U.S. Congress Passes Synthetic Nicotine Regulation Bill

March 11 – The U.S. Congress passed a bill giving the Food and Drug Administration authority over synthetic nicotine and any other non-tobacco-derived nicotine on March 11 as part of a U.S. federal funding bill. Biden is expected to sign the bill into law soon.

As previously reported, the FDA had previously expressed an interest in asserting jurisdiction over synthetic nicotine, and Congress had once considered giving the FDA authority over synthetic nicotine in a separate piece of legislation. The bill recently passed by Congress amends the definition of the term tobacco product in the Food, Drug and Cosmetic Act to include any product made from or derived from tobacco or containing nicotine from any source intended for human consumption.

The amendment takes effect 30 days after the bill’s enactment. It allows manufacturers of tobacco products containing synthetic nicotine (or nicotine from non-tobacco sources) to submit a premarket tobacco application (PMTA) with the FDA 30 days after the effective date. If the FDA does not authorize the product within 90 days of the effective date, the product must be withdrawn from the market. It may be an effective ban on synthetic nicotine products. It is doubtful that the FDA will approve a PMTA for a synthetic nicotine product within 90 days when other PMTAs for electronic nicotine delivery systems have been pending for more than two years.


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