Tag

Deeming Regulations

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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Eight Things: FDA’s Planned Ban on Flavored Vaping Pods & Premium Cigars Being the “Lowest Priority”

Earlier today, the U.S. Food & Drug Administration unveiled draft guidance that would effectively lead to a ban on flavored vaping and e-cigarette pods/cartridges. In...
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FDA: Premium Cigars Are Our Lowest Priority

The U.S. Food & Drug Administration (FDA) has announced plans to more aggressively regulate e-cigarettes and vaping products, specifically flavored pods or cartridges. At the...
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Graded: Ten Questions for 2019

It’s in the mid-50s, the skies are gray and the space heater is fired up on the balcony, which means only one thing: it’s time...
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Micallef Launching PredX, Trade Exchange for FDA Predicate Blends

In a world of strict FDA regulation of cigars, there will likely be some process where companies trade or sell the rights to FDA-approved blends...
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Federal Appeals Court Hears FDA Cigar Warning Label Lawsuit

Earlier today, the cigar industry’s lawsuit over FDA regulations entered a new courtroom. The U.S. Court of Appeals for the District of Columbia Circuit heard...
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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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Cigar Industry Files Amended FDA Lawsuit Complaint

Three cigar trade groups have filed an updated complaint in their lawsuit against the U.S. Food & Drug Administration’s (FDA) deeming regulations and their impacts...
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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 Announces Proposed Record-Keeping Rules for Substantial Equivalence

Yesterday, the U.S. Food & Drug Administration (FDA) published proposed rules for the process of applying for agency approval of e-cigarettes and vaping products. Almost...
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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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