Not even a week after a Washington D.C. judge seemingly slammed the door on extending a key product approval deadline, another door appears to have opened. Today, the Department of Justice filed an appeal on behalf of the Food and Drug Administration that asks the U.S. Court of Appeals for the Fourth Circuit to strike down a Maryland judge’s decision to shorten the deadline for Substantial Equivalence.
One of the three pathways to product approval that the FDA established when it published its Final Deeming Rule in May 2016, Substantial Equivalence allows a cigar manufacturer to file a report showing that a new tobacco product has similar characteristics to a grandfathered (predicate) tobacco product, or has different characteristics, but doesn't raise any new questions of public health. A predicate tobacco product is one that was on the market on February 15, 2007.
In July, Judge Paul Grimm of U.S. District Court for the District of Maryland ruled against the FDA’s decision to extend the Substantial Equivalence deadline to 2021. In his opinion of that case, called American Academy of Pediatrics, et al. v. Food and Drug Administration, Judge Grimm established a new deadline of May 12, 2020.
The FDA believes that Judge Grimm’s ruling violated the principles of separation of powers and interfered with the executive branch’s authority.