Tobacco & Nicotine Products

Dockets

Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products; Notice of Meeting; Establishment of a Public Docket; Request for CommentsFDA
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DAB Civil Money Penalty; Vape & Cigar Cloud, Inc., d/b/a Tobacco Cloud; CLOSED 6/2/2026FDA
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Regulations Restricting the Sale & Distribution of Cigarettes & Smokeless Tobacco to Protect Children & AdolescentsFDA
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Jurisdiction Nicotine Cigarette/Smokeless Tobacco ProductsFDA
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Deeming Tobacco Products To Be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco ProductsFDA
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Petitioner requests that the U.S. Food and Drug Administration’s (“FDA”) Center for Devices and Radiological Health (“CDRH”) withdraw approval of Premarket Approval Number P140018 for the VenaSeal® Closure System (“VenaSeal®”).FDA
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Modified Risk Tobacco Product Applications for VLN™ King and VLN™ Menthol King, Combusted, Filtered Cigarettes, Submitted by 22nd Century Group Inc.FDA
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Requests the Food and Drug Administration (FDA) to take the following actions to accelerate access to Pritelivir, an investigational treatment for Herpes Simplex Virus (HSV) patients. 1. Grant Expanded Access (Compassionate Use) to Pritelivir under the existing Expanded Access Programs (EAP) to allow patients with severe or refractory HSV infections access to the drug.FDA
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DAB Civil Money Penalty: Raz Tobacco & Vape Inc., d/b/a Raz Tobacco & Vape; CLOSED 4/27/2026FDA
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DAB Civil Money Penalty; SRA Inc. d/b/a Vape Lordz & Tobacco; CLOSED 5/14/2026FDA
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DAB Civil Money Penalty; Sky Hookah & Tobacco, Inc. d/b/a Sky Tobacco-Vape-Hookah; CLOSED 03/17/2026FDA
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Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and AdolescentsFDA
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Requesting the FDA to stay of the MDO and asks the Commissioner to direct CTP to reconsider Logic’s menthol ENDS PMTAs in light of the discussion hereinFDA
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Requests that FDA, under FDCA §505G(b) (OTC monograph administrative order process), amend OTC Monograph M013 to update Drug Facts labeling for all over-the-counter acetaminophen-containing products. In the alternative, Petitioner asks FDA to initiate such an order on its ownFDA
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Statement of Policy – Considerations for Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications; Draft Guidance for Industry; AvailabilityFDA
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Enforcement Policies for Certain Electronic Nicotine Delivery Systems (ENDS) Marketed Without Premarket Authorization; Guidance for Industry; AvailabilityFDA
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DAB Civil Money Penalty; Marion Tobacco and Vape LLC d/b/a Marion Tobacco and Vape; CLOSED 3/31/2026FDA
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DAB Civil Money Penalty; Highland Tobacco & Vape, Inc., d/b/a Vape N Tobacco; CLOSED 03/27/2026FDA
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DAB Civil Money Penalty; MSAM Company, Inc., d/b/a Greenleaf Vape & Tobacco; CLOSED 3/18/2026FDA
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DAB Civil Money Penalty; Festus Tobacco & Vape Inc., d/b/a Puff Zone Smoke Shop; CLOSED 4/1/2026FDA
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DAB Civil Money Penalty; Super Tobacco 3 LLC, d/b/a Tobacco Vape Center; CLOSED 3/17/2026FDA
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DAB Civil Money Penalty; Charleston Smoke Shop LLC d/b/a Tobacco & Vape; CLOSED 03/19/2026FDA
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DAB Civil Money Penalty; Express Tobacco & Vape Inc. d/b/a Express Tobacco & Vape; CLOSED 04/01/2026FDA
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DAB Civil Money Penalty; 3M Mart & Vape LLC, d/b/a 3M Tobacco & Vape; CLOSED 4/15/2026FDA
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DAB Civil Money Penalty; Todds Lane Tobacco & Gift LLC, d/b/a Hypernova Smoke Vape; CLOSED 04/16/2026FDA
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DAB Civil Money Penalty; Conway Tobacco & Vapor LLC d/b/a Tobacco & Vape; CLOSED 04/09/2026FDA
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DAB Civil Money Penalty; S Tobacco 5 Inc. d/b/a Tobacco & Vape; CLOSED 4/28/2026FDA
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DAB Civil Money Penalty; Smoke 2 Go LLC d/b/a Smoke To Go Tobacco & Vape; CLOSED 04/10/2026FDA
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DAB Civil Money Penalty; Lakeville Tobacco & Vape LLC d/b/a Tobacco E-Cig's Center; CLOSED 3/17/2026FDA
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DAB Civil Money Penalty; A & A Tobacco, LLC., d/b/a 6th Street Smoke Shop & Vape; CLOSED 4/2/2026FDA
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DAB Civil Money Penalty; Best Vape LLC d/b/a S & N Tobacco & Convenience Store; CLOSED 06/11/2026FDA
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