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.



Disclaimer

This article is provided solely for professional research, industry discussion, and informational purposes. Any references to brands, companies, products, technologies, or policies are made for factual reporting and analytical purposes only, and do not constitute endorsement, recommendation, promotion, or advertising by 2Firsts.

Nicotine-containing products, including but not limited to cigarettes, e-cigarettes, heated tobacco products, and nicotine pouches, carry significant health risks. Readers are responsible for complying with all applicable laws and regulations in their respective jurisdictions, including age restrictions and access limitations.

The information contained in this article should not be regarded as investment, legal, medical, regulatory, or commercial advice. While 2Firsts strives to ensure the accuracy and reliability of its content, it does not assume liability for any direct or indirect loss arising from errors, omissions, inaccuracies, or reliance on the information contained herein.

This article is not intended for individuals below the legal age for accessing tobacco or nicotine-related information in their jurisdiction.

 

Copyright Notice

This article is either original content produced by 2Firsts or content reproduced, translated, summarized, or adapted from third-party sources with attribution where applicable. The intellectual property rights of the original content remain with 2Firsts or the respective original rights holders.

No individual or organization may copy, reproduce, distribute, republish, modify, translate, or otherwise use this content without prior authorization. Any unauthorized use may result in legal action.

For copyright-related inquiries, corrections, or removal requests, please contact: info@2firsts.com.

 

AI-Assisted Translation and Editing Notice

Portions of this article may have been translated, edited, or reviewed with the assistance of artificial intelligence tools to improve efficiency and readability. Due to the limitations of AI-assisted translation and editing, discrepancies, omissions, or inaccuracies may exist when compared with the original source.

Where applicable, readers are advised to refer to the original source for the most complete and accurate information. If you identify any errors or believe that any content infringes upon your rights, please contact us at info@2firsts.com, and we will review and address the matter promptly.

Vape Industry Group Loses Alabama Court Fight as State Tightens Rules on Imported Products
Vape Industry Group Loses Alabama Court Fight as State Tightens Rules on Imported Products
The Alabama Supreme Court affirmed a lower court’s refusal to issue a preliminary injunction blocking the state’s 2025 electronic nicotine delivery systems law, allowing rules requiring covered products to be U.S.-made or FDA-authorized to remain in effect.
Jul.10
Former FDA Scientist Questions ZYN Review Over Pouch Material and Microplastic Risk
Former FDA Scientist Questions ZYN Review Over Pouch Material and Microplastic Risk
A former FDA toxicologist has questioned whether the agency fully assessed the material used in ZYN nicotine pouches before authorizing them for sale, raising concerns over possible microplastic exposure, according to STAT and The Examination.
Jul.16
Malaysia Withdraws Appeal Against Liquid Nicotine Ruling as Vape Regulation Framework Enters New Phase
Malaysia Withdraws Appeal Against Liquid Nicotine Ruling as Vape Regulation Framework Enters New Phase
Malaysia’s government has withdrawn its appeal against a High Court ruling concerning the regulatory status of liquid nicotine used in vape and e-cigarette products, according to reports by New Straits Times, Free Malaysia Today and CodeBlue on August 18, 2026. The Kuala Lumpur High Court ruled on May 15 that the government’s decision to remove liquid nicotine from the scheduled poisons list under the Poisons Act 1952 was irrational and made without proper consultation with the Poisons Board. The withdrawal ends the government’s appeal process, while the future regulatory framework for nicotine vape products remains under discussion.
Aug.21
Product | PMI Introduces VEEV inPrime, Bringing an Induction Vaporization Platform to the Next Generation of the VEEV Portfolio
Product | PMI Introduces VEEV inPrime, Bringing an Induction Vaporization Platform to the Next Generation of the VEEV Portfolio
Philip Morris International (PMI) has introduced VEEV inPrime, the next-generation closed-system vape platform featuring the new AdvanceVape Induction System™. Alongside the new induction platform, PMI has redesigned the pods, e-liquid formulations and user interaction experience. According to PMI and official IQOS websites, VEEV inPrime began a phased European rollout between May and June 2026, with products now available in Greece, Estonia, the United Kingdom and Italy.
Jul.14
Earnings Analysis | CTIHK H1 2026 Revenue Falls 26.9% as Core Businesses Diverge and New Growth Drivers Remain to Be Proven
Earnings Analysis | CTIHK H1 2026 Revenue Falls 26.9% as Core Businesses Diverge and New Growth Drivers Remain to Be Proven
China Tobacco International (HK) reported a 26.9% revenue decline in H1 2026, while gross profit fell only 9.5%, revealing sharp divergence across its businesses. Tobacco leaf imports contracted, while leaf exports and Brazil operations expanded strongly. Cigarette exports faced China duty-free market transition, and new tobacco products remained small. Meanwhile, CTIHK continues to strengthen its role as an investment and financing platform, though major external deals have yet to emerge. 2Firsts examines what these shifts mean for its next growth drivers.
Capital Markets
Aug.24
China’s Shanghai Tobacco Group Launches CNY 10.98 Million (Approximately US$1.53 Million) Procurement for Heated Tobacco Production Utility Equipment
China’s Shanghai Tobacco Group Launches CNY 10.98 Million (Approximately US$1.53 Million) Procurement for Heated Tobacco Production Utility Equipment
Shanghai Tobacco Group Co., Ltd., a tobacco manufacturing company under China National Tobacco Corporation (CNTC), has launched a public tender for heated tobacco products (HTPs) production utility equipment at its Shanghai Cigarette Factory. The project is valued at CNY 10.98 million and covers six combined air-conditioning units, electrical cabinets and control systems for production facilities. The procurement includes equipment design, supply, installation, commissioning and related training services.
Aug.07