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.

Vape Club: Over 1.3 Million Illegal E-Cigarettes Seized in UK by 2025, Worth £10 Million on Streets
Vape Club: Over 1.3 Million Illegal E-Cigarettes Seized in UK by 2025, Worth £10 Million on Streets
Vape Club report reveals 1.3 million illegal e-cigarettes seized in UK by 2025, worth £10 million on the streets.
Mar.12 by 2FIRSTS.ai
Special Report | Breeze and Glas Seek White House Review as FDA Advances Flavored ENDS Guidance
Special Report | Breeze and Glas Seek White House Review as FDA Advances Flavored ENDS Guidance
Breeze Smoke and Glas, Inc. have separately requested White House review under Executive Order 12866 as the FDA advances draft guidance on flavored ENDS (RIN 0910-ZC78). The guidance aims to clarify evidentiary standards under the statutory “appropriate for the protection of public health” (APPH) framework. The parallel filings highlight industry concern over regulatory predictability, particularly as Glas’s PMTA review status has recently drawn market attention.
Special Report
Mar.03
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
Indonesia’s vape retailers adopt 21+ signage and ID verification requirements, report says
Indonesia’s vape retailers adopt 21+ signage and ID verification requirements, report says
RetailNews Asia reported that the Association of Indonesian Vape Retailers (Arvindo) has directed member stores to stop selling e-cigarettes to people under 21 and to display 21+ signage and verify customer age using valid identification.
Feb.27
Special Report | China’s New Five-Year Plan Highlights “Health-First” Strategy, Providing Policy Context for Tobacco Sector
Special Report | China’s New Five-Year Plan Highlights “Health-First” Strategy, Providing Policy Context for Tobacco Sector
China’s 2026 “Two Sessions” reviewed the draft Outline of the 15th Five-Year Plan, which proposes implementing a health-first development strategy and strengthening the effectiveness of the Patriotic Health Campaign. Although the document does not address specific industries, this public-health governance framework provides a new policy context for observing the future regulation, product strategies, and market development of China’s tobacco and next-generation nicotine sectors.
Industry Insight
Mar.08
Special Report|Reynolds’ 337 Patent Case Ends, but a Harsher 337 Compliance Battle Now Targets the Entire Vape Supply Chain
Special Report|Reynolds’ 337 Patent Case Ends, but a Harsher 337 Compliance Battle Now Targets the Entire Vape Supply Chain
The U.S. International Trade Commission (ITC) has terminated Investigation 337-TA-1410 after invalidating key vape patent claims asserted by R.J. Reynolds Vapor Company, removing the immediate risk of import bans for dozens of companies. However, a new case—337-TA-1486—has already opened a more consequential legal front, shifting the focus from patent disputes to regulatory compliance across the vape supply chain, including PACT Act reporting, tax compliance, and FDA marketing authorization.
BAT
Mar.11