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.

PMI Q2 Call: ZYN Growth, IQOS Pricing and a Diverging Global Tobacco Market
PMI Q2 Call: ZYN Growth, IQOS Pricing and a Diverging Global Tobacco Market
Philip Morris International’s second-quarter earnings call offered new detail on its smoke-free strategy. Management said it would increase U.S. investment behind nicotine pouch brand ZYN, keep IQOS focused on volume before stronger pricing, and use SENTIA, DELIA, LEVIA, VEEV and ZYN to manage tax and regulatory pressure across Japan and Europe. Analysts from Goldman Sachs, Morgan Stanley, UBS and other firms also pressed PMI on profitability, market share, cigarette resilience and the durability of its global transformation over coming quarters.
Jul.24
2Firsts Interview | InterTabac 2026 Adapts to a More Complex Tobacco and Nicotine Market
2Firsts Interview | InterTabac 2026 Adapts to a More Complex Tobacco and Nicotine Market
As InterTabac 2026 approaches, Sabine Loos, Managing Director of Westfalenhallen Unternehmensgruppe, tells 2Firsts that global tobacco trade fairs are evolving beyond product display. With new nicotine categories, shifting regulation and more complex supply chains reshaping the industry, InterTabac is positioning itself as a platform for market insight, regulatory discussion and global business connection.
Special Report
Jul.02
BREAKING | China’s Tobacco Regulator Summons iMiracle Over Suspected Compliance Breaches
BREAKING | China’s Tobacco Regulator Summons iMiracle Over Suspected Compliance Breaches
Based on public records reviewed by 2Firsts, this is the first time China’s State Tobacco Monopoly Administration has publicly announced regulatory talks with an e-cigarette company.
Jul.29
Former FDA Scientist Questions ZYN Review Over Pouch Material and Microplastic Risk
Former FDA Scientist Questions ZYN Review Over Pouch Material and Microplastic Risk
A former FDA toxicologist has questioned whether the agency fully assessed the material used in ZYN nicotine pouches before authorizing them for sale, raising concerns over possible microplastic exposure, according to STAT and The Examination.
Jul.16
Malaysia Police Plan Saliva Tests at Roadblocks to Detect Synthetic Drugs Mixed Into Vape Liquids
Malaysia Police Plan Saliva Tests at Roadblocks to Detect Synthetic Drugs Mixed Into Vape Liquids
Malaysian police plan to use saliva test kits at roadblocks to detect drivers using synthetic liquid drugs marketed as “Piu Piu” and “Magic Mushroom,” substances that authorities say are mixed into vape liquids and inhaled through e-cigarette devices, raising road-safety concerns and adding pressure on vape regulation.
Jun.29
Product | PMI Japan Launches SENTIA Passion Fruit Capsule, Expanding the IQOS ILUMA Flavor Portfolio
Product | PMI Japan Launches SENTIA Passion Fruit Capsule, Expanding the IQOS ILUMA Flavor Portfolio
Philip Morris Japan (PM Japan) has introduced SENTIA Passion Fruit Capsule, a new tobacco stick designed for the IQOS ILUMA heated tobacco platform. Featuring a crush-activated capsule, the product combines menthol with passion fruit flavor to provide an additional flavor experience. The product launched in Japan from August 3, 2026, through IQOS official channels, convenience stores and tobacco retailers.
Aug.04