In a significant statement to the court, the FDA has confirmed that Next Generation Labs’ TFN Nicotine® is not subject to regulation under the Deeming Rule.
In a response brief to the Court dated November 1st 2016, the FDA stated that: “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.”
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.
Vincent Schuman, CEO of Next Generation Labs, comments: “The FDA’s statements to the Court seem to confirm our long-held position: TFN Nicotine® products cannot be regulated under the Deeming Rule as they simply are not tobacco products. In order to comply with the FDA, the onus is on e-liquid manufacturers to consider how their TFN Nicotine® product is marketed, distributed and positioned to adult consumers to ensure a complete disassociation from tobacco and tobacco devices.”
In addition to not being subject to regulation, Next Generation Labs’ synthetic nicotine, TFN Nicotine®, benefits from being devoid of off-tasting compounds and other trace chemical residuals that occur in tobacco-derived nicotine, which results in a better tasting e-juice flavor.
Next Generation Labs sells TFN Nicotine® directly to e-liquid manufacturers; to purchase TFN Nicotine® please contact Vincent Schuman directly at Vincent@nextgenerationlabs.com.
See the full story at: http://www.globenewswire.com/news-release/2016/12/15/898116/0/en/Statements-From-FDA-in-NICOPURE-vs-FDA-Lawsuit-Confirm-Next-Generation-Labs-TFN-NICOTINE-Is-Not-A-Tobacco-Product.html