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U.S. Food & Drug Administration

Graded: Ten Questions for 2020

The idea of the words graded and 2020 bring a bit of a smirk and sigh to my face. Certainly conventional wisdom—and an endless stream of social…

What the Election Results Mean for Cigar Smokers: 2020 Edition

Barring some very on-brand 2020 curveballs, Joe Biden will be the next president of the United States. As I did the last time I published…

Cigar Groups Ask Court to Invalidate FDA Cigar Regulations

The cigar industry is once again asking a federal court to throw out FDA’s regulations of cigars. In fact, the plaintiffs in the lawsuit are…

Court Vacates FDA’s Cigar Warning Label Requirement

The U.S. District Court of the District of Columbia has vacated FDA’s warning label requirements for cigars and pipe tobacco. If that sounds familiar, it’s…

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…

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…