FDA Will Now Regulate Synthetic Nicotine

Manufacturers of synthetic nicotine have until May 14 to submit a PMTA or pull their products.

March 18, 2022

Synthetic Nicotine Gum

ALEXANDRIA, Va.—President Biden signed off on a $1.5 trillion spending package giving the Food and Drug Administration (FDA) authority to regulate synthetic nicotine products.

The FDA has had regulatory and enforcement authority over tobacco products since 2009 when Congress passed the Tobacco Control Act. This new measure will give the FDA the same authority over products that contain nicotine that aren’t derived from tobacco but made in a lab, known as synthetic nicotine.

The FDA will have regulatory authority over synthetic nicotine starting on April 15, 2022. Manufacturers of synthetic nicotine have until May 14, 2022, to either submit a premarket tobacco product application (PMTA) or pull their products from the market.

Any retailer selling synthetic nicotine products should contact the manufacturers of the products to see if they have submitted PMTAs by the deadline. If they haven’t, retailers must stop selling the products or else retailers may be subject to FDA enforcement.

If a manufacturer submits a PMTA by the deadline, they can continue marketing their products until July 13, 2022. After that date, the products must be removed from retail shelves unless the FDA has issued a marketing granted order.

In 2020, the FDA announced that they were removing most flavored e-cigarettes from the market pending approval of their PMTAs. During the past two years, products looking to avoid the FDA’s regulations have started using synthetic nicotine.

The bipartisan effort to include this language in the omnibus bill was championed by Sens. Richard Burr (R-NC), Dick Durbin (D-IL) and Patty Murray (D-WA), along with Rep. Frank Pallone (D-NJ), according to Bloomberg.

“This is an enormous win for public health and American consumers,” Rep. Pallone said in a statement. “I’m grateful to members on both sides of the aisle for working with me to close this loophole in the omnibus.”