Deadline Today for Tobacco Premarket Review Submission

Manufacturers that don’t submit e-cigarette systems for approval must pull them from the market. 

September 09, 2020

WASHINGTON—Today is the deadline for tobacco manufacturers to submit premarket tobacco product applications (PMTAs) for any electronic nicotine delivery system (ENDS) seeking a marketing order from the U.S. Food and Drug Administration (FDA). Products pending approval can remain on the market for up to one year, while products that missed the deadline must be pulled from the market.

Because of the pandemic, the agency requested—and was granted—the extension to September 9 for many e-cigarettes and other deemed tobacco products. Last week, Reynolds announced it completed the submission of a group of PMTAs through R.J. Reynolds Vapor Company. And in July, JUUL filed its FDA applications seeking the regulator’s permission to keep selling its devices, as well as Virginia-tobacco- and menthol-flavored pods with 3% and 5% concentrations, in the United States.

NACS requested that FDA publish a PMTA list to help retailers understand which products are OK to continue to sell. Last week, the FDA’s Center for Tobacco Products announced that it intends to publish a list of products for which they received PMTAs by today’s deadline. However, the agency clarified that the list would not be publicly available immediately.

“In the interim, we encourage retailers and other interested parties to refer to the public statements made by the companies or contact the companies directly to get information about applications they may have submitted,” stated the Center for Tobacco Products.  NACS has asked the agency to exercise its enforcement discretion in the interim since a retailer cannot credibly confirm that manufacturers have submitted PMTAs without a published list from the agency.

A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health. In order to reach such a decision and to authorize marketing, the FDA will consider, among other things:

  • Risks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as nonusers;
  • Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available;
  • Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available; and
  • The methods, facilities and controls used to manufacture, process and pack the new tobacco product.