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FDA

IPCPR & CRA Issue Joint Statement on Today’s FDA News

Today, Commissioner of the U.S. Food & Drug Administration, Dr. Scott Gottlieb, announced a new comprehensive plan for the approach the agency will take to the regulation of tobacco products, placing an emphasis on a science-based method, that notes a “continuum of risk” that recognizes the differences in tobacco products. Importantly, Dr. Gottlieb stated that FDA will reexamine the treatment of premium cigars under the agency’s current regulatory structure. Ultimately, the agency will open a […]

July 28, 2017 by The Cigar Authority

FDA Changes Product Application Submission Date To 8/8/21

The FDA issued a press release that announced comprehensive regulatory plan to shift trajectory of tobacco-related disease, death and to pursue lowering nicotine in cigarettes to non-addictive levels and create more predictability in tobacco regulation. The agency plans to issue this guidance describing a new enforcement policy shortly. Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for […]

July 28, 2017 by The Cigar Authority

Premium Cigar Exemption Included In Appropriations Bill

Yesterday, the House Appropriations Subcommittee on Agriculture passed legislation that includes a provision exempting premium cigars from FDA regulations. The provision, which applies the same definition for premium cigars as included in stand alone legislation already introduced and supported by over a quarter of Congress, applies the exemption for one full Fiscal Year (October 1, 2017 – September 30, 2018). The path forward for the bill remains long. The full Appropriations Committee must now consider […]

June 29, 2017 by The Cigar Authority

FDA Announces Revised Deadlines Following 90 Day Delay

The FDA has issued a revised guidance with new compliance deadlines for retailers and manufacturers. Below are highlights of the newly promulgated schedule. New Deadline Highlights Submission of cigar warning plans (August 10th, 2017) Manufacturer registration & product listing (September 30th, 2017) SE exemption requests (November 8th, 2017) Submission of health documents & ingredient listings (November 8th, 2017) Submission of SE Reports for non-grandfathered products (May 8th, 2018) Implementation of required health warnings and labeling […]

May 10, 2017 by The Cigar Authority

Senate Confirms Dr. Scott Gottlieb as FDA Commissioner

Earlier today the United States Senate confirmed Dr. Scott Gottlieb as the next Commissioner of the Food & Drug Administration (FDA). IPCPR applauds the Senate’s decision to put thoughtful and experienced leadership at the head of an organization as critical as the FDA. Dr. Gottlieb’s confirmation puts a reform minded physician with experience in both the public and private sectors in charge of a regulatory body that has too often failed in its mission to […]

May 9, 2017 by The Cigar Authority

Details Of Global Premium Joint Motion For 3 Month Extension On All Pending Deadlines

Earlier this week the FDA announced an extension of upcoming compliance deadlines under the deeming rule. Specifically, on May 1, 2017, the United States Department of Justice advised the United States District Court for the District of Columbia that the FDA will extend and defer enforcement of all future compliance deadlines under the Rule for three months, and that it plans to issue guidance to that effect. Today, The Cigar Authority received a copy of […]

May 3, 2017 by The Cigar Authority

Agreement Reached on Suspension of Regulations Cigar & Pipe Advocacy Groups Announce Rule Deferment Pending Further Review

The following press release comes from Cigar Rights of America announcing an extension of upcoming compliance. WASHINGTON, D.C. – Since July 15, 2016, Cigar Association of America (CAA), Cigar Rights of America (CRA), and the International Premium Cigar and Pipe Retailers Association (IPCPR) have been pursuing litigation in federal court against the United States Food and Drug Administration (FDA), challenging the FDA’s May 10, 2016 Rule deeming cigars and pipe tobacco to be tobacco products subject […]

May 1, 2017 by The Cigar Authority

States File In Support Of Opposition Of FDA Regulations Against Cigars

A rebellion. A group of freedom fights have signed up in support of the cigar industry against the tyrannical reign of the FDA. This group is in the form of states Arizona, Louisiana, Michigan and Texas for filed a 27 page brief opposing the FDA regulations of cigars. The brief which was filed on February 21 is part of the lawsuit which will be heard on July 28th, 2017 that puts plaintiffs Cigar Association of America, Cigar […]

February 22, 2017 by The Cigar Authority

Cigar Industry’s Lawsuit Against FDA Deeming Rule Moves Forward

WASHINGTON, D.C. – Yesterday, in the U.S. District Court for the District of Columbia, the Cigar Association of America, the International Premium Cigar & Pipe Retailers Association and Cigar Rights of America filed a Motion for Summary Judgment and opening brief in the cigar industry’s litigation challenging the FDA’s Final Deeming Rule. This filing serves as the next phase in the premium cigar industry’s joint litigation challenging FDA’s Final Deeming Rule, which began earlier this year in July […]

February 14, 2017 by The Cigar Authority

FDA Creates New Database For Grandfathered Tobacco Products

The FDA refers to a tobacco product that was commercially marketed (other than exclusively in test markets) in the U.S. as of Feb. 15, 2007, as a “grandfathered” tobacco product. These grandfathered products are not subject to the premarket requirements of the Federal Food, Drug, and Cosmetic Act and may serve as the predicate tobacco product in an application demonstrating substantial equivalence (SE) for a new tobacco product. The FDA’s new database contains determination information […]

February 7, 2017 by The Cigar Authority

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