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.

Product | VOZOL’s New E-Cigarette Appears on Middle East Social Media, Touted at 40,000 Puffs with Dual Mesh Coils and Dual Modes
Product | VOZOL’s New E-Cigarette Appears on Middle East Social Media, Touted at 40,000 Puffs with Dual Mesh Coils and Dual Modes
VOZOL has recently promoted its MAGIC FLEX 40000 e-cigarette on its official Iraq social media account, using mainly Arabic-language posts and listing Baghdad as the account location. The campaign highlights a detachable/separate battery, the ability to switch flavors at will, ECO/POWER dual-mode operation, and a display-based user interface.
Jan.27 by 2FIRSTS.ai
Bonnie Herzog:U.S. nicotine market seen at about $67B in revenue by 2035 as smoke-free expands
Bonnie Herzog:U.S. nicotine market seen at about $67B in revenue by 2035 as smoke-free expands
Goldman Sachs Managing Director Bonnie Herzog said the U.S. nicotine market is attractive and growing, with total revenue projected to reach about $67 billion by 2035. She expects cigarettes to account for a smaller share of revenue (47%) as smoke-free revenue expands and becomes a key driver of industry profit growth. Herzog said smoke-free products represent about 48% of U.S. nicotine volumes today and could rise to roughly 75% by 2035.
Mar.04 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
Fourth Circuit denies rehearing bid over stay allowing Virginia e-cigarette rules to be enforced
Fourth Circuit denies rehearing bid over stay allowing Virginia e-cigarette rules to be enforced
The U.S. Court of Appeals for the Fourth Circuit has declined to grant en banc or other rehearing of its decision to stay an order that had blocked enforcement of certain Virginia e-cigarette regulations. In a brief order filed Tuesday, the court denied a rehearing petition by Nova Distro Inc. and Tobacco Hut and Vape Fairfax Inc., noting that no judge requested a poll on the petition.
Mar.05 by 2FIRSTS.ai
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
Michigan Senate Bill 786 Seeks to Ban Sale of Vapes With Metal Heating Elements
Michigan Senate Bill 786 Seeks to Ban Sale of Vapes With Metal Heating Elements
Michigan lawmakers introduced Senate Bill 786 on February 18, 2026, proposing to prohibit the sale or transfer of vapor products that contain heating elements unless those elements are made of or encased in glass or ceramic materials
Regulations
Feb.21