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.

Russia Moves Toward Full Ban on E-Cigarettes and Vapes, With Scope Still Under Discussion
Russia Moves Toward Full Ban on E-Cigarettes and Vapes, With Scope Still Under Discussion
Russia’s State Commission for Countering Illegal Trafficking in Industrial Products on March 25 supported an initiative to fully ban the production, import and circulation of electronic cigarettes, vapes and refill liquids in Russia.
Mar.26 by 2FIRSTS.ai
FDA Opens Public Comment Period on Draft Guidance for Flavored E-Cigarette Applications
FDA Opens Public Comment Period on Draft Guidance for Flavored E-Cigarette Applications
The U.S. Food and Drug Administration’s Center for Tobacco Products announced an open public comment period for a draft guidance titled Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk.
Apr.09 by 2FIRSTS.ai
JTI UK Updates Nordic Spirit Packaging to Strengthen “Strength and Flavour” Guidance
JTI UK Updates Nordic Spirit Packaging to Strengthen “Strength and Flavour” Guidance
Japan Tobacco International UK (JTI UK) has unveiled a refreshed brand identity for Nordic Spirit nicotine pouches. The new packaging is now live on JTI360 and will roll out to shelves over the coming months. The updated design strengthens on-pack guidance on strength and flavour, adding slower/faster release cues and a six-dot strength system (6–17mg). Each can contains 20 pouches and includes a lid compartment for storing used pouches before disposal.
Mar.04 by 2FIRSTS.ai
Fontem Sues FDA Over Refusal-to-File Decision for Nicotine Pouch PMTAs
Fontem Sues FDA Over Refusal-to-File Decision for Nicotine Pouch PMTAs
According to a complaint filed on March 17 in the U.S. District Court for the Northern District of Texas, Fontem US, LLC and Texas retailer OM Investment, LLC sued the Food and Drug Administration and the Department of Health and Human Services over FDA’s refusal-to-file decision for certain Zone nicotine pouch PMTAs.
Mar.19 by 2FIRSTS.ai
Malaysia anti-tobacco groups call for stronger enforcement as unregulated vapes remain on sale offline and online
Malaysia anti-tobacco groups call for stronger enforcement as unregulated vapes remain on sale offline and online
Anti-tobacco groups in Malaysia say the continued sale of unregulated vapes in physical stores and the online availability of vape devices underline the need for comprehensive enforcement.
Mar.02 by 2FIRSTS.ai
Imperial Tobacco Canada Responds to Anti-Smoking Groups on Youth Vaping
Imperial Tobacco Canada Responds to Anti-Smoking Groups on Youth Vaping
Imperial Tobacco Canada responded to the April 17 press conference by anti-smoking groups by calling for a more focused, fact-based discussion on youth vaping that targets the illicit market. The company said youth should not be using nicotine products and that it supports strong measures to prevent youth access, but argued that the discussion failed to clearly distinguish between the regulated market and the illicit market that is driving youth access.
Apr.22 by 2FIRSTS.ai