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.

Reynolds Showcases Vuse Pro Flavors and VELO Nicotine Pouches at NACS Show 2026
Reynolds Showcases Vuse Pro Flavors and VELO Nicotine Pouches at NACS Show 2026
Reynolds American, a BAT subsidiary, showcased four Vuse Pro flavored e-cigarette pods and its VELO nicotine pouch portfolio at NACS Show 2026. Booth staff confirmed to 2Firsts that the Vuse Pro flavors are sold in the U.S., although they have not received FDA marketing authorization. BAT outlined plans to expand Vuse retail distribution and reported that VELO held a 30.5% year-to-date volume share of the U.S. modern oral nicotine category through August 2026. The booth also featured the newly launched VELO MAX range and merchandising displays combining cigarettes, vaping products and oral nicotine brands.
EXPO
Oct.09
GAO Audit Finds Nearly 132,000 FDA Tobacco Applications Waiting an Average 1,266 Days as Nicotine Pouch Pilot Practices Move Into Vape PMTA Reviews
GAO Audit Finds Nearly 132,000 FDA Tobacco Applications Waiting an Average 1,266 Days as Nicotine Pouch Pilot Practices Move Into Vape PMTA Reviews
A U.S. Government Accountability Office audit found that 131,915 tobacco product applications submitted to the FDA since 2018 remained without a final review as of December 31, 2025, with pending applications waiting an average of 1,266 days. GAO also found FDA lacks the data needed to systematically determine whether scientific reviews meet applicable timelines. HHS agreed to upgrade the agency's tracking systems. At the same time, FDA has begun applying lessons from its nicotine pouch PMTA pilot to e-cigarette reviews, while changes to enforcement policy and electronic submissions are making the specific stage of a PMTA increasingly relevant to market access.
FDA
Oct.03
Product | KUMI SCENIC 50K Offers Nicotine and 6-Methyl Nicotine Versions as 6-MN Products Appear in Multiple U.S. State Directories, With Louisiana Listing FDA Exemption
Product | KUMI SCENIC 50K Offers Nicotine and 6-Methyl Nicotine Versions as 6-MN Products Appear in Multiple U.S. State Directories, With Louisiana Listing FDA Exemption
An October 2026 review of U.S. state vapor product directories found KUMI 6 SCENIC 50K listed in Louisiana and Nebraska. Louisiana classifies 20 related product entries as “FDA EXEMPTION.” The SCENIC platform is marketed in both conventional nicotine-salt and NoNic6 formulations, each advertised with 22mL e-liquid capacity and up to 50,000 puffs. U.S. wholesaler Midwest Goods listed both versions in August 2025 with a suggested retail price of $19.99 each. The NoNic6 version is associated with 6-methylnicotine and is also marketed by some distributors as “nicotine-free.”
product
Oct.27
Special Report | From New York to Washington: How FDA’s Tobacco Center Is Reworking Product Review
Special Report | From New York to Washington: How FDA’s Tobacco Center Is Reworking Product Review
FDA’s Center for Tobacco Products is reshaping how it approaches tobacco product review. Based on 2Firsts’ on-site reporting in New York and Washington, this report traces CTP’s emerging direction: stronger links between PMTA and tobacco harm reduction, more category-specific review, greater emphasis on decision-relevant science, more predictable timelines and expanded use of sPMTA for product modifications. CTP also acknowledged major constraints, including just nine PMTA review teams, persistent backlogs and limits on hiring capacity.
Regulations
Oct.08
Reynolds Puts Nearly 183,000 U.S. Contracted Outlets Under Age-Verification Rules, Covering 94% of Volume — Can It Shift an Unauthorized Vape Market?
Reynolds Puts Nearly 183,000 U.S. Contracted Outlets Under Age-Verification Rules, Covering 94% of Volume — Can It Shift an Unauthorized Vape Market?
Reynolds American says nearly 183,000 U.S. retail outlets are under contract, with its Retail Marketing Plan Contract covering about 94% of company volume and requiring point-of-sale age verification. The company combines those contracts with We Card, TruAge, NACS-linked infrastructure and POS integration, while enhanced Vuse Pro retail rules add ID scanning, purchase limits and stronger underage-sales accountability. The initial Vuse Pro rollout targets about 50,000 stores. The system is taking shape as unauthorized vapor products remain dominant in parts of the U.S. market: a 2026 study estimated they accounted for 69.4% of tracked brick-and-mortar e-cigarette dollar sales in December 2025.
Special Report
Oct.15
Product | BAT Expands VELO Peach Ice Medium to FamilyMart Stores Nationwide in Japan
Product | BAT Expands VELO Peach Ice Medium to FamilyMart Stores Nationwide in Japan
British American Tobacco Japan (BAT Japan) expanded VELO Peach Ice Medium to FamilyMart stores nationwide in Japan from September 7, 2026. The oral tobacco product first launched on July 6 and had previously been sold through VELO's official online store, glo Store Ginza and tobacco retailers. It combines peach flavor with menthol cooling at a Medium strength level and is priced at JPY 360. Japanese tobacco retailers list 15 pouches per pack. The move adds the new SKU to an existing nationwide FamilyMart distribution network for VELO rather than marking the brand's first entry into the convenience-store chain.
Sep.15