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David Myles

Cigar Industry, FDA Due Back in D.C. Court Tomorrow

The cigar industry and the U.S. Food & Drug Administration will meet in virtual federal court tomorrow afternoon to discuss FDA’s plans to defer premium…

12 Thoughts: FDA Wants to Reevaluate How to Regulate Premium Cigars

By Sept. 8, 2020 cigar manufacturers and others will have to submit documentation to the U.S. Food & Drug Administration (FDA) for premarket approval to…

FDA Tells Court It Intends to Delay Substantial Equivalence for Premium Cigars, Research Premium Cigars

The U.S. Food & Drug Administration (FDA) intends on re-evaluating how it goes about regulating premium cigars, specifically, researching the potential health effects of smoking…

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…