FDA Makes Statements on Synthetic Nicotine
During NICOPURE vs. FDA lawsuit the agency confirms products not made from tobacco are not regulated tobacco products under recent deeming rule.
Next Generation Labs, the makers of proprietary TFN Nicotine – a non-tobacco derived Synthetic Nicotine liquid and crystals – has noted statements made to the court by the U.S. 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.
In a response brief to the Court dated Nov. 1 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.”
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. 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.
Vincent Schuman, CEO of Next Generation Labs, commented: “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 this recent statement, the FDA has also extended the deadline for the registration and product listing requirements of the Deeming Rule, stating: “U.S. manufacturers of newly-regulated tobacco products who first manufactured those products prior to Aug. 8, 2016, the FDA does not intend to enforce the submission deadline for establishment registration and product listing as long as submissions are received by the FDA on or before June 30, 2017. However, companies which begin manufacturing newly regulated tobacco products in a domestic establishment on or after the Aug. 8 effective date of the deeming rule must register and list immediately with the FDA.”
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