Some in the e-cigarette industry have claimed Synthetic Nicotine products’ escape from the requirements of the deeming rule and the FDA’s tobacco regulatory scheme as a “victory,” seemingly concluding that if Synthetic Nicotine products are not tobacco products, they are not subject to any FDA regulation.

The question of whether Synthetic Nicotine products are tobacco products, however, is not the end of the inquiry into the FDA’s jurisdiction. Examination of the relevant statutory provisions, case law, and regulations, as well as other agency interpretations of the law, suggests that Synthetic Nicotine products should be considered to be drugs under the FDCA.

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Synthetic NicotineSynthetic Nicotine is used for Quitting Smoking
Some in the e-cigarette industry have claimed Synthetic Nicotine products’ escape from the requirements of the deeming rule and the FDA’s tobacco regulatory scheme as a “victory,” seemingly concluding that if Synthetic Nicotine products are not tobacco products, they are not subject to any FDA regulation. The question of whether Synthetic Nicotine products...