UPDATE: With the recent approval of a federal appeals court, the U.S. District Court for the District of Maryland on April 22 granted the FDA’s request for an extension of the premarket review deadline to Sept. 9, 2020.
WASHINGTON — A second federal court has granted the U.S. Food and Drug Administration’s (FDA’s) request for a 120-day extension of its deadline for submission of premarket tobacco applications (PMTAs), effectively moving the May 12 deadline to Sept. 9, according to court documents.
On March 30, the FDA cited the coronavirus pandemic as a reason for the delay. On April 21, the U.S. Circuit Court of Appeals for the Fourth Circuit granted its permission, which, barring formalities, officially extended the deadline. Tobacco and vaping manufacturers will now need to submit PMTAs by September to allow for a large number of their products to remain on the market during FDA review.
The proceedings took some time. For the delay to be official, two federal courts had to act on the FDA’s initial March request. On April 3, the U.S. District Court for the District of Maryland issued a ruling stating it would grant the requested 120-day extension if the U.S. Circuit Court of Appeals also issued a ruling allowing the district court to proceed and modify the previously court-ordered May 12 PMTA filing deadline. On April 21, the court of appeals issued the remand order granting the deadline extension.
For many makers of e-cigarettes and tobacco products, word of the delay was “promising,” said Chris Howard, vice president, general counsel and chief compliance officer for E-Alternative Solutions, Jacksonville, Fla. Responding to CSP prior to the second court approval, he said many companies had been working to meet the May 12 deadline but were experiencing delays because of COVID-19.
Retailers would also have a reprieve, Howard said. “C-store retailers would have more time to assess which manufacturers are planning to submit PMTAs for their products,” he said. “They should be seeking for manufacturers to provide evidence of submission prior to Sept. 9.”
In addition, Howard said retailers can request letters of filing or acceptance from the FDA, which manufacturers should expect to receive in later stages of the FDA review process.