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.

Pennsylvania Lists 163 Vape Products Eligible for Sale, Including Vuse and JUUL; Previously Pending Chinese Brands Such as OXBAR Remain Absent, While Unlisted Products Including Geek Bar Face Enforcement From October 19
Pennsylvania Lists 163 Vape Products Eligible for Sale, Including Vuse and JUUL; Previously Pending Chinese Brands Such as OXBAR Remain Absent, While Unlisted Products Including Geek Bar Face Enforcement From October 19
Pennsylvania begins enforcing its electronic nicotine delivery system (ENDS) directory restrictions on October 19, 2026. The October 18 directory contained 163 product records from seven manufacturers, including Vuse, JUUL, NJOY, Logic and Naked 100. Geek Bar, RAZ and Lost Mary were absent. BAT, Altria, Japan Tobacco and JUUL collectively accounted for 112 records, or 68.7%, while Imperial Brands' blu had no listings. The directory included 15 disposable vape records, 40 bottled e-liquids and 10 products labeled 0mg, but no open-system refillable devices. Twenty-two manufacturer certifications remained under review. Four Logic models corresponding to Smoore's pending records were listed under the brand owner, while LYCO, OXBAR and Boulder/Rock had no approved directory entries.
Regulations
Oct.19
FDA Revises Import Alert 98-07 Rules, Bringing May Enforcement Priorities Into Unauthorized ENDS Detentions
FDA Revises Import Alert 98-07 Rules, Bringing May Enforcement Priorities Into Unauthorized ENDS Detentions
The U.S. Food and Drug Administration has revised the rules under Import Alert 98-07 to incorporate its May 2026 enforcement-priority policy for certain electronic nicotine delivery systems marketed without premarket authorization. The alert continues to allow detention without physical examination, or DWPE, for ENDS lacking required marketing authorization, while directing field divisions to apply the May risk-based framework. When necessary, detention or refusal decisions must also undergo review by the FDA's Center for Tobacco Products. Products including PACHA and Vuse Pro have already emerged as industry examples of the May policy, although enforcement discretion does not constitute FDA marketing authorization.
News
Sep.28 by 2Firsts Perspectives
PMI Expands Its Second Global and First Asian Business Services Hub in the Philippines, Serving 160 Markets and Scaling Up AI Capabilities
PMI Expands Its Second Global and First Asian Business Services Hub in the Philippines, Serving 160 Markets and Scaling Up AI Capabilities
Philip Morris International's PMI Business Solutions Philippines has expanded its global business services hub in Makati and plans to add more than 80 positions. Established in 2021 primarily to provide finance and IT support to about 20 markets, the center now employs 519 professionals delivering roughly 600 services across 160 markets. Its functions now span finance, human resources, IT, commercial operations, data analytics, supply chain and project management. PMI says the hub's next phase will focus on AI-enabled and higher-value work. The company did not disclose the size or investment cost of the expansion.
Sep.24
Spain Cigarette Volumes Fall 5.2% in August, BAT Drops 14.5%, JTI Gains Share; France Down 8.3% on Adjusted Basis
Spain Cigarette Volumes Fall 5.2% in August, BAT Drops 14.5%, JTI Gains Share; France Down 8.3% on Adjusted Basis
Spain's cigarette volumes declined 5.2% year over year in August 2026, according to government data cited by UBS and reported by Investing.com on October 7. British American Tobacco's volumes fell 14.5%, followed by Imperial Brands at 8.8%, Philip Morris International at 6.6% and Japan Tobacco at 4.6%. JTI was the only one of the four companies to gain cigarette market share, rising six basis points to 26.7%. In France, official customs data showed an unadjusted 3.7% decline in cigarette deliveries. Adjusting for the difference in delivery days produces a decline of approximately 8.3%, consistent with the UBS figure. The bank also estimated the earnings exposure of major tobacco companies to both markets.
Market
Oct.13
UK Vape Duty Starts in October as Hayati, DOJO and Others Launch Lower-Capacity Products With Lower Per-Unit Tax
UK Vape Duty Starts in October as Hayati, DOJO and Others Launch Lower-Capacity Products With Lower Per-Unit Tax
The UK's Vaping Products Duty will take effect on October 1, 2026, at a flat rate of £2.20 per 10ml of vaping liquid. Ahead of implementation, DOJO, PIXL and Hayati have introduced or been reported to be adding lower-capacity tiers alongside larger products. DOJO has added a 6ml BLAST7K Fresh below its 10ml BLAST10K Fresh, PIXL offers both a 12ml 8000 and a 6ml 5K, while retailer Ninja Vapes says Hayati is preparing a 7ml 4K alongside its existing 12ml 6K. The pattern points to a growing lower-capacity tier in the UK market, although the brands have not all explicitly linked the changes to the new duty.
Sep.23
Sweden Threatens EU Tobacco Tax Deal as Nicotine Pouch Duty Dispute Looms Over November 9 Meeting
Sweden Threatens EU Tobacco Tax Deal as Nicotine Pouch Duty Dispute Looms Over November 9 Meeting
Sweden is expected to oppose a European Union proposal to raise minimum tobacco excise duties, Law360 reported on October 26, 2026, citing an EU official. A provisional Council agenda dated October 23 confirms that the tobacco taxation package is scheduled for discussion at the November 9 finance ministers' meeting, where member states will seek a general approach. The proposed reforms would raise minimum taxes on conventional tobacco products and establish EU-wide excise rules for vaping liquids, heated tobacco and nicotine pouches. Sweden supports harmonising tobacco taxation rules but objects to requiring nicotine pouches to bear the same minimum tax burden as certain smoking tobacco products. As EU indirect tax legislation requires unanimous Council approval, Swedish opposition could block the proposal in its current form.
Regulations
Oct.29