpected, the deadline for the PMTAs had been pushed back already. It's such an enormous undertaking to have all applications submitted and checked that 2018 always seemed optimistic.
The other thing is whether this will survive the mid-terms and the expected swing back to the Dems. If they regain control of the house, who knows what will happen. Still, it's a welcome reprieve for the whole industry. It wasn't entirely unexpected, the deadline for the PMTAs had been pushed back already. It's such an enormous undertaking to have all applications submitted and checked that 2018 always seemed optimistic.
Any good news is welcome news!
"FDA commissioner Scott Gottlieb said: 'Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground'" Quoted from here
Alternative and less harmful sources .. now what might that be...
Alternative and less harmful sources .. now what might that be...
I like Scott Gottlieb's approach because it's the first truly holistic public health approach. Other health bodies assume smoking is a given, now how can we make all the right noises without really doing anything about the problem. All the while accepting that the next generation will become addicted too. Gottlieb cuts to the chase: nicotine addiction. It's not just the health harm from smoking, there are three other pillars to nicotine addiction that harm users:
1) Financial expense. Exacerbated by smokers generally coming from the poorer and less educated strata of society.
2) Quality of life. Anybody who is addicted to anything suffers a quality of life hit because they spend at least a part of every day thinking about it and trying to satisfy it. If you can't catch a flight or sit in a long business meeting without getting edgy because you can't get nicotine or alcohol or cocaine or whatever, your quality of life is affected.
3) Self-image. Society looks down on addicts of all types. Nobody can feel good about themselves if they smoke or vape or drink or take drugs in public and others look at them with contempt.
If I'm reading Gottlieb correctly, he wants cigarette companies to systematically remove nicotine - and presumably the other chemicals they add to make nicotine more addictive - over time. What we will be left with is cigarettes that just give the user a burnt tobacco taste but with no nicotine hit or addictive properties. It would be like removing alcohol from beer. Once you do it, there is little inclination for people to drink it. People who are addicted to beer will still drink it because they have become accustomed to the taste and routine of drinking. But if alcohol is removed, the main negative of drinking is also removed. You won't find kids drinking alcohol-free beer, there is no reason to. If the alcohol effect is removed, the product's popularity plummets and kids find something else to try instead. They obviously aim to do the same with cigarettes.
Of course, vaping won't be exempt. Nicotine juices as well as flavours will be banned eventually, meaning that people are just allowed a tobacco-flavoured vape with no nicotine. Again, it should serve to dissuade kids from trying it. It'll still be there as a temporary crutch for people who need the mechanical routine and the tobacco taste but it won't attract many (if any) new users.
The big risk, of course, is the black market. Removing nicotine from cigarettes is a gilt-edged invitation to drug cartels to start smuggling in 'real' cigarettes containing nicotine and selling them along with heroin and crack and their other products. I don't know how Gottlieb intends to get around that. The primary benefit of the current campaign against smoking is that it allowed cigarettes to remain legal. So tobacco companies are legit tax-payers and employers dealing in a legal product which, through market forces, remains quite cheap. Once it goes black market, the price skyrockets and it becomes a cash industry where income isn't taxed but vanished into a Colombian money laundering black hole. Additionally all jobs created are untaxed and criminal in nature which massively increases the strain on law enforcement agencies. It also criminalises a large section of the populace and increases the incarcerated % of the population with all the attendant problems of recidivism. Ex-cons don't have many legit career opportunities so they generally return to crime once they are paroled or released. Many Americans whose initial sin was no more serious than smoking a joint are now hardened criminals who are into armed robbery and worse.
It's an extremely ambitious project but if society wants to beat nicotine addiction, it's really the only way to go. My sense, though, is that it's too long-term for the four-year cycle of US politics. If Trump is ousted at the next election, the next Dem President will probably abandon the project for something with more punchy and voter-friendly short-term deliverables.
1) Financial expense. Exacerbated by smokers generally coming from the poorer and less educated strata of society.
2) Quality of life. Anybody who is addicted to anything suffers a quality of life hit because they spend at least a part of every day thinking about it and trying to satisfy it. If you can't catch a flight or sit in a long business meeting without getting edgy because you can't get nicotine or alcohol or cocaine or whatever, your quality of life is affected.
3) Self-image. Society looks down on addicts of all types. Nobody can feel good about themselves if they smoke or vape or drink or take drugs in public and others look at them with contempt.
If I'm reading Gottlieb correctly, he wants cigarette companies to systematically remove nicotine - and presumably the other chemicals they add to make nicotine more addictive - over time. What we will be left with is cigarettes that just give the user a burnt tobacco taste but with no nicotine hit or addictive properties. It would be like removing alcohol from beer. Once you do it, there is little inclination for people to drink it. People who are addicted to beer will still drink it because they have become accustomed to the taste and routine of drinking. But if alcohol is removed, the main negative of drinking is also removed. You won't find kids drinking alcohol-free beer, there is no reason to. If the alcohol effect is removed, the product's popularity plummets and kids find something else to try instead. They obviously aim to do the same with cigarettes.
Of course, vaping won't be exempt. Nicotine juices as well as flavours will be banned eventually, meaning that people are just allowed a tobacco-flavoured vape with no nicotine. Again, it should serve to dissuade kids from trying it. It'll still be there as a temporary crutch for people who need the mechanical routine and the tobacco taste but it won't attract many (if any) new users.
The big risk, of course, is the black market. Removing nicotine from cigarettes is a gilt-edged invitation to drug cartels to start smuggling in 'real' cigarettes containing nicotine and selling them along with heroin and crack and their other products. I don't know how Gottlieb intends to get around that. The primary benefit of the current campaign against smoking is that it allowed cigarettes to remain legal. So tobacco companies are legit tax-payers and employers dealing in a legal product which, through market forces, remains quite cheap. Once it goes black market, the price skyrockets and it becomes a cash industry where income isn't taxed but vanished into a Colombian money laundering black hole. Additionally all jobs created are untaxed and criminal in nature which massively increases the strain on law enforcement agencies. It also criminalises a large section of the populace and increases the incarcerated % of the population with all the attendant problems of recidivism. Ex-cons don't have many legit career opportunities so they generally return to crime once they are paroled or released. Many Americans whose initial sin was no more serious than smoking a joint are now hardened criminals who are into armed robbery and worse.
It's an extremely ambitious project but if society wants to beat nicotine addiction, it's really the only way to go. My sense, though, is that it's too long-term for the four-year cycle of US politics. If Trump is ousted at the next election, the next Dem President will probably abandon the project for something with more punchy and voter-friendly short-term deliverables.
It is important to note that tobacco smoking was only described as an addiction by the 'Surgeon General" in 1988, before that point it was described as a psychological and social habit. This change was brought about, not by a change in the make up of cigarettes, but more likely how addiction was viewed by general society. Pre-1980's view of addiction was defined primarily by how the addict could impact society around him (intoxication, inability to contribute, levels one would go to satisfy the craving) whereas in the more enlightened post 1980's this view was also extended to include the damage the addict did to him/herself. It coincides with the nanny state, e.g. intervention with the citizen, attitude that has now permeated all levels of society, but that is a topic for another day.
Of course all this still relies on the belief that it is in fact nicotine that is the primary addictive substance in tobacco smoke. It may well be that it is a combination of those substances found in tobacco smoke that causes the brain chemistry to change, thereby creating the addiction. It would appear that tobacco addiction requires nicotine to sustain it but perhaps not nicotine to create it. To illustrate more clearly, the tobacco smoke concoction alters the brain chemicals subtly and increased levels of nicotine is then required for it to function normally. The cause and cure in one package.
That's the one theory, there is also now clear evidence that some people are genetically predisposed to nicotine 'addiction'. I propose it may very well be that a certain section of the population have inherent dopamine dysfunction, which is alleviated by the use of nicotine. Keep in mind dopamine plays an important role in modulating attention, concentration, appetite suppression, and movement .. sound familiar? The 'addiction' therefore becomes treatment.
This is of course semantics, but illustrates the point that once an addiction has been created by tobacco smoking, it may effectively be treated by non tobacco burning products, snus, vaping, nicotine patches etc. Vaping works especially well because it emulates the full action of smoking, easily tricking the habituated brain.
In summary the question that begs asking .. Nicotine, is it the demon of addiction or is it a red herring in this affair? If it's the latter, the above mentioned announcement by Gottlieb may be badly misplaced and actually casts a life line to the embattled tobacco industry. Keep in mind that chemical treatment is required to remove nicotine from tobacco introducing an opportunity for manufacturers to introduce even more harmful and possibly addictive by-products into smoking tobacco all under the guise of the 'legal requirement' and very likely without proper scrutiny.
Interesting reads:
Nicotine for treating ADHD, nicotine and its use for treating Parkinsons and possibly Alzheimers
Of course all this still relies on the belief that it is in fact nicotine that is the primary addictive substance in tobacco smoke. It may well be that it is a combination of those substances found in tobacco smoke that causes the brain chemistry to change, thereby creating the addiction. It would appear that tobacco addiction requires nicotine to sustain it but perhaps not nicotine to create it. To illustrate more clearly, the tobacco smoke concoction alters the brain chemicals subtly and increased levels of nicotine is then required for it to function normally. The cause and cure in one package.
That's the one theory, there is also now clear evidence that some people are genetically predisposed to nicotine 'addiction'. I propose it may very well be that a certain section of the population have inherent dopamine dysfunction, which is alleviated by the use of nicotine. Keep in mind dopamine plays an important role in modulating attention, concentration, appetite suppression, and movement .. sound familiar? The 'addiction' therefore becomes treatment.
This is of course semantics, but illustrates the point that once an addiction has been created by tobacco smoking, it may effectively be treated by non tobacco burning products, snus, vaping, nicotine patches etc. Vaping works especially well because it emulates the full action of smoking, easily tricking the habituated brain.
In summary the question that begs asking .. Nicotine, is it the demon of addiction or is it a red herring in this affair? If it's the latter, the above mentioned announcement by Gottlieb may be badly misplaced and actually casts a life line to the embattled tobacco industry. Keep in mind that chemical treatment is required to remove nicotine from tobacco introducing an opportunity for manufacturers to introduce even more harmful and possibly addictive by-products into smoking tobacco all under the guise of the 'legal requirement' and very likely without proper scrutiny.
Interesting reads:
Nicotine for treating ADHD, nicotine and its use for treating Parkinsons and possibly Alzheimers
Red herring, no doubt imho. There is enough scientific evidence that nicotine per se is in the same class as caffeine at most.
If nicotine on its own isn't addictive then vapers can surely have no objection to Gottlieb mandating zero-nic juice. If we're not hooked on it we shouldn't need it and its omission thus becomes a trivial matter.
For smokers and ex-smokers it is not that easy - this part from @JakesSA's post above is key: "It may well be that it is a combination of those substances found in tobacco smoke that causes the brain chemistry to change, thereby creating the addiction. It would appear that tobacco addiction requires nicotine to sustain it but perhaps not nicotine to create it.". I have read a research article that confirms this. Also, never smokers injected with nicotine over a long period of time in research around Alzheimers, Parkinsons, etc, did not become addicted.
I think it may have to do with the intake mechanism rather than any chemicals that big tobacco are adding. Ex-smokers who have tried patches have reported that vaping is more satisfying. Yet ostensibly there should be little or no difference between the nicotine in a patch and in juice. I suspect it's the intake mechanism - inhaling it with a very short time duration before it affects the brain rather than applying a patch to the skin which takes longer to act - that creates a better nic hit and thus a more tangible addiction.
I find it very difficult to believe that the addiction is caused by something else but sustained/satisfied by nicotine. Smoking started centuries ago, long before Big Tobacco as we know it even existed or had the power or the technology to add chemicals that create addiction. Over the centuries, smoking gradually grew in popularity. I don't think it was because of how nice tobacco tastes for a first-time smoker so I can only assume that there is some sensory hit to which users easily become addicted.
I find it very difficult to believe that the addiction is caused by something else but sustained/satisfied by nicotine. Smoking started centuries ago, long before Big Tobacco as we know it even existed or had the power or the technology to add chemicals that create addiction. Over the centuries, smoking gradually grew in popularity. I don't think it was because of how nice tobacco tastes for a first-time smoker so I can only assume that there is some sensory hit to which users easily become addicted.
Found this article.
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