FDA Granted Authority to Regulate Synthetic Nicotine Products
July 1, 2022
On Tuesday, March 15, 2022, President Biden signed a new law that grants the U.S. Food and Drug Administration (FDA) authority to regulate synthetic nicotine products as tobacco products.
This legislation will have an important impact on the U.S. tobacco and nicotine industry. Below is a summary of the key provisions:
· FDA has been given regulatory authority over all nicotine products – whether derived from tobacco or synthetically derived.
· The legislation will become effective on April 15, 2022.
· Synthetic nicotine products are permitted to stay on the market until 30 days from the effective date of the new legislation (May 14, 2022). After this date, synthetic nicotine products are not allowed to be marketed unless the manufacturer filed a premarket tobacco product application (PMTA) by May 14, 2022.
· If the manufacturer filed a PMTA by the May 14, 2022 deadline, a synthetic nicotine product can remain on the market pending the outcome of its PMTA for an additional 60 days (i.e., until July 13, 2022), after which the product must be removed unless FDA has issued a marketing granted order or exercises discretionary authority to allow the product to remain on the market.