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.


This document has been generated through artificial intelligence translation and is provided solely for the purposes of industry discourse and learning. Please note that the intellectual property rights of the content belong to the original media source or author. Owing to certain limitations in the translation process, there may be discrepancies between the translated text and the original content. We recommend referring to the original source for complete accuracy. In case of any inaccuracies, we invite you to reach out to us with corrections. If you believe any content has infringed upon your rights, please contact us immediately for its removal.

Belgium Approves Vape Flavor Ban, Allowing Only Tobacco-Flavored and Unflavored Products From September 2028
Belgium Approves Vape Flavor Ban, Allowing Only Tobacco-Flavored and Unflavored Products From September 2028
Belgium’s federal government on Thursday approved a ban on flavored vapes, allowing only tobacco-flavored and unflavored e-cigarettes on the market from September 2028. Health Minister Frank Vandenbroucke said the measure is aimed at protecting the health of children and young people and preventing a new generation from becoming dependent on tobacco.
May.06 by 2FIRSTS.ai
FDA Says It Will Not Take Enforcement Action Against Zone Nicotine Pouches Until Lawsuit Is Resolved
FDA Says It Will Not Take Enforcement Action Against Zone Nicotine Pouches Until Lawsuit Is Resolved
The U.S. Food and Drug Administration has told vape manufacturer Fontem US that it does not presently intend to take enforcement action against the company’s Zone nicotine pouches while litigation over the agency’s handling of the application remains unresolved.
Apr.07 by 2FIRSTS.ai
Exclusive | TPE 2026 Cools as Caution Deepens in the U.S. Vape Market
Exclusive | TPE 2026 Cools as Caution Deepens in the U.S. Vape Market
The show had become an important check-in point for Chinese manufacturers and brand owners looking for signs of change in the U.S. market after months of softer demand. Instead, participants said the event highlighted a more restrained mood: traffic in the vape section was uneven, standout launches were limited, and conversations often failed to turn into orders.
Special Report
Apr.12
Serbian Parliament Passes Trade Laws Banning Sales of E-Cigarettes and Nicotine Products to Minors
Serbian Parliament Passes Trade Laws Banning Sales of E-Cigarettes and Nicotine Products to Minors
Serbia’s parliament has adopted a package of trade laws aimed at increasing consumer protection while introducing a range of changes for merchants and online platforms. One of the most important new measures is a ban on the sale of e-cigarettes and other nicotine products to minors, tightening youth protection rules.
Apr.24 by 2FIRSTS.ai
2Firsts Data|China Vape Exports Sink to Three-Year April Low After Tax Rebate Ends, Falling to $694 Million
2Firsts Data|China Vape Exports Sink to Three-Year April Low After Tax Rebate Ends, Falling to $694 Million
China’s e-cigarette export value declined to $694 million in April 2026, marking the lowest April level in the past three years. The data is notable because April was the first full month after China removed export VAT rebates for certain e-cigarette products. Compared with April 2025, export value fell 20.9%; compared with April 2024, it was down 22.3%. Month-on-month, exports dropped 23.2% from March 2026.
Special Report
May.23
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