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.

U.S. Fifth Circuit judges question FDA’s claim it has no de facto ban on flavored refillable e-cigarettes
U.S. Fifth Circuit judges question FDA’s claim it has no de facto ban on flavored refillable e-cigarettes
Law360 reports that a Fifth Circuit panel expressed skepticism about the FDA’s claim that it has no de facto ban on flavored refillable e-cigarette products, noting that only six applications had been approved out of hundreds of thousands and that near-100% denials look like a ban.
Jan.07 by 2FIRSTS.ai
Kyrgyzstan Extends Import Ban on E-Cigarettes and Nicotine Liquids by Six Months
Kyrgyzstan Extends Import Ban on E-Cigarettes and Nicotine Liquids by Six Months
The Kyrgyz government has extended its ban on the import of electronic cigarettes and nicotine-containing liquids for another six months. The decision, signed by the chairman of the Cabinet of Ministers, covers e-cigarettes, integrated nicotine delivery systems, and nicotine liquids used in such devices. The original ban was introduced in July and was due to expire soon.
Dec.24 by 2FIRSTS.ai
U.S. vape firms appeal Mississippi synthetic-nicotine ban, citing FDA authority preemption
U.S. vape firms appeal Mississippi synthetic-nicotine ban, citing FDA authority preemption
A coalition of U.S. vape industry groups has appealed a Mississippi law banning the sale of e-cigarette products containing synthetic nicotine, arguing the statute effectively conditions sales on FDA authorization and unlawfully encroaches on federal regulatory authority. The law took effect in July 2025 and has already begun to be enforced.
Dec.17 by 2FIRSTS.ai
Spain’s new e-cigarette e-liquid tax, in force since April 1, raises €26 million through November
Spain’s new e-cigarette e-liquid tax, in force since April 1, raises €26 million through November
Spain’s Tax Agency monthly collection report shows the new tax on e-cigarette e-liquids, in force since April 1, raised €26 million through November, including €4 million in November. The levy began three months later than the usual fiscal timetable to allow the sector to adapt, making 2025 the first year in which vaping products are taxed under a specific category.
Dec.30 by 2FIRSTS.ai
Report Says Teen e-cigarette use on the rise, with majority of sales coming from disposable products
Report Says Teen e-cigarette use on the rise, with majority of sales coming from disposable products
Monitoring a Changing Tobacco Product Market in the United States is the second annual review from the Monitoring Tobacco Product Use project, analyzing retail scanner data from January 2019 to December 2024 and TEEN+ survey data.
Jan.07 by 2FIRSTS.ai
China Opens 2026 National E-Cigarette Standards Project for Public Submissions
China Opens 2026 National E-Cigarette Standards Project for Public Submissions
The State Administration for Market Regulation (SAMR) and the State Tobacco Monopoly Administration (STMA) jointly announced the launch of the 2026 National Standardization Project for E-cigarettes. The initiative, coordinated by the National Technical Committee on Standardization of E-cigarettes, aims to enhance the industry’s regulatory framework through new standards on manufacturing, storage, distribution, and evaluation.
Nov.27 by 2FIRSTS.ai