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U.S. Food & Drug Administration

Court Signals FDA Substantial Equivalence Deadline Will be Delayed Until Sept. 9

While not yet official, the deadline for cigar companies to submit substantial equivalence reports to the U.S. Food & Drug Administration (FDA) will almost certainly...
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FDA Asks Court to Delay Substantial Equivalence Deadline Until Sept. 9, 2020 Due to Coronavirus

The U.S. Food & Drug Administration (FDA) has asked a federal court to delay the substantial equivalence deadline—currently set for May 12, 2020—due to the...
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Court Tells FDA to Make a Decision Regarding Substantial Equivalence Extension This Week or Risk Trial

The U.S. Food & Drug Administration (FDA) will have until this Friday to grant an extension for the upcoming substantial equivalence deadline, set for May...
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CRA, PCA Petition HHS/FDA to Delay May 2020 Substantial Equivalence Deadline

Two cigar trade groups have asked FDA to delay the May 2020 substantial equivalence submission deadline due to the coronavirus COVID-19 pandemic. If it doesn’t...
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Appeals Court Moves FDA Cigar Lawsuit Hearing to Video Conference Due to Coronavirus (Update)

A key court hearing regarding the cigar industry’s lawsuit over regulations by the U.S. Food & Drug Administration (FDA) has been moved from a courtroom...
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House of Representatives Passes Sweeping Anti-Tobacco Bills, Cigars Exempt from Some Regulations

The U.S. House of Representatives has approved a major anti-tobacco bill, one that if enacted would change the fabric of the cigar industry. Earlier today,...
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Trump’s Budget Says FDA Shouldn’t Regulate Tobacco, Calls for New Agency

President Donald Trump’s proposed FY 2021 budget calls for a new agency to regulate tobacco products, removing that control from the U.S. Food & Drug...
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Court Rules FDA Cigar Warning Labels are Illegal

Warning labels will not be coming to premium cigars. Earlier today, U.S. District Court Judge Amit P. Mehta ruled in favor of the premium cigar...
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Appeals Court Denies Motion to Stay May 2020 Substantial Equivalence, Schedules Appeal Hearing for March 18

The U.S. Court of Appeals for the Fourth Circuit has denied a motion by cigar trade groups to grant a stay on the May 12, 2020...
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FDA: Not Enforcing Tobacco 21 Yet

The U.S. Food & Drug Administration (FDA) has clarified its position on a new federal that bans those under 21-years-old from purchasing tobacco products. While...
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PCA & Others Seek Clarification on Federal Tobacco 21 Age Increase Implementation

The Premium Cigar Association (PCA) and other trade groups have asked the U.S. Food & Drug Administration (FDA) to clarify the implementation of the new...
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