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.

Goyang City Urges Relevant Sellers to Apply for Tobacco Retailer Designation by April 23
Goyang City Urges Relevant Sellers to Apply for Tobacco Retailer Designation by April 23
Goyang Special City in South Korea said it has informed local sellers about the revised Tobacco Business Act, which will take effect on April 24, 2026, and urged them to apply for tobacco retailer designation.
Mar.13 by 2FIRSTS.ai
French Anti-Tobacco Group Contre-Feu Calls for Plain Packaging Across All Vaping Products
French Anti-Tobacco Group Contre-Feu Calls for Plain Packaging Across All Vaping Products
French anti-tobacco group Contre-Feu said in a statement released on April 14 that e-cigarette manufacturers are encouraging nicotine dependence among young people through targeted marketing and called for concrete measures to protect minors. The group asked for plain packaging for all vaping products, strict regulation of flavor names, and a ban on online sales.
Apr.15 by 2FIRSTS.ai
Guernsey Rejects Petition to Overturn Under-18 Vape Shop Ban
Guernsey Rejects Petition to Overturn Under-18 Vape Shop Ban
A petition seeking to overturn a new ban on under-18s entering vape shops in Guernsey has been rejected. The Health and Social Care Committee said the measure meets its objective of protecting children from exposure to vaping products.
Mar.23 by 2FIRSTS.ai
UK OPSS launches vape safety campaign focusing on use, charging and disposal
UK OPSS launches vape safety campaign focusing on use, charging and disposal
The UK Office for Product Safety and Standards (OPSS) published information on March 4, 2026, launching a new campaign to raise awareness among young people about safety issues linked to using, charging and disposing of vapes.
Mar.06 by 2FIRSTS.ai
KT&G Approves Plan to Establish Guatemala Branch as First Local Base in Central and South America
KT&G Approves Plan to Establish Guatemala Branch as First Local Base in Central and South America
KT&G has approved a plan to establish a branch in Guatemala, which will serve as its first local base in Central and South America. The company is currently preparing office space, staffing, and operating systems. KT&G said the branch is intended to secure a regional distribution base and will focus on local channel management and new sales channel expansion. Meanwhile, overseas cigarette revenue in 2025 exceeded the domestic share for the first time.
Mar.09 by 2FIRSTS.ai
Philippine Anti-Smoking Groups Urge DTI Action Over Alleged Vape Law Violations by ZYN and IQOS
Philippine Anti-Smoking Groups Urge DTI Action Over Alleged Vape Law Violations by ZYN and IQOS
Several anti-smoking and health advocacy groups in the Philippines urged the Department of Trade and Industry to take action against tobacco companies accused of violating the Vape Regulation Act of 2022. The groups said three consecutive complaints had been filed involving nicotine pouch brand ZYN and heated tobacco product company IQOS Philippines.
Apr.27 by 2FIRSTS.ai