For Special Edition #8, Bear and Coop discuss FDA Commissioner Dr. Scott Gottlieb’s announcements from 7/27/17. This included moving the date for pre-market approval for premium cigars to remain on the market that were not grandfathered, re-opening the discussion for how premium cigars should be regulated, and focusing around reducing nicotine in tobacco products. The guys also discuss […]
Cigar News: Global Premium Cigars Lawsuit Against FDA Suspended
William Cooper Cigar News No Comments FDA, News
H New Media, the law firm owned by Frank Herrera representing a group led by Global Premium Cigars in a lawsuit against the U.S Food and Drug Administration (FDA) has announced that both parties have agreed to a Joint Motion to Stay the Case. This essentially suspends the case, but gives an option for either […]
Feature Story: Evaluating the Three-Year Delay Issued by the FDA
William Cooper Feature Story 2 Comments FDA, Feature Story
On July 28, 2017, newly appointed U.S. Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb unveiled a tobacco program known as Protecting American Families: Comprehensive Approach to Nicotine and Tobacco. One component of this program was a plan to push the deadline for cigar and pipe tobacco companies to submit products for FDA approval out nearly […]
Cigar News: FDA Extends Market Approval Date for Premium Cigars and Pipe Tobacco to August 8, 2021
William Cooper Cigar News 1 Comment FDA, News
In a speech to U.S. Food and Drug Administration (FDA) employees, FDA Commissioner Scott Gottlieb announced a near-three-year delay for cigar makers to be required to get agency approval for any product marketed after February 15, 2007. This moves the deadline from November 8, 2018 to August 8, 2021 to keep a non-grandfathered product on […]
Cigar News: Seven Vitolas of Illusione Original Documents Receive Grandfather Determination
William Cooper Cigar News No Comments FDA, Illusione, News
This past week Illusione Cigars received a grandfather determination by the U.S. Food and Drug Administration (FDA) on seven sizes from its “Original Document” line. The five products are individual vitolas: Illusione 2 Illusione 4/2g Illusione 68 Illusione 88 Illusione 888 Illusione cg4 Illusione f9 Under the Deeming Regulations, products that were commercially marketed on […]
Cigar News: Six Public Health Organizations Petition Federal Court for Motion to Intervene in Cigar Industry Lawsuit
William Cooper Cigar News 2 Comments FDA, News
This past Monday, July 24, six public health organizations have filed a motion to intervene as defendants in two lawsuits against the U.S. Food and Drug Administration (FDA) brought forward by the premium cigar and electronic cigarette industries. The six organizations include: The American Academy of Pediatrics The American Cancer Society Cancer Action Network The American Heart […]
News: Court Rules in Favor of FDA in Summary Judgment Against Nicopure and Vaping Industry
William Cooper Cigar News 1 Comment FDA, News, Nicopure Labs LLC
The U.S. District Court for the District of Columbia has ruled in favor of the U.S. Food and Drug Administration (FDA) in a motion for Summary Judgment in a case against Nicopure LLC and the Vaping Industry. For now, this essentially throws out the legal challenge initiated by the vaping community last year. The decision was made by […]
Cigar News: Senators Rubio and Manchin Push for Premium Cigar Exemption from FDA Regulation
William Cooper Cigar News 6 Comments FDA, News
Last week, language was placed in the House Appropriations Bill calling for a premium cigar exemption from FDA regulation. A companion bill is now being deliberated in the Senate – and its a bill that doesn’t currently contain language for an exemption. Today, Senators Marco Rubio [R-Florida] and Joe Manchin [D-West Virginia] expressed support before a Senate Appropriations Committee […]
Cigar News: Premium Cigar Exemption and Predicate Date Change Make Final Appropriations Bill
William Cooper Cigar News 5 Comments FDA, News
Yesterday, the U.S. House of Representatives Appropriations Committee approved the Agriculture Appropriations Bill, which was drafted by a subcommittee last month. Included in the bill is an exemption for premium cigars from regulation as well as a recommended change of the predicate date from the U.S. Food and Drug Administration (FDA). That language has now made it […]
Cigar News: Proposed Premium Cigar Exemption and Grandfather Date Change Clears House Appropriations Subcommittee
William Cooper Cigar News 1 Comment FDA, News
It’s a road the premium cigar business has been down before, but yesterday a proposed House Agriculture Appropriations Bill has cleared a subcommittee with language that contains an exemption for premium cigars and for a change in the grandfather date for premium cigar products to be exempted from regulation. The central point of interest for cigar […]