Congress Directs FDA to Regulate Synthetic Nicotine

Lab-made nicotine will face the same scrutiny as tobacco-derived products.

March 11, 2022

Synthetic Nicotine Gum

ALEXANDRIA, Va.—Within the $1.5 trillion spending package to keep the U.S. government funded, Congress included language that would give the Food and Drug Administration (FDA) authority to regulate synthetic nicotine products. The measure was included in the omnibus bill that passed out of the House of Representatives on Wednesday and the Senate yesterday, the final step before the president signs it into law.

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 FDA that same authority over products that contain nicotine that isn’t derived from tobacco but made in a lab, known as synthetic nicotine.

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

The new law would require that manufacturers of synthetic nicotine products submit PMTAs to the FDA within 60 days of the law’s enactment to avoid their products having to be taken off of store shelves. While the measure doesn’t include direct retailer penalties, if the FDA were to deem a product illegal, any retailer selling the product would be subject to enforcement, which could include fines.

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.”