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.

Cambodia Moves to Draft New Tobacco Control Strategy Targeting Illicit Products and E-Cigarette Spread
Cambodia Moves to Draft New Tobacco Control Strategy Targeting Illicit Products and E-Cigarette Spread
Cambodian Health Minister Cheang Ra has called for the development of a tobacco control strategy for 2027–2031, with the goal of reducing tobacco use by 30% by 2030. The directive was issued during a Tobacco Product Control Committee meeting in Phnom Penh. Priority areas include reducing tobacco use, protecting the public from secondhand smoke, tackling illegal and counterfeit tobacco products, and preventing the spread of e-cigarettes.
Apr.29 by 2FIRSTS.ai
Russian Duma Speaker Says Amendment Giving Regions Power to Ban Vape Sales Is Planned for Adoption in May
Russian Duma Speaker Says Amendment Giving Regions Power to Ban Vape Sales Is Planned for Adoption in May
Russian State Duma Speaker Vyacheslav Volodin said an amendment that would give Russian regions the power to ban vape sales is planned for adoption in May. Volodin said the decision concerns the health of citizens, especially children. He also said doctors have recorded a 30% increase in patients with respiratory diseases caused or aggravated by vape use, with adolescents and people under 35 most often affected.
Apr.24 by 2FIRSTS.ai
AHA Journal Study: WS-23 Triples Premature Heartbeats, Raising Concerns Over Vape Cooling Agents
AHA Journal Study: WS-23 Triples Premature Heartbeats, Raising Concerns Over Vape Cooling Agents
A University of Louisville research team published a study in an American Heart Association journal suggesting that synthetic cooling agents used in e-cigarettes, including WS-3 and WS-23, may disrupt cardiac electrical activity and increase arrhythmia risk. In animal experiments, WS-23 tripled premature heartbeats.
Jun.16
 NYT: Reynolds American Donated $5 Million Before FDA Vape Policy Shift
NYT: Reynolds American Donated $5 Million Before FDA Vape Policy Shift
According to The New York Times, Reynolds American donated $5 million to a Trump-backed super PAC shortly before the FDA introduced a new policy that could benefit major tobacco companies seeking to sell flavored vaping products.
News
May.21
CBP and FDA Seize 18 Million Illegal Vapes Worth $175 Million in Maritime Cargo Operation
CBP and FDA Seize 18 Million Illegal Vapes Worth $175 Million in Maritime Cargo Operation
U.S. Customs and Border Protection (CBP) announced that more than 18 million illegal e-cigarettes valued at over $175 million were seized during “Operation Red Mist,” a joint enforcement initiative involving the U.S. Coast Guard and the FDA. The operation primarily targeted maritime vape shipments originating from China and focused on combating illicit importation, transportation, and distribution activities.
Regulations
May.14
2Firsts Data|China Vape Exports Sink to Three-Year April Low After Tax Rebate Ends, Falling to $694 Million
2Firsts Data|China Vape Exports Sink to Three-Year April Low After Tax Rebate Ends, Falling to $694 Million
China’s e-cigarette export value declined to $694 million in April 2026, marking the lowest April level in the past three years. The data is notable because April was the first full month after China removed export VAT rebates for certain e-cigarette products. Compared with April 2025, export value fell 20.9%; compared with April 2024, it was down 22.3%. Month-on-month, exports dropped 23.2% from March 2026.
Special Report
May.23