Category

FDA/Deeming Regulations

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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Trump Administration Plans Flavored E-Cigarette Ban, Flavored Cigars Untouched

The Trump Administration will ask FDA to ban the sale of flavored e-cigarettes. Flavored cigars annd menthol cigarettes are not expected to be part of...
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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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Oral Arguments for D.C. Lawsuit Scheduled for July 31

The latest courtroom battle in the fight over FDA’s regulations of premium cigars will take place July 31 in Washington, D.C. Oral arguments for the...
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FDA Asks Court to Delay Substantial Equivalence Deadline by At Least 10 Months

The U.S. Food & Drug Administration (FDA) has asked a federal court in Maryland to order that FDA’s substantial equivalence deadline should begin no sooner...
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FDA Extends Comment Period for Revised Substantial Equivalence Process to July 17

The U.S. Food & Drug Administration (FDA) has announced a 30-day extension to its current request for comments on how it should revise its substantial...
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Plaintiffs Respond to FDA in Texas Lawsuit Summary Judgement

Earlier this week, attorneys for the plaintiffs in the Texas FDA lawsuit responded to the FDA’s arguments against summary judgment. The case, En Fuego et al....
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