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 Synthetic 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 Synthetic 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.
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