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.


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.

UK Tobacco and Vapes Bill Enters House of Lords Report Stage
UK Tobacco and Vapes Bill Enters House of Lords Report Stage
The Tobacco and Vapes Bill has entered the report stage in the UK House of Lords, with further examination scheduled to begin on February 24, 2026. The legislation aims to create the first “smoke-free generation” by ensuring that individuals who are 15 years old or younger in 2026 can never legally be sold tobacco.
Regulations
Feb.22
Azerbaijan moves to fine and confiscate e-cigarettes across supply chain; full ban expected April 1, 2026
Azerbaijan moves to fine and confiscate e-cigarettes across supply chain; full ban expected April 1, 2026
Azerbaijan is considering administrative penalties for the use, import, export, production, wholesale and retail sale, and storage for sale of e-cigarettes, including confiscation of products. The proposed amendments were discussed at a parliamentary committee meeting. The draft sets fine ranges for individuals, officials, and legal entities, and introduces a separate fine for vaping in prohibited places and public areas.
Feb.27 by 2FIRSTS.ai
BAT’s Product Strategy Reset: A Structural Analysis of Its Post-FY2025 Competitive Architecture
BAT’s Product Strategy Reset: A Structural Analysis of Its Post-FY2025 Competitive Architecture
Drawing on BAT’s FY2025 results and earnings call, 2Firsts finds the company shifting from category expansion to competitive entrenchment across Vapour, Modern Oral, Heated Products and Combustibles. The strategy centers on connected devices, geographic customization and portfolio tiering. While structurally coherent, financial returns depend on consistent regulatory enforcement against illicit competitors, making policy execution a key variable for 2026 performance.
Feb.12
Malaysia joint operation seized $19,000 worth of vape liquid in Likas
Malaysia joint operation seized $19,000 worth of vape liquid in Likas
More than 2,300 units of vape liquid worth over RM75,000 were seized during an integrated operation at premises in Likas near Kota Kinabalu. During Ops Taring Landai E-Cigarette Mega on Feb 10 night, the Marine Police, Sabah Health Department officials and district police detected a shop displaying 92 types of vape pods and, after further searches, found 2,353 units of vape liquid stored on the premises.
Feb.11 by 2FIRSTS.ai
Scottish retailers call for tougher action as illegal vape black market “deepens,” SGF says
Scottish retailers call for tougher action as illegal vape black market “deepens,” SGF says
Scottish retailers, through the Scottish Grocers’ Federation (SGF), are calling for tougher action and more investment to tackle a “deepening black market” in illegal vapes, including illegal sales to children. SGF warns the problem will worsen, with negative health impacts, if incoming regulations on vaping product sales are not carefully crafted and if shopkeepers’ views are not heard.
Jan.14 by 2FIRSTS.ai
Russia proposes extending voluntary labeling pilot for reusable e-cigarettes to Aug. 31, 2026
Russia proposes extending voluntary labeling pilot for reusable e-cigarettes to Aug. 31, 2026
Russia’s Ministry of Industry and Trade has proposed extending a voluntary labeling pilot covering reusable e-cigarettes and similar personal electric vaporizing devices until August 31, 2026. A draft government decree has been published on the unified portal for posting drafts of normative legal acts.
Jan.22 by 2FIRSTS.ai