Court Denies Injunction Seeking to Delay FDA Substantial Equivalence Deadline Pending Appeal
An appeal filed by the Cigar Association of America (CAA) to suspend enforcement of certain upcoming FDA deadlines pending an appeal has been denied. Judge…
Cigar Association of America Begins Appeal of FDA Substantial Equivalence Ruling
As expected, the Cigar Association of America (CAA) has formally begun the appeals process over last week’s ruling regarding the U.S. Food & Drug Administration’s…
10 Thoughts: FDA’s Substantial Equivalence Requirements Delayed for Premium Cigars
Yesterday, the U.S. District Court for the District of Columbia ruled that the U.S. Food & Drug Administration’s premarket approval deadline of Sept. 9, 2020…
Court Delays FDA Product Approval Requirements for Premium Cigars Indefinitely
The FDA’s ability to require premium cigar companies to seek product approval for its cigars has been delayed indefinitely by a federal court. Judge Amit…
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…
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…
Eight Cigar Companies & Two Cigar Trade Groups Seek Indefinite Delay of FDA Substantial Equivalence Due to Coronavirus
A new motion has been filed in one of the lawsuits related to the U.S. Food & Drug Administration’s (FDA) regulation of cigars, this time…
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…
Graded: Ten Questions for 2019
It’s in the mid-50s, the skies are gray and the space heater is fired up on the balcony, which means only one thing: it’s time…
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…
