FDA Finally Addresses Synthetic Nicotine; Confirming Next Generation Labs’ Position that Synthetic Nicotine Is Not A Tobacco Product

SAN DIEGO, Jan. 20, 2017 -- Next Generation Labs, the makers of proprietary TFN Nicotine® – a non-tobacco derived synthetic nicotine – is pleased to report an update from the FDA that finally addresses the question of synthetic nicotine, confirming that e-liquids made with synthetic nicotine will not be regulated.

Vincent Schuman, CEO of Next Generation Labs, comments: “The FDA is slowly revealing its stance on regulating synthetic nicotine and while this latest update is a welcome one, we fully anticipate further clarification from the FDA as the August PMTA deadline approaches. All indications from the FDA confirm our long-held position: TFN Nicotine products cannot be regulated under the Deeming Rule as they are not tobacco products, and we continue to believe that an open or closed system device for use with a choice of synthetic nicotine products will qualify as a non-tobacco product.”

In an update to its online Q&A, the FDA stated: “It’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product, if it is not intended or reasonably be expected to be used in such a fashion.” The statement reaffirms the FDA’s position that a ‘tobacco product’ is defined as “any product made or derived from tobacco, including any component, part, or accessory of a tobacco product.”

Following announcement of the Deeming Rule in 2016 – which was designed to extend the agency’s regulatory authority over a variety of tobacco products – the industry has desperately sought answers on what this means for no-nicotine and synthetic nicotine products. Despite avoiding the topic of synthetic nicotine by providing general statements in the past, the FDA has finally taken a good first step in confirming 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.

“The FDA is starting to develop its thinking on synthetic nicotine, making this a critical time for e-liquid manufacturers to enter the market with a synthetic nicotine product. As FDA clarifications emerge, Next Generation Labs will strive to protect the synthetic nicotine market, offering practical solutions to any requirements that may develop between now and August 2017,” concludes Schuman.

Next Generation Labs continues to develop its partnerships with device manufacturers, such as Vapeix, that offer dedicated open and closed system devices for use with synthetic and no nicotine e-liquids. These partnerships will create a new vape market which is unequivocally disassociated from tobacco, and therefore not subject to FDA regulation.
  
Next Generation Labs sells TFN Nicotine directly to e-liquid manufacturers. To purchase TFN Nicotine, please contact Vincent Schuman at [email protected].

About Next Generation Labs
Founded in 2014, Next Generation Labs developed TFN Nicotine®, the world’s leading synthetic nicotine that is not derived from tobacco. TFN Nicotine is used in over 40 e-liquid brands in the US and is playing a central role in revolutionizing the e-cigarette and vaping industry.
www.nextgenerationlabs.com

Contacts
Katie Ray
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