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.

West Virginia Bill Seeks to Replace Per-mL Vape Liquid Tax With 50% Sales-Price Tax
West Virginia Bill Seeks to Replace Per-mL Vape Liquid Tax With 50% Sales-Price Tax
West Virginia proposes tax rate adjustments on e-cigarette devices and e-liquids, with penalties for late reporting. Effective from July 1, 2026.
Feb.02 by 2FIRSTS.ai
Product | Pixx Nicotine Toothpicks Listed on UK Retail Website, Said to Be Unaffected by Upcoming Vape Tax
Product | Pixx Nicotine Toothpicks Listed on UK Retail Website, Said to Be Unaffected by Upcoming Vape Tax
2Firsts has noted that a nicotine toothpick product named Pixx has appeared on a UK retailer website. The product page describes it as a smoke-free nicotine product, and the packaging image shows “UK MADE.” A nicotine-industry professional wrote on LinkedIn that the UK is set to introduce vape tax changes that may increase pressure on the retail side, and said Pixx is expected not to be included in the upcoming vape tax.
Mar.05 by 2FIRSTS.ai
Singapore New bill would raise maximum fines to S$200,000 for sellers and S$300,000 for smugglers
Singapore New bill would raise maximum fines to S$200,000 for sellers and S$300,000 for smugglers
A bill introduced in Singapore’s Parliament on Feb. 12 proposes major increases in penalties for vaping-related offences, including higher maximum fines for users, sellers and smugglers. The draft would also rename the current Tobacco (Control of Advertisements and Sale) Act as the Tobacco and Vaporisers Control Act.
Feb.28 by 2FIRSTS.ai
New York Proposal to Tax Nicotine Pouches at 75% Draws Opposition
New York Proposal to Tax Nicotine Pouches at 75% Draws Opposition
A proposal by New York Governor Kathy Hochul to impose a steep tax on nicotine pouches has drawn opposition from law-enforcement officials and business groups, who say it could expand the state’s illicit tobacco market. The measure was included in Hochul’s preliminary two-year USD 260 billion budget plan and would treat nicotine pouches like other tobacco products.
Mar.17 by 2FIRSTS.ai
ACT Health Minister Vows Continued Crackdown on E-Cigarettes and Illicit Tobacco
ACT Health Minister Vows Continued Crackdown on E-Cigarettes and Illicit Tobacco
ACT Health Minister Rachel Stephen-Smith said the government would not ease its action against e-cigarettes and illicit tobacco and would continue strengthening regulation, legislation, and enforcement. Speaking at the launch of a new program to help young people quit vaping, she said reducing tobacco excise would not materially reduce profits in the illicit tobacco market.
Mar.10 by 2FIRSTS.ai
Kumulus Vape launches Labster production unit for e-liquids and DIY concentrates
Kumulus Vape launches Labster production unit for e-liquids and DIY concentrates
Kumulus Vape has launched Labster, a 700 sq m production unit in the Lyon Metropolis near the group’s headquarters, for e-liquids and DIY concentrates. The site is equipped with automated lines supplied by CDA (Constructions d’Automatismes) to carry out bottling and labeling. Its theoretical capacity is described as several million bottles per year in 10–100 ml formats, and it is already operational.
Feb.06 by 2FIRSTS.ai