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.

 $20 Million, a Permanent Injunction and Distributor Controls: Posh Deal Tightens Illinois Vape Compliance
$20 Million, a Permanent Injunction and Distributor Controls: Posh Deal Tightens Illinois Vape Compliance
An Illinois court ordered three companies tied to Posh vapes to pay $20 million and permanently restricted the sale, marketing and distribution in Illinois of products lacking required FDA authorization. The consent order also imposes downstream distributor controls, age-verification measures and social-media marketing limits, creating a new state-level compliance benchmark for disposable vape businesses.
Regulations
Aug.05
Tasmania Reports Annual Enforcement Results: 5.5 Million Illegal Cigarettes and Nearly 30,000 Vapes Seized, With IGET Products Visible in Official Images
Tasmania Reports Annual Enforcement Results: 5.5 Million Illegal Cigarettes and Nearly 30,000 Vapes Seized, With IGET Products Visible in Official Images
Tasmania reported its 2025/26 illicit tobacco enforcement results on July 14, with authorities seizing about 5.5 million illegal cigarettes, more than 2,500 kilograms of loose tobacco and nearly 30,000 vapes.
Jul.15
U.S. Convenience Stores Rebalance Backbar as Nicotine Pouches Outpace Cigarettes
U.S. Convenience Stores Rebalance Backbar as Nicotine Pouches Outpace Cigarettes
As cigarette volumes continue to decline, U.S. convenience-store operators are reconfiguring backbar space to accommodate modern oral nicotine products such as nicotine pouches. Industry data show nicotine pouches have become one of the fastest-growing nicotine categories while generating higher margins for retailers.
Jun.12
Italian Court Ends Six-Year Cigarette Excise Dispute, Rejecting Damages Claim
Italian Court Ends Six-Year Cigarette Excise Dispute, Rejecting Damages Claim
Italy’s Lazio Regional Administrative Court has dismissed an appeal by Italian Tobacco Manufacturing and Manifattura Italiana Tabacco over the cigarette excise calculation mechanism, upholding the minimum tax burden rules and excluding compensation for smaller tobacco operators.
News
Jun.26 by 2Firsts Perspectives
Product | SKE Launches FRESA PRO in the U.S., Introducing Fresh Lock Technology for E-Liquid Management in High-Capacity Vapes
Product | SKE Launches FRESA PRO in the U.S., Introducing Fresh Lock Technology for E-Liquid Management in High-Capacity Vapes
Shenzhen SKE Technology has launched the FRESA PRO in the United States, a high-capacity rechargeable disposable vape featuring Fresh Lock electromagnetic valve supply control technology. The device combines a claimed capacity of up to 40,000 puffs, dual mesh coils, dual output modes and a transparent tank design. The launch reflects the high-capacity disposable vape segment’s shift from puff-count competition toward improved e-liquid management and device-level experience.
Aug.03
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