Some news came out this week from the FDA. How is the FDA defining a premium cigar, and what does it mean to the cigar industry? The Cigar Authority is a member of the United Podcast Network and is recorded live in front of a studio audience at Studio 21 Podcast Cafe upstairs at Two Guys Smoke Shop in Salem, NH and as always you can find many of the cigars we discuss at https://www.2GuysCigars.com/.
Judge Mehta of US District Court of Washington has issued a ruling that provides a temporary win for the cigar industry. In his 38 page ruling, Judge Mehta ruled, “The court therefore remands the Final Deeming Rule to the FDA to consider developing a streamlined substantial equivalence process for premium cigars. The court further enjoins the FDA from enforcing the premarket review requirements against premium cigars, as those products are defined in the August 2020 […]
The United States Food and Drug Administration and the United States Department of Health and Human Services, through the U.S. Justice Department, filed an appeal the decision of Judge Paul Grimm to the United States Court of Appeals for the Fourth Circuit in the case of American Academy of Pediatrics, et al. v. United States Food and Drug Administration, et al. On May 15, 2019, Judge Grimm found, in an opinion focused almost exclusively on […]
Cigar Rights of America is pleased to report that the FDA has appealed the decision of Judge Grimm of the United States District Court for the District of Maryland which dissolved the Guidance issued by the Food and Drug Administration delaying the filing date of Substantial Equivalence Reports for all newly deemed tobacco products, including Premium Cigars. The Government’s appeal of Judge Grimm’s ruling indicates that they believe that the FDA Guidance postponing enforcement of […]
The following statement from Dr. Scott Gottlieb was issued today via an FDA Press Release which deals with substantial equivalence among other things. Our comprehensive plan on tobacco and nicotine regulation, unveiled in July 2017, aims to tackle the leading cause of preventable death in the U.S. by focusing on two key areas: reducing the nicotine levels in combustible cigarettes to render them minimally or nonaddictive; and harnessing new forms of nicotine delivery that could […]