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U.S. Food & Drug Administration

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 bussiiness 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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FDA Loses Maryland Court Battle, Substantial Equivalence Delay in Jeopardy

There are some court battles the cigar industry would like FDA to win—and it just lost one of them. Earlier today, the U.S. District Court...
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Rubio Hosting Field Hearing on Premium Cigars Next Week

Next Friday, Sen. Marco Rubio, R-Fla., will chair a field hearing on premium cigar regulation. The hearing is entitled Keeping Small, Premium Cigar Businesses Rolling and will...
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FDA Plans Updated Substantial Equivalence Process for Tobacco Products

One of the many complaints cigar companies have with the FDA and the agency’s regulations on tobacco products is a lack of clarity. Nowhere is...
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New House Bill Introduced to Exempt Premium Cigars from FDA Regulation

Over three months after a bill was first reintroduced in the Senate, a bill has been introduced in the U.S. House of Representatives that would...
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