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.

Altria and Juul Ask Court to Pause Antitrust Case Pending Ninth Circuit Review
Altria and Juul Ask Court to Pause Antitrust Case Pending Ninth Circuit Review
Altria and Juul are asking a California federal court to pause an antitrust case while they appeal a class certification ruling to the Ninth Circuit. The case alleges that Altria’s 2018 investment in Juul, a $12.8 billion deal for a 35% stake.
May.07 by 2FIRSTS.ai
FDA Warns Retailers Over Unauthorized Nicotine Pouches Resembling Candy and Everyday Products
FDA Warns Retailers Over Unauthorized Nicotine Pouches Resembling Candy and Everyday Products
The FDA issued warning letters to eight retailers selling unauthorized nicotine pouches and dissolvable tobacco products resembling candy, breath strips and cough drops. The action highlights rising scrutiny of packaging, youth appeal and accidental ingestion risks, as the agency clarifies enforcement priorities for unauthorized ENDS and nicotine pouch products while maintaining PMTA as the legal market pathway.
Special Report
May.21
Malaysian Court Rules Liquid Nicotine Exemption Irrational, Renewing Vape Regulation Debate
Malaysian Court Rules Liquid Nicotine Exemption Irrational, Renewing Vape Regulation Debate
Malaysia’s High Court ruled that the government’s earlier decision to remove liquid nicotine from the country’s Poisons List was “irrational,” reigniting debate over vape regulation, illicit trade, and youth protection.
Regulations
May.18
Portugal and Other Countries Submit Objections in Brussels Over UK Smoke-Free Generation Bill
Portugal and Other Countries Submit Objections in Brussels Over UK Smoke-Free Generation Bill
Portugal is among the countries opposing the UK Tobacco and Vapes Bill, which would ban tobacco sales to people born on or after Jan. 1, 2009. According to the report, Portugal, Croatia, the Czech Republic, Greece, Italy, Slovakia and Romania have submitted reasoned opinions and formal observations to Brussels, arguing that the bill breaches post-Brexit arrangements including the Windsor Framework.
Apr.24 by 2FIRSTS.ai
WHO’s First Global Report on Nicotine Pouches: Harm Reduction Questions Remain Amid Global Regulatory Warning
WHO’s First Global Report on Nicotine Pouches: Harm Reduction Questions Remain Amid Global Regulatory Warning
Ahead of World No Tobacco Day 2026, WHO released its first global report on nicotine pouches, warning that rapid market growth, youth-oriented marketing and weak regulation are converging. 2Firsts views the report as an important warning, but not a complete risk assessment, with harm-reduction questions still unresolved.
Special Report
May.17
Canada Studies UK-Style “Smoke-Free Generation” Tobacco Ban
Canada Studies UK-Style “Smoke-Free Generation” Tobacco Ban
Canada’s federal health minister, Majorie Michel, said she is looking into legislation that would permanently ban the sale of tobacco products to anyone born after 2008. She said Canada has seen the approach recently proposed in the United Kingdom and is reviewing it with partners. Health Canada previously said the Government of Canada has invested C$66 million annually since 2018 to help Canadians quit smoking and reduce the harms of nicotine addiction.
Apr.29 by 2FIRSTS.ai