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.

ATF Cancels Webloc Contract, Raising Questions Over Commercial Location Data in Enforcement
ATF Cancels Webloc Contract, Raising Questions Over Commercial Location Data in Enforcement
The U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) has stopped using Webloc, a commercial phone-tracking tool, after lawmakers, a prosecutor and a judge raised legal and privacy concerns over warrantless use of ad-tech location data, a development that may affect data-use boundaries in U.S. enforcement against illicit tobacco, nicotine products and cross-border distribution networks.
Jun.29
Special Report | China’s Tobacco Tax Debate Shifts Toward Tax Design as Policy Trade-offs Come Into Focus
Special Report | China’s Tobacco Tax Debate Shifts Toward Tax Design as Policy Trade-offs Come Into Focus
China’s tobacco tax debate is moving from whether to raise prices to how the tax system should be designed. At a Beijing forum on World No Tobacco Day, experts discussed higher specific excise taxes, minimum tax burdens and dynamic adjustments linked to income and inflation. The issue also connects to China’s broader consumption tax reform, health financing and chronic disease costs. Public reports did not mention e-cigarettes, heated tobacco, nicotine pouches or other new nicotine products.
Jun.11
Product | OLIVEBAR Launches RAZ PRO 85K, Combining Up to 85,000 Puffs With a Transparent Pod Design
Product | OLIVEBAR Launches RAZ PRO 85K, Combining Up to 85,000 Puffs With a Transparent Pod Design
OLIVEBAR has introduced the RAZ PRO 85K disposable vape, featuring up to 85,000 puffs, a transparent e-liquid pod, and a Mega HD display. As competition in the ultra-high-puff disposable segment continues to intensify, the new device reflects an industry shift from simply increasing puff counts toward enhancing visual interaction and user experience.
Jul.03
2Firsts Data | China’s U.S. Vape Exports Have Yet to Regain Previous Growth Momentum in H1 2026, but Hardware Grew 15.2% and 6-Methyl Nicotine-Related Products Rose 234.7%
2Firsts Data | China’s U.S. Vape Exports Have Yet to Regain Previous Growth Momentum in H1 2026, but Hardware Grew 15.2% and 6-Methyl Nicotine-Related Products Rose 234.7%
China’s vape exports to the U.S. reached approximately $1.58 billion in the first half of 2026, remaining broadly stable from a year earlier but still below previous growth momentum. 2Firsts’ analysis of China Customs data shows that the U.S. market has not simply returned to its previous trajectory after the enforcement shock and inventory-driven swings of 2025. Instead, export momentum is shifting across product categories. Vaping devices and atomization hardware increased 15.2% year over year, while 6-methyl nicotine-related and other nicotine substitute products surged 234.7%. Meanwhile, traditional nicotine-containing vaping products continued to face pressure.
Jul.22
Indiana’s Foreign-Made Vape Ban Takes Effect, Forcing Brands and Retailers to Adjust Supply Chains
Indiana’s Foreign-Made Vape Ban Takes Effect, Forcing Brands and Retailers to Adjust Supply Chains
A new Indiana law restricting the sale of foreign-made vape products has taken effect, requiring retailers to adjust inventory and sourcing practices. According to The Sun, WDRB and other reports, some local vape shops are reviewing product origins and supplier information to comply with the new requirements. The measure represents a broader shift in U.S. vape regulation, with oversight expanding beyond product authorization and sales rules toward manufacturing origin and supply-chain management.
Jul.24
Shopify Requires Merchants to Remove All Vape Products by July 8, Reshaping Online Sales Channels
Shopify Requires Merchants to Remove All Vape Products by July 8, Reshaping Online Sales Channels
Shopify has instructed merchants using its web-hosting services to remove vape products from their online stores by July 8, 2026. The policy expands beyond illegal products and applies to all electronic nicotine delivery systems (ENDS), marking a broader shift in online platform oversight of nicotine sales.
Innovation
Jul.14 by 2Firsts Perspectives