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.

Imperial Brands Pulls myblu Vape Business From U.S., Citing Prolonged FDA Approval Process
Imperial Brands Pulls myblu Vape Business From U.S., Citing Prolonged FDA Approval Process
Imperial Brands said it will phase out its myblu vaping business in the United States, citing prolonged FDA approval timelines for new vape products. The company said it will instead focus on modern oral nicotine products in the U.S., including the expansion of its Zone brand and new flavors. While overall next-generation product revenue continued to grow, revenue from the category in the Americas declined sharply.
May.12
India Seizes $14 Million Worth of Illegal Vaping Products Imported From China
India Seizes $14 Million Worth of Illegal Vaping Products Imported From China
India’s Directorate of Revenue Intelligence (DRI) seized approximately 300,000 illegal e-cigarettes and vaping devices worth more than ₹120 crore (approximately $14 million) during coordinated multi-state enforcement operations.
Regulations
May.22
Thailand’s Bangkok Port Customs Reports E-Cigarette and Nitrous Oxide Seizure Worth More Than THB 27 Million
Thailand’s Bangkok Port Customs Reports E-Cigarette and Nitrous Oxide Seizure Worth More Than THB 27 Million
Bangkok Port Customs on April 28 announced the seizure of 52,000 complete e-cigarettes, 100 gallons of e-liquid and 126,226 canisters of nitrous oxide, with total economic damage exceeding THB 27 million, or about USD 831,178 based on an April 28 USD/THB rate of 32.484. The e-cigarette and e-liquid shipment was valued at THB 5.56 million, or about USD 171,161, while the nitrous oxide shipment was valued at THB 21.27 million, or about USD 654,784.
Apr.29 by 2FIRSTS.ai
OLAF and Customs Authorities From 30 Countries Seize More Than 94 Million Illicit Vape and Heated Tobacco Items
OLAF and Customs Authorities From 30 Countries Seize More Than 94 Million Illicit Vape and Heated Tobacco Items
The European Anti-Fraud Office said on April 17 that its “JCO VAPE” operation, carried out together with customs authorities from 30 countries, successfully targeted the illicit trade in e-cigarettes and heated tobacco products. The operation, conducted from November 14 to December 15, 2025, resulted in seizures of more than 94 million items and more than 2,500 kg/l of tobacco products, e-cigarettes, devices, and related goods.
Apr.20 by 2FIRSTS.ai
Japan Says Heated Tobacco and E-Cigarette Use Is a Key Factor Behind Rising In-Flight Smoking
Japan Says Heated Tobacco and E-Cigarette Use Is a Key Factor Behind Rising In-Flight Smoking
Japan’s transport ministry said on April 14 that major Japanese airlines reported 429 passenger smoking incidents on domestic and international flights in 2025, the highest level since comparable data collection began in 2004. The government said the spread of heated tobacco products and e-cigarettes was an important factor behind the increase. Japan plans to work with airlines to raise public awareness of fire risks on aircraft.
Apr.14 by 2FIRSTS.ai
Philippines Draft Order Would Bring Nicotine Pouches Under PS Licensing Scheme
Philippines Draft Order Would Bring Nicotine Pouches Under PS Licensing Scheme
The Philippine Department of Trade and Industry is planning to impose mandatory product certification on nicotine pouches in an effort to curb illicit nicotine product trade.
Apr.13 by 2FIRSTS.ai