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.

Nature Health Comment Urges Wider Role for Smoke-Free Nicotine Products in Tobacco Control
Nature Health Comment Urges Wider Role for Smoke-Free Nicotine Products in Tobacco Control
Ahead of World No Tobacco Day, a Nature Health Comment by Robert Beaglehole, Ruth Bonita and Tikki Pang argues that regulated smoke-free nicotine products could help accelerate the global decline in smoking. The authors propose a “smoke-free 2040” goal and call for risk-proportionate regulation distinguishing cigarettes from lower-risk nicotine alternatives.
News
May.20
Jinjia Shares Discloses 2025 Annual and Q1 2026 Results With Revenue Growth, Profit Pressure and Expanding New Tobacco Business
Jinjia Shares Discloses 2025 Annual and Q1 2026 Results With Revenue Growth, Profit Pressure and Expanding New Tobacco Business
Jinjia Shares’ 2025 annual report summary and first-quarter 2026 report show that the company recorded 2025 revenue of RMB 2.988 billion, up 4.57% year on year, while net profit attributable to shareholders turned to a loss of RMB 346 million. In the first quarter of 2026, revenue rose 58.13% year on year to RMB 1.005 billion, but attributable net profit fell 45.16% to RMB 36.5349 million. The company said both revenue and cost growth were related to the expansion of its new tobacco business.
Apr.28 by 2FIRSTS.ai
FDA Says It Will Not Take Enforcement Action Against Zone Nicotine Pouches Until Lawsuit Is Resolved
FDA Says It Will Not Take Enforcement Action Against Zone Nicotine Pouches Until Lawsuit Is Resolved
The U.S. Food and Drug Administration has told vape manufacturer Fontem US that it does not presently intend to take enforcement action against the company’s Zone nicotine pouches while litigation over the agency’s handling of the application remains unresolved.
Apr.07 by 2FIRSTS.ai
Korean Vape Retailers Warn of Possible Store Closures After New Tobacco Rules Take Effect
Korean Vape Retailers Warn of Possible Store Closures After New Tobacco Rules Take Effect
South Korea’s revised Tobacco Business Act will take effect on April 24, bringing synthetic nicotine liquid vapes into the legal definition of tobacco and subjecting both retailers and manufacturers to formal regulation.
Apr.13 by 2FIRSTS.ai
BAT France Confirms Full Compliance as France Implements Nicotine Pouch Ban on April 1from April 2026
BAT France Confirms Full Compliance as France Implements Nicotine Pouch Ban on April 1from April 2026
BAT France said that, under the decree of September 5, 2025 that entered into force on April 1, 2026, it has stopped commercialising its nicotine pouch products in France from that date.
Apr.03 by 2FIRSTS.ai
Dutch Data Show 244 Companies Continued Illegal Vape Sales After Two Fines
Dutch Data Show 244 Companies Continued Illegal Vape Sales After Two Fines
According to RTL Nieuws, citing figures from the Netherlands Food and Consumer Product Safety Authority (NVWA), hundreds of Dutch shops continue to sell illegal vapes, often even after repeated fines.
Apr.08 by 2FIRSTS.ai