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…
FDA Tells Court It Intends to Delay Substantial Equivalence for Premium Cigars, Research Premium Cigars
The U.S. Food & Drug Administration (FDA) intends on re-evaluating how it goes about regulating premium cigars, specifically, researching the potential health effects of smoking…
Federal Appeals Court Rejects Cigar Industry’s Appeal to Move Substantial Equivalence Deadline to August 2021
The substantial equivalence deadline will not be moving back to August 2021. A three-judge panel of the U.S. Court of Appeals for the Fourth Circuit…
FDA’s Substantial Equivalence Deadline Delayed Until Sept. 9, 2020
Cigar companies will not have to submit substantial equivalence until Sept. 9, 2020. After weeks of procedural legal functions, an agreed-upon 120-day delay of the…
Appeals Court Gives Green Light for FDA Substantial Equivalence Delay to September
As expected, a federal appeals court will allow for a 120-day delay of FDA’s substantial equivalence deadline—currently set for May 12—due to the coronavirus COVID-19…
Eight Cigar Companies & Two Cigar Trade Groups Seek Indefinite Delay of FDA Substantial Equivalence Due to Coronavirus
A new motion has been filed in one of the lawsuits related to the U.S. Food & Drug Administration’s (FDA) regulation of cigars, this time…
Court Signals FDA Substantial Equivalence Deadline Will be Delayed Until Sept. 9
While not yet official, the deadline for cigar companies to submit substantial equivalence reports to the U.S. Food & Drug Administration (FDA) will almost certainly…
FDA Asks Court to Delay Substantial Equivalence Deadline Until Sept. 9, 2020 Due to Coronavirus
The U.S. Food & Drug Administration (FDA) has asked a federal court to delay the substantial equivalence deadline—currently set for May 12, 2020—due to the…