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.

Interpreting FDA’s on! PLUS Authorization: What the Agency’s Press Release Reveals About Its Nicotine Pouch Review Model
Interpreting FDA’s on! PLUS Authorization: What the Agency’s Press Release Reveals About Its Nicotine Pouch Review Model
The U.S. Food and Drug Administration has confirmed that six on! PLUS nicotine pouch products have received Marketing Granted Orders (MGO) through the PMTA pathway. The authorizations were completed under the agency’s nicotine pouch review pilot program in “record time,” with the FDA citing lower levels of harmful constituents while stressing that the decision applies only to the specified products and does not mean they are safe or FDA approved.
Regulations
Dec.20
Two Taunton Shops Closed After Seizure of Illegal Tobacco and Vapes
Two Taunton Shops Closed After Seizure of Illegal Tobacco and Vapes
Two shops in Taunton have been ordered to close for three months after authorities found illegal tobacco and vape products worth around £50,000. The seizures followed joint operations involving Trading Standards officers, police and tobacco detection dogs. Magistrates ruled that closing the premises was necessary to prevent further criminal activity.
Dec.23 by 2FIRSTS.ai
KT&G Revises Partnership Terms with PMI, Secures Overseas Commercialization Rights for Multiple Heated Tobacco Platforms
KT&G Revises Partnership Terms with PMI, Secures Overseas Commercialization Rights for Multiple Heated Tobacco Platforms
KT&G has revised the terms of its 15-year partnership agreement with Philip Morris International (PMI), securing overseas commercialization rights for multiple heated tobacco platforms and adjusting the minimum guaranteed sales volume for lil-exclusive heated tobacco sticks from 16 billion units to 11 billion units.
Dec.12 by 2FIRSTS.ai
Philippines Probe Agency Seizes 800 Smuggled Vape Products in Manila, Stores Face Multiple Charges
Philippines Probe Agency Seizes 800 Smuggled Vape Products in Manila, Stores Face Multiple Charges
The National Bureau of Investigation (NBI) recently seized around PHP 250,000 (approximately USD 4,250) worth of smuggled and unregistered vape devices and liquids—about 800 items in total—from two stores in Manila. Authorities said the devices could be modified to discreetly consume cannabinoids and other illegal drugs, and that those involved will face charges under the Philippines’ Vaporized Nicotine and Non-Nicotine Products Regulation Act and the Consumer Act.
Dec.02 by 2FIRSTS.ai
Spain’s new e-cigarette e-liquid tax, in force since April 1, raises €26 million through November
Spain’s new e-cigarette e-liquid tax, in force since April 1, raises €26 million through November
Spain’s Tax Agency monthly collection report shows the new tax on e-cigarette e-liquids, in force since April 1, raised €26 million through November, including €4 million in November. The levy began three months later than the usual fiscal timetable to allow the sector to adapt, making 2025 the first year in which vaping products are taxed under a specific category.
Dec.30 by 2FIRSTS.ai
JUUL Files ITC Complaint over Vaporizer Device Infringement
JUUL Files ITC Complaint over Vaporizer Device Infringement
The U.S. International Trade Commission has instituted a Section 337 investigation following a complaint filed by JUUL Labs, Inc. and VMR Products LLC. The complaint alleges that certain vaporizer devices, cartridges and related components infringe two U.S. patents. The investigation covers importation, sale for importation and post-importation sales in the United States, with the complainants seeking a limited exclusion order and cease and desist orders.
Dec.19 by 2FIRSTS.ai