FDA finally clarifies about NFLs and Synthetic Nicotine?

Synthetic Nicotine manufacturers announce they get some answers from the US Food and Drug Administration, (FDA), and finally confirms that products that are not derived from tobacco will not be regulated as tobacco products under the current deeming rule. Will synthetic nicotine follow the rule?

Diane Caruana

December 19, 2016

According to an article published yesterday on Convenience Store Decisions news site, during the NICOPURE vs. FDA lawsuit, Next Generation Labs, the manufacturers of TFN Nicotine, a non-tobacco derived synthetic nicotine liquid, noted that in a response brief to the court on the 1st of November, the agency “confirmed” that e-liquids that are either nicotine-free, or not derived from tobacco, will not be considered as tobacco products.

The FDA confirmed that e-liquids that are either nicotine-free, or not derived from tobacco, will not be considered as tobacco products.

“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 and NFLs not considered as tobacco products?

This could have been good news to the vaping industry as this matter had up to then been considered a grey area, as when experts had attempted to obtain answers from the agency, the response received was vague and remains vague. TFN Nicotine is promoted by its manufacturers as not extracted from tobacco, nor is any part of it, hence its manufacturers have always argued that it should not be regulated as such.

In an interview on Vape radio back in June, Ron Tully, a founder member of Next Generation Labs, had explained what TFN (synthetically derived nicotine) is, and why it is a great alternative to conventional nicotine. Next Generation Labs has also trademarked their synthetic nicotine as a pharmaceutical product as Big Pharma are interested in nicotine, but also in its analogues for the treatment of brain disorders like Parkinson’s, Alzheimer’s, Attention-Deficit Hyperactivity Disorder (ADHD) and Epilepsy.

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.Vincent Schuman, CEO of Next Generation Labs

The CEO of Next Generation Labs, Vincent Schuman, said, “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.”

But unfortunately, this is the interpretation Next Generation Labs makes of the brief and not a ruling the FDA made on this marginal case. E-liquids containing Tobacco-Free Nicotine (TFN) are not nicotine-Free e-liquids (NFL), even if nicotine comes from other sources than tobacco crops. An announcement effect from Next Generation Labs?

What about nicotine e-liquid regulation in the EU?

In Europe where the EU TPD also regulated e-cigarettes and e-liquids as tobacco products, the ambiguity around nicotine and its origin does not stand because a juice that contains nicotine is regulated must follow the rule, wherever nicotine comes from.