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.

Louisiana lawmaker pushes bill to ban vape product sales within 300 feet of schools
Louisiana lawmaker pushes bill to ban vape product sales within 300 feet of schools
A Louisiana lawmaker has introduced HB 302, which would prohibit businesses from selling vapor products within 300 feet of schools. The bill would measure the distance by a person walking on the sidewalk from the nearest point on school property to the nearest point of the business. It would also give the commissioner authority to modify how the distance is calculated, while maintaining the 300-foot limit.
Feb.26 by 2FIRSTS.ai
PMJ Expands SENTIA Tobacco Stick Lineup, Adds Blueberry Menthol Capsule Flavor
PMJ Expands SENTIA Tobacco Stick Lineup, Adds Blueberry Menthol Capsule Flavor
Philip Morris Japan (PMJ) announced that it will launch “SENTIA Purple Capsule,” the first capsule-equipped product in its SENTIA lineup dedicated to the heated tobacco “IQOS ILUMA” series, as an early release in Japan. The product will roll out nationwide starting from IQOS Stores, and will enter tobacco retail channels nationwide from April 6.
Mar.03 by 2FIRSTS.ai
PMI Launches Mass Production of ZYN at $600M Aurora Manufacturing Hub
PMI Launches Mass Production of ZYN at $600M Aurora Manufacturing Hub
Philip Morris International (PMI), through its subsidiary Swedish Match, has started large-scale production at a 600,000-square-foot ZYN nicotine pouch facility in Aurora, Colorado. The $600 million investment makes the site one of three ZYN manufacturing plants in the United States and the company’s second U.S. facility after Owensboro, Kentucky.
PMI
Feb.21
Malaysia anti-tobacco groups call for stronger enforcement as unregulated vapes remain on sale offline and online
Malaysia anti-tobacco groups call for stronger enforcement as unregulated vapes remain on sale offline and online
Anti-tobacco groups in Malaysia say the continued sale of unregulated vapes in physical stores and the online availability of vape devices underline the need for comprehensive enforcement.
Mar.02 by 2FIRSTS.ai
Special Report|From Nicotine Pouches to Jelly? A China Tobacco Patent Explores Dual-Release NRT
Special Report|From Nicotine Pouches to Jelly? A China Tobacco Patent Explores Dual-Release NRT
A patent published on February 24, 2026, by China Tobacco Hubei Industrial Co., Ltd. introduces a “nicotine jelly” product designed to combine rapid and sustained nicotine delivery. By integrating both free and microencapsulated nicotine, the product aims to address key limitations of traditional nicotine replacement therapy (NRT), while also raising new regulatory and product classification questions.
Innovation
Mar.18
France’s ANSES warns vaping carries health risks, urges limiting e-cigarette use to smoking cessation
France’s ANSES warns vaping carries health risks, urges limiting e-cigarette use to smoking cessation
France’s National Agency for Food, Environmental and Occupational Health & Safety (ANSES) says vaping poses health risks because users inhale toxic or harmful substances, even if e-cigarettes are generally considered less harmful than cigarettes.
Feb.04 by 2FIRSTS.ai