Tag

Deeming Regulations

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...
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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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Cigar Industry, FDA Meet in Court Ahead of September Substantial Equivalence Deadline

Attorneys for the cigar industry and the U.S. Food & Drug Administration (FDA) were back in federal court to present arguments about whether part or...
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Six Thoughts: Appeals Court Strikes Down All FDA Cigar & Pipe Warning Labels

Earlier today, the U.S. Court of Appeals for the District of Columbia Circuit ruled that the U.S. Food & Drug Administration (FDA) could not require...
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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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