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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
At a June 20th, 2017 Senate Appropriations Committee to discuss the 2018 Fiscal Year Budget for the U.S. Food and Drug Administration, Senator Marco Rubio brought up the Deeming Rule and the current impacts on the premium cigar market. Senator Rubio asked FDA Commissioner Dr. Scott Gottlieb if there were any plans to re-evaluate the inclusion of […]
Last week came word that the U.S. Food and Drug Administration (FDA) will extend and defer enforcement of all future compliance deadlines under the Rule for cigar and pipe tobacco products for three months (90 days). Yesterday, the FDA published a guidance document containing the revised compliance dates. The new timetable applies to compliance deadlines […]
The U.S. Food and Drug Administration (FDA) has a new Commissioner in Dr. Scott Gottlieb. Today Gottlieb was confirmed by the United States Senate in a vote of 57 -42. Gottlieb, a physician and former Deputy Commissioner at the FDA was nominated by President Donald Trump back in March. Late last month, he was approved […]
