Steven Hirsch

Federal Appeals Court Rejects Cigar Industry’s Appeal to Move Substantial Equivalence Deadline to August 2021

The substantial equivalence deadline will not be moving back to August 2021. A three-judge panel of the U.S. Court of Appeals for the Fourth Circuit…

Appeals Court Moves FDA Cigar Lawsuit Hearing to Video Conference Due to Coronavirus (Update)

A key court hearing regarding the cigar industry’s lawsuit over regulations by the U.S. Food & Drug Administration (FDA) has been moved from a courtroom…

Appeals Court Denies Motion to Stay May 2020 Substantial Equivalence, Schedules Appeal Hearing for March 18

The U.S. Court of Appeals for the Fourth Circuit has denied a motion by cigar trade groups to grant a stay on the May 12, 2020…

FDA Appeals Maryland Court Ruling that Accelerated Substantial Equivalence Deadlines

The U.S. Food & Drug Administration (FDA) has appealed a ruling from a federal court in Maryland that changed the date substantial equivalence submissions are…

D.C. Court Rules Against Cigar Industry’s Petition to Delay Substantial Equivalence Deadline

The cigar industry’s desire to delay the upcoming substantial equivalence deadline will have to find a new approach. U.S. District Court Judge Amit P. Mehta…

FDA, Cigar Industry Due Back in Court in October

The cigar industry is due back in court, two courts actually, in October to continue its legal fight against the U.S. Food & Drug Administration…

Federal Judge Says Substantial Equivalence Applications are Due May 12, 2020

A federal judge in Maryland has ruled that cigarmakers have until May 12, 2020, to submit applications for substantial equivalence, about 450 days earlier than…

Cigar Trade Groups Appeal Court Decision to Throw Out FDA Substantial Equivalence Delay

Earlier today, attorneys for three cigar trade groups and three Texas-based cigar businesses filed a motion to throw out a May court decision that would…

FDA Asks Court to Delay Substantial Equivalence Deadline by At Least 10 Months

The U.S. Food & Drug Administration (FDA) has asked a federal court in Maryland to order that FDA’s substantial equivalence deadline should begin no sooner…

FDA Loses Maryland Court Battle, Substantial Equivalence Delay in Jeopardy

There are some court battles the cigar industry would like FDA to win—and it just lost one of them. Earlier today, the U.S. District Court…

Health Groups Sue FDA Over Delay in Deeming Regulations

Seven health groups and five Maryland-based doctors filed a lawsuit today against the U.S. Food & Drug Administration (FDA) and its delay of the deeming…