U.S. FDA Could Enforce Synthetic Nicotine on July 13

The U.S. Food and Drug Administration tomorrow is expected to officially close the loophole that allows synthetic nicotine to be sold. July 13 is the deadline for the regulatory agency to complete its approval process on synthetic nicotine products.

It is unlikely the FDA will have been able to have reviewed premarket tobacco product applications (PMTAs) that were submitted by the May 14 deadline. The agency has not yet completed reviews for many other electronic nicotine-delivery system (ENDS) products using tobacco-derived nicotine that submitted PMTAs by the Sept. 9, 2020 due date.

Attorneys in the vaping industry say Congress set unrealistic deadlines for manufacturers to submit PMTAs and for the FDA to review them. The law, which took effect April 14, gave companies until May 14 to submit a PMTA, and all existing products that haven’t garnered authorization must come off the market by July 13.

The FDA said last week that it’s still reviewing the “large number of applications” it received for synthetic nicotine products, but declined to share the total number submitted, according to media reports.

Synthetic nicotine products on the market after July 13 “without an FDA marketing granted order” would be considered in violation of federal law and “may be subject to FDA enforcement,” the agency stated.

It is expected that FDA will issue at least some marketing denial orders for companies that submitted a PMTA but didn’t include required data, such as an environmental impact assessment.

In March, the U.S. Senate approved a $1.5 trillion legislation by a 68-31 bipartisan margin that included language that changed the definition of a tobacco product to include synthetic nicotine.

The rule became law 30 days after the bill’s passage date. Congress further granted synthetic nicotine products a transition period in which such products would be allowed to stay on the market until July 13, 2022, provided that they submit the required PMTA by the May 14 deadline—unless the FDA had already denied a non-synthetic version of the same product (meaning those manufacturers were subject to enforcement 30 days after the passage of the bill).

The language of the Tobacco Control Act changed to define a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.”

Matthew Myers, president of the Campaign for Tobacco-Free Kids, said that the FDA needs to act on Congress’ rules for synthetic products.

“It would be outrageous if the FDA failed to enforce the law after Congress acted with urgency to address a growing threat to the health of our nation’s kids: E-cigarette manufacturers’ use of synthetic nicotine to evade FDA regulation and keep selling flavored products that attract and addict kids,” he said. “In recent years, a growing number of e-cigarette makers have switched to using synthetic nicotine – nicotine that is made in a lab, rather than derived from tobacco – after the FDA acted against their flavored products made with tobacco-derived nicotine.”