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.

Smoore Seeks to Toss CCELL Price-Fixing Claim as Court Weighs Vertical Distribution Versus Horizontal Conspiracy
Smoore Seeks to Toss CCELL Price-Fixing Claim as Court Weighs Vertical Distribution Versus Horizontal Conspiracy
Smoore and four authorized U.S. CCELL distributors are asking a California federal court to permanently dismiss a core antitrust claim brought by direct purchasers. Plaintiffs allege that Smoore coordinated minimum wholesale prices, customer allocation and limits on price competition among distributors, amounting to a per se unlawful horizontal conspiracy. The defendants say the alleged conduct reflects ordinary vertical relationships between a manufacturer and its distributors. The court previously dismissed a similar claim, and the latest dispute centers on whether the second amended complaint adds sufficient facts to establish a horizontal agreement.
Sep.14
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
Juul Displays FDA-Authorized JUUL2, Highlights Age Verification at NACS Show 2026
Juul Displays FDA-Authorized JUUL2, Highlights Age Verification at NACS Show 2026
At the 2026 NACS Show in Las Vegas, Juul Labs displayed its JUUL2 e-cigarette system alongside existing products, age-verification messaging and mobile coupons, 2Firsts observed. The JUUL2 device and Virginia Tobacco and Polar Menthol pods received FDA marketing authorization in August 2026. Booth materials highlighted longer battery life, greater e-liquid capacity and connected-device features. A TruAge sign and a mobile coupon presentation also featured at the booth, with weekly offers available to age-verified adult nicotine consumers at participating retailers.
EXPO
Oct.09
FRE and ALP Push Modern Oral to 48% of Q2 Sales as Turning Point Brands Changes CEO and Lowers Profit-Guidance Ceiling
FRE and ALP Push Modern Oral to 48% of Q2 Sales as Turning Point Brands Changes CEO and Lowers Profit-Guidance Ceiling
Turning Point Brands said Executive Chairman David E. Glazek will become CEO on October 1, replacing Graham Purdy, who is stepping down for personal reasons. The company narrowed its 2026 adjusted EBITDA outlook to $70 million-$80 million from $70 million-$90 million while maintaining Modern Oral gross sales guidance of $330 million-$350 million and net sales guidance of $260 million-$270 million. In the second quarter, Modern Oral net sales rose 128% to $68.4 million and accounted for 48% of company-wide net sales. Adjusted EBITDA fell 50% year over year. TPB shares closed about 10% lower on September 21.
Market
Sep.22 by 2Firsts Perspectives
JTI Liggett Puts U.S. Value Cigarette Brands in Spotlight at 2026 NACS Show
JTI Liggett Puts U.S. Value Cigarette Brands in Spotlight at 2026 NACS Show
At the 2026 NACS Show in Las Vegas, JTI Liggett highlighted its value-priced cigarette portfolio, including LD and Montego, following JT Group's acquisition of Vector Group. The company's U.S. business reported market share gains, with LD sales volume rising 32.6% in the first half of 2026. Meanwhile, Ploom was displayed separately at Altria's booth under an existing partnership. JTI Liggett booth staff told 2Firsts that the company had not yet launched nicotine pouch products in the United States.
EXPO
Oct.09
German Tobacco Tax Revenue Falls 10.8% Through August as Tax-Paid Cigarette Volume Drops 12.6%
German Tobacco Tax Revenue Falls 10.8% Through August as Tax-Paid Cigarette Volume Drops 12.6%
Germany collected €9.789 billion in total tobacco tax revenue from January through August 2026, down 10.8% from a year earlier, according to the Federal Ministry of Finance. Germany's tobacco tax base covers not only cigarettes and fine-cut tobacco but also heated tobacco and vaping liquids taxed as tobacco substitutes. The German Association of the Tobacco Industry and Novel Products, or BVTE, citing federal statistical data, said tax-paid cigarette volume fell 12.6% to 40.6 billion sticks. BVTE is using the latest figures to argue against further tax increases planned from 2027 through 2030, while Germany's parliament is scheduled to hold a first reading of the bill on September 24.
Sep.23