FDA Issues Warnings to Online Retailers for Selling Unauthorized E-cigarette Products

Aug.24.2023
FDA Issues Warnings to Online Retailers for Selling Unauthorized E-cigarette Products
FDA Warns Online Retailers for Selling Unauthorized E-cigarette Products with Child Attractive Packaging Designs.

On August 23rd, the Food and Drug Administration (FDA) issued warning letters to 15 online retailers for the sale and/or distribution of unauthorized e-cigarette products. The packaging designs of these products appeared to be targeting children, resembling characters, educational materials, toys, and beverages.


The FDA also stated that, considering the deceiving appearance of these illicit products, they are also planning to caution parents, teachers, and other adults to remain vigilant before the start of the new school year.


Dr. Brian King, director of the FDA's Center for Tobacco Products (CTP), stated


The design of these products shamelessly aims to attract children, even though adults use e-cigarettes to quit smoking, they don't need them to look like SpongeBob SquarePants in order to be successful.


The unauthorized products described in the warning letter include:


Featuring popular characters that captivate children in TV shows, movies, and video games, including "SpongeBob SquarePants," "Care Bears," and "Mario.


Designed to resemble learning tools that appeal to children, such as highlighter pens, and toys like Nintendo Game Boy and digital cameras; imitating beverages that attract children, like Starbucks and Dunkin' Donuts' coffee cups, soda cans, and water bottles.


The FDA states that the retailers who received these warning letters have been selling and/or distributing e-cigarette products in the United States without FDA authorization, which is a violation of the Federal Food, Drug, and Cosmetic Act's requirement for legally selling new tobacco products.


In addition to the specified products mentioned in the warning letter, these retailers have also been cautioned to address any similar violations to those described in the warning letter and promptly take any necessary actions to ensure that their tobacco products sold in the United States comply with the Federal Food, Drug, and Cosmetic Act.


These retailers have been asked to respond within 15 working days, outlining the measures they will take to rectify the violations and prevent future non-compliance. If the violations are not promptly addressed, the FDA may take further action, such as imposing bans, sealing premises, and/or imposing civil fines.


The following is a list of retailers who were recently issued warning letters:


Dr. Ann Simoneau, Director of FDA Compliance and Enforcement Office, stated:


As usual, we will hold responsible anyone involved in the sale of unauthorized tobacco products that are designed with promotions, advertisements, and/or encourage the use by our country's youth.


As of August 2023, the FDA has issued warning letters to approximately 600 companies for manufacturing and/or distributing illegal tobacco products, including e-cigarette products. It has also filed civil penalty complaints against 26 e-cigarette manufacturers and is collaborating with the Department of Justice to seek injunctions against six e-cigarette manufacturers.



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.

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
UK HMRC Launches Vape Duty Stamps on October 1, Ushering in Supply-Chain Traceability as Chinese Exporters Face New Compliance Hurdles
UK HMRC Launches Vape Duty Stamps on October 1, Ushering in Supply-Chain Traceability as Chinese Exporters Face New Compliance Hurdles
HM Revenue & Customs put the UK's Vaping Products Duty and Vaping Duty Stamps Scheme into effect on October 1. All vaping liquids manufactured in or imported into the UK are now subject to duty at £2.20 per 10ml, regardless of nicotine content. The stamp regime will introduce digital functionality designed to provide traceability throughout the supply chain, with approved manufacturers, importers and warehousekeepers required to report product movements and retailers and consumers eventually able to scan stamps to verify authenticity. China exported $177 million of vape-related products to the UK in August, up 51.4% year over year, increasing the significance of the new compliance regime for China's Shenzhen-centered vape supply chain.
Regulations
Oct.04
Imperial Brands Acquires Helwit Owner Yoik Group for SEK 515 Million, More Than Doubling Swedish Nicotine Pouch Share
Imperial Brands Acquires Helwit Owner Yoik Group for SEK 515 Million, More Than Doubling Swedish Nicotine Pouch Share
Imperial Brands has agreed to acquire 100% of Swedish modern oral nicotine company Yoik Group AB for an initial SEK515 million, equivalent to about US$53.9 million, plus a deferred payment linked to performance over the next two years. Yoik owns nicotine pouch brand Helwit, which held about 3.4% of Sweden’s modern oral nicotine market over the past 12 months. Imperial says the acquisition will more than double its existing share of the Swedish market. Helwit is also sold elsewhere in the Nordics, through European online channels and in selected UK retail outlets.
Sep.08
2Firsts Compliance Solutions Hosts PMTA Briefing on FDA Review Signals After JUUL2 Authorization
2Firsts Compliance Solutions Hosts PMTA Briefing on FDA Review Signals After JUUL2 Authorization
Following recent FDA authorizations for JUUL2 and ZYN ULTRA, 2Firsts Compliance Solutions held an online PMTA briefing on Sept. 4 to examine what the decisions may signal about review efficiency, scientific evidence and U.S. market access. Nearly 30 participants from brands, manufacturers, compliance service providers and investment firms joined the discussion.
2Firsts Events
Sep.06
Product | Four CrossBar 20K 13mL High-Puff Vapes Listed on Pennsylvania's ENDS Directory, Rated for Up to 20,000 Puffs
Product | Four CrossBar 20K 13mL High-Puff Vapes Listed on Pennsylvania's ENDS Directory, Rated for Up to 20,000 Puffs
Four CrossBar 20K disposable e-cigarettes appeared on Pennsylvania's 163-entry ENDS directory ahead of enforcement beginning October 19, 2026. The devices feature 13mL e-liquid reservoirs, 50mg/mL nicotine, 2,000mAh batteries and 0.9Ω mesh coils, with advertised puff counts of up to 20,000. CrossBar was the only modern high-puff disposable series among the directory's 15 disposable entries. Its packaging emphasizes New York design and Japanese-origin flavoring, while historical CrossBar records identify a registered U.S. tobacco manufacturing-related establishment. The link between the newer 13mL devices and earlier 1.3mL PMTA filings remains unconfirmed.
product
Oct.26
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