Synthetic Nicotine – What is it, Who Makes it, & Why

 

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Synthetic nicotine is now upon us! Well, it’s been here for quite some time now; it’s not relatively new. But now more than ever will we start to see a major push from e-liquid companies and vaping manufacturers alike using this non-tobacco derived compound. This article will detail what synthetic nicotine is, why someone would use it, and the potential downsides of its presence. So, let’s get into it!

What is Synthetic Nicotine?

The idea of synthetic nicotine is quite simple. It’s a compound made in a lab to emulate the same chemical structure of nicotine, without it being derived from the tobacco plant. There is no difference between synthetic nicotine (SN) & tobacco-derived nicotine (TDN) in terms of effects. Because it is created to model the nicotine chemical structure, it works on the body the same way. The difference is really in just how the product is made.

So how is it made? Well, TDN is of course derived from the tobacco plant, a member of the nightshade plant family. Nicotine developers use a specific genetically modified tobacco plant that yields high amounts of nicotine, and through the use of curing and chemical solvents, extract the available nicotine from the plant which is then suspended in a base such as PG or VG. The upside to this is that tobacco is quite abundant and the process is quite cheap. The downsides to this process is it is much more involved (you need farms, processing facilities, etc), it may contain trace amounts of impurities, and you rely on the tobacco plant for the nicotine alkaloid which is a plant under fire in the US and around the globe.

Synthetic nicotine on the other hand does not rely on the tobacco The companies who produce SN keep their processes and raw materials close to the chest, for monetary reasons of course. But again, the important distinction is the product is without tobacco which yields nicotine without any of the impurities found in the more “naturally” derived process.

Next Gen vs CNT

Currently, it seems two companies dominate the SN segment. First is Next Generation Labs headed by Ron Tully. Next Gen is the owner of “TFN” or Tobacco-Free-Nicotine, a patented synthetic nicotine which is based upon the S + R isomer combination. They also offer the more advanced S isomer based nicotine, though it is not under their patent. This allowed another nicotine giant, Contraf-Nicotex-Tobacco or CNT, to come into the space. CNT focuses on producing solely the S-isomer synthetic nicotine.

You might be asking what the difference is. Well a great blog post from Five Pawns – which is currently developing products using CNT’s synthetic offering – explains the difference between R+S & S-isomer nicotine, as well as why S-isomer nicotine is the superior option.

“R+S Isomer Nicotine products would require the consumer to consume twice as much of a product when compared to S only products. So if you typically vape a 6mg of tobacco-derived nicotine then you can still vape a 6mg S Isomer tobacco-free nicotine and get the same exact effects, but on the other hand, if you use R+S nicotine you will need to buy products twice as potent, like a 12mg, as only half the molecule is active.”

Essentially, R+S-isomer nicotine is a less synthesized version, which would then need to be further synthesized into S-isomer nicotine to produce the same physiological effects of TDN, due to only half of the molecule being active. This is further confirmed by an article in the TobaccoReporter where Managing Director of CNT, Torsten Siemann, 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…There is not enough scientific evidence about the effects of the R form, but it is common knowledge in the pharmaceutical industry that enantiomers often exhibit profound differences in pharmacology and toxicology, some of which could be potentially harmful. 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.”

Tully of Next Gen seems to hold the position that nicotine in the R+S form has a place in the marketplace where they state in the same article “Manufacturers have access to nicotine in its chiral R and S forms that may offer distinct benefits to consumers in potential take up pathways for nicotine satiation” due to offering subjectively satisfying nicotine effects at lower levels. This may seem, though, to be a position held thanks to their holding of the R+S patent.

That said, the science is pretty clear on which is the “superior” version of nicotine. S-isomer SN seems to provide not only a more satisfying experience, but a cleaner one as well, free of any taste or aroma, while still allowing the same amount compared to TDN to be effective. Ultimate, choosing between R + S and S-isomer SN comes down to cost.

The Real Cost of TFN

One of the reasons we haven’t seen SN sweep the vaping world, is cost. The raw materials, the R&D, and the production costs of SN are higher than the more natural process. In comparison, the cost for 1 liter of 100mg TDN, enough to create nearly 18,000ml of 6mg e-liquid, is only around $100 (price to consumers). The same amount for Next-Gen’s TFN at 100mg is $259.99 according to prices from River Supply Co.

That is a price difference of $0.10/ml for 1L of 100mg TDN vs $0.26/ml for 1L of 100mg TFN. Now, if we take the information from the Five Pawns article, you would need twice as much to achieve the same effects of TDN which would then slash your available stock by half moving up to almost $0.50/ml.

Let’s now take a look at how this affects the overall composition of an e-liquid. I’m going to use the calculations of this article I created a few years back. A product containing 4 flavorings, 70VG, 30PG, and using 1L of 100mg nicotine, we can expect the production to cost $0.94 for a 30ml 3mg e-liquid for the raw materials. Using TFN, that would slightly bump up the price to only $1.08. And in order to achieve the same effects as our 3mg TDN, we would increase the nicotine level to 6mg which then adds up to $1.33. A 35% increase in price.

As you can see, the price is noteworthy. In terms of startup investments, it’s around 4x the cost – with an added 35% to each product. That said, these aren’t unbearable metrics. These prices are certainly within the scope of the market. Though, how much more of a markup these companies will add to their SN products is not quite realized yet.

According to prices on VapeJuiceDepot.com, a 60ml bottle of NKTR Shake Strawberry which utilizes Next Gen’s TFN retails for $24.99. where some products with TDN retail for $18.99 for 100ml’s. But these products are quite rare, so I’ll do my best to keep an eye on the market to ensure you’re not getting ripped off.

Regulatory Voids

Now that we understand what Synthetic Nicotine is & the cost of it, the next question is “why would you use it?”. Well it seems to me, the current regulatory landscape in the US is forcing companies to look at these alternatives. Any company claiming to use SN over TDN due to “unparalleled taste” or “purity” is really just marketing for “we’re taking a risk using SN because we hope it doesn’t force us into submitting PMTA’s”.

You see, the Tobacco Control Act defines a tobacco product as “any product made or derived from tobacco and intended for human consumption, including any component, part, or accessory of a tobacco product”. Synthetic nicotine challenges this entire definition, because it is not made or derived from tobacco. Therefore, any e-liquids that are made with SN would not meet the definition of a finished tobacco product. Furthermore, any component or accessory made to be used with tobacco-free SN e-liquids, would not fall under this TCA definition nor the definition under the Federal Food, Drug and Cosmetic Act. Next Gen, CNT, and the companies using them, are placing big bets on this loophole.

Now, that’s not to say there will be no regulation facing these products. In fact, in this article in the TobaccoReporter, Tully expects regulation to come once the market has reached “critical size”. That said, moving vapor products away from the prison that is the TCA would be a huge win for harm-reduction advocates.

Not too mention, FDA is already aware of Synthetic Nicotine. According to this FAQ posted on the FDA.gov website

The product I manufacture contains no substance made or derived from tobacco, e.g. is zero-nicotine, or has synthetic nicotine or nicotine made from tomatoes. Is my product subject to FDA regulation?

The definition of “tobacco product” includes any product made or derived from tobacco, including any component, part, or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to FDA’s tobacco control authorities. However, it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product, if it is not intended or reasonably be expected to be used in such a fashion. FDA intends to make these determinations on a case-by-case basis, based on a totality of the circumstances.

This points to closed-system vapor products that only contain SN and that cannot be altered to be used with TDN, may be safe from the stranglehold of the FDA. But this also begs the question, what if products claim “not to be used with Tobacco Derived Nicotine”? These types of questions are exacerbated by the “enforcement discretion” the FDA is already taking on the vapor market. Will the FDA go after a small business utilizing Synthetic Nicotine, with products claiming “not for use with TDN”, that also contain adult marketing and labelling? That will remain to be seen.

The Future of Synthetic Nicotine

Currently, the entire US vapor market is sitting on the brink of collapse. With the PMTA deadline here and many companies submitting PMTA’s, it seems many are going down the path the FDA has set forth for them. It’s unclear if that path is viable at the moment, as not one vapor company has acquired market approval. But we do know it’s not a viable path for many of the small businesses in the industry currently. The process is too expensive for them and in today’s economic climate with Covid-19 pressing on their necks, it’s a non-starter.

On the other side, you have many companies who don’t feel the FDA will ever give market approval to a vapor product containing any flavor outside tobacco. They feel the PMTA process is not just expensive, but a waste of resources. Why would you throw away hundreds of thousands of dollars on a corrupt process from a corrupt organization that has no regard whatsoever for tobacco harm reduction? It’s a worthy question.

For them, they may find betting on the promises of Synthetic Nicotine a much more viable path to take. I, for one, tend to agree with them based on the evidence and arguments provided so far. Much of the success vaping has seen, is laid on the foundation of the thousands of flavors available and ability for smokers to tailor their products specifically for them. Once you take that away, you sterilize the tech. Doing what is necessary to allow consumers to purchased flavored vapor products, in my opinion, is vital for continued success. And the companies using SN may be that vanguard. It will be interesting to see how the industry, and the regulatory snakes, react to the onset of these new challenging compounds. Where there is a will, there is a way…to vape it.

Make sure to stay tuned to DIYORDIEVAPING.COM to stay updated on all of this. I’ll be sure to keep you informed of how this fight continues. And feel free to head to the shop to pick up a DIYorDIE Membership, which allows me to do this work, and gives you complete access to all the exclusive articles on DIY e-liquid mixing. Lastly, feel free to share this article with your friends and family who may be interested in this topic. Till next time!

 

 

 

 

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