Will the May 12 deadline for premarket tobacco applications and substantial equivalence reports remain in place?  The FDA has decisively moved in that direction, but the final answer will depend upon further proceedings

There was a significant development on April 3, 2020, when Judge Paul W. Grimm of the U.S. District Court for the District of Maryland issued an indicative ruling in American Academy of Pediatrics, et al. v. FDA, et al., No. 8:18-cv-00883 (D. Md.), on appeal, Nos. 19-2130, -2132, -2198, -2242 (4th Cir.).  Judge Grimm indicated that, “if the case were remanded for that purpose,” he would grant the FDA’s motion to extend the deadline to September 9 “in light of the global outbreak of respiratory illness caused by a new coronavirus.”  The case is pending with the U.S. Court of Appeals for the Fourth Circuit, which would have to order a limited remand prior to Judge Grimm’s issuing any actual ruling on the extension.

The matter of the indicative ruling proceeded fairly quickly last week.  On March 30, the FDA requested Judge Grimm’s indicative ruling on the extension and also notified the Fourth Circuit.  The plaintiffs in the case responded on April 2, expressing some misgivings but not opposing the requested extension.  The same day, the FDA waived its right to file a reply and asked for an indicative ruling by April 7, “due to the need for certainty in light of the coronavirus outbreak and the upcoming May 12 deadline.”

The FDA’s March 30 filing with the Fourth Circuit indicated that, “[i]f the district court issues a ruling indicating that it is inclined to grant the motion, the government would ask this Court for a limited remand to allow the district court to modify the injunction” that previously set the deadline at May 12.  The FDA accordingly moved for a limited remand on April 3, and on April 6 the Fourth Circuit requested responses to the FDA’s motion by April 10.


While the indicative ruling is a very significant development, it is only indicative.  The May 12 deadline still remains in place.  We will continue to closely monitor the ensuing proceedings and will update our blog with further developments with respect to the deadline.