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.

JUUL Purchasers Ask Ninth Circuit to Preserve Antitrust Classes in Case Over Altria’s $12.8 Billion Investment
JUUL Purchasers Ask Ninth Circuit to Preserve Antitrust Classes in Case Over Altria’s $12.8 Billion Investment
Private antitrust litigation stemming from Altria's 2018 $12.8 billion investment for a 35% economic interest in JUUL is advancing before the U.S. Court of Appeals for the Ninth Circuit. Direct purchasers, indirect purchasers and indirect resellers of JUUL products filed answering briefs this week seeking to preserve class certifications granted by a California federal court in February. Altria and JUUL argue that individual consumers and large distributors differ too much in purchasing terms to remain in a single direct-purchaser class, while a separate dispute concerns whether California antitrust law can apply to indirect purchasers across 27 jurisdictions. A September trial has been put on hold during the appeal.
Sep.23
Major U.S.  Vape Distributor Demand Vape Pays at Least $300,000 for White House Lobbying Amid Enforcement Pressure
Major U.S. Vape Distributor Demand Vape Pays at Least $300,000 for White House Lobbying Amid Enforcement Pressure
New York vape distributor Ecto World, which operates as Demand Vape, hired political consultant Roger Stone to lobby the Executive Office of the President on regulation of vaping and related products while facing state enforcement and multiple lawsuits. Public lobbying disclosures show that Ecto World paid at least $300,000 for the work through June 30, 2026. Separately, New York State announced in March that more than 28,500 pounds of vaping products tied to the company had been seized, while New York City and the state have pursued legal or enforcement actions. Public records do not show that the lobbying directly changed any specific regulatory or enforcement outcome.
Sep.08
Product | Four CrossBar 20K 13mL High-Puff Vapes Listed on Pennsylvania's ENDS Directory, Rated for Up to 20,000 Puffs
Product | Four CrossBar 20K 13mL High-Puff Vapes Listed on Pennsylvania's ENDS Directory, Rated for Up to 20,000 Puffs
Four CrossBar 20K disposable e-cigarettes appeared on Pennsylvania's 163-entry ENDS directory ahead of enforcement beginning October 19, 2026. The devices feature 13mL e-liquid reservoirs, 50mg/mL nicotine, 2,000mAh batteries and 0.9Ω mesh coils, with advertised puff counts of up to 20,000. CrossBar was the only modern high-puff disposable series among the directory's 15 disposable entries. Its packaging emphasizes New York design and Japanese-origin flavoring, while historical CrossBar records identify a registered U.S. tobacco manufacturing-related establishment. The link between the newer 13mL devices and earlier 1.3mL PMTA filings remains unconfirmed.
product
Oct.26
Global Nicotine-Pouch E-Commerce Group Haypp Shuts Sweden’s Snusnetto Over Age Verification as Identity Checks Become Industry Infrastructure for New Nicotine Products
Global Nicotine-Pouch E-Commerce Group Haypp Shuts Sweden’s Snusnetto Over Age Verification as Identity Checks Become Industry Infrastructure for New Nicotine Products
Sweden's Supreme Administrative Court has declined to hear an appeal over age verification for tobacco and nicotine products collected from parcel lockers, leaving in place a lower-court ruling that geo-located BankID verification is insufficient to securely verify the actual recipient. Haypp Group has stopped tobacco and nicotine sales through Snusnetto and is deploying a new system across its other Swedish e-commerce sites to verify the age of the person who actually opens the locker and receives the shipment. The change comes as age verification across next-generation nicotine products expands from purchase checks into retail, delivery and, for some e-cigarettes, device access itself.
Regulations
Oct.20
Couche-Tard Posts Double-Digit U.S. Same-Store Growth in Other Nicotine Products, Led by Pouches
Couche-Tard Posts Double-Digit U.S. Same-Store Growth in Other Nicotine Products, Led by Pouches
Alimentation Couche-Tard said U.S. same-store sales in its “other nicotine products” category grew at a double-digit rate in the first quarter of fiscal 2027, led by nicotine pouches, while overall U.S. same-store merchandise revenues increased 1.7%. The company also said its Canadian nicotine business continued to face regulatory pressure and illicit-market headwinds. The U.S. performance coincides with Couche-Tard's participation in efforts to reopen Canadian convenience-store access to authorized nicotine pouches, though the company has not established a direct causal link between the two.
Sep.14
2Firsts Data|China’s Vape-Related Exports Rose 3.3% in August 2026 as UK Shipments Jumped 51.4% and U.S. Exports Fell 12.4%
2Firsts Data|China’s Vape-Related Exports Rose 3.3% in August 2026 as UK Shipments Jumped 51.4% and U.S. Exports Fell 12.4%
China exported $979 million of vape-related products in August 2026, up 3.3% from a year earlier but down 6.4% from July. The UK replaced the U.S. as the main source of growth: UK-bound shipments jumped 51.4% to a 2026 high of $177 million, while exports to the U.S. fell 12.4% to $339 million. Shipments to markets outside the U.S. increased 14.2%, broadening growth beyond the market that had driven July’s rebound.
News
Sep.23 by 2Firsts Perspectives