Generation Labs, the makers of proprietary TFN Nicotine – a non-tobacco derived synthetic nicotine –reported an update from the Food and Drug Administration (FDA) that addresses the question of synthetic nicotine, confirming that e-liquids made with synthetic nicotine will not be regulated.
“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,” Vincent Schuman, CEO of Next Generation Labs, commented. “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,” concluded Schuman.