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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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,…
