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.

Philippines BIR Steps Up Illicit Vape Enforcement Ahead of Christmas Shopping
Philippines BIR Steps Up Illicit Vape Enforcement Ahead of Christmas Shopping
The Philippines’ Bureau of Internal Revenue is intensifying enforcement against illicit vape and tobacco products ahead of the Christmas shopping season, directing regional and enforcement offices to strengthen monitoring of production sites, warehouses, distribution channels and retail outlets. The BIR destroyed 240,550 illicit vape products in August with an estimated tax liability of about PHP1.53 billion. A nationwide tax-compliance operation in July also inspected 3,590 businesses involved in tobacco and vapor products.
Regulations
Sep.17 by 2Firsts Perspectives
U.S. House Defense Bill Includes Pilot Review of Vapes, Nicotine Pouches and Heated Tobacco for Military Smokers
U.S. House Defense Bill Includes Pilot Review of Vapes, Nicotine Pouches and Heated Tobacco for Military Smokers
On July 23, 2026, the U.S. House of Representatives passed its version of the Fiscal Year 2027 National Defense Authorization Act (NDAA), which includes Section 707 provisions requiring the Department of Defense to evaluate tobacco use and nicotine alternatives among military personnel. The pilot program would examine products including vapes, nicotine pouches and heated tobacco products, primarily among active-duty service members who continue using combustible tobacco. The provision is a policy evaluation effort, not an authorization for military vaping promotion or a ban on vape products.
Jul.28
South Korea Extends Vape Rules to Unmanned Stores After Bringing Synthetic Nicotine Under Tobacco Law
South Korea Extends Vape Rules to Unmanned Stores After Bringing Synthetic Nicotine Under Tobacco Law
South Korea's Ministry of Gender Equality and Family said on September 14 that it plans to designate unmanned e-cigarette stores as businesses where minors are prohibited from entering or working. Operators would be required to verify customers' ages and display notices restricting access by minors. The proposal is open for public comment through October 6. The move follows an April expansion of South Korea's statutory tobacco definition that brought products made with natural or synthetic nicotine under the Tobacco Business Act. Nicotine-free liquids and products using nicotine analogues such as 6-methylnicotine, however, remain an emerging regulatory issue.
Sep.21
JT’s Ploom Volumes Rise 43.5% as Cigarettes Anchor Its Transition
JT’s Ploom Volumes Rise 43.5% as Cigarettes Anchor Its Transition
JT’s Ploom heated-tobacco volumes rose 43.5% in the first half of 2026, while combustibles still represented about 97% of its tobacco volume and remained the main earnings base. In Japan, reduced-risk products now account for 48.7% of industry shipments, shifting competition from category adoption towards brand share, pricing and consumer retention. JT’s results offer a revealing case of a traditional tobacco company pursuing a prolonged, dual-track transformation.
JTI
Jul.30
EU Tobacco Tax Reform Targets November Push as Sweden Holds Nicotine-Pouch Minimum at €20 per Kilogram
EU Tobacco Tax Reform Targets November Push as Sweden Holds Nicotine-Pouch Minimum at €20 per Kilogram
The Irish presidency of the Council of the European Union is using bilateral talks to push the bloc’s Tobacco Taxation Directive toward a political agreement in November. According to Law360, citing an EU official, Sweden is unwilling to accept a minimum excise threshold above €20 per kilogram for nicotine pouches. Council negotiations have already lowered the European Commission’s original proposal, but a May 2026 presidency compromise still set the minimum at 10% of the tax-inclusive retail price or €30 per kilogram in 2028-29, with higher levels later.
Market
Sep.17 by 2Firsts Perspectives
WIRED Investigation: Chinese-Made Vapes Turn to 6-Methyl-Nicotine and Other Analogs, Challenging U.S. Regulation
WIRED Investigation: Chinese-Made Vapes Turn to 6-Methyl-Nicotine and Other Analogs, Challenging U.S. Regulation
U.S. technology and investigative publication WIRED has examined how nicotine analogs are emerging as a new challenge for the country’s vape regulatory framework. The article argues that after the U.S. expanded federal oversight of nicotine products in 2022, some manufacturers began using nicotine-like compounds such as 6-methyl-nicotine that may fall outside existing definitions. Researchers cited by WIRED said some nicotine analogs could be more potent than traditional nicotine, although human health impacts remain unclear. U.S. policymakers are considering broader definitions of nicotine to bring these compounds under federal oversight.
Jul.27