Is Synthetic Nicotine a Tobacco Product?
A statement from a manufacturer of synthetic nicotine indicates that the FDA may not consider a nicotine free liquid as a tobacco product. From reading the court brief, the FDA’s attorneys use very vague language in the response.
Next Generation Labs, the makers of proprietary TFN Nicotine® – a non-tobacco derived synthetic nicotine liquid and crystals – is pleased to note statements made to the court by 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 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.”
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.