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.

Reuters Tracks Big Tobacco’s Shift Beyond Cigarettes as Nicotine Pouches Vie for the Next Growth Curve
Reuters Tracks Big Tobacco’s Shift Beyond Cigarettes as Nicotine Pouches Vie for the Next Growth Curve
As cigarette markets face long-term pressure, major tobacco companies are increasingly turning to nicotine pouches in search of growth beyond combustible tobacco. Reuters has examined whether nicotine pouches can become the next strategic growth platform for companies including Philip Morris International, British American Tobacco and Japan Tobacco. PMI strengthened its position through the acquisition of Swedish Match and its ZYN brand, while BAT and JTI continue expanding their own nicotine pouch portfolios. The category has gained attention because of its smoke-free, device-free format, but regulation, youth-use concerns and market scale will determine whether it can become a long-term growth engine.
Regulations
Aug.18 by 2Firsts Perspectives
JTI’s Nordic Spirit Signs Co-op Live Partnership Ahead of New UK Nicotine Sponsorship Restrictions
JTI’s Nordic Spirit Signs Co-op Live Partnership Ahead of New UK Nicotine Sponsorship Restrictions
JTI nicotine pouch brand Nordic Spirit has entered a long-term partnership with Manchester’s Co-op Live, becoming the venue’s Official Nicotine Pouch Partner. The 23,500-capacity venue is the UK’s largest indoor live entertainment arena. Nordic Spirit will run in-venue activations for existing adult nicotine consumers and sell products at selected arena bars. The agreement was entered into before the relevant UK sponsorship restrictions were introduced, while the government intends to implement a comprehensive ban on advertising and sponsorship of vaping and nicotine products from June 1, 2027.
Sep.07
Product | JT to Launch MEVIUS Tropical Option in Japan, Expanding Ploom Tobacco Stick Lineup to 32
Product | JT to Launch MEVIUS Tropical Option in Japan, Expanding Ploom Tobacco Stick Lineup to 32
Japan Tobacco (JT) will launch MEVIUS Tropical Option, a new tobacco stick for Ploom, nationwide in Japan from October 6, 2026. The capsule-format product combines mango-oriented sweetness with menthol cooling, adding a tropical flavor to the MEVIUS Ploom tobacco-stick lineup for the first time. Each pack contains 20 sticks and will launch at JPY 590. The product is compatible with all Ploom devices, and its addition will expand the Ploom tobacco-stick portfolio to 32 variants.
Sep.08
HG Innovation, linked to IMiracle and ELFBAR, wins China patent for 6-methylnicotine salts covering vaping and oral products
HG Innovation, linked to IMiracle and ELFBAR, wins China patent for 6-methylnicotine salts covering vaping and oral products
HG Innovation Limited has been granted a Chinese invention patent covering 6-methylnicotine salt formulations and their use in oral and vaping products. The technology forms salts between 6-methylnicotine and alicyclic carboxylic acids, with granted claims extending to oral products, atomization substrates and electronic atomization devices. Applicant-generated tests reported differences in oxidation stability, in-vitro cytotoxicity and aerosol heavy-metal performance compared with selected benzoate or lactate controls. HG Innovation is directly linked to the broader IMiracle and ELFBAR business network.
Sep.04
Russia’s Vape Device Labeling Regime Enters Force: Registration Starts in September, Mandatory Coding in December
Russia’s Vape Device Labeling Regime Enters Force: Registration Starts in September, Mandatory Coding in December
Russia's digital labeling regime for reusable e-cigarettes and similar personal vaping devices entered its first mandatory phase in September 2026. From September 1, manufacturers, importers and other market participants must register with the national Chestny ZNAK tracking system. From December 1, newly manufactured and imported covered devices will be required to carry digital identification codes and be reported as entering circulation. Russia has also issued new operational guidance for imports, marking the transition from a voluntary pilot to phased mandatory implementation.
Sep.15
Product | JT Launches Ploom AURA Glacier White in Japan, Expanding the Device Ecosystem Through Color and Accessories
Product | JT Launches Ploom AURA Glacier White in Japan, Expanding the Device Ecosystem Through Color and Accessories
Japan Tobacco Inc. (JT) has introduced the Ploom AURA Glacier White heated tobacco device in Japan, adding a new color option to the existing Ploom AURA lineup. The device maintains the existing SMART HEATFLOW technology and HEAT SELECT SYSTEM with four heating modes, while expanding the ecosystem through new accessories including front panels, back covers, a car holder and wireless charging covers. The product entered pre-sale in Japan on June 30, 2026, followed by broader retail availability from July 7.
Aug.03