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.

France plans to impose new taxes on e-liquids, with the vape industry association warning of unemployment risk
France plans to impose new taxes on e-liquids, with the vape industry association warning of unemployment risk
French government proposes tax on e-liquid, sparking concerns over job losses and increased smuggling and underage sales risks.
Oct.16 by 2FIRSTS.ai
Philippines’ DTI Proposes Mandatory Advertising Permits for Vape Products
Philippines’ DTI Proposes Mandatory Advertising Permits for Vape Products
The Philippine Department of Trade and Industry (DTI) has released a draft Department Administrative Order (DAO) seeking public feedback on a new permitting system for advertising and promoting vaporized nicotine and non-nicotine products.
Dec.08 by 2FIRSTS.ai
FDA’s Makary on CNN: The Triple Challenge in Vape Regulation — New Opioids, Illicit Trade, and Youth Protection
FDA’s Makary on CNN: The Triple Challenge in Vape Regulation — New Opioids, Illicit Trade, and Youth Protection
In an interview with CNN’s Chasing Life, U.S. Food and Drug Administration (FDA) Commissioner Dr. Marty Makary warned that new health risks — from emerging opioids such as 7-OH to unregulated vaping products — are slipping through regulatory cracks. His remarks reveal the FDA’s growing challenge to balance harm reduction for adult smokers with youth protection and cross-border enforcement.
Oct.10
Russia Plans to Allow Regional Vape Sales Bans from September 2026
Russia Plans to Allow Regional Vape Sales Bans from September 2026
Russia’s Ministry of Finance (Минфин) has drafted amendments to an existing licensing bill that would grant regional authorities the power to ban retail sales of vapes and nicotine liquids from September 1, 2026, to September 1, 2031, RBC reported. Stores violating the ban would lose their tobacco retail licenses.
Nov.19 by 2FIRSTS.ai
Poland Plans Total Prohibition of Single-Use Vapes to Protect Youth
Poland Plans Total Prohibition of Single-Use Vapes to Protect Youth
Poland’s Ministry of Health has proposed legislation to ban all disposable e-cigarettes — both with and without nicotine — under a new amendment to tobacco product laws. The government aims to protect youth from nicotine addiction while reducing public health and environmental harm. Medical professionals largely support the move but call for balanced harm-reduction strategies.
Nov.25 by 2FIRSTS.ai
JTI launches Ploom AURA new heated tobacco device device in Romania
JTI launches Ploom AURA new heated tobacco device device in Romania
Japan Tobacco International(JTI) introduces Ploom AURA in Romania, combining SMART HEATFLOW technology to preserve tobacco flavor, aiming at high-end consumers.
Oct.17 by 2FIRSTS.ai