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TFN E Liquid Is Not A Tobacco Product According to FDA

 

This. Is. Huge. It's president-elect Donald Trump "Yuuuge." Yesterday (December 15) the Food and Drug Administration, in comments related to a lawsuit brought by Nicopure, makers of the Halo e-liquid line, had the following to say:

 

Not all nicotine-free e-liquids (NFLs) are subject to the deeming rule. Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a ‘component or part’ —that is, if it is ‘intended or reasonably expected’ either…(1) To alter or affect [a] tobacco product’s performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product; and is not an accessory.

 

What does this mean? First, e-liquids containing synthetic (non-plant-derived) nicotine may not have to apply for FDA approval, meaning e-liquid manufacturers now have an "out" that would allow them to bring new products to market without spending hundreds of thousands or even millions of dollars performing scientific research in order to obtain the FDA's blessing.

 

It also means that zero-nicotine juices, since they're clearly "not made or derived from tobacco," could also escape FDA's burdensome oversight.

 

Next, we turn to vape hardware. The FDA has said that mods, tanks, RDAs, and to take their broad conclusions to the farthest-reaching extremes, even batteries, wicks, and wire for coil building could be considered "tobacco products." But if it could be reasonably argued that said devices are intended for use only with tobacco-free e-liquid, one could make the case they're also not subject to FDA interference. Not to draw a parallel to cannabis, which is still a regulated substance, but devices for smoking the federally-banned substance have for years remained on the market under the guise that they're intended only for tobacco use. Using the same line of thought, why couldn't any mod or other piece of hardware be designed only for tobacco-free liquid use?

 

There is a catch, however, and that lies in the marketing of a product. If, for example, a tobacco-free product is sold along with a vial of tobacco-containing nicotine, or advertised as "enhancing your nicotine buzz!" (the FDA's words, we know e-liquids have never been marketed in such a way), it could still be subject to the deeming regulations.

 

We have yet to see how this will all shake out, but there's a good chance it's a major turning point for the industry. Unless and until other laboratories are able to bring suitable replacements for plant-based nicotine to market (or perhaps present an argument that nicotine derived solely from tomatoes, broccoli, eggplant, or one of a host of other nicotine-producing plants also cannot be considered tobacco) this is a huge boon for Next Generation's Tobacco-Free Nicotine and HiLiq's Non-Tobacco Nicotine (the first two lab-synthesized products to market), as using their product at any price is likely to be cheaper than complying with the FDA's overbearing mandate.

 

Even if this development ends up raising the price of e-juice going forward a bit (Next Generation has yet to release their product to the general public, and HiLiq's costs about four times as much as other top-quality producers), we're still excited at the prospect of manufacturers, who otherwise risked shutting down, having an opportunity to stay in business, protecting jobs and continuing to amaze us with new flavor development. We can only hope Next Generation is ready to ramp up production of Nicopure in a yuuuge way, as demand is about to go through the roof. The FDA's complete statement is available here.

acuity