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.

Australia Quantifies Black Market for First Time, Illicit Nicotine Products Account for About 80% of Consumption
Australia Quantifies Black Market for First Time, Illicit Nicotine Products Account for About 80% of Consumption
The Australian Bureau of Statistics (ABS) has released its first estimate of the illicit nicotine market, finding that about 80% of cigarettes, vapes and other nicotine products consumed in 2025 came from illegal sources, reigniting debate over tobacco taxation and enforcement policies.
Jun.03
EU Novel Tobacco Regulation Trends and Business Response | Guest Contribution by a European Legal and Compliance Expert
EU Novel Tobacco Regulation Trends and Business Response | Guest Contribution by a European Legal and Compliance Expert
Carlos Cabrera, founder of CabLab Law & Advocacy, contributes this article to 2Firsts, arguing that the EU’s evolving approach to novel tobacco regulation may unintentionally reinforce cigarette use by narrowing alternatives. He warns companies to watch signals on flavours, labelling, traceability, nicotine pouch rules and digital marketing, while grounding business decisions in realistic timelines, compliance planning and continuous monitoring.
Apr.22
German Environment Minister Plans Bill to Ban Disposable E-Cigarettes This Year
German Environment Minister Plans Bill to Ban Disposable E-Cigarettes This Year
German Federal Environment Minister Carsten Schneider said he is preparing legislation to ban disposable e-cigarettes and will present a bill this year. Industry data estimated that legal e-cigarette sales in Germany rose by about one quarter in 2025 to €2.4 billion. Refillable devices are not expected to be affected by the ban.
May.09 by 2FIRSTS.ai
WSJ: White House Pushes for More Flavored Vape Approvals as FDA Commissioner Makary Blocks Move
WSJ: White House Pushes for More Flavored Vape Approvals as FDA Commissioner Makary Blocks Move
According to The Wall Street Journal, the White House is pushing to allow more flavored vape products onto the market for the first time in years, but FDA Commissioner Marty Makary opposes the move and has blocked the plan. The report said a memo from Makary’s office prevented authorization of several flavors from vape maker Glas, even after FDA scientific reviewers had supported them.
Apr.20 by 2FIRSTS.ai
Innovation, Insights and Networking: NUBIZ Brings the Global NGP Industry Together in Dortmund
Innovation, Insights and Networking: NUBIZ Brings the Global NGP Industry Together in Dortmund
The market for next-generation products is expanding rapidly, with vapes, e-cigarettes, pouches, snus and heat-not-burn products among the industry’s most innovative segments. As part of InterTabac, NUBIZ provides a central platform for reduced-risk tobacco and nicotine products, bringing together global leaders and newcomers from 15 to 17 September. The show combines market insights, product comparisons, networking, a high-level conference programme and exclusive side events.
Jun.03
Product|PMI Expands High-Strength Nicotine Pouch Portfolio With Zyn 16.5mg
Product|PMI Expands High-Strength Nicotine Pouch Portfolio With Zyn 16.5mg
According to Better Retailing, Philip Morris International (PMI) has launched Zyn Menthol Ice 16.5mg in the UK, marking the highest-strength nicotine pouch in the Zyn range to date. The eucalyptus- and menthol-flavored product is now available through PMI Open and will begin rolling out to wholesale channels from the end of May.
PMI
May.28