FDA Increases Regulation on Synthetic Nicotine Products

Sep.23.2022
FDA Increases Regulation on Synthetic Nicotine Products
FDA issues warnings to retailers selling synthetic nicotine products to minors and unapproved manufacturers. 85% of applications reviewed.

Electronic cigarette products containing synthetic nicotine (NTN) have recently been exempted from FDA regulations because they are made with laboratory-produced nicotine instead of nicotine extracted from tobacco leaves.


However, according to a legislation issued on March 15th, the FDA has been authorized to regulate any source of nicotine-containing tobacco products.


In March, legislation was passed requiring synthetic nicotine manufacturers to submit premarket applications before May 14, 2022. Any brands that fail to submit these documents will be considered illegal. However, this has not been enforced, leading to endless criticism of the FDA.


On July 13th, the FDA announced that they had issued two warning letters to manufacturers of unauthorized synthetic nicotine products or non-tobacco nicotine products. Additionally, they sent over 100 warning letters to retailers selling synthetic nicotine products to minors.


85% of applications for synthetic nicotine products have been reviewed.


The FDA has reported that it has issued new warning letters to 102 retailers for illegally selling NTN products to minors. The agency also revealed that it has received nearly 1 million applications from over 200 companies for NTN, and all applications submitted by May 14 have been processed, with over 85% of applications being reviewed.


The FDA has announced that it has rejected 800,000 applications for NTN products and accepted over 350. "The accepted applications will undergo further review to ensure they meet certain standards for additional scrutiny," wrote the FDA.


Statement:


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


This article does not represent the views of 2FIRSTS, and 2FIRSTS cannot confirm the authenticity or accuracy of its contents. The translation of this article is solely for the purpose of industry exchange and research.


Due to the limitations of the translator's skills, the translated article may not fully convey the same meaning as the original. Please refer to the original article for accuracy.


2FIRSTS is fully aligned with the Chinese government's positions and statements on domestic, Hong Kong, Macao, Taiwan, and foreign affairs.


The compilation of information is copyrighted to the original media and authors. If there is any infringement, please contact us for deletion.



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.

South Korea Fully Reviews Nicotine-Analog and Nicotine-Free Vape Liquid Imports, With Over 99% From China and Chinese Supply-Chain Documents Under Scrutiny
South Korea Fully Reviews Nicotine-Analog and Nicotine-Free Vape Liquid Imports, With Over 99% From China and Chinese Supply-Chain Documents Under Scrutiny
Korea Customs Service has tightened import controls on nicotine-analog and nicotine-free e-cigarette liquids, placing the products under 100% document review and subjecting all e-cigarette liquid import declarations to pre-clearance ingredient analysis. As of September 20, 2026, South Korea had imported about 15 metric tons of nicotine-analog liquids, 99.99% from China, and about 316 metric tons of nicotine-free liquids, including roughly 315 metric tons, or 99.7%, from China. The measures follow South Korea's April expansion of its tobacco definition to include synthetic nicotine products and include new checks on Chinese manufacturing, transaction and export documentation.
Sep.24
China Discloses First Criminal Case Over Counterfeit Vapes Disguised as “Medical Nebulizers” and “Zero-Nicotine” Products
China Discloses First Criminal Case Over Counterfeit Vapes Disguised as “Medical Nebulizers” and “Zero-Nicotine” Products
Chinese authorities have disclosed the country’s first reported criminal case involving counterfeit vapes marketed as “medical nebulizers” and “zero-nicotine” products. Authorities determined that the products involved were counterfeit vapes and pursued criminal charges for producing and selling counterfeit goods. According to the report, the case resulted in the seizure of 347,000 counterfeit vape pods and 53,700 vape devices, with physical goods valued at 22.13 million yuan.
Aug.04
From Nicotine Pouches to Soft Candy Forms: China Tobacco Hubei explores adjustable-release oral nicotine products
From Nicotine Pouches to Soft Candy Forms: China Tobacco Hubei explores adjustable-release oral nicotine products
China-based China Tobacco Hubei Industrial Co., Ltd. has filed a patent application covering an oral nicotine product and its preparation method. The patent proposes a soft candy-shaped oral nicotine product containing nicotine ingredients, gelling agents, sweeteners and alkaline pH regulators. Through formulation adjustments and homogeneous or dual-layer structures, the technology aims to achieve different nicotine release profiles. The filing reflects exploration of new oral nicotine product formats and controlled nicotine delivery approaches.
Aug.06
Russian Strikes Destroy JTI and Imperial Brands Ukraine Warehouses, With Losses Reaching Tens of Millions of Hryvnias
Russian Strikes Destroy JTI and Imperial Brands Ukraine Warehouses, With Losses Reaching Tens of Millions of Hryvnias
According to Ukrainska Pravda, Russian strikes on the Kyiv region during the night of Aug. 4-5, 2026, damaged warehouses storing products of Japan Tobacco International (JTI) and Imperial Brands Ukraine. JTI said a finished goods warehouse in Kyiv Oblast was destroyed, with no employees injured, and that it did not expect disruptions to retail supplies. Imperial Brands Ukraine said products stored at warehouses of distributors and retail partners were affected and estimated losses from the strikes at “tens of millions of Ukrainian hryvnias” (roughly hundreds of thousands of U.S. dollars).
JTI
Aug.07
UK-Listed Consumer Goods Group Supreme Sees Vape Duty as Potential Consolidation Opportunity, Holds FY27 Outlook
UK-Listed Consumer Goods Group Supreme Sees Vape Duty as Potential Consolidation Opportunity, Holds FY27 Outlook
UK-listed consumer goods group Supreme plc says it continues to expect FY27 trading to meet market expectations as the Vaping Products Duty takes effect on October 1, while maintaining a comparatively positive view of the new tax and compliance regime. Supreme has said the framework could increase compliance complexity for smaller operators and contribute to market consolidation, while its manufacturing, compliance and distribution scale may allow it to gain share. Its 88Vape brand will retain its value positioning.
Sep.18
Altria Smokeable Profit Rises 2.4% as Marlboro Share Falls and U.S. Discounts Gain
Altria Smokeable Profit Rises 2.4% as Marlboro Share Falls and U.S. Discounts Gain
Altria’s second-quarter results show a U.S. nicotine market splitting across price, product and regulation. Smokeable profit rose 2.4% as Marlboro pricing offset lower volumes, while discount brand Basic gained share among value-conscious smokers. In oral nicotine, on! PLUS expanded distribution but faced intensifying competition from ZYN and Velo. NJOY remained off the market as patent and regulatory hurdles delayed its return. The broader lesson: U.S. growth increasingly depends on price-tier strategy, retail execution, authorisation and enforcement readiness across the industry.
Special Report
Jul.31