Tag

Deeming Regulations

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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CRA Gives FDA Three Options for the Future of Cigar Regulation

The Cigar Rights of America (CRA), representing roughly 100 companies that are involved with the production of premium cigars, has filed its comments to the...
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Six Companies File Joint Comments Seeking Premium Cigar Exemption from FDA

Six of the world’s largest cigar companies have filed joint comments regarding the FDA’s regulation of premium cigars, advocating that the agency is not able...
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Federal Judge Says Substantial Equivalence Applications are Due May 12, 2020

A federal judge in Maryland has ruled that cigarmakers have until May 12, 2020, to submit applications for substantial equivalence, about 450 days earlier than...
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Cigar Trade Groups Appeal Court Decision to Throw Out FDA Substantial Equivalence Delay

Earlier today, attorneys for three cigar trade groups and three Texas-based cigar businesses filed a motion to throw out a May court decision that would...
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