Deeming Regulations

Judge Critical of FDA’s Deferment Plan for Premium Cigars

Barring an immediate ruling in its favor, the cigar industry could not have had a much better day in court than the one it had…

Cigar Industry, FDA Due Back in D.C. Court Tomorrow

The cigar industry and the U.S. Food & Drug Administration will meet in virtual federal court tomorrow afternoon to discuss FDA’s plans to defer premium…

12 Thoughts: FDA Wants to Reevaluate How to Regulate Premium Cigars

By Sept. 8, 2020 cigar manufacturers and others will have to submit documentation to the U.S. Food & Drug Administration (FDA) for premarket approval to…

FDA Tells Court It Intends to Delay Substantial Equivalence for Premium Cigars, Research Premium Cigars

The U.S. Food & Drug Administration (FDA) intends on re-evaluating how it goes about regulating premium cigars, specifically, researching the potential health effects of smoking…

Cigar Industry, FDA Meet in Court Ahead of September Substantial Equivalence Deadline

Attorneys for the cigar industry and the U.S. Food & Drug Administration (FDA) were back in federal court to present arguments about whether part or…

Six Thoughts: Appeals Court Strikes Down All FDA Cigar & Pipe Warning Labels

Earlier today, the U.S. Court of Appeals for the District of Columbia Circuit ruled that the U.S. Food & Drug Administration (FDA) could not require…

District Court Strikes Down FDA Warning Labels for All Cigars & Pipes

In a move that could end up being a mixed bag for premium cigar smokers, a federal appeals court has ruled that the U.S. Food…

FDA Tells Court It Won’t Delay September Substantial Equivalence Deadline

The U.S. Food & Drug Administration (FDA) is not planning on delaying the current Sept. 9, 2020 deadline by which cigar companies will have to…

Federal Appeals Court Rejects Cigar Industry’s Appeal to Move Substantial Equivalence Deadline to August 2021

The substantial equivalence deadline will not be moving back to August 2021. A three-judge panel of the U.S. Court of Appeals for the Fourth Circuit…

FDA’s Substantial Equivalence Deadline Delayed Until Sept. 9, 2020

Cigar companies will not have to submit substantial equivalence until Sept. 9, 2020. After weeks of procedural legal functions, an agreed-upon 120-day delay of the…

Appeals Court Gives Green Light for FDA Substantial Equivalence Delay to September

As expected, a federal appeals court will allow for a 120-day delay of FDA’s substantial equivalence deadline—currently set for May 12—due to the coronavirus COVID-19…