FDA Orders Cease and Desist of Unauthorized E-Cigarette Sales

Dec.14.2022
FDA Orders Cease and Desist of Unauthorized E-Cigarette Sales
Six US companies and individuals face legal action for unlawfully manufacturing and selling unauthorised e-cigarette products.

In December of last year, the United States filed a complaint against six companies and associated individuals, demanding that they cease the illegal manufacture and sale of unauthorized e-cigarette products. These charges were brought on behalf of the US Food and Drug Administration.


According to Bloomberglaw, two of the six companies, Seditious Vapors LLC and Vapor Craft LLC, which manufacture electronic cigarettes, must stop distribution and sales of their products based on two separate court orders that comply with the ban requested by the FDA.


Judge Douglas L. Rayes of the Arizona District Court has ruled in favor of the Food and Drug Administration's argument that Seditious Vapors failed to submit a pre-market application for their electronic cigarettes and subsequently illegally manufactured, sold, and distributed them. The order was submitted on Friday.


Two days ago, Judge Clay D. Land of the U.S. District Court for the Middle District of Georgia issued a permanent injunction against Vapor Craft.


The FDA has stated that the accused has continued to manufacture, sell, and distribute unauthorized electronic cigarettes to consumers despite receiving a warning letter from the agency. The previous warning from the FDA had indicated that further violations could lead to enforcement actions, including a ban.


These cases are an important step in stopping the illegal sale of unauthorized electronic nicotine delivery system products," said Brian M. Boynton, Chief of Staff and Senior Counselor of the Civil Division of the Department of Justice. "The Department of Justice will continue to work closely with the FDA to crack down on the distribution of illegal and unauthorized tobacco products.


When a company produces and sells unauthorized tobacco products, the FDA typically issues a warning letter first in an attempt to achieve voluntary compliance with the law. If the FDA documents continued noncompliance, the agency may request that the Department of Justice take enforcement actions, such as injunctions or seizures.


The six companies who initially proposed the ban were:


Morin Enterprises Inc. operates E-Cig Crib in the Minnesota region, Soul Vapor LLC located in the southern district of West Virginia, Super Vape'z LLC in the western district of Washington, Vapor Craft LLC in the central region of Georgia, Lucky's Convenience & Tobacco LLC d/b/a Lucky's Vape & Smoke Shop in the Kansas area, and Seditious Vapors LLC d/b/a in the Arizona region. Additionally, Seditious Vapors LLC has administrative and civil penalty authority over violations of the FD&C Act related to tobacco products in their jurisdiction, working closely with the FDA.


2FIRSTS will continue to report on this topic and further updates will be available on the '2FIRSTS APP'. Scan the QR code below to download the app.



Disclaimer

This article is provided solely for professional research, industry discussion, and informational purposes. Any references to brands, companies, products, technologies, or policies are made for factual reporting and analytical purposes only, and do not constitute endorsement, recommendation, promotion, or advertising by 2Firsts.

Nicotine-containing products, including but not limited to cigarettes, e-cigarettes, heated tobacco products, and nicotine pouches, carry significant health risks. Readers are responsible for complying with all applicable laws and regulations in their respective jurisdictions, including age restrictions and access limitations.

The information contained in this article should not be regarded as investment, legal, medical, regulatory, or commercial advice. While 2Firsts strives to ensure the accuracy and reliability of its content, it does not assume liability for any direct or indirect loss arising from errors, omissions, inaccuracies, or reliance on the information contained herein.

This article is not intended for individuals below the legal age for accessing tobacco or nicotine-related information in their jurisdiction.

 

Copyright Notice

This article is either original content produced by 2Firsts or content reproduced, translated, summarized, or adapted from third-party sources with attribution where applicable. The intellectual property rights of the original content remain with 2Firsts or the respective original rights holders.

No individual or organization may copy, reproduce, distribute, republish, modify, translate, or otherwise use this content without prior authorization. Any unauthorized use may result in legal action.

For copyright-related inquiries, corrections, or removal requests, please contact: info@2firsts.com.

 

AI-Assisted Translation and Editing Notice

Portions of this article may have been translated, edited, or reviewed with the assistance of artificial intelligence tools to improve efficiency and readability. Due to the limitations of AI-assisted translation and editing, discrepancies, omissions, or inaccuracies may exist when compared with the original source.

Where applicable, readers are advised to refer to the original source for the most complete and accurate information. If you identify any errors or believe that any content infringes upon your rights, please contact us at info@2firsts.com, and we will review and address the matter promptly.

New York’s 75% Wholesale Tax on Nicotine Pouches Takes Effect Sept. 1, With Aug. 31 Inventory Subject to Floor Tax
New York’s 75% Wholesale Tax on Nicotine Pouches Takes Effect Sept. 1, With Aug. 31 Inventory Subject to Floor Tax
New York State will extend its tobacco products tax to “alternative nicotine products,” including tobacco-free nicotine pouches, from September 1, 2026, at a rate of 75% of the wholesale price. Distributors, wholesalers and retailers must also inventory products held as of 11:59 p.m. on August 31 and pay a floor tax. Vapor products are excluded from the new category and remain subject to New York's separate 20% supplemental sales tax on the retail price.
Aug.26
Canada Health Minister Says She Is Not Considering Looser Nicotine Pouch Retail Rules as PMI-Linked Group Pushes for Wider Access
Canada Health Minister Says She Is Not Considering Looser Nicotine Pouch Retail Rules as PMI-Linked Group Pushes for Wider Access
Canadian Health Minister Marjorie Michel says she is not considering loosening retail restrictions on nicotine pouches. Canada regulates pouches containing 4 mg or less of nicotine per unit as non-prescription nicotine replacement therapy and requires newer NRT formats such as pouches to be sold from behind pharmacy counters. Meanwhile, Unsmoke Canada, linked to Philip Morris International's Canadian business, is pushing to allow pouches in convenience stores and other general retail outlets. Health Canada also acknowledges continued unauthorized sales, while recent research shows rising pouch use among Canadian youth aged 16 to 19.
Sep.24
China Tobacco Zhejiang files patent for pressure-triggered, on-demand oral nicotine release
China Tobacco Zhejiang files patent for pressure-triggered, on-demand oral nicotine release
China Tobacco Zhejiang Industrial Co., Ltd. has filed a patent application for an oral nicotine delivery product designed to let users actively adjust nicotine release. The product embeds two types of nicotine reservoirs with different wall thicknesses and positions inside a deformable matrix. Pressure applied with the tongue or lips can rupture the reservoirs and accelerate nicotine release. In simulated oral tests, several patent examples showed sharply higher peak nicotine release rates as applied force increased from 0 N to 1 N and 3 N. The filing explores a shift from preset release profiles toward user-triggered nicotine delivery.
Sep.01
NATO Executive Director David Spross Sees U.S. Vape Regulation Improving, Calls for More PMTA Authorizations and Warns of 2027 State Tax Pressure
NATO Executive Director David Spross Sees U.S. Vape Regulation Improving, Calls for More PMTA Authorizations and Warns of 2027 State Tax Pressure
The National Association of Tobacco Outlets is calling for more FDA marketing authorizations, greater transparency in the PMTA process and continued enforcement against unauthorized e-cigarettes, even as its executive director, David Spross, points to recent regulatory developments as signs of progress. At the state level, excise taxes, flavor restrictions and vapor product directories remain major issues for tobacco retailers. By August 2026, 17 states had enacted laws establishing state-managed e-cigarette directories or similar systems.
Innovation
Sep.29 by 2Firsts Perspectives
PMI Expands U.S. ZYN Portfolio With New 1.5 mg and 8 mg Strengths, Moves Toward a Unified 20-Pouch-Per-Can Format
PMI Expands U.S. ZYN Portfolio With New 1.5 mg and 8 mg Strengths, Moves Toward a Unified 20-Pouch-Per-Can Format
Philip Morris International is expanding its U.S. ZYN nicotine pouch portfolio with new 1.5 mg and 8 mg strengths and plans to move its core 3 mg and 6 mg dry-pouch products from 15 to 20 pouches per can in the fourth quarter of 2026. ZYN ULTRA is also commercially available, with FDA authorization covering 10 products at 9 mg and one 11 mg Smooth product. PMI U.S. lists the new 1.5 mg and 8 mg strengths as commercially available, but as of September 10 they do not appear on the FDA’s public authorization list. Public materials do not identify which PMTA submissions cover the two new strengths or their current review status.
Sep.11
EU Tobacco Tax Reform Targets November Push as Sweden Holds Nicotine-Pouch Minimum at €20 per Kilogram
EU Tobacco Tax Reform Targets November Push as Sweden Holds Nicotine-Pouch Minimum at €20 per Kilogram
The Irish presidency of the Council of the European Union is using bilateral talks to push the bloc’s Tobacco Taxation Directive toward a political agreement in November. According to Law360, citing an EU official, Sweden is unwilling to accept a minimum excise threshold above €20 per kilogram for nicotine pouches. Council negotiations have already lowered the European Commission’s original proposal, but a May 2026 presidency compromise still set the minimum at 10% of the tax-inclusive retail price or €30 per kilogram in 2028-29, with higher levels later.
Market
Sep.17 by 2Firsts Perspectives