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.

Australia’s Daily Smoking Rate Falls to Record Low of 5.8% as Nicotine Use Patterns Shift
Australia’s Daily Smoking Rate Falls to Record Low of 5.8% as Nicotine Use Patterns Shift
According to the Australian Institute of Health and Welfare’s National Drug Strategy Household Survey, daily smoking among Australians aged 18 and over fell to a record low of 5.8% in 2025. Health Minister Mark Butler said Australia now has around 500,000 fewer daily smokers than three years ago and credited the government’s vaping reforms as part of broader progress. Among people aged 14 and over, daily smoking declined from 8.3% in 2022-23 to 5.6% in 2025. Daily vaping rates stabilised at 3.6%, while the government also moved to further restrict access to nicotine pouches through unapproved therapeutic import pathways.
Jul.21
PMI Q2 Revenue Rises 10.4% as IQOS and VEEV Expand, U.S. ZYN Growth Slows
PMI Q2 Revenue Rises 10.4% as IQOS and VEEV Expand, U.S. ZYN Growth Slows
Philip Morris International’s second-quarter net revenues rose 10.4% to a record $11.19 billion, as heated tobacco and e-vapor expanded across international markets. IQOS remained the main smoke-free growth engine, while VEEV shipments jumped 55.1%. In the United States, however, ZYN shipments increased just 1.8% and consumer offtake was broadly flat to slightly higher. Cigarette volumes also rose, showing that PMI’s transformation is advancing, but growth is becoming increasingly uneven across categories and markets.
PMI
Jul.22
Former ATF Official’s Claims on Chinese Vape Companies and 6-Methyl Nicotine Fuel US Regulatory Debate
Former ATF Official’s Claims on Chinese Vape Companies and 6-Methyl Nicotine Fuel US Regulatory Debate
Former ATF Deputy Director Edgar Domenech has warned that some Chinese vape companies may be using 6-methyl nicotine, a nicotine analogue, raising new questions over how US regulators should classify emerging nicotine compounds.
Jul.13
Yinghe-Controlled Vape Maker SKE Ordered to Post £569,039 Security as It Pursues Crystal Bar Design Infringement Case in UK
Yinghe-Controlled Vape Maker SKE Ordered to Post £569,039 Security as It Pursues Crystal Bar Design Infringement Case in UK
The UK High Court has ordered Chinese vape manufacturer Shenzhen SKE Technology to provide £569,039 ($776,000) in security for costs in its design infringement proceedings against Vapepen London and other defendants over its Crystal Bar vape product. The court did not accept the defendants’ main argument that recovering costs from a China-based company would face significant enforcement obstacles, but found that SKE had not sufficiently disclosed its own financial position. The order is procedural and does not determine the underlying infringement claims.
News
Aug.21
Senate Democrat Wyden Probes Trump Administration Vape Policy Shift, Seeks Records From HHS and Reynolds American
Senate Democrat Wyden Probes Trump Administration Vape Policy Shift, Seeks Records From HHS and Reynolds American
U.S. Senator Ron Wyden, the Democratic ranking member of the Senate Finance Committee, has launched an investigation into flavored vape policy changes and requested records from the Department of Health and Human Services (HHS), Reynolds American and Botanic Tonics. The investigation focuses on a timeline involving Reynolds American’s $5 million donation to MAGA Inc. in April 2026 and subsequent vape policy developments. Wyden said the review aims to examine potential links between political donations, corporate communications and government decisions. The investigation does not represent a finding of wrongdoing.
Innovation
Aug.07 by 2Firsts Perspectives
Vietnam’s Vape Crackdown Expands From Ban Proposal to Grassroots Enforcement
Vietnam’s Vape Crackdown Expands From Ban Proposal to Grassroots Enforcement
Vietnam tightens e-cigarette rules. Health Ministry proposes banning production, trade, transport, storage, ads, promotion, sponsorship, and use of e-cigarettes, heated tobacco, and new products. Hanoi also urges residents to report illegal activities, showing enforcement moves from lawmaking to local action.
Jul.08