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.

Nicotine Pouches Gain Ground in U.S. Convenience Stores as Vape Unit Sales Fall 14%
Nicotine Pouches Gain Ground in U.S. Convenience Stores as Vape Unit Sales Fall 14%
According to convenience retail publication CStore Decisions, U.S. convenience store tobacco categories are undergoing a structural shift. Based on Circana OmniMarket Total U.S. Convenience data for the 52 weeks ending June 14, 2026, cigarettes remained the largest category with $50.8 billion in sales, but unit sales declined 5.3%. Electronic smoking devices and vaping products also declined, while modern oral nicotine products continued to grow, with nicotine pouch sales rising 29% in dollars and 17% in units. Retailers said changing consumer preferences are reshaping tobacco product assortments at convenience stores.
Regulations
Aug.07
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
GSTHR Estimates 200 Million People Use Non-Combustible Nicotine Products as 28 Countries Show Rising Use Alongside Falling Smoking Rates
GSTHR Estimates 200 Million People Use Non-Combustible Nicotine Products as 28 Countries Show Rising Use Alongside Falling Smoking Rates
The Global State of Tobacco Harm Reduction, a project operated by Knowledge·Action·Change, estimates that about 200 million people worldwide use non-combustible nicotine products including vapes, heated tobacco, nicotine pouches and snus. Its 2026 report says use of these products rose alongside declining smoking rates in 28 countries it analyzed. The data do not establish that all 200 million users have quit smoking, nor do they prove a direct causal relationship. GSTHR also says regulatory restrictions on the products continue to expand in many markets.
Sep.10
2Firsts Data | China’s Vape-Related Exports Rise 16.5% in July 2026 as U.S.-Bound Shipments Jump 53.5%
2Firsts Data | China’s Vape-Related Exports Rise 16.5% in July 2026 as U.S.-Bound Shipments Jump 53.5%
China’s vape-related exports reached $1.047 billion in July 2026, up 16.5% year on year and the highest monthly total of the year. Growth was heavily concentrated in the U.S., where exports jumped 53.5% to $404 million and accounted for 94.9% of the overall increase. Exports to all other markets rose just 1.2%. By category, nicotine-containing non-combustible products—primarily vapes—under HS24041200 rose 24.7% and generated 95.5% of the total increase. Vape-device exports under HS85434000 fell 0.4%, while other nicotine-substitute products under HS24041990 grew 88.9% but remained comparatively small.
DATA
Aug.24
InterTabac 2026: Further Sessions on Regulation, Market Access and Innovation Confirmed; 2FIRSTS to Host China Market Forum
InterTabac 2026: Further Sessions on Regulation, Market Access and Innovation Confirmed; 2FIRSTS to Host China Market Forum
InterTabac 2026 will bring together international experts to discuss European regulation, tax policy, Track & Trace, market access, retail impacts, consumer behavior and innovation. Sessions will also examine Poland’s tobacco-growing perspective and the growing fragmentation of Europe’s tobacco and nicotine market. Media partner 2FIRSTS will host the second “2FIRSTS Connect at InterTabac” on September 16, focusing on developments in China’s tobacco and nicotine industry.
Aug.06
BAT Expands ITC Infotech Partnership Across Poland, Romania and India to Advance AI
BAT Expands ITC Infotech Partnership Across Poland, Romania and India to Advance AI
ITC Infotech has expanded its multi-year strategic technology partnership with British American Tobacco (BAT), providing technology services across Poland, Romania and India while continuing to support BAT's newly launched Future Capabilities Centre in India and existing technology hubs in Malaysia and Mexico. The companies said the agreement will focus on AI-enabled innovation, technology capability building and greater operational efficiency. The partnership also aligns with BAT's broader Fit2Win transformation programme, under which the group is expanding the use of external technology and business-services partners to simplify its global operating model.
Aug.13