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.


This document has been generated through artificial intelligence translation and is provided solely for the purposes of industry discourse and learning. Please note that the intellectual property rights of the content belong to the original media source or author. Owing to certain limitations in the translation process, there may be discrepancies between the translated text and the original content. We recommend referring to the original source for complete accuracy. In case of any inaccuracies, we invite you to reach out to us with corrections. If you believe any content has infringed upon your rights, please contact us immediately for its removal.

Kenya’s BAT Kenya resumes Velo nicotine pouches after citing regulatory clarity
Kenya’s BAT Kenya resumes Velo nicotine pouches after citing regulatory clarity
BAT Kenya says it has resumed sales of Velo oral nicotine pouches after receiving regulatory clarity, reinforcing its push into non-combustible products as cigarette consumption falls.The company reported a 10% drop in turnover in 2025, with revenue closing at KSh23.2 billion (about $178.64 million), largely attributed to the growing presence of illegal tobacco products.
Mar.03 by 2FIRSTS.ai
Philip Morris Korea launches TEREA “Shine Pearl” for IQOS ILUMA, expands capsule range to seven variants
Philip Morris Korea launches TEREA “Shine Pearl” for IQOS ILUMA, expands capsule range to seven variants
Philip Morris Korea said on Feb. 5 it has introduced “TEREA Shine Pearl,” a new TEREA stick designed for the IQOS ILUMA heated-tobacco device. The company said the product delivers a cool sensation and adds a fresh, fruity note when the capsule is crushed, bringing TEREA’s capsule-based lineup in South Korea to seven variants.
Feb.05 by 2FIRSTS.ai
South Dakota Senate Committee Advances Bill Tightening Nicotine Retail Rules
South Dakota Senate Committee Advances Bill Tightening Nicotine Retail Rules
South Dakota Senate Bill 221 (SB 221), which seeks to regulate the retail sale of nicotine products, has passed the Senate Health and Human Services Committee with a unanimous 7–0 recommendation. The bill was significantly amended, expanding from three to nine pages and shifting its focus from vapor products alone to all nicotine products.
Regulations
Feb.22
Fourth Circuit weighs federal preemption challenge to North Carolina’s vape sales restrictions
Fourth Circuit weighs federal preemption challenge to North Carolina’s vape sales restrictions
Vape manufacturers and sellers urged the U.S. Court of Appeals for the Fourth Circuit to find that the federal Food, Drug, and Cosmetic Act (FDCA) preempts North Carolina’s new law restricting the sale of certain e-cigarette/ENDS products.
Feb.03 by 2FIRSTS.ai
The Volume Illusion: Measuring the Future of Nicotine with the Tools of the Past
The Volume Illusion: Measuring the Future of Nicotine with the Tools of the Past
As next-generation nicotine products become economically central rather than marginal, traditional volume-based metrics are increasingly unable to explain consumption, risk, and value. Units designed for a cigarette-based economy struggle to describe systems defined by delivery speed, pharmacokinetics, and adaptive user behavior. Drawing on financial reporting, regulation, and nicotine science, a fundamental question: can the future of nicotine still be measured using the tools of its past?
Feb.09 by Alan Zhao | 2Firsts Perspectives
PMI Launches Mass Production of ZYN at $600M Aurora Manufacturing Hub
PMI Launches Mass Production of ZYN at $600M Aurora Manufacturing Hub
Philip Morris International (PMI), through its subsidiary Swedish Match, has started large-scale production at a 600,000-square-foot ZYN nicotine pouch facility in Aurora, Colorado. The $600 million investment makes the site one of three ZYN manufacturing plants in the United States and the company’s second U.S. facility after Owensboro, Kentucky.
PMI
Feb.21