FDA makes a statement on Synthetic Nicotine

FDA makes a statement on Synthetic Nicotine

 I’m sure you’ve heard a lot about the FDA and the vape industry this year. Earlier this year, the FDA’s Deeming Rule was designed to extend the agency’s regulatory authority over a variety of tobacco products, which greatly impacts the vape industry. The FDA assumes it has authority over vapor products because of the Family Smoking Prevention and Tobacco Control Act passed by Congress in 2009, but the FDA has used this new authority to interpret the act to also include vapor products based on the fact they use nicotine primarily derived from Tobacco. That presents an obvious legal question that is being brought to court through the Nicopure vs FDA lawsuit working its way through a court in Washington D.C..  Does the FDA have authority to regulate a product based on this interpretation? That is just one of the many arguments being made by Nicopure, but this is one worth discussing. (We will continue to discuss these regulations as things change)

Recently, the FDA made a statement on this issue, and more specifically about the use of Synthetic Nicotine. According to a press release “During NICOPURE vs. FDA lawsuit the agency confirms products not made from tobacco are not regulated tobacco products under recent deeming rule”. Simple enough right? Well not quiet, because the FDA also says “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.”

(Read the full article here:

This is where things become ironic and just plain awesome. So theoretically based on this, all mods and tanks will be considered a “Tobacco product” and will carry a warning on it, whereas any E-liquid that uses nicotine derived from a potato or made in a lab, will not! Can you imagine the confusion this will cause consumers? I read this stuff all day and I can’t make sense of it.

Up until recently, synthetic nicotine meant for human consumption was hard to come by and extremely expensive. There was no reason for it. Nicotine could be sourced from Tobacco cheaply. But with the FDA playing games with definitions, there’s a new market. Enter Next Generation Labs, the makers of proprietary TFN Nicotine – a non-tobacco derived synthetic nicotine liquid and crystals. As it stands now, any juice that uses their nicotine will not be subject to the FDA’s rules surrounding the vapor industry.  I think this is where most of us say “Hahaha FDA, gotcha!”

But before we celebrate, I think this will change. First, Nicotine is not tobacco and tobacco is not nicotine. Congress gave the FDA authority to regulate TOBACCO, they did not say nicotine. The advent of the E-cig has forced all of us to address this new question. Historically these terms have been used interchangeably, as tobacco was the primary source to get nicotine. There were no reasons to pass regulations specific to nicotine, as the regulations controlling tobacco sufficed. E-cigs really fucked things up for the poor FDA now didn’t they. I’ll save my sympathy until later.

Mitch Zellar, the FDA director in charge of the new rules has recently said “We need a national debate on Nicotine” and man was he right.  Classifying vapor products as tobacco products because nicotine came from tobacco, was nothing but a challenge to an industry that loves innovation and technology. This classification of a tobacco product has been met with serious opposition, and rightfully so. One thing is clear though, the FDA doesn't just take "no" for an answer, this simple solution most likely won't be as simple as it would seem. We will have to wait and see the results of the Nicopure lawsuit before we know for sure.  

“Necessity is the mother of invention” -Plato A need or problem encourages creative efforts to meet the need or solve the problem.

Leave a comment

Please note, comments must be approved before they are published