US FDA Approves Limited Tobacco Products: PMTA Regulations Discussed

Dec.28.2022
US FDA Approves Limited Tobacco Products: PMTA Regulations Discussed
The FDA approved few tobacco product applications and only from large companies with e-cigarette business, drawing controversy.

According to a report published in early December by Reagan-Udall, a limited number of tobacco product applications have been approved by the US Food and Drug Administration (FDA), and all products approved through PMTA are from large tobacco companies with electronic cigarette businesses.


Following the new regulations under PMTA, the Center for Tobacco Products (CTP) has received approximately 432 premarket applications for tobacco products. However, only a few applications have been approved, with the majority of PMTA approved products coming from large tobacco companies such as RJ Reynolds and independent e-cigarette manufacturers operating in the middle market like NJOY.


At present, the FDA is revising a controversial tobacco regulation plan due to numerous lawsuits faced by both the Center for Tobacco Products (CTP) and the entire FDA regarding public health and the tobacco industry.


In 2023, the Biden administration will be obligated to consider criticism and suggestions regarding the FDA's Center for Tobacco Products (CTP) and its policy on fairly allowing products to be released to the market.



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.

Namibia Moves to Tighten Laws on E-Cigarettes and Emerging Nicotine Products
Namibia Moves to Tighten Laws on E-Cigarettes and Emerging Nicotine Products
Namibia is moving to tighten regulation of e-cigarettes and other emerging nicotine products as part of broader tobacco control efforts. Deputy health minister Susan Ndjaleka said the government is reviewing the Tobacco Products Control Act to close regulatory gaps and address emerging tobacco products. Namibia is also working toward joining the Protocol to Eliminate Illicit Trade in Tobacco Products in order to curb the black market and protect public revenue.
Apr.17 by 2FIRSTS.ai
Bringing Tax and Insurance Into Nicotine Regulation: Insights From a Tobacco Harm-Reduction Report
Bringing Tax and Insurance Into Nicotine Regulation: Insights From a Tobacco Harm-Reduction Report
A smoke-free nicotine policy report argues that tobacco harm reduction should move beyond product bans and health warnings into tax policy, insurance pricing and risk-based regulation. While some projections remain open to debate, the report highlights a wider challenge: nicotine products, technologies and consumer behavior have changed sharply over the past decade, and regulatory systems may need new tools to better align tobacco control with harm-reduction goals.
Jun.08
Argentina’s New Nicotine Rules Draw Cautious Optimism and Market Concerns, Local Tobacco Harm Reduction Advocate Says
Argentina’s New Nicotine Rules Draw Cautious Optimism and Market Concerns, Local Tobacco Harm Reduction Advocate Says
Argentina’s new tobacco and nicotine framework marks a shift from prohibition toward registration, traceability and health surveillance. Argentine THR advocate Juan Facundo Teme told 2Firsts that adult consumers and parts of the local commercial sector are cautiously optimistic, but concerns remain over flavor limits, registration costs and market access. The policy’s implementation may determine whether Argentina can move informal sales into regulated channels.
May.11
RJR Vapor Loses Tax Refund Case as Texas High Court Finds VELO Pouches Taxable
RJR Vapor Loses Tax Refund Case as Texas High Court Finds VELO Pouches Taxable
The Texas Supreme Court issued a case summary on May 8, 2026, describing its decision in Hancock v. RJR Vapor Co. LLC. The dispute centered on whether RJR Vapor’s VELO oral nicotine pouches are taxable as “tobacco products” under the Texas Tax Code. Lower courts had held that the pouches were not taxable tobacco products, but the Texas Supreme Court reversed, concluding that VELO pouches are taxable because they are made of “a tobacco substitute.”
May.09 by 2FIRSTS.ai
EU Novel Tobacco Regulation Trends and Business Response | Guest Contribution by a European Legal and Compliance Expert
EU Novel Tobacco Regulation Trends and Business Response | Guest Contribution by a European Legal and Compliance Expert
Carlos Cabrera, founder of CabLab Law & Advocacy, contributes this article to 2Firsts, arguing that the EU’s evolving approach to novel tobacco regulation may unintentionally reinforce cigarette use by narrowing alternatives. He warns companies to watch signals on flavours, labelling, traceability, nicotine pouch rules and digital marketing, while grounding business decisions in realistic timelines, compliance planning and continuous monitoring.
Apr.22
Argentina Issues Resolution 549/2026 to Regulate Vapes, Heated Tobacco and Nicotine Pouches
Argentina Issues Resolution 549/2026 to Regulate Vapes, Heated Tobacco and Nicotine Pouches
Argentina’s government has created a comprehensive regulatory framework for nicotine products, including vapes, heated tobacco and nicotine pouches, through Resolution 549/2026 published in the Official Gazette. The new regulation ends the previous prohibitive framework and establishes rules to organize the market by requiring traceability, quality standards and mandatory registration for all manufacturers and retailers operating in the country.
May.06 by 2FIRSTS.ai