Tag

substantial equivalence

Court Declines to Throw Out Substantial Equivalence Requirements for Premium Cigars

Yesterday, the U.S. District Court for the District of Columbia rejected a long shot legal argument that sought to have FDA’s substantial equivalence requirements for...
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Biden Administration Announces Regulatory Freeze, Includes Substantial Equivalence Updates Passed Earlier This Week

As is common for new presidential administrations, the Biden administration has announced a regulatory freeze on all new and pending rules introduced in the last...
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FDA Codifies Premium Cigar Definition; Finalizes SE for Flavored Cigars & Other Tobacco Products

Yesterday, the U.S. Food & Drug Administration (FDA) announced finalized rules for premarket product approval through substantial equivalence (SE) or the premarket tobacco product applications...
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Cigar Groups Ask Court to Invalidate FDA Cigar Regulations

The cigar industry is once again asking a federal court to throw out FDA’s regulations of cigars. In fact, the plaintiffs in the lawsuit are...
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Court Denies Injunction Seeking to Delay FDA Substantial Equivalence Deadline Pending Appeal

An appeal filed by the Cigar Association of America (CAA) to suspend enforcement of certain upcoming FDA deadlines pending an appeal has been denied. Judge...
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Cigar Association of America Begins Appeal of FDA Substantial Equivalence Ruling

As expected, the Cigar Association of America (CAA) has formally begun the appeals process over last week’s ruling regarding the U.S. Food & Drug Administration’s...
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10 Thoughts: FDA’s Substantial Equivalence Requirements Delayed for Premium Cigars

Yesterday, the U.S. District Court for the District of Columbia ruled that the U.S. Food & Drug Administration’s premarket approval deadline of Sept. 9, 2020...
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Court Delays FDA Product Approval Requirements for Premium Cigars Indefinitely

The FDA’s ability to require premium cigar companies to seek product approval for its cigars has been delayed indefinitely by a federal court. Judge Amit...
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Judge Critical of FDA’s Deferment Plan for Premium Cigars

Barring an immediate ruling in its favor, the cigar industry could not have had a much better day in court than the one it had...
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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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