Category

FDA/Deeming Regulations

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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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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