Deeming Regulations

Vape Companies Asks Supreme Court to Throw Out FDA’s Deeming Regulations

Eight vaping companies have asked the U.S. Supreme Court to consider whether the U.S. Food & Drug Administration (FDA) acted improperly when enacting its deeming…

Senate Bill Introduced to Exempt Premium Cigars from FDA Regulation

There is once again a bill that seeks to exempt premium cigars from regulation by the U.S. Food & Drug Administration (FDA) in the U.S….

Cigar Industry Asks Court to Throw Out FDA Regulations for Premium Cigars

Once again, the cigar industry has asked a federal court to vacate the U.S. Food & Drug Administration’s (FDA) deeming regulations against “premium” cigars. Last…

Court Declines to Throw Out Substantial Equivalence Requirements for Premium Cigars

Yesterday, the U.S. District Court for the District of Columbia rejected a long shot legal argument that sought to have FDA’s substantial equivalence requirements for…

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…