Next Generation Labs (NGL), the makers of proprietary TFN Nicotine – non-tobacco derived synthetic nicotine liquid and crystals – says that it has noted court statements made by the US Food and Drug Administration (FDA) in the Nicopure vs. FDA lawsuit that confirms products not made or derived from tobacco are not regulated tobacco products under the recent deeming rule, according to a cstoredecisions.com story.
The story said that, in a response brief to the court dated November 1, the FDA had stated that not all nicotine-free e-liquids (NFLs) were 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,” the FDA was quoted as having said.
‘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,’ according to cstoredecisions. ‘However, the recent clarification from FDA attorneys appears to confirm that the deeming rule does not extend to e-liquids that are either nicotine-free, or not made or derived from tobacco, when marketed and sold appropriately.
‘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.’
“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,” said Vincent Schuman, CEO of NGL. “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.”
Whether or not the FDA will regulate synthetic nicotine as a drug is still a question.