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.

Product | DOJO Launches 0+6ml BLAST7K Fresh in UK in September, Retaining 2+8ml Pod Compatibility Ahead of October Per-Milliliter Vaping Duty
Product | DOJO Launches 0+6ml BLAST7K Fresh in UK in September, Retaining 2+8ml Pod Compatibility Ahead of October Per-Milliliter Vaping Duty
DOJO officially launched the BLAST7K Fresh on September 17, 2026, introducing a UK-market prefilled pod product with 6ml of e-liquid and a manufacturer-rated capacity of up to 7,000 puffs. The device features a 1000mAh rechargeable battery, the INSTA-JUICED structure and COREX BLAST dual-mesh technology, while retaining compatibility with existing BLAST pods. The launch comes less than two weeks before the UK's Vaping Products Duty takes effect on October 1. At the new duty rate, 6ml of vaping liquid would correspond to £1.32 in VPD. DOJO has not stated that the product's 6ml format was designed in response to the new duty.
Sep.20
China Tobacco Yunnan files patent for cellulose-free nicotine pouch scaffold to replace microcrystalline cellulose
China Tobacco Yunnan files patent for cellulose-free nicotine pouch scaffold to replace microcrystalline cellulose
China Tobacco Yunnan Industrial Co., Ltd. has filed a patent application for a cellulose-free scaffold material for nicotine pouches, proposing a combination of bioceramic material, polydextrose and sugar alcohols to replace conventional microcrystalline cellulose and cellulose derivatives. The filing aims to address issues including powdery mouthfeel, residue and limited release control, while also reducing reliance on existing cellulose-based patent portfolios. In patent examples, one fast-release formulation reached a nicotine release rate of 50% at 10 minutes and more than 90% at 20 minutes.
Sep.02
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
Snowplus Enters Japan’s FamilyMart Network With Zero-Nicotine NEO Line and Kishidan Campaign
Snowplus Enters Japan’s FamilyMart Network With Zero-Nicotine NEO Line and Kishidan Campaign
Snowplus distributor H&S said the zero-nicotine, zero-tar NEO vaping line will begin rolling out across FamilyMart stores in Japan from September 14, 2026, excluding some locations. The DASH line will also be sold at selected FamilyMart stores in southern Kyushu and Okinawa. Snowplus simultaneously named Japanese rock band Kishidan as a brand ambassador, combining convenience-store distribution with a broader consumer marketing push in Japan.
Sep.15
Charlie’s Says 30 PACHA Vape SKUs Tentatively Identified for FDA’s Non-Priority Enforcement Public List
Charlie’s Says 30 PACHA Vape SKUs Tentatively Identified for FDA’s Non-Priority Enforcement Public List
Charlie’s Holdings said the U.S. Food and Drug Administration notified the company on June 23, 2026, that 30 PACHA vape SKUs with submitted PMTAs had been tentatively identified for inclusion on a planned public-facing FDA webpage. Under enforcement guidance issued by FDA in May, the webpage is intended to identify certain unauthorized products for which the agency generally does not intend to prioritize enforcement of premarket authorization requirements. Charlie’s disclosed the development alongside second-quarter revenue of $3.8 million, up 116% year over year.
Aug.25
Product | PMJ Adds Bold Ruby to IQOS ILUMA i Lineup in Japan, Convenience-Store Rollout Starts Sept. 29
Product | PMJ Adds Bold Ruby to IQOS ILUMA i Lineup in Japan, Convenience-Store Rollout Starts Sept. 29
Philip Morris Japan (PMJ) launched Bold Ruby as a new regular color for the IQOS ILUMA i and IQOS ILUMA i ONE in Japan on September 16, 2026, priced at JPY 6,980 and JPY 3,980, respectively. Initial sales began through IQOS online and physical channels, with convenience stores and selected tobacco retailers set to follow from September 29. Bold Ruby is a regular rather than limited-edition colorway and is available for the ILUMA i and ILUMA i ONE, but not the ILUMA i PRIME. The release does not involve changes to the devices' core hardware or functions.
Sep.22