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.


This document has been generated through artificial intelligence translation and is provided solely for the purposes of industry discourse and learning. Please note that the intellectual property rights of the content belong to the original media source or author. Owing to certain limitations in the translation process, there may be discrepancies between the translated text and the original content. We recommend referring to the original source for complete accuracy. In case of any inaccuracies, we invite you to reach out to us with corrections. If you believe any content has infringed upon your rights, please contact us immediately for its removal.

UK’s North Yorkshire Council plans up to £477,000 spend on e-cigarettes to support quitting smoking
UK’s North Yorkshire Council plans up to £477,000 spend on e-cigarettes to support quitting smoking
North Yorkshire Council in the UK is set to spend up to £477,000 on e-cigarettes to support residents quitting smoking. Since e-cigarettes were added to the council’s Living Well Smokefree service in July 2023, 487 people have used them to quit, with about a third remaining smoke-free after a year.
Mar.03 by 2FIRSTS.ai
York Traders Could Face Fines of Up to GBP 200 Under New Illegal Vape Enforcement Plans
York Traders Could Face Fines of Up to GBP 200 Under New Illegal Vape Enforcement Plans
City of York Council is considering new plans that would allow fines of up to GBP 200.00 (approximately USD 260.00) for traders caught selling illegal single-use vapes.
Apr.09 by 2FIRSTS.ai
Singapore New bill would raise maximum fines to S$200,000 for sellers and S$300,000 for smugglers
Singapore New bill would raise maximum fines to S$200,000 for sellers and S$300,000 for smugglers
A bill introduced in Singapore’s Parliament on Feb. 12 proposes major increases in penalties for vaping-related offences, including higher maximum fines for users, sellers and smugglers. The draft would also rename the current Tobacco (Control of Advertisements and Sale) Act as the Tobacco and Vaporisers Control Act.
Feb.28 by 2FIRSTS.ai
2Firsts|Sesh Advances Nicotine Pouch PMTA to Filing Stage, Experts Highlight Regulatory Threshold and Market Window
2Firsts|Sesh Advances Nicotine Pouch PMTA to Filing Stage, Experts Highlight Regulatory Threshold and Market Window
Sesh said its Premarket Tobacco Product Application (PMTA) for 64 nicotine pouch SKUs has been accepted by the U.S. Food and Drug Administration (FDA) and advanced to the Filing stage, entering substantive scientific review. Industry experts say the development signals that the application has crossed a key technical and regulatory threshold, while also highlighting growing divergence in regulatory capability and market positioning within the nicotine pouch category.
Special Report
Mar.24 by 2FIRSTS.ai
Nicokick and zone Extend NASCAR Collaboration for April 19 Kansas City Race
Nicokick and zone Extend NASCAR Collaboration for April 19 Kansas City Race
Nicokick.com said it will continue its collaboration with zone for a second year at the April 19 NASCAR race in Kansas City, appearing on Richard Childress Racing’s No. 8 Chevrolet driven by Kyle Busch. The 2026 race-weekend campaign for verified adult nicotine consumers aged 21 and older includes the exclusive launch of zone Cranberry and a limited-edition five-flavor mix pack selected by Busch.
Apr.16 by 2FIRSTS.ai
France’s HAS to Address Role of E-Cigarettes in Updated Smoking-Cessation Guidelines, Tells 2Firsts
France’s HAS to Address Role of E-Cigarettes in Updated Smoking-Cessation Guidelines, Tells 2Firsts
2Firsts has learned that France’s national health authority, the Haute Autorité de Santé (HAS), confirmed the role of e-cigarettes will be addressed in updated national smoking-cessation guidelines expected by the end of 2026. HAS said the recommendations will focus on clinical and public-health considerations, will not set technical standards for vaping products, and that current studies are insufficient to clearly assess risks and benefits across different product categories.
Mar.10