The FDA’s disastrous deeming regulations for e-cigarettes are all based around the legal definition of “tobacco product”:
“Any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.”This means that e-juice is a “tobacco product” because the nicotine used is “made or derived from tobacco.” Devices and other vaping products are classed as components, parts or accessories.This all suggests one interesting approach for companies hoping to avoid the expensive and challenging business of attempting to get their liquids FDA-approved: what if the nicotine in your e-juice isn’t made or derived from tobacco?
- Could synthetic nicotine find its way onto the market through a loophole?
- Are there any benefits to using it anyway?
- And what does synthetic nicotine even mean?
What is Synthetic Nicotine?Nicotine has the chemical formula C10 H14 N2. This means that it’s a compound composed of ten carbon atoms, 14 hydrogen atoms and two nitrogen atoms, roughly arranged into two linked rings.
Regardless of how these atoms came to be in this structure, the result is nicotine.
If you had one nicotine molecule extracted from a tobacco plant and another where the constituent parts had come from elsewhere but then were combined to form the same structure, there would be no way to tell the difference between them. They would be fundamentally identical.
The distinction between natural and synthetic nicotine therefore doesn’t really mean too much. Regardless of where nicotine comes from, it has the same chemical structure and is indistinguishable from nicotine created any other way.
That said, “natural” nicotine is that which is obtained directly from a tobacco plant. Other plants in the same family – including tomato, potato and aubergine – also contain naturally-occurring nicotine, but in much lower quantities.Synthetic nicotine is the term used when that exact same chemical has been produced from other sources. This can be done in a variety of ways, for instance, using niacin, ethanol, sulphuric acid and some other chemicals, or by starting with a nicotinate ester and producing nicotine after several intermediate steps. It doesn’t really matter how it’s done; the key point is that it’s the exact same chemical, just produced in a different way using a different source and some clever chemistry.
The Chirality of Nicotine – Another Challenge for Synthetic Nicotine Production"Although the above discussion gives a basic definition of synthetic nicotine, there is one additional issue that should be mentioned.
Nicotine is a “chiral” molecule, which basically means it exists in two forms that can’t be superimposed on each other.
It’s often described as “handedness” for chemicals: in the same way that your right hand is a mirror image of your left, (S)-nicotine is a mirror image of (R)-nicotine.
Despite the fact that your left hand has all of the same components as your right, the arrangement of the fingers and thumb means you can’t possibly rotate, flip or otherwise reorient your right hand to make it indistinguishable from your left.
The same is true for (S) and (R)-nicotine.
The problem for makers of synthetic nicotine is that (S)-nicotine is the type created by tobacco and the type that has the desired effect on users. This means it’s really the only type vapers would want.In practice, though, a mixture of both versions of the chemicals is the easiest to make, and from then it would have to be further purified to produce a usable sample of (S)-nicotine. If this last step wasn’t completed and a mixture of both types was used, the finished e-liquid would only have half the strength advertised.
Is Anybody Making Synthetic Nicotine?Despite the challenges in producing synthetic nicotine, there are companies in the business of making it.
The most well-known is Next Generation Labs, who make “tobacco free nicotine” with a specific focus on the vaping industry. Their process is described in one published patent, with others pending about which fewer details are known. The result is a non-tobacco-derived nicotine solution that is over 99.5 % pure, exceeding the requirements for pharmaceutical-grade nicotine.Their nicotine is currently used by several e-juice brands, including NKTR, Cypher, Origins, Defiant and Klir. It’s only used by a very small number of brands when you consider how many different mixers there are on the market, but things could change in the future.
How Much Does Synthetic Nicotine Cost?The most obvious problem with synthetic nicotine is that it isn’t as easy to obtain as natural nicotine. For the usual approach to making nicotine, tobacco plants are loaded with substantial quantities of (S)-nicotine and it can be extracted fairly easily.
For synthetic nicotine, you have to obtain the raw materials then go through a multi-step process to turn them into the finished product. This is more labour-intensive, more time consuming and more expensive.
Previously, the costs of doing this put synthetic nicotine out of the realms of possibility.
Next Generation Labs’ process for making synthetic nicotine has been refined over several years to allow for large-scale production of synthetic nicotine and to keep the price as low as possible.It’s still much more expensive than natural nicotine – about 13 times more expensive – but it’s finally reaching the point where it could be a viable option for a company.
The Benefits of Synthetic Nicotine E-JuiceAside from the potential benefits related to regulation – which we’ll come to soon – with the added expense, the immediate question is: why would companies bother using synthetic nicotine?
The main advantages stated by companies like Next Generation Labs both come down to the purer source of the nicotine.
When you extract nicotine from tobacco, you always take some tobacco-derived impurities into the mix too. These can be kept to very low levels, but will still be present. These impurities (in much larger quantities) can be dangerous, and also reportedly have a small effect on the flavour of the finished e-juice.When nicotine is produced synthetically, there are no tobacco-derived impurities ruining the mix. This means a cleaner flavour, with the nicotine being effectively odourless and tasteless. Without the plant-like taste from the impurities creeping into the flavour, there isn’t as much need to use tons of flavourings to produce a palatable e-juice. Additionally, with no impurities, any potential risk posed by miniscule amounts of things like tobacco-specific nitrosamines is completely avoided.
Is Synthetic Nicotine E-Juice Covered by the FDA Regulations?This is the million-pound question. The logic behind it seems hard to fault: if the FDA’s authority is based on the “made or derived from tobacco” element of the definition of “tobacco product,” but tobacco is never involved, then the product shouldn’t be covered. Even more than this, if you released a tank and claimed it was specifically for use with non-tobacco-derived nicotine, could the tank really be called a tobacco product?
In a world where regulators robotically followed the letter of the law without taking any further action or clarifying things, this theory could play out as intended. This is the hope of Next Generation Labs’ Ron Tully, but things probably won’t be so easy.
As Tully himself mentioned in an interview with Wired:
It’s almost a pointless exercise talking to FDA because they never give you clarity. When I asked the FDA the same question about synthetic nicotine’s status as a tobacco product, the agency replied, ‘These products will be evaluated on a case-by-case basis.’This is very similar to the FDA’s response when questioned about the status of nicotine-free e-liquids.
Since nicotine is the only tobacco-derived ingredient, then nicotine-free juices would seem that they shouldn’t qualify as a tobacco product. However, the FDA’s response to this question was overly long, convoluted and confusing, and ended by saying they’ll be evaluated on a case-by-case basis. Most readings of the response would suggest that no-nicotine e-liquids aren’t covered, but there is definitely some uncertainty.
The situation for synthetic nicotine containing products is much less hopeful. You can make a strong argument that with no nicotine at all, calling nicotine-free e-juice a tobacco product would be taking the definition too far.
But for synthetic nicotine the only defence is a technicality. You’d have to argue that one e-liquid is a tobacco product but another – which is identical apart from the source of the nicotine – is not a tobacco product. Chemical analyses may reveal small differences in the levels of tobacco-derived impurities, but for all intents and purposes, they’d be identical.
If the FDA is planning on evaluating these products on a “case by case basis,” will they really be won over by this argument? It’s basically a loophole, and nothing in the FDA’s approach to vaping thus far would suggest they’re going to be happy to let this fly. They’ll stretch the definition as far as it can go, and if that doesn’t work, they’ll undoubtedly take further action.
Even if the FDA couldn’t take action as things stand now, the definition could easily be altered or expanded to ensure that all forms of nicotine were covered. You might object and say that since aubergines or tomatoes also contain nicotine, any expansion of the definition would quickly descend into farce. Potatoes contain nicotine, so chips would become “tobacco products” and the forks you use to eat them become “components, parts or accessories” and therefore also tobacco products.
This seems incredibly silly, but it’s hard to imagine that regulators would really care.
If the FDA can claim, with a straight face, that “programmable software” is a tobacco product, would it really be all that more ridiculous for them to just define tobacco product as “anything containing nicotine that isn’t a fruit, vegetable or pharmaceutical medicine”?If you were trying to have a rational discussion about what should be considered “tobacco” in an everyday sense, then this would be completely idiotic. But that’s not what’s happening: this is about legislation, and agreement with common sense is much less important than coming up with a definition that permits regulation and closes loopholes.
Could Synthetic Nicotine Save Vaping?After the last section, it shouldn’t come as a surprise that synthetic nicotine is unlikely to save vaping. Even if synthetic nicotine could be produced cheaply enough to be a commercially-viable alternative to tobacco-derived nicotine, it wouldn’t take much tweaking for the FDA to gain control over it too.
However, that doesn’t mean it’s completely useless as an approach. It might not seem likely that the FDA will roll over and accept synthetic nicotine e-juices as non tobacco products, but it could easily present a legal roadblock that would slow the process down.
Many of the lawsuits against the FDA with regards to the currently-proposed regulations take issue with how the definition of “tobacco product” has been expanded to cover “components or parts” that have basically nothing whatsoever to do with tobacco. Covering non-tobacco-derived nicotine would be an even bigger stretch. While they’d probably be successful, it might take them a while to win the legal battles or change definitions accordingly.However, this would only really delay the inevitable. In time, the FDA’s authority would be extended to cover synthetic nicotine and vapers would be back to square one. As a reddit poster commented in a thread boldly entitled “the synthetic nicotine fantasy”:
If regulation of nicotine is a concern for you, your most realistic course of action is through supporting advocacy and making your voice heard. Expecting synthetic nicotine to ever be a realistic solution instead of protesting the regulation of natural nicotine is a dangerous fantasy and distraction.
Synthetic Nicotine: The Fantasy vs. RealityThe upshot is that synthetic nicotine is a nice idea but one that can’t save vaping from unnecessarily burdensome regulation.
If you want nicotine completely free from tobacco-derived impurities and with a cleaner taste profile – and if you don’t mind spending a little more – then synthetic nicotine is something you might want to consider.
However, if like most vapers your interest in synthetic nicotine depends largely on its ability to produce e-juice that can evade regulations, you’re destined to end up very disappointed.
Would you use synthetic nicotine? Why or why not? Let us know in the comments!