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…
Biden Administration Announces Regulatory Freeze, Includes Substantial Equivalence Updates Passed Earlier This Week
As is common for new presidential administrations, the Biden administration has announced a regulatory freeze on all new and pending rules introduced in the last…
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…
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…
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…