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U.S. Food & Drug Administration

District Court Strikes Down FDA Warning Labels for All Cigars & Pipes

In a move that could end up being a mixed bag for premium cigar smokers, a federal appeals court has ruled that the U.S. Food...
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FDA Tells Court It Won’t Delay September Substantial Equivalence Deadline

The U.S. Food & Drug Administration (FDA) is not planning on delaying the current Sept. 9, 2020 deadline by which cigar companies will have to...
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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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FDA’s Substantial Equivalence Deadline Delayed Until Sept. 9, 2020

Cigar companies will not have to submit substantial equivalence until Sept. 9, 2020. After weeks of procedural legal functions, an agreed-upon 120-day delay of the...
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Appeals Court Gives Green Light for FDA Substantial Equivalence Delay to September

As expected, a federal appeals court will allow for a 120-day delay of FDA’s substantial equivalence deadline—currently set for May 12—due to the coronavirus COVID-19...
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Eight Cigar Companies & Two Cigar Trade Groups Seek Indefinite Delay of FDA Substantial Equivalence Due to Coronavirus

A new motion has been filed in one of the lawsuits related to the U.S. Food & Drug Administration’s (FDA) regulation of cigars, this time...
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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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