substantial equivalence

FDA Publishes Finalized Substantial Equivalence Rule, Impact for Cigars Unclear

Today, the U.S. Food & Drug Administration (FDA) announced finalized rules for companies wishing to get FDA approval for tobacco products through the substantial equivalence…

FDA Says Premium Cigar Review Won’t Be Done Until Spring 2022, Withdraws ANRPM

It seems likely that cigar companies will have, at the very least, another year before the substantial equivalence process for “premium cigars” might resume according…

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 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…