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.

Fontem Sues FDA Over Refusal-to-File Decision for Nicotine Pouch PMTAs
Fontem Sues FDA Over Refusal-to-File Decision for Nicotine Pouch PMTAs
According to a complaint filed on March 17 in the U.S. District Court for the Northern District of Texas, Fontem US, LLC and Texas retailer OM Investment, LLC sued the Food and Drug Administration and the Department of Health and Human Services over FDA’s refusal-to-file decision for certain Zone nicotine pouch PMTAs.
Mar.19 by 2FIRSTS.ai
Costa Rica’s Constitutional Court Rejects Challenge, New Vape Rules to Take Effect on August 6
Costa Rica’s Constitutional Court Rejects Challenge, New Vape Rules to Take Effect on August 6
Costa Rica’s Constitutional Court has rejected an injunction seeking to stop a new vape regulation from taking effect, ruling that there was no specific harm to constitutional rights. As a result, Technical Regulation RTCR 519-2025, promoted by the Health Ministry, will enter into force on August 6 as originally planned.
Mar.20 by 2FIRSTS.ai
Kyrgyzstan Plans to Extend E-Cigarette Import Ban by Another Six Months
Kyrgyzstan Plans to Extend E-Cigarette Import Ban by Another Six Months
According to Kyrgyzstan’s Ministry of Economy, the government plans to extend the current ban on e-cigarette imports by another six months once the existing measure expires, with the new restriction set to take effect on July 10, 2026. The ban covers disposable e-cigarettes as well as nicotine-containing liquids for reusable systems.
Apr.17 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
South Korea Set to Enforce Liquid Vape Ban in Smoke-Free Areas, but Welfare Ministry Abruptly Adds Two-Month Guidance Period
South Korea Set to Enforce Liquid Vape Ban in Smoke-Free Areas, but Welfare Ministry Abruptly Adds Two-Month Guidance Period
Local governments across South Korea recently issued press releases saying they would intensively crack down on the use of liquid e-cigarettes in smoke-free areas. Since the revised Tobacco Business Act, passed in December last year, included liquid e-cigarettes within the definition of tobacco and took effect on April 24, local authorities had prepared to begin enforcement immediately.
Apr.27 by 2FIRSTS.ai
Philip Morris Ukraine Says Ukraine’s Flavored Vape Ban Still Lacks Effective Enforcement
Philip Morris Ukraine Says Ukraine’s Flavored Vape Ban Still Lacks Effective Enforcement
Mikhail Polyakov, deputy general director for corporate affairs at Philip Morris Ukraine, said Ukraine’s ban on flavored and aromatic additives for e-cigarettes, in force since July 11, 2024, has not worked in practice because compliance is not being enforced.
Mar.17 by 2FIRSTS.ai