In recent news, an article was released by Next Generation Labs on Globe Newswire sharing that the FDA has confirmed that tobacco free nicotine (TFN) is not considered a tobacco product.
Nearly seven months ago we released an article titled Tobacco Free Nicotine 101, where we shared doubt that TFN would become our saving grace, but this new statement seems to shine with a glimmer of hope. The FDA continued its statement saying “Assuming an NFL (nicotine free e-liquid) 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 human consumption of a tobacco product; and is not an accessory.”
As you can tell, the FDA’s attorneys response was very vague, in one hand confirming that tobacco free nicotine isn’t an actual tobacco product, yet on the other hand it’s saying if it’s used for human consumption with a tobacco product, then it falls under the deeming rule. What you must understand is that this is the way the FDA has responded to everything when it comes to the Nicopure versus FDA Lawsuit. In fact, we told you about this same vague language just four months ago in our FDA Responds To FDA Lawsuit With Mumbo Jumbo article.
However, Next Generation Labs says that “TFN Nicotine is not made or derived from tobacco, nor is it a component or part of any tobacco product; as such Next Generation Labs does not believe e-liquids made with TFN Nicotine are required to list their product as a tobacco product with the FDA, or prepare a Pre-Market Tobacco Application (PMTA) submission before launching a new vape liquid brand in the USA.”
Not only does the FDA have its hands full with the ongoing lawsuit, but it also has a battle with a tobacco free nicotine that can now potentially slide under the regulations it set in place. On top of that, the FDA has also felt the surge of vape product manufacturers registering and listing their products, which has caused the FDA to extend the Company Registration and Product Listing deadline to June 30th, 2017.