E-Cig Makers May Get FDA Extension

The agency seeks a 120-day delay of the deadline for premarket tobacco product applications.

April 02, 2020

WASHINGTON—Citing the coronavirus outbreak , the Food and Drug Administration is seeking a 120-day reprieve for e-cigarette and tobacco manufacturers who are facing a May deadline to either submit their products for federal review or take them off the market. The previous deadline of May 12 was set by a federal judge in Maryland, and the FDA is now asking the court’s permission to extend the deadline to Sept. 9. 

According to the Wall Street Journal, many laboratories that perform the required studies for the manufacturers’ applications have shut down or halted in-person work due to the coronavirus pandemic. What’s more, many clinical studies requiring human participants have been suspended, the FDA said in a court document filed Monday.

In addition, employees from the agency’s Center for Tobacco Products, some of whom would be required to review the e-cigarette applications, have been redeployed to work for the U.S. Public Health Service during the outbreak, the FDA said.

Any tobacco product not on the market as of the February 15, 2007, the predicate date in the Tobacco Control Act, must submit premarket tobacco product applications (PMTAs) by May 12, 2020, to remain on the market.  This includes e-cigarettes, flavored cigars, smokeless tobacco and hookah products. 

Earlier this year, FDA published guidance banning flavored cartridge-based e-cigarettes, with the exception of tobacco and menthol flavors, which took effect on February 6.  However, flavored single-use disposable e-cigarettes and flavored e-liquids used in open-tank systems were allowed to stay on the market provided the manufacturers file PMTAs by the May deadline. Those products can then stay on the market for up to 12 months while FDA reviews the applications and following that timeframe the products can only be sold if the FDA approves them. 

According to the FDA guidance, vape shops or other retailers that mix their own vape juice must submit PMTAs because they are, in those cases, manufacturing the product.

The cartridge-based flavored e-cigarettes products banned in February could be allowed back onto the market if their products are approved by FDA in the PMTA process.

The “FDA remains acutely aware of the recent surge in youth use of e-cigarettes and the public health imperative to ensure” that these products undergo review, Mitch Zeller, director of the FDA’s tobacco center, wrote in a court filing. “However, given the severe, unforeseen disruptions that are affecting this industry and the world, I believe it is appropriate for applicants to have an additional 120 days.”

Many industry representatives had asked for a 180-day extension, he wrote.

Coronavirus Resources

NACS has compiled resources to help the convenience retail community navigate the COVID-19 crisis. For news updates and guidance, visit our coronavirus resources page.