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.

Puerto Rico House Files P.C. 1070 to Ban Flavored Vaping Product Sales to Under-21s
Puerto Rico House Files P.C. 1070 to Ban Flavored Vaping Product Sales to Under-21s
According to a statement from the Puerto Rico House of Representatives, House Speaker Carlos Méndez and Rep. Pedro Julio Santiago announced the filing of House Bill 1070 (P.C. 1070), which would prohibit sales to people under 21 of vaping devices, liquids, or cartridges featuring a flavor and/or aroma other than nicotine.
Jan.29 by 2FIRSTS.ai
BAT CEO Says 2026 Return to Growth Hinges on U.S. Enforcement, Highlights Oral Leadership
BAT CEO Says 2026 Return to Growth Hinges on U.S. Enforcement, Highlights Oral Leadership
British American Tobacco said 2026 will mark a return to its mid-term growth algorithm, but CEO Tadeu Marroco stressed that deliverywill depend heavily on enforcement against illicit vapour products in the United States. Speaking at the FY2025 results call, he positioned Modern Oral as the company’s primary structural growth engine, reframed accelerating cigarette declines through “poly-usage,” and reinforced capital discipline with an expanded share buyback plan.
Feb.12
Thai Customs Region 2 seizes 22,800 YOOZ-branded vape pod heads
Thai Customs Region 2 seizes 22,800 YOOZ-branded vape pod heads
Thailand’s Customs Region 2 searched a private logistics company in Mukdahan province and seized 22,800 vape pod heads with no evidence of customs clearance. The seized items weighed 389.50 kg in total and were valued at more than THB 4.5 million (about USD 143,581.90). The photo shows packaging marked “YOOZ”.
Jan.16 by 2FIRSTS.ai
2Firsts Interview | Bengt Wiberg: Why the Oral Health Risks of Nicotine Pouches Merit Further Study
2Firsts Interview | Bengt Wiberg: Why the Oral Health Risks of Nicotine Pouches Merit Further Study
As nicotine pouches gain global traction as a lower-risk alternative to smoking, questions are emerging about their potential oral health effects. In a 2Firsts interview, Stingfree AB founder Bengt Wiberg discusses why gum irritation and oral lesions warrant closer scrutiny within the broader framework of tobacco harm reduction.
Jan.06
2Firsts Outlines 2026 Global Product Trends in the New Tobacco Industry
2Firsts Outlines 2026 Global Product Trends in the New Tobacco Industry
As regulation tightens and innovation matures, competition in the new tobacco industry is shifting. In its 2026 Global Product Trends in the New Tobacco Industry report, 2Firsts examines how heated tobacco, nicotine pouches, and vape products are moving beyond feature-driven upgrades toward system-level design, where experience management, compliance structure, and engineering capability increasingly shape long-term competition.
Jan.13 by 2Firsts Perspectives
South Korea to Classify Synthetic Nicotine E-Cigarettes as Tobacco from April 2026
South Korea to Classify Synthetic Nicotine E-Cigarettes as Tobacco from April 2026
South Korea will implement amendments to its Tobacco Business Act on April 24, 2026, officially classifying synthetic nicotine liquid e-cigarettes as tobacco. This marks the first revision of the legal definition of tobacco since 1988. Once in effect, synthetic nicotine e-cigarettes will be subject to existing tobacco regulations, including health warnings, advertising restrictions, smoke-free area enforcement, and youth protection measures.
Dec.29 by 2FIRSTS.ai