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.

NAS 2026 | Former FDA Tobacco Chief Mitch Zeller Calls for Shift From “End Game” to “End State”
NAS 2026 | Former FDA Tobacco Chief Mitch Zeller Calls for Shift From “End Game” to “End State”
At the 2026 New Approaches Summit in New York, former FDA Center for Tobacco Products Director Mitch Zeller called for the tobacco harm reduction debate to shift from the traditional “end game” toward defining a desired “end state.” He also highlighted unresolved concerns around dual use, argued that biomarkers of exposure may be more meaningful than cigarettes-per-day in assessing risk reduction, and said nicotine misperceptions remain a major barrier to public health progress.
Sep.25
German Tobacco Tax Revenue Falls 10.8% Through August as Tax-Paid Cigarette Volume Drops 12.6%
German Tobacco Tax Revenue Falls 10.8% Through August as Tax-Paid Cigarette Volume Drops 12.6%
Germany collected €9.789 billion in total tobacco tax revenue from January through August 2026, down 10.8% from a year earlier, according to the Federal Ministry of Finance. Germany's tobacco tax base covers not only cigarettes and fine-cut tobacco but also heated tobacco and vaping liquids taxed as tobacco substitutes. The German Association of the Tobacco Industry and Novel Products, or BVTE, citing federal statistical data, said tax-paid cigarette volume fell 12.6% to 40.6 billion sticks. BVTE is using the latest figures to argue against further tax increases planned from 2027 through 2030, while Germany's parliament is scheduled to hold a first reading of the bill on September 24.
Sep.23
Product | BAT Launches VELO WRKS Nicotine Pouches in Sweden, Introducing Dual-Compartment Cans With Two Flavours
Product | BAT Launches VELO WRKS Nicotine Pouches in Sweden, Introducing Dual-Compartment Cans With Two Flavours
British American Tobacco (BAT)'s VELO brand launched the VELO WRKS nicotine pouch range in Sweden on November 2, 2026. The initial release features three Dual Can variants, each containing two separate flavours in a dual-compartment container. Each can holds 20 slim pouches with 8mg of nicotine per pouch and retails for SEK 52.99. According to VELO, the first release, Drop 1, is limited to 75,000 cans and will remain available until February 2027 or while stocks last. VELO positions WRKS as a platform for testing new product concepts and has introduced an online consumer feedback survey. EU trademark records show BAT applied to register VELO WRKS in March 2026 under Class 34, covering nicotine pouches, e-cigarettes, heated tobacco products and other tobacco-related goods.
product
Nov.03
Product | KUMI SCENIC 50K Offers Nicotine and 6-Methyl Nicotine Versions as 6-MN Products Appear in Multiple U.S. State Directories, With Louisiana Listing FDA Exemption
Product | KUMI SCENIC 50K Offers Nicotine and 6-Methyl Nicotine Versions as 6-MN Products Appear in Multiple U.S. State Directories, With Louisiana Listing FDA Exemption
An October 2026 review of U.S. state vapor product directories found KUMI 6 SCENIC 50K listed in Louisiana and Nebraska. Louisiana classifies 20 related product entries as “FDA EXEMPTION.” The SCENIC platform is marketed in both conventional nicotine-salt and NoNic6 formulations, each advertised with 22mL e-liquid capacity and up to 50,000 puffs. U.S. wholesaler Midwest Goods listed both versions in August 2025 with a suggested retail price of $19.99 each. The NoNic6 version is associated with 6-methylnicotine and is also marketed by some distributors as “nicotine-free.”
product
Oct.27
Imperial Brands Acquires Helwit Owner Yoik Group for SEK 515 Million, More Than Doubling Swedish Nicotine Pouch Share
Imperial Brands Acquires Helwit Owner Yoik Group for SEK 515 Million, More Than Doubling Swedish Nicotine Pouch Share
Imperial Brands has agreed to acquire 100% of Swedish modern oral nicotine company Yoik Group AB for an initial SEK515 million, equivalent to about US$53.9 million, plus a deferred payment linked to performance over the next two years. Yoik owns nicotine pouch brand Helwit, which held about 3.4% of Sweden’s modern oral nicotine market over the past 12 months. Imperial says the acquisition will more than double its existing share of the Swedish market. Helwit is also sold elsewhere in the Nordics, through European online channels and in selected UK retail outlets.
Sep.08
Product | Four CrossBar 20K 13mL High-Puff Vapes Listed on Pennsylvania's ENDS Directory, Rated for Up to 20,000 Puffs
Product | Four CrossBar 20K 13mL High-Puff Vapes Listed on Pennsylvania's ENDS Directory, Rated for Up to 20,000 Puffs
Four CrossBar 20K disposable e-cigarettes appeared on Pennsylvania's 163-entry ENDS directory ahead of enforcement beginning October 19, 2026. The devices feature 13mL e-liquid reservoirs, 50mg/mL nicotine, 2,000mAh batteries and 0.9Ω mesh coils, with advertised puff counts of up to 20,000. CrossBar was the only modern high-puff disposable series among the directory's 15 disposable entries. Its packaging emphasizes New York design and Japanese-origin flavoring, while historical CrossBar records identify a registered U.S. tobacco manufacturing-related establishment. The link between the newer 13mL devices and earlier 1.3mL PMTA filings remains unconfirmed.
product
Oct.26