1 Year of Cigar Aficionado for $10 PLUS a Free Gift!

Legislation

Justice Department Appeals Judge’s Decision to Shorten Product Approval Deadline

Oct 24, 2019 | By Andrew Nagy
Justice Department Appeals Judge’s Decision to Shorten Product Approval Deadline

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.

FDA

More in Legislation

See all
Court Strikes Down Key Premarket Review Process for Premium Cigars

Court Strikes Down Key Premarket Review Process for Premium Cigars

Premium cigar manufacturers no longer have to worry about the upcoming September 9 deadline for some …

Aug 19, 2020
FDA Asks Court to Consider Premium Cigar Deferral Proposal

FDA Asks Court to Consider Premium Cigar Deferral Proposal

As the September 9 deadline for cigar manufacturers to submit their premarket applications to the FDA …

Aug 6, 2020
Pennsylvania Reps Prod President to Eliminate Premium Cigar Regulations

Pennsylvania Reps Prod President to Eliminate Premium Cigar Regulations

Half of Pennsylvania’s 18 representatives earlier this week signed and sent a letter to President …

Jul 15, 2020
Court Strikes Down FDA’s Cigar Warning Label Plan

Court Strikes Down FDA’s Cigar Warning Label Plan

A trio of judges on the U.S. Court of Appeals for the Washington D.C. Circuit ruled unanimously this …

Jul 7, 2020
Florida Representatives Urge President to Drop Cigar Industry Regulations

Florida Representatives Urge President to Drop Cigar Industry Regulations

In response to the economic downturn, a dozen representatives from Florida have signed and sent a …

Jun 8, 2020
Court Ruling Ends Chances of 2021 Deadline for FDA Product Reports

Court Ruling Ends Chances of 2021 Deadline for FDA Product Reports

The FDA’s pre-market application deadline for cigars will remain September 9 after a trio of judges …

May 5, 2020