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.

PMI says Colorado ZYN plant build advances as first pouches hit market in 2025
PMI says Colorado ZYN plant build advances as first pouches hit market in 2025
Philip Morris International (PMI) is investing $600 million to build a ZYN nicotine pouch plant in Aurora, Colorado. While the facility is still under construction, PMI said production started in September 2025 and the first pouches made at the site have already gone to market.
Feb.10 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
IQOS UK unveils 2026 pop-up events plan, first stops set for London and three other cities
IQOS UK unveils 2026 pop-up events plan, first stops set for London and three other cities
IQOS’ UK website shows the company will roll out time-limited pop-up experience spaces across Britain in 2026 for adult consumers. The first confirmed locations are London, the West Midlands area near Birmingham, Manchester and Romford, offering product demonstrations, pop-up-only promotions and nicotine pouch sampling. Entry will be restricted to those aged 18 and over, with “Challenge 25” ID checks in place.
Feb.03 by 2FIRSTS.ai
British American Tobacco to close South Africa cigarette plant by end-2026, citing illicit trade squeezing legal market
British American Tobacco to close South Africa cigarette plant by end-2026, citing illicit trade squeezing legal market
British American Tobacco South Africa (BATSA) said it will halt local production of factory-made cigarettes and close its manufacturing plant in Heidelberg, Gauteng by the end of 2026, shifting to an import-led supply model. The company said illicit cigarettes now account for about 75% of South Africa’s market, making local manufacturing “unsustainable” and putting around 230 jobs at risk.
Jan.16
New Nicotine Products Added to Tax List in Delaware Budget Proposal
New Nicotine Products Added to Tax List in Delaware Budget Proposal
Delaware Governor Matt Meyer’s proposed FY2027 budget would significantly raise cigarette and nicotine product taxes to help close a $500 million budget gap and generate new revenue. The cigarette tax would rise from $2.10 to $3.60 per pack, with increases on moist snuff, e-liquids and other tobacco products. Supporters say the move is justified, while small businesses warn of potential sales losses.
Feb.17
Indonesia’s Vape Excise Revenue Rises 7.38% in 2025 to $170.4M Amid Broader Tobacco Excise Decline
Indonesia’s Vape Excise Revenue Rises 7.38% in 2025 to $170.4M Amid Broader Tobacco Excise Decline
Indonesia’s customs data show vape (REL) excise revenue reached Rp 2.84 trillion in 2025 (≈$170.4 million), up 7.38% year over year. The gain came even as overall tobacco excise revenue declined. Minimum retail price benchmarks (HJE) for vape products rose in 2025, while excise rates remained unchanged from 2024; open-system e-liquids accounted for the largest share of revenue.
Jan.27 by 2FIRSTS.ai