FDA Codifies Premium Cigar Definition; Finalizes SE for Flavored Cigars & Other Tobacco Products
Yesterday, the U.S. Food & Drug Administration (FDA) announced finalized rules for premarket product approval through substantial equivalence (SE) or the premarket tobacco product applications…
Ten Questions for 2021
There are less than a dozen hours of the year—the year—remaining. As I’ve done at this point of each year for over a decade, it’s…
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…
