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,…
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…
Top Trump Official Suggests FDA Shouldn’t Regulate Tobacco
A top policy official for the Trump Administration has suggested that the U.S. Food & Drug Administration (FDA) should not be regulating tobacco products. At…
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…
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…
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…
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…
FDA Announces Proposed Record-Keeping Rules for Substantial Equivalence
Yesterday, the U.S. Food & Drug Administration (FDA) published proposed rules for the process of applying for agency approval of e-cigarettes and vaping products. Almost…
Trump Administration Plans Flavored E-Cigarette Ban, Flavored Cigars Untouched
The Trump Administration will ask FDA to ban the sale of flavored e-cigarettes. Flavored cigars and menthol cigarettes are not expected to be part of…
FDA, Cigar Industry Due Back in Court in October
The cigar industry is due back in court, two courts actually, in October to continue its legal fight against the U.S. Food & Drug Administration…
