FDA Unauthorizes Over 1 Million E-Cigarette Products in US Market

Oct.24.2022
FDA Unauthorizes Over 1 Million E-Cigarette Products in US Market
FDA warns over 900,000 e-cigarette products remain unauthorized for sale as only 1,600 have obtained regulatory clearance.

Nearly one million electronic cigarette products have yet to receive approval from the Food and Drug Administration for sale, while only 1,600 are regularly available on the US market. These figures were released by the FDA following the end of a lengthy verification process starting in April last year, when new federal laws came into effect granting the FDA the power to regulate tobacco products containing nicotine, including those not derived directly from tobacco but created in labs.


An anti-regulation campaign by consumers and businesses opposing restrictions on e-cigarettes has resulted in the release of a first set of data indicating that up to 890,000 products cannot be sold due to not meeting public health safety standards or incomplete documentation provided by the companies. Around 95% of requests have been processed so far.


The FDA has stated that no liquid containing synthetic nicotine has been authorized, therefore all products on the market will be considered illegal and sellers (wholesale and retail) will be punished. Among these companies is the popular brand Puff Bar, which essentially relates to disposable e-cigarettes and has been ordered to remove the device from the US market.


Statement:


This article is compiled from third-party information and is only intended for industry professionals' exchange and learning purposes.


This article does not represent the views of 2FIRSTS, and 2FIRSTS cannot confirm the truth or accuracy of the article's content. The translation of this article is only intended for industry communication and research purposes.


Due to limitations in our translation abilities, the translated article may not accurately reflect the original text. Please refer to the original article for accuracy.


2FIRSTS fully aligns with the Chinese government on all domestic, Hong Kong, Macau, Taiwan, and foreign-related statements and positions.


The copyright of the compiled information belongs to the original media and authors. If there is any infringement, please contact us to request removal.


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.

The U.S. FDA has launched a pilot program for PMTA review of nicotine pouches to expedite the approval process and enhance regulatory efficiency
The U.S. FDA has launched a pilot program for PMTA review of nicotine pouches to expedite the approval process and enhance regulatory efficiency
In Sept 2025, the US FDA launched a nicotine pouch PMTA pilot to boost review efficiency, streamline processes and uphold strict scientific standards. Based on the "tobacco product health risk continuum" concept, it shortens cycles by focusing on key product factors and enhancing real-time communication with applicants. The FDA also urges child-resistant packaging to tackle kids’ accidental exposure, emphasizes scientific review for new tobacco products, and has approved 20 nicotine pouches so f
Sep.19 by 2FIRSTS.ai
Study: Specialist e-cigarette stores in Western Australia close after new federal regulations, but convenience stores continue illegal sales
Study: Specialist e-cigarette stores in Western Australia close after new federal regulations, but convenience stores continue illegal sales
A study led by the University of Notre Dame Australia reveals that since the 2024 e-cigarette regulations, all 117 specialized e-cigarette stores in Western Australia have closed, and 76 other shops have stopped selling e-cigarettes. However, some central Perth convenience stores continue to sell them illicitly. Experts warn this undermines the regulations and call for increased monitoring, stricter enforcement, and higher penalties.
Sep.03 by 2FIRSTS.ai
A joint operation by multiple departments in Brazil seized 20 boxes of illegal e-cigarettes worth about $90,000
A joint operation by multiple departments in Brazil seized 20 boxes of illegal e-cigarettes worth about $90,000
Brazilian federal police, border patrol, and military jointly seize 20 crates of illegal e-cigarettes in Altônia National Park.
Sep.18 by 2FIRSTS.ai
Three Refuse Truck Fires in Two Weeks in Glasgow; GMB Calls for Stronger E-Cigarette Battery Recycling and Public Awareness
Three Refuse Truck Fires in Two Weeks in Glasgow; GMB Calls for Stronger E-Cigarette Battery Recycling and Public Awareness
The GMB union says three compartment fires occurred in Glasgow’s newly deployed refuse trucks over the past two weeks, with initial checks pointing to lithium-ion batteries from e-cigarettes being crushed and igniting during compaction.
Sep.23 by 2FIRSTS.ai
After Singapore strengthened e-cigarette regulations, the price of black market products increased by three times
After Singapore strengthened e-cigarette regulations, the price of black market products increased by three times
Malaysian merchants in Johor Bahru report that up to 95% of their e-cigarette customers are from Singapore. Since Singapore intensified penalties from September 1st, some stores have provided discreet packaging or smuggling tips, though most have stopped cross-border deliveries. Black market e-cigarette prices in Johor Bahru have tripled, and shipping fees across the border have risen sharply.
Sep.11 by 2FIRSTS.ai
Argentina's Neuquén province reiterates e-cigarette ban, covering import, distribution, and marketing
Argentina's Neuquén province reiterates e-cigarette ban, covering import, distribution, and marketing
The Consumer Protection Agency of Neuquén Province, Argentina, reiterated on September 24 that the ban on the import, distribution, marketing and advertising of e-cigarettes, similar devices and related accessories is fully effective. The restriction also covers "heated tobacco products" based on Resolution No. 565/2023 of the Ministry of Health and Regulation No. 3226/2011 of ANMAT.
Sep.25 by 2FIRSTS.ai