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Well-funded attacks on the flavored e-liquids that adult vapers have progressed to the point where it may seem that combustible cigarettes or tobacco flavored e-cigarettes manufactured by Big Tobacco companies will be the only remaining options. This virtual prohibition is naturally a serious concern for anyone who has or will consider making the switch to vaping.
During these tumultuous times where the very future of adult access to combustible cigarette alternatives remains in doubt, there have been advances that make it possible to manufacturer nicotine without using the tobacco plant at all. Regulatory questions still abound but the availability of tobacco free nicotine will continue to increase. Manufacturing of such products is now efficient enough where synthetic nicotine would be hitting the market no matter what is happening in Washington.
With tobacco free nicotine and synthetic nicotine hitting the market in ever greater numbers, a vaper may naturally wonder what is tobacco free nicotine? The short answer is it is nicotine manufactured without the use of the tobacco materials.
Our previous feature, What is Synthetic Nicotine?, investigated the science and advantages of nicotine that is manufactured without using any plant material at all. Today we are going to look at tobacco free nicotine and two of the major players in this industry. They both manufacturer nicotine without the use of tobacco plants but have rather disparate views when it comes to S and R-isomer nicotine.
Nicotine made without using the tobacco leaf is generically referred to as tobacco free nicotine. There is also a brand manufactured by Next Generation Labs (NGL) sold under the TFN® Nicotine trademark. They manufacture R tobacco derived nicotine (TDN), R-S tobacco free nicotine (TFN) and S-isomer synthetic nicotine. If this isomer business looks seems confusing, we discuss the difference in detail.
TFN has doubled their production during 2021 as demand from the United States and South Korea have spiked.
While Tobacco Free Nicotine and TFN are Next Generation Lab’s trademarked terms of art, for the vaping layman tobacco free nicotine is most commonly used to describe nicotine derived from plants other than tobacco that contain both R and S isomer nicotine. That the largest seller of this style of nicotine is TFN can make things a bit confusing. The situation is akin to every copier machines being referred to as a “Xerox” due to Next Generation Labs prominent market position.
As the name suggests, Next Generation Labs uses no part of the tobacco plant when manufacturing their nicotine. Instead, Next Generation Labs relies on a patented process, based on natural starter materials, to create a pure synthetic nicotine. Naturally, they are protective of their intellectual property and proprietary processes and materials. It is here that it should be noted that whether it is derived from organic Burley tobacco, broadleaf tobacco or the scientists at NGL, the actual nicotine molecule is always the same.
It also must be pointed out that Next Generation Lab’s TFN products are not some last second effort to evade the FDA or the PMTA process. They have had products on the market since 2014. This predates Juul’s arrival on the market and the vaping landscape looked awfully back then.
As founding member of Next Generation Labs Ron Tully explained during an interview with the Tobacco Reporter, “What we can say is that over the past five years, NGL has created this market for nicotine that did not exist prior to our innovation and commercialization of TFN. As we have become more established and our TFN nicotine has gained acceptance with manufacturers, the trade and consumers, we have scaled accordingly. The current market demand for synthetic nicotine has increased annually and continues to grow year on year.”
Contraf-Nicotex-Tobacco or CNT is a long-standing manufacturer of nicotine. Operating out of Heilbron in Germany, they have been the leading provider of tobacco derived nicotine since 1982. Initially, they supplied the pharmaceutical industry with purified nicotine but transitioned to supply the growing vaping industry as that market boomed.
Their research into synthetic nicotine started back in 2015 and their pure S-Isomer synthetic was made commercially available in 2018. Also interviewed by the Tobacco Reporter, their synthetic and tobacco free nicotine products avoid the use R-isomer nicotine, which is found in several of TFN’s nicotine products.
CNT is quick to point out the many advantages of synthetic nicotine. Keep in mind they have skin in the game, manufacturing exclusively products that contain no R-isomer nicotine.
CNT considers R-isomer to be an impurity, and their synthetic nicotine contains only S-Isomer nicotine. The extensive processing necessary to extract nicotine from plant material is not required and synthetic nicotine has a neutral flavor. The biggest advantage is in terms of production. Tobacco derived nicotine requires an extensive agricultural infrastructure and all the pesticides and energy input that industrial scale farming entails.
Any tobacco being processed into e-liquids must be purchased from somewhere, usually Big Tobacco. Tobacco acreage is limited but the manufacturing capacity for synthetic nicotine can be expanded, and scaling up would potentially bring down the price.
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.”
Synthetic nicotine currently makes up only a small percentage of CNT’s total sales, estimated at 1-2% globally, but the number could potentially increase dramatically depending on how regulators choose to approach its use. Ninety five percent of their synthetic nicotine orders are coming from the United States.
While synthetic and natural are buzzwords that really resonate with the modern consumer, R-isomer and S-isomer are not words that roll easily off the tongue. The nicotine molecule, C10 H14 N2, is the same whether it is manufactured in a lab or processed from tobacco leaves.
But the nicotine molecule occurs in two forms. There is an S-isomer and an R-isomer. The S-isomer is the variant that has a physiological effect on the user. The R-isomer occurs in small amounts and is inert. According to Science Daily, it is the process of smoking tobacco in combustible cigarettes that increases R-isomer to detectable levels through racemization.
In terms of manufacturing, it is easier to produce tobacco free nicotine that contains both the R and S isomer. But because the R isomer is inert, twice the amount of nicotine would need to be added to have the potency as a pure S-isomer variant. If you are looking for an analogy, the R-isomer waters down the S-isomer which is the molecule that actually impacts the user. In CNT labs view, it is a negative to include R-isomer in their synthetic formulations.
Despite these objections from a rival manufacturer, Next Generation Labs has a patent on their R-S Isomer Tobacco Free Nicotine and a pure S-isomer synthetic nicotine. At CNT, the focus is on synthetic with no R-isomer or a purified tobacco derived nicotine that makes up the bulk of their sales.
The subject of S-isomer and R-isomer nicotine is an area where Next Generation Labs and CNT leadership differ. Torsten Siemen states, “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.”
By Siemen’s reckoning, “In the best case, the same quantity of R-S nicotine can be considered to be only 50 percent effective, but we also foresee mislabeling concerns by describing R-S nicotine as equivalent to nicotine USP/EUP. Eur. For these reasons, CNT does not sell R-S nicotine.”
He concluded with thoughts on potential regulatory headaches created by R-isomer, “If you look at the European and the U.S. Pharmacopeias, the percentage of S isomers in nicotine must be higher than 99 percent,” Siemann explains. “The nicotine used in the pharmaceutical industry needs to have a specific optical rotation that only S nicotine can achieve.”
It will be up to the consumers and scientists to determine if these are just swipes at a rival company or if the future of synthetic nicotine will be entirely S-isomer.
Next Generation Labs founder Ron Tully takes a rather brighter view of R-isomer. While it does not have physiological impact of S-isomer, he feels full role of R-isomer nicotine should be further explored.
He says that NGL Labs with continue to market and sell R, R-S and synthetic S-isomer nicotine. “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”.
The current body of scientific research has been largely conducted tobacco derived nicotine which contains naturally occurring r-isomer molecules, “There is nothing to indicate that the R isomer is anything other than a positive attribute to the nicotine molecule.”
“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.”
In a recent press release announcing that Australia had granted a patent for the use of TFN Combinational R- and S-Isomer synthetic nicotine in tobacco cessation products, 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 that deliver only the purported highly addictive ‘S’ form of nicotine.”
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