FDA Poised to Gain Regulatory Power Over Synthetic Nicotine


Lawmakers have inserted language into a federal spending bill that would give the Food and Drug Administration (FDA) regulatory authority over synthetic nicotine, clamping down on a legal gray area for vapes.

The proposed legislation would change the definition of a “tobacco product,” which currently means anything made or derived from tobacco, to include products “containing nicotine from any source”—with the exception of foods with trace amounts.

Legislators are working quickly to pass the omnibus spending bill, in part to avoid a government shutdown. According to a copy of the bill reviewed by Filter, should this version pass, the synthetic nicotine amendments will go into effect 30 days after. Synthetic nicotine producers would then have 60 days from its enactment—or 30 days after it becomes effective—to file premarket tobacco product applications (PMTAs) with the FDA to legally stay on the market. Ninety days after the effective date, or 120 days after the bill’s passing, these manufacturers would have to stop selling their products if the FDA has not authorized them. At that point, the FDA could exercise its enforcement discretion.

Read full article here.

Alex Norcia – Filter – 2022-03-08.

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