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.

JTI Proposes 25-Cent Irish Cigarette Tax Increase, Says It Could Raise €45 Million
JTI Proposes 25-Cent Irish Cigarette Tax Increase, Says It Could Raise €45 Million
Japan Tobacco International's Irish business has proposed a €0.25 tax increase on a pack of 20 cigarettes in its pre-Budget 2027 submission, below the €0.50-or-more increases typically imposed in recent Irish budgets. JTI says the proposal could generate around €45 million in additional Exchequer revenue while limiting further movement toward illicit and non-Irish-tax-paid tobacco. Revenue's existing estimate for a comparable €0.25 increase, including pro-rata rises on other tobacco products, is about €18 million for a full year.
JTI
Sep.18 by 2Firsts Perspectives
Product | BAT Revises Japan's VELO Convenience Store Lineup, Adding ¥380 Mango Pouches as Selected SKUs Exit
Product | BAT Revises Japan's VELO Convenience Store Lineup, Adding ¥380 Mango Pouches as Selected SKUs Exit
British American Tobacco's Japanese subsidiary, BAT Japan, launched VELO Mango Ice Medium on November 2, 2026, with distribution expanding to selected 7-Eleven, FamilyMart, NewDays and Seicomart stores from November 3. The new oral tobacco product contains 15 pouches per can and retails for ¥380, featuring a mango and cooling flavor profile at Medium intensity. At the same time, BAT Japan raised prices on multiple existing VELO products from ¥360 to ¥380 per can and withdrew selected SKUs from convenience store distribution without discontinuing them entirely. The changes affect product assortment, pricing and retail channel allocation.
product
Nov.04
Product | SMOORE's VAPORESSO Introduces VAST Refillable Vape With Three Resistances in One Pod
Product | SMOORE's VAPORESSO Introduces VAST Refillable Vape With Three Resistances in One Pod
SMOORE-owned vaping brand VAPORESSO introduced the VAST refillable open-system vape in October 2026, featuring Tri-Core Mesh technology that integrates three resistance configurations—0.8Ω, 0.6Ω and 0.4Ω—within a single pod. The device supports different operating modes and e-liquid types. The standard version features a 10mL pod, while a TPD-labelled configuration combines a 2mL pod with an 8mL refill container. The device has a 1,600mAh battery and a maximum output of 30W. VAPORESSO claims up to six pod refills and a tested coil lifespan of up to 150,000 puffs. The UK's MHRA published a related device notification on October 12. The official MSRP is $25.90, compared with a $35.90 listing on VAPORESSO's direct store.
product
Oct.30
Charlie’s Bets on Age-Gating and 678 PMTA Assets as U.S. Vape Enforcement Landscape Shifts
Charlie’s Bets on Age-Gating and 678 PMTA Assets as U.S. Vape Enforcement Landscape Shifts
Charlie’s Holdings said in its latest shareholder letter that it is moving to commercialize PACHA products and monetize its PMTA assets as the FDA changes enforcement priorities for unauthorized ENDS products. Thirty PACHA SKUs were previously tentatively identified for a proposed public list of products that the FDA generally does not intend to prioritize for enforcement. Charlie’s is also preparing test-market sales of age-gated flavored disposables and says it currently holds 678 PMTA-related product assets while seeking additional strategic transactions and partnerships.
Sep.11
R.J. Reynolds Vapor Company Launches Flavored Vuse Pro Pods in U.S. Without FDA Marketing Authorization
R.J. Reynolds Vapor Company Launches Flavored Vuse Pro Pods in U.S. Without FDA Marketing Authorization
R.J. Reynolds Vapor Company has begun selling four flavored Vuse Pro pods — Peach, Berry, Watermelon and Fresh Mint — in Ohio and selected other U.S. markets. According to the Vuse U.S. FAQ, Vuse Pro contains approximately 5.0% nicotine by weight, and Vuse Pro pre-filled pods are intended for use with Vuse Alto devices. Reynolds told 2Firsts that product labeling lists an e-liquid capacity of 2.0 mL per pod. The Vuse Alto Power Unit received FDA marketing authorization in 2024, while the new Vuse Pro pods themselves have not received marketing granted orders. The rollout follows the FDA’s May 2026 revision of enforcement priorities for certain unauthorized vaping products with qualifying pending applications.
BAT
Sep.10
Australia Adds 6-Methylnicotine to Schedule 9 Prohibited Substances, Effective October 1
Australia Adds 6-Methylnicotine to Schedule 9 Prohibited Substances, Effective October 1
Australia's Therapeutic Goods Administration published a final decision on September 25 to classify 6-methylnicotine as a Schedule 9 prohibited substance under the Poisons Standard, effective October 1, 2026. TGA said the chemical has been reported in e-cigarette liquids sold in Australia and marketed as nicotine-free or nicotine alternatives, while evidence also indicates its use in preparations such as oral pouches. The government originally proposed a Schedule 7 classification but ultimately adopted the stricter Schedule 9 designation, citing acute toxicity, dependence risk, use in unapproved consumer products and misleading marketing.
News
Sep.29 by 2Firsts Perspectives