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FDA

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UPS No Longer To Handle Tobacco Weighing Less Than 4 pounds per 1,000

In recent days United Parcel Service has visited shippers of tobacco products with an agreement form prohibiting the shipment of tobacco products that weigh less than 4lbs per 1,000. These products are known in the industry as “Little Cigars.” According the the UPS website, the new measures being enforced are due to the FDA’s Final Rule which can be found at https://www.gpo.gov/fdsys/pkg/FR-2016-05-10/pdf/2016-10685.pdf. “Little Cigar” means any roll for smoking made of tobacco, wrapped in either paper or […]

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FDA Extending Ingredient Listing by 6 Months

This afternoon the FDA announced via its twitter feed that it was extending the compliance deadline for submitting ingredient listings for deemed tobacco products by 6 months. The move comes a little over two weeks after they announced they would be delaying the listing for people in areas affected by hurricanes flooding and fires. News of the delay came this morning from a major manufacturer who confirmed the news with IPCPR. Then at 2pm eastern time, […]

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House Bill Passes With Premium Cigar Exemption

Earlier today the US House of Representatives passed a 12 bill spending package that includes a provision prohibiting the FDA from enforcing regulations against premium cigars. The bill, known as an omnibus appropriations package, passed the House by 211-198 votes and will now move to the Senate for consideration. Congress has until December 8th to pass spending legislation and fund the federal government. So what does this mean? Section 752 of the House Agriculture Appropriations […]

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FDA Product Registration Remains September 30, 2017

Last month, the FDA issued a press release that changed the date product could stay on the shelves that was not FDA approved. The date changed from August 8, 2018 to August 8th, 2021. In that press release was language that stated, “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.” In an email with the FDA today a Food […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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