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.

Nevada Considers Nearly Doubling Tobacco Taxes, With $65 Million in New Revenue Expected From Expanded Nicotine Levies
Nevada Considers Nearly Doubling Tobacco Taxes, With $65 Million in New Revenue Expected From Expanded Nicotine Levies
Health groups in Nevada are urging lawmakers to nearly double the state cigarette tax and extend similar tax changes to other nicotine products, including e-cigarettes and nicotine pouches.
Jul.17
Dutch NVWA Seizes Record 277,000 Illegal Vapes; Video Shows “AL FAKHER” Cartons
Dutch NVWA Seizes Record 277,000 Illegal Vapes; Video Shows “AL FAKHER” Cartons
The Dutch Food and Consumer Product Safety Authority, known as the NVWA, seized more than 277,000 illegal vapes near Rotterdam and nearly 150,000 boxes of nicotine pouches in Utrecht and Rotterdam, calling them the largest batches of such products it has found to date. Video footage released by the NVWA shows some cartons in the warehouse bearing the “AL FAKHER / الفاخر” name, though the agency did not identify brands.
Jul.10
EU ‘TPD3’ Enters Next Phase on Aug. 14 as Fragmented Vape and Nicotine Pouch Rules Push the Single Market Toward Regulatory Overhaul
EU ‘TPD3’ Enters Next Phase on Aug. 14 as Fragmented Vape and Nicotine Pouch Rules Push the Single Market Toward Regulatory Overhaul
A 12-week European Commission consultation on revising the Tobacco Products Directive and Tobacco Advertising Directive is due to close on Aug. 14, 2026. The Commission has identified e-cigarette flavours, disposable vapes, tobacco heating devices, nicotine pouches, nicotine-free e-cigarettes, packaging and digital marketing among areas for possible new EU rules. National regulations already vary significantly across the bloc, a fragmentation the Commission says creates internal-market barriers and distorts competition. No formal revised TPD/TAD legislative text has yet been published, with the Commission currently indicating December 2026 for the legislative initiative.
Aug.14
Scottish Vape Display Rules Could Cost Businesses £61 Million, Affecting More Than 11,000 Retail Outlets
Scottish Vape Display Rules Could Cost Businesses £61 Million, Affecting More Than 11,000 Retail Outlets
A Scottish government impact assessment estimates that proposed vape display and packaging rules could create up to £61 million ($82 million) in compliance costs for businesses, affecting more than 11,000 retail outlets. The estimated costs are mainly linked to inventory adjustments, retail storage changes and the resources required for businesses to understand and implement the new requirements. The measures form part of the UK’s broader efforts to tighten vape regulation, particularly around product displays, packaging and sales practices.
Aug.10
BP, Marathon and Valero Warn U.S. Gas-Station Stores: Illegal Vape Sales Could Bring Heavy Fines and Card-Processing Limits
BP, Marathon and Valero Warn U.S. Gas-Station Stores: Illegal Vape Sales Could Bring Heavy Fines and Card-Processing Limits
Fiserv and service station operators including BP, Marathon Petroleum and Valero have warned U.S. partners and gas-station convenience-store owners that selling illegal vapes could lead to heavy fines, breach brand agreements and even put stores’ card-processing access at risk, according to Reuters.
Regulations
Jul.07 by 2Firsts Perspectives
Data|China’s January-May 2026 Device Exports Rise 13% While Nicotine Product Exports Decline 6.9%
Data|China’s January-May 2026 Device Exports Rise 13% While Nicotine Product Exports Decline 6.9%
According to China Customs export data analyzed by 2Firsts, China’s vape export mix continued to evolve during January-May 2026. Exports of electronic vaporisation devices (HS 85434000) increased 13.00% year on year, supported by growth in both shipment volume and average export prices. Meanwhile, exports of nicotine-containing non-combustible products (HS 24041200) declined 6.89%, with lower shipment volumes partly offset by higher average export prices.
Special Report
Jun.30