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.

EU Trade Department Faces Scrutiny Over Contacts With Tobacco Industry
EU Trade Department Faces Scrutiny Over Contacts With Tobacco Industry
European Ombudswoman Teresa Anjinho has opened an inquiry into how the European Commission’s Directorate-General for Trade handles interactions with the tobacco industry. The case follows a complaint from a civil society organisation that alleges regular, unnecessary and non-transparent contacts between DG TRADE and tobacco industry representatives, raising questions over compliance with the EU’s obligations under the WHO Framework Convention on Tobacco Control. The inquiry remains ongoing, and the Ombudswoman has not reached any finding of maladministration.
Aug.24
BAT CFO Dragos Constantinescu Takes Office, Returning After Seven Years and Former Asahi Europe Leadership Role
BAT CFO Dragos Constantinescu Takes Office, Returning After Seven Years and Former Asahi Europe Leadership Role
Dragos Constantinescu has officially taken up his role as Chief Financial Officer and Executive Director at British American Tobacco (BAT). He previously spent 16 years at BAT across finance and general management roles in Europe before joining Asahi in 2019 and becoming CEO of Asahi Europe & International in 2025. His return comes as BAT continues to advance its “A Better Tomorrow” transformation.
BAT
Sep.01
FDA Authorizes Four More Nicotine Pouches as Review Pilot Expands Beyond Initial Decisions
FDA Authorizes Four More Nicotine Pouches as Review Pilot Expands Beyond Initial Decisions
The FDA has authorized four additional on! nicotine pouches, bringing the U.S. total to 30. The decision marks another outcome of the agency’s nicotine pouch review pilot, whose communication and review practices are now being applied more broadly across the category. It also extends Helix’s authorized portfolio from on! PLUS to the earlier on! line. Yet all FDA-authorized nicotine pouches still come from subsidiaries of PMI or Altria, underscoring how concentrated U.S. regulatory access remains.
Aug.05
Minnesota Sues Loon as State Enforcement Targets U.S. Vape Brand Operators
Minnesota Sues Loon as State Enforcement Targets U.S. Vape Brand Operators
Minnesota Attorney General Keith Ellison sued Maduro Distributors, Inc., doing business as Loon, on July 15, 2026, alleging that the company illegally manufactured, distributed and sold flavored vapes that appeal to minors.
Jul.16
Gallup Tracks Nicotine Pouch Use for the First Time: 11% of U.S. Adults Smoke, 9% Vape and 4% Use Nicotine Pouches
Gallup Tracks Nicotine Pouch Use for the First Time: 11% of U.S. Adults Smoke, 9% Vape and 4% Use Nicotine Pouches
Gallup’s 2026 Consumption Habits survey tracked nicotine pouch use for the first time. The survey found that 11% of U.S. adults reported smoking cigarettes in the past week, 9% reported vaping, and 4% reported using nicotine pouches. Cigarette smoking remained near Gallup’s long-term low, while adult vaping rates stayed relatively stable in recent years.
Market
Aug.25 by 2Firsts Perspectives
WIRED Investigation: Chinese-Made Vapes Turn to 6-Methyl-Nicotine and Other Analogs, Challenging U.S. Regulation
WIRED Investigation: Chinese-Made Vapes Turn to 6-Methyl-Nicotine and Other Analogs, Challenging U.S. Regulation
U.S. technology and investigative publication WIRED has examined how nicotine analogs are emerging as a new challenge for the country’s vape regulatory framework. The article argues that after the U.S. expanded federal oversight of nicotine products in 2022, some manufacturers began using nicotine-like compounds such as 6-methyl-nicotine that may fall outside existing definitions. Researchers cited by WIRED said some nicotine analogs could be more potent than traditional nicotine, although human health impacts remain unclear. U.S. policymakers are considering broader definitions of nicotine to bring these compounds under federal oversight.
Jul.27