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.”
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.
We continue to develop our 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.