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.

Philip Morris Malaysia Again Meets Religious Authority Over Cigarette Alternatives as Perlis Mufti Responds on Halal Criteria
Philip Morris Malaysia Again Meets Religious Authority Over Cigarette Alternatives as Perlis Mufti Responds on Halal Criteria
Philip Morris Malaysia Managing Director Naeem Shahab Khan met Perlis Mufti Mohd Asri Zainul Abidin on September 17 and presented the company's shift from conventional cigarettes toward alternative products. The mufti said a product could be considered halal if it is clean, its side effects are not harmful or can be controlled, and it does not involve excessive waste. His remarks did not mention IQOS or any other specific PMI product and did not amount to a new product-specific religious ruling. It was at least the second publicly reported engagement between Philip Morris Malaysia and a Malaysian religious institution over cigarette alternatives within six months.
Regulations
Sep.18 by 2Firsts Perspectives
Malaysia’s Vape Rules Face Review as Health Minister Dzulkefly Ahmad Addresses Dropped Nicotine Appeal
Malaysia’s Vape Rules Face Review as Health Minister Dzulkefly Ahmad Addresses Dropped Nicotine Appeal
According to Free Malaysia Today on August 26, 2026, Malaysia’s Health Minister Dzulkefly Ahmad said the Health Ministry would explain the government’s decision to withdraw its appeal against a High Court ruling involving the exemption of liquid nicotine used in vape products from the Poisons List. The High Court previously ruled that the exemption decision was irrational. Dzulkefly said withdrawing the appeal did not mean the government would stop regulating vaping, and that future regulatory approaches would continue under existing legal frameworks.
Aug.28
Special Report|AIR H1 Revenue Rises 3.7% as Shisha Volumes Fall 9%, Testing Its Shift Beyond Traditional Hookah
Special Report|AIR H1 Revenue Rises 3.7% as Shisha Volumes Fall 9%, Testing Its Shift Beyond Traditional Hookah
AIR’s first half-year results as a listed company offer a new test of how far a traditional hookah business can transform. H1 2026 revenue rose 3.7%, even as Flavored Shisha Molasses shipments fell 9%, with pricing and mix supporting growth. Traditional shisha still generates almost all revenue, while OOKA, Crown Switch, Greentank and U.S. regulatory spending point to accelerating diversification. The next test is whether those investments can become a second business of meaningful scale and profitability.
Capital Markets
Aug.21
UAE Sets Dh1-Per-ml Minimum Excise Price for Vape Liquids From Sept. 1 While Keeping 100% Tax Rate
UAE Sets Dh1-Per-ml Minimum Excise Price for Vape Liquids From Sept. 1 While Keeping 100% Tax Rate
The UAE Ministry of Finance will introduce a minimum excise price for e-liquids used in vaping and electronic smoking devices from September 1, 2026. The minimum excise price will be set at AED 1 per millilitre. The existing 100% excise tax rate will continue to apply to tobacco and electronic smoking products. The measure changes the minimum taxable base rather than the tax rate, with the UAE government saying it aims to establish unified tax standards, improve market compliance and prevent pricing loopholes.
Regulations
Aug.07 by 2Firsts Perspectives
BAT Calls for Retailer Input in Future Nicotine Regulations
BAT Calls for Retailer Input in Future Nicotine Regulations
British American Tobacco (BAT) has called for stronger retailer involvement in shaping future nicotine product regulations in the UK, arguing that frontline market feedback should be considered during policy development. BAT said retailers provide direct insight into consumer behavior, market changes and regulatory implementation challenges. The comments come as the UK nicotine market undergoes regulatory changes, including the disposable vape ban, Vaping Products Duty and efforts to address illicit vape sales.
Jul.29
Product | BAT Expands VELO Travellers’ Collection With Mexico, Spain and Sweden Summer Edition Nicotine Pouches
Product | BAT Expands VELO Travellers’ Collection With Mexico, Spain and Sweden Summer Edition Nicotine Pouches
British American Tobacco (BAT) Global Travel Retail has expanded the VELO Travellers’ Collection with three new Summer Editions: Mexico, Spain and Sweden. Inspired by destination themes, the new nicotine pouch variants are designed for global travel-retail channels. The launch further strengthens VELO’s positioning as a travel-retail exclusive product collection.
Aug.27