If you are a vaper who is closely following the PMTA process and the long-standing campaign against vapes, it may seem that tobacco flavored e-cigarettes sold at a gas station and made by Big Tobacco will soon be your only option.
Behind the scenes, manufacturers of e-liquid nicotine have been hard at work creating a product that does not require tobacco leaves. There is some hope that these will provide regulatory relief and allow adult vapers to continue enjoying the e-liquid flavor profiles that most prefer.
Tobacco free nicotine (TFN) has been in the works for years, long before synthetic nicotine appeared to be a final option for independent vape companies that cater to adult vapers and hobbyists. Today it is possible to efficiently manufacturer nicotine without using the tobacco plant at all.
There remains the fundamental question: What is tobacco free nicotine? The short answer, it is nicotine manufactured without the use of the tobacco. How is it made? Companies that have invested millions developing proprietary processes and materials are not eager to share this information. Fortunately, they have been more open about their competing visions on the future of vaping.
Currently, the term Tobacco Free Nicotine is akin to Xerox. Just as all copy and copies machines were once called a Xerox, Tobacco free nicotine (TFN) sounds like a basic term but is a trademark of Next Generation Labs (NGL).
NGL manufactures R-isomer tobacco derived nicotine (TDN), R-S tobacco free nicotine (TFN) and S-isomer synthetic nicotine. As you may have guessed, Next Generation Labs uses no part of the tobacco plant when manufacturing these products.
Their patented process and intellectual property are closely guarded secrets. But the product is still nicotine. Synthetic may be a scary word in 2021, with the concepts of “nature” and “organic” so popular with consumers, but at the end of the day a nicotine molecule is a nicotine molecule.
Next Generation Labs
Next Generation Lab’s is not some fly by night operation that appeared with the sole purpose of thwarting the Orwellian named Truth Initiative and saving the vaping industry from destruction. NGL and TFN products have been on the market since 2014. That is like 1970 in vape technology terms, with Juul, vape pods and nic salts not hitting market until 2015.
The Tobacco Reporter interviewed founding NGL leader Ron Tully: “Over the past five years, NGL has created this market for nicotine that did not exist prior to our innovation and commercialization of TFN.” Sales have spiked due to demand in the US and South Korea, and NGL has doubled their manufacturing capacity.
CNT Synthetic Nicotine
Next Generation Labs is not unchallenged in the synthetic nicotine and tobacco free nicotine arena. Across the ocean in Heilbronn, Germany is Contraf-Nicotex-Tobacco or CNT. They have been manufacturing nicotine since 1982. As vapes didn’t exist for another quarter century, their initial nicotine output was being directed to the pharmaceutical industry.
CNT is quick to point out the many advantages of synthetic nicotine. For the end user, it is the neutral flavor of synthetic nicotine that is a big selling point. For the environmentally conscious, the manufacturing of synthetic nicotine is a net gain.
In an interview with Tobacco Asia, CNT Managing Director Torsten Siemen said that, “Currently, CNT has a vast production capacity of over 500 metric tons of tobacco-derived nicotine per year, but since synthetic nicotine is made in an industrial setting using various chemical raw materials, there really is no cap as to how much we can potentially produce.”
Tobacco is cultivated using industrial farming methods and requires considerable energy and chemical inputs to remain viable. This means millions of acres, pesticides, machinery, logistics for transportation, and labor. And that is just growing the tobacco. Who is growing this tobacco? Big Tobacco and they directly profit from the nicotine sold to the vaping industry.
The bulk of CNT’s sales are still tobacco derived nicotine (TDN). Synthetic nicotine only represents 1 to 2 percent of global demand, but their research into synthetic nicotine started back in 2015.
The molecular formula for nicotine is C10 H14 N2. Whether you are growing heirloom tobacco on a compost heap or buy it from NGL or CNT, the active nicotine molecule remains unchanged. There are two variations of the nicotine molecule: S-isomer and an R-isomer. Nicotine is chiral molecule, meaning that it is not superimposable as a mirror image. The molecular formula may remain the same, but S-Isomer and R-Isomer have totally different biological effects. The R-isomer occurs in small amounts in whole leaf tobacco and is inert. S-Isomer is the molecule that impacts the nicotine user.
In a lab setting, it is easier and cheaper to manufacturer nicotine that is half R and half S isomer nicotine. But as the R-Isomer is inert, it takes twice the quantity of R and S-Isomer nicotine to match the potency of pure S-Isomer.
CNT’s Torsten Siemen takes a dim view of R-Isomer nicotine: “We think R-S nicotine, which contains a significant amount of R nicotine, can only be considered to be an intermediate, which requires further purification to the S form. For these reasons, CNT does not sell R-S nicotine…In the best case, the same quantity of R-S nicotine can be considered to be only 50 percent effective.”
R-isomer does not have noticeable physiological impact of S-isomer, but Next Generation Labs founding member Ron Tully feels R-isomer nicotine merits further exploration.
“Nicotine has been studied extensively in its naturally derived tobacco form, which includes the naturally occurring S and R isomers, which are metabolized in the consumption of current cigarette, vape and smokeless tobacco products. There is nothing to indicate that the R isomer is anything other than a positive attribute to the nicotine molecule.”
A July 2021 press release by Next Generation Labs announced that Australia had granted a patent for the use of TFN Combinational R- and S-Isomer synthetic nicotine in tobacco cessation products. In this release, NGL elaborated on their vision of a future that heavily features R-isomer nicotine.
“Next Generation Labs believes future combinational R- and S-isomer nicotine formulations may prove to be less addictive than natural or biosimilar standalone S-isomer nicotine and could potentially help achieve the broader public health goal of providing adult consumers with a satisfying, but non-addictive form of nicotine to replace current products. These new variable isomeric ratios of synthetic nicotine products may ultimately assist adults in quitting or reducing their overall dependence on current tobacco, vape and nicotine products.”
“We are at an early stage in the evolution of isomeric nicotine and its utility. NGL is trying to ensure that companies have the option based on their evaluation of the utility and safety of synthetic nicotine in their products.”
Food and Drug Administration
Whether it is nicotine pouches, vapes, or smokes, nicotine and tobacco products are under the purview of the FDA. The big question is if tobacco free nicotine will join products derived from the tobacco leaf or if the FDA even has the resources to handle such an expansion.
Tobacco free nicotine products at this time are one of the few ways that adult vapers can access the characterizing flavors that most prefer.
No reputable vape company is marketing synthetic nicotine as a health product or a replacement for cigarettes. Ideally, adults would abstain from all risk and anything resembling addiction would be a thing of the past. And certainly, youth engaged in behaviors such as smoking is something that society should hope to curtail.
Whether it is a nicotine Zyn pouch, smokeless tobacco, or a smoke related product, e-cigs are not to be considered an alternative. The inclusion of synthetics makes no difference in this regard. In the United States, oral nicotine therapy products and patches that contain synthetic nicotine are viewed as the only viable alternative to smoking- apart from total abstinence or if you quit cold turkey.
Smoking rates have declined significantly among youth under the age of 18. It was not long ago that a third of high school seniors consumed tobacco in the form of the combustible cigarette.
In the United States, e liquid flavors are rarely on the news unless they are under attack and being falsely blamed for tobacco product consumption by youth.
At times it seems every news report and article wheels out the same group of max-VG vape juices that minors simply were not using in any great numbers but happened to have fanciful sounding names like Unicorn Milk. With nicotine derived from tobacco, these products were formulated for use in loud and thirsty vape mods. Not surprisingly, minors flocked to discrete and silent devices that did not emit a ton of smell.
Addiction is no laughing matter, but that data shows that the most popular style of e-cig during the height of the teen vaping epidemic was the prefilled vape pod kit and the Juul Mint pod.
The whole question of if there was marketing to minors is not clear cut. Juul had brief Instagram campaign but otherwise steered clear of paid social media.
National Health Service UK
Nicotine products are treated quite differently in the UK. The National Health Service views smoking as a serious concern and hosts a website titled: Using E-Cigarettes to Stop Smoking. Most meaningful research on electronic nicotine delivery systems is conducted in the UK due to their focus on harm reduction strategies. Research like this would run afoul of the FDA, as they are always on the lookout for an illegal health claim.
The famous New England Journal of Medicine Study that found nicotine replacement therapy was easily outperformed by an old-fashioned cartomizer ecig took place in the UK.
Keep in mind the NHS does not encourage anyone, no matter their age, to consume products derived from tobacco but convincing them to quite combustible tobacco products is their top priority. The FDA has spurned this approach, even though former FDA Chief Scott Gottlieb has stated it would be a net gain if all the cigs that are sold in the US were replaced with vapes.
It would be a sign of major changes if the FDA were ever to host a website that contains information comparable to NHS. For now, they want you to quit using an oral gum or patch. Nicotine pouches and ecigs are treated the same as a pack of unfiltered squares.