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.


This document has been generated through artificial intelligence translation and is provided solely for the purposes of industry discourse and learning. Please note that the intellectual property rights of the content belong to the original media source or author. Owing to certain limitations in the translation process, there may be discrepancies between the translated text and the original content. We recommend referring to the original source for complete accuracy. In case of any inaccuracies, we invite you to reach out to us with corrections. If you believe any content has infringed upon your rights, please contact us immediately for its removal.

Guam checks 277 eligible retailers in 2025; eight found selling tobacco or disposable vapes to minors aged 16–20
Guam checks 277 eligible retailers in 2025; eight found selling tobacco or disposable vapes to minors aged 16–20
he Guam Behavioral Health and Wellness Center said that out of 277 eligible tobacco retailers inspected in 2025, eight were found selling tobacco or disposable e-cigarettes or vapes to minors aged 16–20, and one retailer failed to display the required “No Sale Under 21” prohibition sign.
Jan.05 by 2FIRSTS.ai
Türkiye’s trade minister: valued at USD 40 million in illicit e-cigarette products seized over five years
Türkiye’s trade minister: valued at USD 40 million in illicit e-cigarette products seized over five years
Türkiye’s Trade Minister Ömer Bolat said that over the past five years, authorities carried out 4,589 operations seizing 28,683,985 e-cigarette devices and parts and 1,070,586 grams/ml of e-liquid, valued at TL 1,762,796,000 (about USD 40,544,308).
Jan.20 by 2FIRSTS.ai
Belgium seizes 140,019 disposable vapes since the start of 2025 after sales ban took effect
Belgium seizes 140,019 disposable vapes since the start of 2025 after sales ban took effect
Belgium’s Federal Public Health Service said it has seized 140,019 disposable vapes since the start of 2025. The crackdown follows a ban on the sale of disposable e-cigarettes that came into force on January 1.
Dec.31 by 2FIRSTS.ai
NielsenIQ Data Shows UK Tobacco Market Decline of 12.7% with E-Cigarettes Dropping GBP 225 Million
NielsenIQ Data Shows UK Tobacco Market Decline of 12.7% with E-Cigarettes Dropping GBP 225 Million
According to NielsenIQ data published on December 7, 2025, overall tobacco and nicotine product sales in the UK dropped 12.7% in the 12 months ending September 6, representing more than £1 billion in lost sales.
Dec.15 by 2FIRSTS.ai
Exclusive: Altria Confirms FDA Grants Marketing Authorization to on! PLUS, Ending More Than a Year of PMTA Review
Exclusive: Altria Confirms FDA Grants Marketing Authorization to on! PLUS, Ending More Than a Year of PMTA Review
Altria on December 19 confirmed that six on! PLUS nicotine pouch products had received U.S. FDA marketing authorization, ending a PMTA review lasting more than a year after the company moved ahead with launch plans before clearance.
Regulations
Dec.20
Japan Tobacco Launches Limited-Edition “Purple Dusk” Colorway for Ploom AURA, Priced at JPY 2,980
Japan Tobacco Launches Limited-Edition “Purple Dusk” Colorway for Ploom AURA, Priced at JPY 2,980
Japan Tobacco has launched the fourth installment of its limited-color series for the Ploom AURA heated-tobacco device, unveiling “Purple Dusk” . Priced at JPY 2,980 (about USD 18.7, tax included), it goes on limited early sale via official channels from Jan 13, before rolling out to convenience stores and other retail outlets across Japan from Jan 20.
Jan.13 by 2FIRSTS.ai