As a vaper, you may have noticed the sudden proliferation of synthetic nicotine and tobacco free nicotine (TFN). Depending on how the PMTA process plays out, these two forms of nicotine may play a crucial role in the future of a viable and independent vaping industry. Synthetic nicotine may be a lifeline for small vape juice companies and allow adults to continue to have access to the vape juice flavors they prefer. Will the future of vaping hinge on synthetic nicotine and TFN replacing the traditional tobacco derived nicotine?
Despite a massive drop in teen vaping rates, no doubt due to Tobacco 21 laws and the removal of a certain mint flavored closed vape pod system from the market, relentless anti-vaping zealots have now placed synthetic nicotine in their crosshairs. The elephant in the room is how the FDA's Center for Tobacco Products will choose to deal with synthetic nicotine.
Their pursuit of vaping prohibition and total nicotine abstinence has already made the use of vape juice flavors that use a tobacco-derived nicotine formula increasingly precarious.
At the same time, nicotine that does not use plant materials has declined in price and is price competitive with tobacco-derived nicotine. These developing stories will play out over the coming year. Today, we are going to answer a question many adult vapers will be asking in the coming months: What is synthetic nicotine?
However, the long-term question is if synthetic nicotine will be regulated in the same way that a regular tobacco leaf-derived product would be.
What sets apart synthetic nicotine from tobacco-derived nicotine is that it is not a tobacco product. As it is not harvested from tobacco, there are some questions about how much oversight the Food and Drug Administration will be given over it and if they will attempt to enforce new regulatory procedures.
If synthetic nicotine is treated like a tobacco product, then the consequences for adult vapers who enjoy non-tobacco flavors will be catastrophic. Essentially, their options will be to go back to combustible tobacco products, embrace nicotine abstinence, or rely on the gas station e-cigarettes that are sold by Big Tobacco companies.
In the current regulatory framework, vaping products have been treated as tobacco products, but there is some hope that adult vapers can still access the non-tobacco flavors if synthetic nicotine is treated as a fundamentally different product.
Tobacco Derived Nicotine
Most vape juices on the market have traditionally used tobacco-derived nicotine. In other words, there is no escape from Big Tobacco and their tobacco products. Of course, tobacco is cultivated using industrial farming techniques. Heavy in pesticides and petroleum inputs, the current combustible smokes are rather far removed from crude cigarettes, which were first exported from Virginia some 400 years ago.
Nicotine pouches were one of the first synthetic nicotine products to hit the market. The use of nicotine not derived from the tobacco plant in nicotine pouches predates the use in vape juices by several years.
Nicotine Replacement Therapy
The sundry patches and gums that are available at your local drug store are another synthetic nicotine product. As an FDA-sponsored form of nicotine replacement therapy, these products are generally not derived from tobacco and regulated totally differently than an e-cigarette.
Although the combination of vape juice and e-cigarettes vastly outperformed nicotine replacement therapy in a New England Journal of Medicine Study, the patch and similar synthetic nicotine products remain the favored method of smoking cessation by the CDC, and also avoid the capricious judgments of the Food and Drug Administration.
Tobacco Free Nicotine
Tobacco Free Nicotine (TFN) is a brand of nicotine offered by Next Generation Labs, but it is also a term used to describe nicotine used in vaping products that is not derived from tobacco products. Tobacco free nicotine’s manufacturer has several versions of nicotine. There is a blend of S-isomer and R-isomer, an R-isomer, and a pure synthetic S-isomer tobacco free nicotine. None of the products use tobacco harvested from tobacco plants in their manufacture, but the process of how these synthetic nicotine products are made is a closely guarded trade secret, complete with patents.
Nicotine is a stimulant and is an addictive substance. Most nicotine initiates pick up the habit because nicotine is viewed as an anxiolytic drug. While a bad idea, this is the primary reason for its initial use. The UK’s National Health Service promotes e-cigarettes as an alternative to cigarettes, something no US company or medical authority could get away with. They also argue nicotine is a terrible anxiolytic and advocate for total avoidance.
The family of plants known as nightshades (Solanaceae) contain nicotine. This family includes eggplants, tomatoes, potatoes, and green peppers. Nicotine is also present in the coca plant, but tobacco contains far more nicotine than any of these other plants. Nonetheless, the levels of nicotine in the other nightshades are not so minute that it cannot be efficiently extracted. This is a likely source of tobacco free nicotine in the future.
Nicotine makes up 0.3 to 0.5 percent of the tobacco plant by dry weight. Nicotine is classified as an alkaloid, which is simply a chemical term for any organic nitrogenous compound of plant origin that interacts physiologically with humans. Quinine, a common treatment for malaria, is also an alkaloid. So is atropine, which is used as an antidote for mushroom poisoning and has other medical uses, such as treating low heart rate. The painkiller, morphine, is an alkaloid too, but so is the pesticide, strychnine.
Synthetic nicotine products do not use any nicotine from plants at all. They instead rely on raw materials that can be processed in a lab setting or manufacturing facility. Synthetic nicotine products, therefore, do not require water, fertilizer, or acreage, and production can be easily scaled up to meet demand.
Synthetic Nicotine Products
What is the difference between synthetic and tobacco free nicotine (TFN)? Tobacco requires the use of a nicotine containing plant for manufacture, but synthetic nicotine is synthesized in a lab. Although it is pure S-nicotine, it is molecularly identical to naturally occurring nicotine and designed to have the exact same effects.
What synthetic nicotine does not contain is tobacco. This is one of its biggest features, and not just because of regulatory concerns. The extraction of nicotine from tobacco requires the use of solvents and chemicals. While these are safely removed, it is still a form of waste and pollution that is not present in the production of synthetic nicotine.
Tobacco is a cash crop that is grown on an industrial scale. Those tobacco products used worldwide have traditionally tied up vast tracts of farmland, relies heavily on pesticides and petrochemical inputs during harvest. Efforts have been made to reduce the tobacco industry’s carbon footprint, but synthesizing nicotine is still far more efficient.
A final consideration is that the tobacco derived nicotine used in e-liquids must be purchased from somewhere. That somewhere is Big Tobacco. It is unlikely that many vapers look forward to putting more money in the hands of that industry.
Improved and efficient methods of manufacturing synthetic nicotine mean that production can be ramped up without planting and processing more acres of tobacco. In fact, the price point has been reduced to the point where synthetic nicotine is competitively priced with e-liquid that use tobacco products.
The upshot is that your favorite e liquid may soon be a synthetic nicotine product that is not derived from tobacco. In the future you e juice bottle may say "Product Contains Nicotine" but you will be vaping a non tobacco product.
E-juices and e-liquids remain in the crosshairs of regulators, whether they are a synthetic nicotine product or derived from tobacco. While most adult vapers prefer a vape juice that has a flavor other than tobacco, with characterizing flavors like fruits and beverages being the most popular. In the United States, whether it is a nicotine pouch or a vape mod, if the product is extracted from tobacco, it cannot claim to be a smoking cessation product.
An increase in nicotine levels over the years has also caught the attention of anti-vapers. Interestingly, most of the UK's regulations regarding vaping focus on lower nicotine levels. There is a 20mg threshold that even purveyors of e-liquids and pre-filled vape pods submit to.
In the UK, public health is more of a national concern, and taxpayers are footing the bill for everything. This may explain why the National Health Service (NHS) has an entire website dedicated to using the humble e cigarette as smoking cessation product: Using E-Cigarettes to Stop Smoking . Such a claim in the US would send the blood pressure of any Truth Initiative executive through the roof.
The threat of FDA scrutiny precludes any manufacturer from claiming they are selling smoking cessation products, but former FDA Commissioner, Scott Gottlieb, has stated that it would be a net gain if all smokers switched to vaping.
While one would never recommend picking up nicotine products for the novelty, the impact of taking an adult vaper’s favorite vape juice and funneling them back onto combustible cigarettes cannot be construed as a good thing. While they are both nicotine products, only one involves the burning of tobacco leaf.
Historically, the strong arm of FDA regulation fell hard on all products containing nicotine, but vape juices have been getting far more attention than other nicotine products in recent years. Until the advent of synthetic nicotine, e-juices, e-liquids, and combustible cigarettes were directly extracted from tobacco.
S-nicotine and R-nicotine are the two stereoisomers of nicotine. Isomeric molecules do not necessarily interact the same way physiologically or have the same chemical properties. Even though both isomers have the formula of C10 H14 N2, they are spatially distinct when viewed in 3-D.
The nicotine used in pharmaceutical products, such as nicotine replacement patches, is pure S-nicotine. It has been used for decades, and until recently, was quite expensive. Nicotine derived from plant material other than tobacco also contains naturally occurring R-nicotine. Therefore, tobacco free nicotine will usually contain some blend of S- and R-nicotine.
As patents are filed and synthetic nicotine becomes less expensive, you can expect to see purer S-nicotine in your e-juices, e-liquids, and disposable vapes.
Whether synthetic nicotine ever replaces tobacco-derived nicotine in other tobacco products is an issue that has yet to be resolved, but the ability to scale up manufacturing gives synthetic nicotine a long-term advantage over other tobacco products.
Depending on how the FDA handles PMTAs, products containing a non-tobacco nicotine might become the go-to for any manufacturer of vaping products. We may even see companies that manufacture hardware market coils that maximize the flavor benefits of synthetic nicotine.
The vaping industry has faced countless regulatory hurdles, and while nicotine remains a legal chemical, if synthetic nicotine is regulated in the same manner as a cigarette, then manufacturers will be at risk of running afoul of capricious FDA decisions.
Time will tell if the style of vape juices that most adult vape users prefer can stay on the market or if the FDA will act to shut down everyone except the Big Tobacco companies that manufacture tobacco flavored cig-a-likes and pods.
What is ironic is that the company most frequently accused of marketing to minors, Juul, had the money to provide research and seemingly has a solid chance of surviving regulatory review.
On the other hand, you would have to search far and wide to find a minor who prefers clunky box mods and the Unicorn Milk max-VG e-juice that was so frequently featured on the news and in political press conferences.
Smoking and High Risk Teen Behavior
What is often lost in the discussion is how smoking rates have plummeted over the last ten years and cigarette use among minors is virtually nil.
The FDA was quick to review the vapes on the market and acted when teen vaping surged several years ago, a justifiable concern considering nicotine is an addictive chemical. They have not been so quick to scale back their efforts as the teen vaping rate has dropped precipitously in the last two years.
Yet anyone over the age of 35, and this includes many Millennials at this point, lived through an era when a quarter to a third of high school seniors were smoking. Cigarette companies were done marketing to minors, but the call of addictive nicotine still hooked teen smokers.
Other high risk and harmful activities among teens have also dropped over the last several decades. No one should ever downplay the fact that minors should not be using products containing harmful nicotine, whether they smoke, use pouches, or are partaking in e-liquid usage. Yet if saving lives is really the goal, why is more attention not paid to underage drinking?
The death toll from drunk driving among minors is far greater than drugs. The dangers are much more instant and prevalent than ill-advised smoking or vaping.
You do not have to search long or hard to find a tragic story about a teen alcohol-related death. There are 3500 underage deaths attributed to alcohol annually. According to the CDC, alcohol sends 150,000 minors to the emergency room every 12 months. The question is why does alcohol get a free pass in the news media?
The Wealthy Do Not Smoke or Use Nicotine
Alcohol avoids the harsh scrutiny that e-cigs and synthetic nicotine receive because these are alien activities for the wealthiest Americans. You could conduct an extensive search and probably not find a friend of Michael Bloomberg who has enjoyed a smoke in the last 20 years, with the notable exception of President Obama. Certainly, very few of the richest Americans have ever considered pouches or dipping synthetic nicotine. Wealthy Americans simply do not smoke.
The users of tobacco and nicotine products are most frequently found in marginalized groups. No group uses vaping products at a higher rate than the LGBTQ+ community, according to the CDC. Rural and poor Americans are the most likely to smoke and the wealthiest Americans are the least likely to do so.
This is not just an issue of reading warning labels. The wealthy are most likely to drink to excess. Yet there is no scenario where any federal agency could attempt to regulate their preferred vices in the same way that electronic nicotine delivery systems are.
It turns out that those with wealth and power are in contact with each other, while vapers are on the outside looking in.
Drug Administration: FDA
The vaping industry is under the regulatory control of the FDA. The PMTA process is currently determining which products could make it to market, and in the process, the traditional Mom and Pop vape company is at risk.
Whether the FDA will soon have the power to control synthetic nicotine will also have its day in court.
While kicking the can down the road is common bureaucratic response, rare is the agency that willingly surrenders the power to regulate an industry that is already in the crosshairs of well-funded lobbyists.
If you are an adult vaper who prefers flavored vape juices in the vaping device of your choice, consider this a warning. They are coming for synthetic nicotine.