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.

India Tobacco Board urges Finance Minister Nirmala Sitharaman to revisit cigarette duty hike
India Tobacco Board urges Finance Minister Nirmala Sitharaman to revisit cigarette duty hike
The Tobacco Board, under the administrative control of India’s Department of Commerce, has written to Finance Minister Nirmala Sitharaman (Nirmala Sitharaman) flagging the adverse impact of an “unprecedented” increase in cigarette excise duties on the industry and on millions of farmers and workers, and urging a revision of duty rates.
Feb.11 by 2FIRSTS.ai
Bangkok Police Bust Illegal E-Cigarette Warehouse, Seize Vapes Worth Over $112,000
Bangkok Police Bust Illegal E-Cigarette Warehouse, Seize Vapes Worth Over $112,000
Thai police raided an illegal e-cigarette warehouse, arrested a man accused of selling vapes online, and seized a large quantity of improperly imported products worth more than 4 million baht (about $112,000).
Dec.25 by 2FIRSTS.ai
Arizona Moves to Tighten Vape Supply-Chain Enforcement, Targeting Illicit Products
Arizona Moves to Tighten Vape Supply-Chain Enforcement, Targeting Illicit Products
Arizona state Sen. Shawnna Bolick introduced SB 1397 to curb illicit vapes by tracing product origins, intercepting illegal shipments, and cracking down on retailers that violate state law. The proposal would require manufacturers to hold a state license to sell in Arizona, with fines up to $10,000 for unlicensed sales.
Jan.30 by 2FIRSTS.ai
Pakistan Senate bill seeks strict control of vapes and e-cigarettes in Islamabad, including under-18 sales ban
Pakistan Senate bill seeks strict control of vapes and e-cigarettes in Islamabad, including under-18 sales ban
Following approval by the Senate Standing Committee on National Health Services, the Electronic Nicotine Delivery Systems (Regulation) Bill is set to be tabled in the Senate to impose strict controls on the sale, marketing and use of vapes and e-cigarettes in Islamabad.
Jan.08 by 2FIRSTS.ai
FDA schedules online roundtable to gather small manufacturers’ input on ENDS PMTA requirements
FDA schedules online roundtable to gather small manufacturers’ input on ENDS PMTA requirements
FDA announced it will convene a Feb. 10, 2026 roundtable with small tobacco product manufacturers to gather feedback on PMTA submissions for ENDS products. The discussion will be viewable online, and a public docket is open for comments through March 12, 2026.
Feb.10 by 2FIRSTS.ai
Russia to Start Extrajudicial Blocking of Sites Selling Tobacco and Nicotine Products Online From March 1
Russia to Start Extrajudicial Blocking of Sites Selling Tobacco and Nicotine Products Online From March 1
Russia will introduce an extrajudicial (non-court) blocking mechanism starting March 1, 2026, allowing authorities to block websites selling tobacco and nicotine-containing products online without a court order. State Duma member Anton Nemkin said the change will place offending sites directly onto the prohibited information registry, speeding up enforcement, reducing the court burden, and increasing platform obligations to proactively monitor content.
Jan.29 by 2FIRSTS.ai