Tag

Leah Brasch

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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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