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.

State Tobacco Monopoly Administration Chief Meets with President of South Korean Tobacco Company Wang Gongcheng also in attendance; friendly talks held between the two parties.
State Tobacco Monopoly Administration Chief Meets with President of South Korean Tobacco Company Wang Gongcheng also in attendance; friendly talks held between the two parties.
State Tobacco Monopoly Administration director Zhang Jianmin met with Korean Tobacco Company president Fang Jingwan in Beijing on October 31.
Nov.03 by 2FIRSTS.ai
Global Tobacco Companies’ Latest Earnings Review: Nicotine Pouch Business Shows Broad Strength, Emerging as a Key Growth Driver
Global Tobacco Companies’ Latest Earnings Review: Nicotine Pouch Business Shows Broad Strength, Emerging as a Key Growth Driver
Multiple global tobacco and next-generation nicotine companies reported solid Q3 performance, with the nicotine-pouch category showing broad-based strength across seven firms. Growth was reflected in higher shipment volumes, expanded market coverage, and new product launches. Several companies also reported rising revenue contributions from pouches and continued investment in this fast-growing segment, underscoring its position as a key driver of future growth.
Nov.14
 Number of Vapers in Britain Surpasses Smokers for the First Time, Government Tightens Nicotine Regulations
Number of Vapers in Britain Surpasses Smokers for the First Time, Government Tightens Nicotine Regulations
For the first time, more people in Britain now vape than smoke. According to the Office for National Statistics (ONS), 10% of adults (5.4 million) regularly use e-cigarettes compared with 9.1% (4.9 million) who smoke cigarettes. The government credits vaping for the decline in smoking but plans tougher rules through the Tobacco and Vapes Bill, including a generational smoking ban and restrictions on nicotine pouch flavours, packaging, and sales.
Nov.05 by 2FIRSTS.ai
Echo Guo: The Accumulating Risks Behind the Surge in Chinese Vape Exports to the U.S.
Echo Guo: The Accumulating Risks Behind the Surge in Chinese Vape Exports to the U.S.
Chinese vape exports to the U.S. jumped from about 2.2 million kg in June to 14.8 million kg in October 2025, despite tougher enforcement, the Washington Examiner reported. 2Firsts finds the surge reflects delayed bulk shipments, not demand recovery. With U.S. inventory exceeding 160 million devices and distributors paying ~10% upfront, cash-flow stress has shifted to Chinese manufacturers, and discounted stock is spilling into other markets.
Dec.14 by Echo Duo
South Korea’s National Assembly Passes Law Classifying E-Cigarettes as Tobacco Products with Full Equivalent Regulation
South Korea’s National Assembly Passes Law Classifying E-Cigarettes as Tobacco Products with Full Equivalent Regulation
South Korea’s National Assembly recently passed a comprehensive package of 79 bills that, among other measures, formally classifies liquid vapes — e-cigarette products using nicotine-containing e-liquids — as tobacco products. These products will now be subject to the same taxation, sales restrictions and advertising controls as traditional cigarettes, and the vaping industry in South Korea is expected to face significant adjustments in compliance costs, market access and business strategy.
Dec.03
From Partnership to Acquisition: Why KT&G Is Betting on the Global Nicotine Pouch Market
From Partnership to Acquisition: Why KT&G Is Betting on the Global Nicotine Pouch Market
As global competition in the nicotine pouch market accelerates, Korea’s tobacco major KT&G has moved with a “Partnership + Acquisition” strategy, teaming up with Altria to acquire Nordic pouch maker Another Snus Factory (brand “LOOP”). Why deploy capital now, and why take this route? Drawing on company disclosures, regulatory monitoring and on-site observations from InterTabac Dortmund, 2Firsts analyzes KT&G’s strategic calculus and the signals behind this move.
Nov.05