Tag

Deeming Regulations

Court Signals FDA Substantial Equivalence Deadline Will be Delayed Until Sept. 9

While not yet official, the deadline for cigar companies to submit substantial equivalence reports to the U.S. Food & Drug Administration (FDA) will almost certainly...
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FDA Asks Court to Delay Substantial Equivalence Deadline Until Sept. 9, 2020 Due to Coronavirus

The U.S. Food & Drug Administration (FDA) has asked a federal court to delay the substantial equivalence deadline—currently set for May 12, 2020—due to the...
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Court Tells FDA to Make a Decision Regarding Substantial Equivalence Extension This Week or Risk Trial

The U.S. Food & Drug Administration (FDA) will have until this Friday to grant an extension for the upcoming substantial equivalence deadline, set for May...
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CRA, PCA Petition HHS/FDA to Delay May 2020 Substantial Equivalence Deadline

Two cigar trade groups have asked FDA to delay the May 2020 substantial equivalence submission deadline due to the coronavirus COVID-19 pandemic. If it doesn’t...
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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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Court Rules FDA Cigar Warning Labels are Illegal

Warning labels will not be coming to premium cigars. Earlier today, U.S. District Court Judge Amit P. Mehta ruled in favor of the premium cigar...
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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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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Earlier today, the U.S. Food & Drug Administration unveiled draft guidance that would effectively lead to a ban on flavored vaping and e-cigarette pods/cartridges.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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