NACS urges FDA for transparency in PMTA process

Jun.05.2023
NACS urges FDA for transparency in PMTA process
NACS requests FDA transparency on tobacco product application process and public list of legal e-cigarette products.

Recently, the National Association of Convenience Stores (NACS) wrote a letter to the U.S. Food and Drug Administration (FDA) requesting greater transparency in the pre-market tobacco product application (PMTA) process. The association also called for a publicly available list of legally sold electronic cigarette products.


The association stated in the letter:


It has been 18 months since the PMTA (premarket tobacco product application) requirement was introduced and the agency has received millions of applications, with 99% of them having been decided upon. Retailers abiding by the law need to know which specific products are legal to sell and which ones are not.


In October 2021, NACS and five other retail associations sent a letter to the FDA requesting that the agency release the names of electronic cigarettes that have been taken off the market. The associations emphasized the importance of this list for retail members, who need to know which products can be legally sold.


The FDA officially responded in January 2022, stating that they understand the retail group's request for specific product names and are working to update their list. This includes final measures taken on individual products, including those that have received market rejection notices.


In its latest letter to the FDA, NACS acknowledged the challenging task of reviewing millions of applications. However, there is still widespread confusion in the market about which products can be sold and which should be taken down.


The National Association of Convenience Stores (NACS) stated that manufacturers' lists cannot guarantee accuracy or provide assurance like verified lists from institutions can. Retailers who violate the law will face enforcement penalties, and the only way to ensure their compliance is to obtain a verified list from an institution.


NACS ultimately stated that it will notify its members when the FDA updates its PMTA product list.


Reference materials


The National Association of Convenience stores (NACS) is urging the U.S. Food and Drug Administration (FDA) to publish the list of Electronic Nicotine Delivery System (ENDS) products that have been rejected for marketing approval. This comes as NACS continually seeks clarification from the FDA over the guidelines to be followed when selling ENDS products.



Disclaimer

This article is provided solely for professional research, industry discussion, and informational purposes. Any references to brands, companies, products, technologies, or policies are made for factual reporting and analytical purposes only, and do not constitute endorsement, recommendation, promotion, or advertising by 2Firsts.

Nicotine-containing products, including but not limited to cigarettes, e-cigarettes, heated tobacco products, and nicotine pouches, carry significant health risks. Readers are responsible for complying with all applicable laws and regulations in their respective jurisdictions, including age restrictions and access limitations.

The information contained in this article should not be regarded as investment, legal, medical, regulatory, or commercial advice. While 2Firsts strives to ensure the accuracy and reliability of its content, it does not assume liability for any direct or indirect loss arising from errors, omissions, inaccuracies, or reliance on the information contained herein.

This article is not intended for individuals below the legal age for accessing tobacco or nicotine-related information in their jurisdiction.

 

Copyright Notice

This article is either original content produced by 2Firsts or content reproduced, translated, summarized, or adapted from third-party sources with attribution where applicable. The intellectual property rights of the original content remain with 2Firsts or the respective original rights holders.

No individual or organization may copy, reproduce, distribute, republish, modify, translate, or otherwise use this content without prior authorization. Any unauthorized use may result in legal action.

For copyright-related inquiries, corrections, or removal requests, please contact: info@2firsts.com.

 

AI-Assisted Translation and Editing Notice

Portions of this article may have been translated, edited, or reviewed with the assistance of artificial intelligence tools to improve efficiency and readability. Due to the limitations of AI-assisted translation and editing, discrepancies, omissions, or inaccuracies may exist when compared with the original source.

Where applicable, readers are advised to refer to the original source for the most complete and accurate information. If you identify any errors or believe that any content infringes upon your rights, please contact us at info@2firsts.com, and we will review and address the matter promptly.

Russian Strikes Destroy JTI and Imperial Brands Ukraine Warehouses, With Losses Reaching Tens of Millions of Hryvnias
Russian Strikes Destroy JTI and Imperial Brands Ukraine Warehouses, With Losses Reaching Tens of Millions of Hryvnias
According to Ukrainska Pravda, Russian strikes on the Kyiv region during the night of Aug. 4-5, 2026, damaged warehouses storing products of Japan Tobacco International (JTI) and Imperial Brands Ukraine. JTI said a finished goods warehouse in Kyiv Oblast was destroyed, with no employees injured, and that it did not expect disruptions to retail supplies. Imperial Brands Ukraine said products stored at warehouses of distributors and retail partners were affected and estimated losses from the strikes at “tens of millions of Ukrainian hryvnias” (roughly hundreds of thousands of U.S. dollars).
JTI
Aug.07
Product | Summo 150K Introduces Refillable Design With Up to 150,000 Puffs, Exploring a New High-Capacity Vape Format
Product | Summo 150K Introduces Refillable Design With Up to 150,000 Puffs, Exploring a New High-Capacity Vape Format
Summo has introduced the Summo 150K Refillable Disposable Vape, entering the ultra-high-puff vape segment with a claimed capacity of up to 150,000 puffs. The device combines a 40ml dual e-liquid system, transparent tank design, dual mesh coils and a 900mAh rechargeable battery, using a refillable structure to differentiate itself from conventional disposable vapes. The product appeared on overseas online retail channels including Vapesourcing and VapeBarTime between late June and early July 2026.
Jul.22
BAT New Categories Revenue Rises 18% in H1 2026 as Broad Portfolio Offers More Ways to Win—and Lose
BAT New Categories Revenue Rises 18% in H1 2026 as Broad Portfolio Offers More Ways to Win—and Lose
British American Tobacco’s New Category revenue rose 18% at constant rates in the first half of 2026. Nicotine-pouch brand Velo expanded rapidly, while Vuse recovered as U.S. enforcement against illicit e-vapor products strengthened. Heated-tobacco platform glo remained under pressure, and cigarettes continued to provide most of the group’s profit and cash. Compared with PMI and JT, BAT has more routes to growth—but also greater regulatory, investment and execution risks across its broader portfolio.
BAT
Jul.30
South Korea’s New Vape Rules Raise Bar for E-Liquid Makers and China-Linked Supply Chains, Expert Says
South Korea’s New Vape Rules Raise Bar for E-Liquid Makers and China-Linked Supply Chains, Expert Says
South Korea’s new vape regulations are reshaping the e-liquid market, raising compliance requirements for manufacturers, retailers and overseas suppliers. In an interview with 2Firsts, Korean nicotine products specialist Sam Kim discusses licensing barriers, inventory impacts, China-linked supply chains, and emerging regulatory challenges around nicotine analogues, nicotine-free products and DIY mixing. The Korean case may offer broader insights as governments worldwide adapt to rapidly evolving nicotine products.
Jul.16
AIR Invests $20 Million in Greentank, Deepening Capital Ties Across the Vape Supply Chain
AIR Invests $20 Million in Greentank, Deepening Capital Ties Across the Vape Supply Chain
Nasdaq-listed AIR Global has invested $20 million in preferred shares of Canadian vaporization technology company Greentank, deepening a partnership established in 2023. AIR gains a board nomination right, access to new technologies, enhanced commercial terms and long-term supply assurances, while retaining an option to increase its stake. Greentank’s Quantum Chip platform powers Crown Switch and forms part of AIR’s planned U.S. PMTA dossier, linking capital investment more closely with product technology, regulatory evidence and supply-chain control.
Special Report
Jul.29
China’s Shanghai Tobacco Group Launches CNY 10.98 Million (Approximately US$1.53 Million) Procurement for Heated Tobacco Production Utility Equipment
China’s Shanghai Tobacco Group Launches CNY 10.98 Million (Approximately US$1.53 Million) Procurement for Heated Tobacco Production Utility Equipment
Shanghai Tobacco Group Co., Ltd., a tobacco manufacturing company under China National Tobacco Corporation (CNTC), has launched a public tender for heated tobacco products (HTPs) production utility equipment at its Shanghai Cigarette Factory. The project is valued at CNY 10.98 million and covers six combined air-conditioning units, electrical cabinets and control systems for production facilities. The procurement includes equipment design, supply, installation, commissioning and related training services.
Aug.07