If you want to jump straight to my policy proposals, scroll down to the bottom.
It’s taken me some time to get this together as the concept is fairly controversial inside the Vaping industry. Many proponents of not ‘harming’ the industry see any criticism of products or business practices as harming the industry overall and shouldn’t be discussed. While I can appreciate the philosophical basis for this line of argumentation, these people will simultaneously bemoan the anti-vaping groups for the variety of untruth in their statements and campaigns. I find this intellectually dishonest, and instead our mission should be to pursue our higher virtues and truth. The truth fears no investigation and if made clear should arm policy makers with the ability to make rational decisions.
Now that most of the Moral Panic has subsided over “Vaping Injuries”, the information dissemination by the Government could only be described as a total failure at best, and near criminal endangerment at worst, we should be able to look at the strict subject of Commercial Nicotine Vaping and Youth Access without the need for hyper reactionary emergency measures. If you still have any confusion before proceeding, please read this Leafy article to understand that the lung injuries were caused by one cutting agent supplier that introduced product exclusively into the supply chain of black market THC vaporizers. This may be an important point to reflect on that as of May 2020 much of the Commercial Nicotine Vaping segment will move into the black market and we are liable to repeat as many injuries and deaths, if not more, if sensible reforms are not made to the PMTA process proposed by the FDA.
With that said, let me introduce my own biases to you, so that we are not on uneasy terms. I smoked from 1998 until 2012. I quit using an eCig with Raspberry Mojito flavor. I no longer vape (I gave it up for Lent this year and it stuck). I quit my startup in software that same year and helped my partner open a chain of vape shops. We were divested of those vape shops in 2016. In 2013 I was part of a company that helped create new vaping products. I became the chief designer at the company designing many vaporizers, some of the designs became very successful. My designs were copied by the Chinese and sold as counterfeit that I estimate numbered into at least 1M units globally in sales across all the various designs I made. I no longer design vaporizers and the business of these designs is no longer a going commercial concern. Now my interest is in designing even further reduced harm products than eCigs. So I do a lot of reading.
Before proceeding any further, I will lay out clearly what I hope to illustrate. Nicotine Salt is very different than Freebase Nicotine. Juul and others introduced Nicotine Salt into retail channels with high rates of failure to ID knowing that Nicotine Salt was more prone to abuse. A regulatory approach that tackles Nicotine Salt vs Freebase Nicotine is important to balance youth exposure vs adult access, and can be done quite easily.
Now lets define some terms. You may be somewhat confused reading about this topic in other places, or are being required by your constituents to make legislation to “do something”. Hopefully this will help you both understand the following as well as the issue more broadly when weighing the merits of what you may read elsewhere.
Freebase Nicotine: The pure nicotine product that is refined from tobacco leaves using a method developed by Phillip Morris in the 1950’s. The nicotine is extracted and used in various preparations such as the Nicotine Patch, Nicotine Gum, Nicotine Toothpicks and the “Regular” Electronic Cigarette Vaping liquids.
Salt Nicotine: A modification made to Freebase Nicotine based on an RJ Reynolds patent from the late 1970’s. Benzoic Acid is added to Freebase Nicotine. This turns the Nicotine into a “Salt”. The outcome of this is that higher quantities of nicotine can be ingested without as much side effect (coughing, irritation, nausea).
Nicotine Blood Plasma Level: This is probably the best way to judge nicotine absorption. Important things we want to see is this value over time. Both how fast it peaks after usage and how long it lasts. This will predict how much Euphoria can be induced (peak) and how soon someone will need to use the product again (halflife).
Nicotine in the Body
How fast nicotine gets to the bloodstream is critically important to the success or failure of a nicotine device. Different routes of administration yield different results, as does the type of Nicotine used.
Fig 1 is from a 1995 Study Abuse Potential of Nicotine Replacement Therapies. It is a great slide that shows varying speeds and peaks of Nicotine Blood Plasma with different routes of administration. One of the standouts to me is that Nicotine Gum is quite slow to take action and peaks with only half the peak as a cigarette does. It would be fairly easy to predict that someone using Nicotine Gum may feel significant Nicotine cravings. It also should be noted that Nicotine Gum is quite unpleasant to chew, leading to an overwhelming nicotine feeling in the mouth. I tried and failed to quit using the gum multiple times.
Fig 2 is from a 1991 Study comparing Nicotine Toothpicks to Nicotine Gum with current smokers. The takeaway is that the Nicotine Toothpick puts the plasma nicotine level at the same or higher than the before state than the Nicotine Gum, while the Nicotine Gum actually leads to a reduced plasma nicotine level. Even though both products contain 4mg of Nicotine, the route of administration can be made to be more effective of one over the other. This is important to remember that not all devices and not all nicotine is created equal on a level for level basis. One device may be spiking plasma nicotine levels faster than the other.
Fig 3 is from Juul’s (Pax Labs) own published study from 2015 on their Nicotine Salt product (JuulSalts). Here we can see a very large divergence between the Freebase Nicotine (traditional e-liquid) level and the Juul, both as tested and their own commercial version. Plasma nicotine levels are spiked much higher and also fall much faster than the Freebase Nicotine product.
Interpreting these results.
Juul’s defense to designing a product with such a fast spike is that it closely mimics the performance of a Cigarette without the tar and cancer causing elements. While this is a valid use and a noble goal, it’s impossible to say Juul is not well read on the various research around nicotine. Just reading through this recent LA Times article shows just how well researched they in fact are. With this in mind, it should be assumed that they were aware of the study from the above referenced slide, Abuse Potential of Nicotine Replacement Therapies.
The conclusion of this study reads as such.
“NRT’s (Nicotine Replacement Therapies) are important pharmacological adjuncts to the behavioural treatment of cigarette smoking. However, it is important to ensure that the products developed for treating nicotine dependence associated with cigarette smoking themselves have a low potential for abuse.
Based on the available evidence, it can be concluded that most of the NRT’s have a low liability for abuse compared with tobacco cigarettes. Nevertheless, the various NRT’s available and under development may differ in both the likelihood of repeated use (e.g related to their rates of absorption and onset of pharmacodynamic effects) and the likelihood of adverse consequences (e.g. adverse effects).
Both of these factors may influence the abuse liability of NRT’s and should be considered in future research into the development of new pharmacological aids to smoking cessation.”
With the conclusion set out first, why did the authors correlate abuse potential with nicotine levels equal to cigarettes? From the study:
“There is some controversy about the degree to which nicotine produces pleasurable, ‘euphorigenic’ subjective effects in individuals who are dependent on it. On one hand, nicotine is not thought to produce the kind of clearly definable intoxication, or ‘high’, that is associated with other prototypic drugs of abuse, nor does it produce the psychomotor impairment that is usually associated with abused drugs. Nevertheless, it has been shown that nicotine administered intravenously to cigarette smokers does produce increased ratings of drug liking, and one recent study demonstrated increases in self-reported euphoria from smoked cigarettes. Thus, subjective reports of liking and euphoria may be valid measures on which to assess the abuse potential of NRT’s.”
This is something that has gone under reported and under studied, and some will claim that I am doing “anti-vapings” job for them, but it must be addressed. High levels of Nicotine produces effects of Euphoria. I can still remember the effects of my very first cigarette, very Euphoric! In 1995 the state of the art with the highest dosing of Nicotine was the Nicotine Nasal Spray. In Fig 1 we can see that it spikes plasma nicotine almost as fast as the cigarette. The paper tracked that several patients of the spray ended up using it for long periods of time(12+ Months). While they did not track the euphoric effects, this differed substantially from both the gum and patch and showed that the spray was much more liable for abuse. Because of the speed of the blood plasma spike euphoria is to be assumed. The problem with the nasal spray was a large number of users who reported irritation with the product and discontinued use. This is similar for most other NRT’s as too high a level of Freebase Nicotine will produce negative side effects. Such was the state of the art (publicly) in 1995.
Here it should be noted that the breakthrough for Nicotine Salt is that a much higher concentration of Nicotine can be ingested with fewer side effects and absorbed much more quickly. When a person with no prior nicotine habit then accesses this product with no adverse effects such as nausea or burning smoke, the result would be only a pleasurable euphoria. One that is prone to abuse, as predicted in this above study from 1995. Juul had to be aware that they had created a product with huge abuse potential from their demonstrated history of digging through large portions of historical research on the performance of nicotine.
Teen Usage, A Timeline.
When we opened our doors, or actually before we could, we met our first customer. A husband and wife couple. They had been mail ordering eCigs online for 6 months prior and were so excited to see our printed banner go up above our cheap strip mall location that when they saw the lights on at 8pm the night before our opening, they knocked on the door to make a purchase. At this point in 2012, there was no state or federal requirement to ID buyers of eCigs. We ID’d them. Then they tried some of the 50 varieties of flavors we had stocked, purchased a handful and a new device. We had learned quite a bit about the trade from other Vape Shops we had visited in the Los Angeles area. They had all started checking ID early on. All of their mission statements to us was to convert people away from combustible tobacco. They wouldn’t sell to kids. The market was large enough. There was no reason. Customers were beating down the doors. This was largely before the Anti-Tobacco lobby had shifted their focus to Anti-Vaping with ridiculous unsubstantiated health claims to scare away people smoking cigarettes. It’s unbelievable at how effective these propaganda campaigns have been, American smokers now believe that eCigs are more dangerous than combustible cigarettes. This is truly a dark age for public health in the United States.
It wasn’t until the following year that we started noticing what could be described as “youth participation” and mostly online. Young looking people were showing up on Instagram doing “vape tricks”. We had some customers come in who were underage. They begged us to be able to purchase eCig liquid without nicotine. We resisted, as our primary mission was to convert smokers away. This subculture, to be known as cloud chasing went about as quickly as it came, by mid 2015 it had almost entirely disappeared. The proposed thought experiment here is this:
“If eCigs with good tasting flavors and cool instagram influencers had initiated a whole subculture of youth to a serious nicotine addiction, why did they disappear so quickly?”
The truth here is that, when they did use nicotine, it did not produce euphoric effects. It also stung the throat, which interfered with their ability to inhale candy flavored vapor deeply and blow smoke rings on instagram. No one can look cool to a prospective mate while choking red in the face on simulated smoke. That’s not quite the James Dean image teen girls are dreaming of.
There’s also a pharmacological reason. These Freebase Nicotine eCigs had the same plasma nicotine performance as Nicotine Gum. The same 1995 Study actually tested an early prototype eCig and had the blood plasma results.
“Finally, Leischow reviewed experimental and clinical studies with a nicotine vaporizer, which may have potential as a NRT. The Smoke-Free vaporiser consists of a hollow plastic tube that contains a porous sponge permeated with nicotine. It delivers less nicotine per puff than a cigarette, and it results in a relatively slow time to Cmax similar to that of nicotine gum.”
Freebase Nicotine did not change between 1960, 1995 or 2015. There is a maximum tolerable amount of Freebase Nicotine able to be added to an eCig and not produce harsh side effects, such as coughing or nausea. There is also the issue that it is absorbed quite slowly compared to Salt Nicotine, so it does not produce a fast spike of plasma nicotine and it’s expected euphoric effects. In essence the kids of the 2014 “Cloud Tricks” trend were blowing bubbles with nicotine chewing gum at most. They were able to cease use just as easily and predictably as the studies of Nicotine Gum predicted and demonstrated.
So in 2016, youth eCig use actually dropped. Teens are into fashionable trends (have you seen a flossing dance recently?) and many gave up as posting a Harambe or “Build the Wall” meme became the new way to be edgy and signal ingroup preference on instagram.
2016–2017 became an explosive year for Juul’s sales. Their new Salt Nicotine and discreet package suddenly became a blockbuster product. Yet it was not a staple in the Vape shops. Many Vape shops did not carry this product. It was instead inserted into traditional tobacco distribution channels such as Convenience Stores, Gas Stations and Drug Stores. On the surface, these distribution points should be reliable and trustworthy good actors who have long histories selling age restricted products in a responsible manner. At that very same time, youth usage of eCig’s exploded. Why would something that had fallen out of trend see a sudden 2nd life? Especially the Juul which more and more parents and teachers ended up finding? As revealed by the FDA, those historical distribution chains turned out not to be as strict as specialty Vape Shops had been.
Here we need to place serious scrutiny onto Juul and other vendors of small Salt Nicotine devices distributed in these locations. The products will produce euphoria in people without a nicotine tolerance, and are made to be easily accessible because these retailers are not as single mission dedicated to vending their one product. Juul could have scaled back distribution to locations where youth usage was heat mapping. They could have rolled out mandatory ID check software to their retailers. They could have been incredibly explicit with their messaging that their product was designed for smokers who had failed using traditional eCigs. Instead they marketed their euphoria producing product to young people, with a youth marketing campaign.
Did Juul’s flavors play a part in their appeal to underage youth?
Flavored eCig liquid has been a staple of the business since the start. 2015 was a banner year with ever greater flavors coming out replicating pastries, some even to the point of intellectual property infringement, yet we saw underage vaping collapse. Juul’s allure to teens is entirely is pharmacokinetic action.
Recently, Juul has worked to make symbolic reforms. Removing the CEO, and removing their flavors. They are smart to do this, while their parent company donates money to anti-vaping organisations calling for bans on flavors. “Tobacco Flavor” does not produce a harsh burning in the throat, it just tastes like a dark whiskey with a nicotine high. Flavors are not a serious part of Juul’s business model. Loose ID check retailers and Salt Nicotine is.
Ultimately, it must be addressed in clear terms that Youth Usage of eCig increases while Youth Usage of traditional Cigs collapses is not the end of the world. This reminds me a lot of the culture war for sex education, specifically abstinence only education. My faith informs that I would prefer my own children to remain chaste before marriage. Yet we saw the catastrophic consequences of abstinence only with an explosion in youth STI’s and unwanted pregnancies. Now in our more informed cultural place of 2019 we would prefer kids are educated about proper usage of condoms and safe sex.
In many ways the eCig is the Condom of tobacco. Would we prefer total abstinence from tobacco? Of course. If I could have started using a Juul rather than Marlboro Lights at 15, would it have been better for me? Undoubtedly. We cannot look at this data as a horrible result for public health over the long term. Unfortunately the over-reaction of hysteria from the anti-vaping groups may be creating a vape-to-cigarette pipeline themselves, instead of helping. A Nicotine only addiction may not be as bad as you think.
Nicotine. The Devil?
There’s three main components that make cigarettes addictive.
- Physical Habit
- Tobacco MAOI
Now if number 3 is a shock to you, perhaps we’ll delve into this.
“Although nicotine has been identified as the main ingredient in tobacco responsible for aspects of the tobacco dependence syndrome, not all of the psychopharmacological effects of smoking can be explained by nicotine alone. Accumulating preclinical and clinical evidence has demonstrated that smoking also leads to potent inhibition of both types (A and B) of monoamine oxidase (MAO). Smokers have 30–40% lower MAOB and 20–30% lower MAOA activity than non-smokers. Reduced MAO activity in smokers has been shown by direct measures (platelets, positron emission tomographic studies) or by indirect measures (concentration of monoamine catabolites in plasma or CSF). We examine the hypothesis that chronic habitual smoking can be better understood in the context of two pharmacological factors : nicotine and reduced MAO activity. We speculate that MAO inhibition by compounds found in either tobacco or tobacco smoke can potentiate nicotine’s effects. Based on this concept, more effective anti-smoking drug strategies may be developed. As a practical consequence of tobacco smoke’s MAO-inhibitory properties, comparative psychiatric research studies need to screen and control for tobacco use.”
This research spawned a number of MAOI based drug therapies to quit smoking, notably Chantix and a reuse of Wellbutrin. This unexpected development in what actually makes cigarette smoking addictive has lead to widespread prescription of these Black Label drugs, with unfortunate side effects that don’t always seem to fetch the same media headlines.
The eCig works to replace both the Nicotine and Physical Habit but eliminates the presence of the tobacco MAOI. This is a much safer addiction with fewer addictive active ingredients than traditional cigarettes. This should make quitting eCigs for someone who never used traditional cigarettes before, or who has abstained from cigarettes for a long period of time easier. Again the goal here is to convince youth to quit eCigs for abstinence, not quit for cigarettes as has been happening. Freebase Nicotine alone is about as difficult an addiction profile as Caffeine (and I am not sure if I could give up caffeine for Lent).
So now that you’ve read through this, and all the links, and have become an expert on the complications of this subject matter, I do not want to leave you with just another position of defense with no viable solution. We’ve defined our terms. Now let’s define our goals. I agree that our goal should be a near 100% abstention of youth use of Nicotine. Nicotine has been shown to alter developing brains, which development stops at 17 for Females and 25 for Males. No one read on the subject matter should endorse youth usage of Nicotine.
(Don’t think all Nicotine usage is bad btw, Nicotine use in adults acts as a neuro-enhancer, with incredibly promising results from nicotine therapy for alzheimers and parkinsons.)
Measures to reduce youth usage of eCigs.
- Reduce access to Salt Nicotine
- Branding of eCigs as dangerous plays to youth admiration of fatalistic fantasy, instead program ‘anti’ messaging that eCigs are for older uncool people
- Increase penalties for youth possession
- Mandatory ID check software on each purchase
- Possible to require digital serialization of devices and tie sale to an ID to identify straw purchasers
- Require Online vendors to use ID check software and ban individual International imports of eCigs.
Reduce access to Salt Nicotine, by requiring vendors allowed to sell Salt Nicotine devices, such as Juul, are in the top 10% of Age Check compliant retailers. Salt Nicotine is a specialized tool to address long time smokers who cannot stop smoking cigarettes using Freebase Nicotine eCigs. Placing this product in a more tightly controlled retail environment with only the most compliant vendors reduces the likelihood of youth access.
Branding of eCigs as dangerous plays to youth admiration of fatalistic fantasy, instead program ‘anti’ messaging that eCigs are for older uncool people, not hip. This is important. When you’re young you think you’ll live forever, or could really care less what happens to you after you’re 27. That is until you are 28. The current public policy of making eCigs appear to be equivalently dangerous as cigarettes is pushing youth to simply smoking. Much like the abstinence only campaigns attack on condom safety led to young people simply having unprotected sex. Telling youth that eCigs are for old smokers, and possibly a marketing requirement of model age for eCig companies can remove the appeal with the result similar to the drop seen in 2015.
Increase penalties for youth possession. This should be obvious, but in many states youth possession is illegal. Increased enforcement of citations and community service will reduce youth possession. To deny the efficacy of enforcing this law is to deny the efficacy of enforcing all laws as a deterrent to orderly behaviour in our society.
Mandatory ID check Software has come a LONG way. It is easy and cheap to use. Many of the issues with the large chain ID check failures is simply low engaged employees. By mandating the use of ID check software in the checkout process, it will put an ID on record for each purchase, otherwise disallow the sale entirely.
Require digital serialization of devices and tie sale to an ID to identify straw purchasers would be the capstone to the above two other policies. Most eCig devices are USB capable and have digital chips on them. It is a trivial cost to add an additional “unique serial number” onto each device, and print it’s barcode on it’s packaging. This means that each device will have a serial number tied to an ID at the time of sale. When enforcing youth possession, it will be possible to recover the serial number, and discover who purchased the device and where and launch the appropriate investigation. Do you have a repeat straw purchaser? Do you have a retailer that is consistently cheating the system? This is a very cheap requirement to close the youth access issue.
Websites such as Wish and other Chinese retailers must be addressed. They will not fall into compliance, so international sales of eCigs for individual use must be banned, both by USPS and using payment processor bans (Paypal, Visa, Mastercard etc). This will ensure that kids don’t simply circumvent actions within the US to regulate eCigs by going outside of it.
Properly Regulate the Industry
Finally, all the good from this revolution in tobacco harm reduction must not be wasted. Outside of Juul, Vuse and Blu the eCig industry is made up of 14,000 small businesses in the US.
The FDA has self expanded their mandate from Congress to regulate tobacco products under the 2007 Tobacco Control Act to include eCigs and any product containing nicotine. They require any product put on the market after 2007 to undergo a PMTA process, which to date only one product has passed with an estimated cost of $2M+ to Phillip Morris for their “heat not burn” iQos product.
This process is not prescribed to be as expensive or burdensome by the TCA and is purely up to the discretion of the FDA. To take no action to reform the PMTA process to be friendly to small business will only have the result of stifling innovation of new harm reduced products in the future and creation of a new black market.
Remember that Phillip Morris had isolated Freebase Nicotine in the late 1950’s to spray onto Marlboro cigarettes, and RJ Reynolds had developed Salt Nicotine in the late 1970’s, yet both of these products did not become freely available to the average consumer until this decade. A hugely expensive regulatory process only ensures more innovations will be locked away by gate keepers never to see the light of day as they cannot be put on the market.