Category

FDA/Deeming Regulations

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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FDA: Premium Cigars Are Our Lowest Priority

The U.S. Food & Drug Administration (FDA) has announced plans to more aggressively regulate e-cigarettes and vaping products, specifically flavored pods or cartridges. At the...
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Dr. Stephen Hahn Confirmed as FDA Commissioner

Dr. Stephen Hahn is the new commissioner of the U.S. Food & Drug Administration (FDA). Earlier today, Hahn was confirmed by the Senate by a...
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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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Senate Committee Approves Stephen Hahn’s Nomination as FDA Head

Dr. Stephen Hahn is just one step away from becoming the next commissioner of the U.S. Food & Drug Administration (FDA). The Senate Health, Education,...
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House Committee Exempts $12+ Cigars from FDA’s Substantial Equivalence, Most New Anti-Tobacco Regulations

And finally some good news. Last week, the U.S. House of Representatives Subcommittee on Health passed H.R. 2339, the Reversing the Youth Tobacco Epidemic Act of...
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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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