FDA Announces Decision to Publish ENDS Products List

NACS had requested that the agency publicly release a list of products for which a PMTA had been submitted.

September 02, 2020

WASHINGTON—The U.S. Food and Drug Administration (FDA) announced that it intends to publish a list of products for which they received premarket tobacco applications (PMTAs) by the agency’s  Sept. 9 deadline. These products will be allowed to stay on the market for one year from the deadline. However, products that don’t submit a PMTA by the deadline will no longer be allowed on the market. NACS had been a signatory on a retail group letter sent to the agency last week requesting a PMTA list to avoid confusion about which electronic nicotine delivery system (ENDS) products can still be sold.

“Our retailers look to FDA to know which tobacco products are legal to sell,” said Anna Ready Blom, NACS director of government relations. “We’ve been asking the FDA to publish a list noting which e-cigarette manufacturers have filed premarket tobacco product applications (PMTAs) so our retailers can ensure they are in compliance. We are pleased to see the agency intends to publish a list and we urge them to do it expeditiously,” stated Anna Ready Blom, NACS director of government relations.

FDA did note in their release that they PMTA list would not be ready immediately. “We request your patience as we work through the appropriate processes to ensure the posted information is accurate and compliant with federal laws,” FDA Center for Tobacco Products (CTP) Director Mitch Zeller said in a statement. “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.”

In its release, the CTP said of the review process that the “likelihood of FDA reviewing all of these applications during the one-year review period is low, [because the agency…] has received applications for around 2,000 deemed products—of which around 40% have already been resolved.”