Due to the COVID-19 pandemic, the U.S. District Court granted the Food and Drug Administration’s (FDA) request for an extension of the premarket review submission deadline for certain tobacco products. Applications are now required to be filed by Sept. 9, 2020 for many e-cigarettes, cigars and other deemed tobacco products.
And on May 4, the Court of Appeals for the Fourth Circuit issued a ruling on the appeals of the U.S. District Court of Maryland’s decisions in the American Academy of Pediatrics v. FDA case, dismissing the appeals in entirety. The Sept. 9, 2020, deadline for submitting Premarket Tobacco Product Application (PMTA) applications remains in place for deemed “new tobacco products” that were on the U.S. market on Aug. 8, 2016.
Timeline of events, via Vapor Technology Association (VTA):
In May 2019, the district court in AAP granted summary judgment in favor of the plaintiffs, public health groups and individual physicians who challenged FDA’s extensions of the deadlines for submitting marketing applications for deemed “new tobacco products” that were on the U.S. market on the effective date of the deeming regulation, i.e., Aug. 8, 2016.
In July 2019, the district court moved the August 2022 deadline for submission of PMTA applications to May 12, 2020.
In October 2019, the district court issued an order (1) permitting vapor industry trade associations to intervene for the purposes of appeal; (2) denying the cigar associations’ motion to intervene for purpose of appeal; and (3) denying the vapor associations’ motion for stay pending appeal.
Subsequently, FDA and the vapor associations appealed the district court’s summary judgment and remedy orders, and the cigar associations appealed the denial of their motion to intervene for purpose of appeal.
On Jan. 2, 2020, while the appeals remained pending, FDA finalized its new compliance policy guidance, replacing the original August 2017 guidance that had been challenged in the AAP case. The FDA also indicated it would impose a May 12, 2020, PMTA deadline irrespective of the district court’s order.
On April 22, 2020, and at FDA’s request, the district court modified its remedy order to change the May 12, 2020 deadline to Sept. 9, 2020 due to the impacts of the COVID-19 pandemic.
On April 30, 2020, FDA issued a revised version of the January 2020 guidance to reflect the extension to Sept. 9, 2020.
The Fourth Circuit’s decision on May 4 held that:
- The vapor associations’ appeal is now moot in light of FDA’s replacement of the challenged August 2017 guidance, “leaving no possible meaningful relief that this court could grant,” and
- The district court did not abuse its discretion when it denied the cigar associations’ motion to intervene on timeliness grounds.
- The FDA’s appeal is dismissed (something the FDA requested if the court reached the foregoing conclusions).
Moving forward in this case, the industry appellants have the following options:
- File a petition for rehearing and/or rehearing en banc (i.e., a hearing before the full appellate court) within 45 days, or
- File a petition for a writ of certiorari with the Supreme Court of the United States within 90 days. (A writ of certiorari is a request for the Supreme Court to hear an appeal. The Supreme Court decides whether it will hear an appeal.)
The court also noted that parties could challenge the FDA’s 2020 Guidance “in a separate action brought in the appropriate district court.”