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.

Breaking News | China Deploys Full-Chain Crackdown on Illicit Tobacco, Enforcement Storm Looms for Illegal Tobacco and E-Cigarettes
Breaking News | China Deploys Full-Chain Crackdown on Illicit Tobacco, Enforcement Storm Looms for Illegal Tobacco and E-Cigarettes
China has issued a high-level directive to crack down on illicit tobacco activities, bringing e-cigarettes and nicotine pouches under tighter enforcement. The move follows a Premier-led meeting and underscores stepped-up oversight across the tobacco supply chain, amid the sector’s continued fiscal importance.
Dec.18
Kentucky to issue provisional state licenses to tobacco, nicotine and vapor retailers who applied before Jan. 1, 2026
Kentucky to issue provisional state licenses to tobacco, nicotine and vapor retailers who applied before Jan. 1, 2026
Kentucky will issue provisional state licenses to tobacco, nicotine and vapor product retailers that applied for a license with the Department of Alcoholic Beverage Control (ABC) before Jan. 1, 2026.
Dec.31 by 2FIRSTS.ai
Australia’s TGA Seizes Illicit Vaping Products Worth Over  US$670,000 in Bendigo
Australia’s TGA Seizes Illicit Vaping Products Worth Over US$670,000 in Bendigo
Australia’s Therapeutic Goods Administration (TGA) has seized illicit vaping products with an estimated street value exceeding A$1 million (approximately US$670,000) following an enforcement operation in Bendigo, Victoria.
Dec.24 by 2FIRSTS.ai
PMI reports full-year 2025 results with net revenues of $40.6 billion and smoke-free net revenues were about $16.9 billion
PMI reports full-year 2025 results with net revenues of $40.6 billion and smoke-free net revenues were about $16.9 billion
Philip Morris International (PMI) released its Q4 and full-year 2025 results on February 6, 2026. PMI reported full-year net revenues of $40,648 million ($40.6 billion), reported diluted EPS of $7.26 and adjusted diluted EPS of $7.54. PMI said smoke-free net revenues were $16.9 billion and represented 41.5% of total net revenues, with smoke-free products available in 106 markets and over 43 million estimated adult consumers.
Feb.06 by 2FIRSTS.ai
BAT rolls out VELO nicotine pouches in Argentina as social media buzzes about ZYN distribution
BAT rolls out VELO nicotine pouches in Argentina as social media buzzes about ZYN distribution
BAT Argentina says it has launched VELO nicotine pouches in Argentina, positioning the product as an adult alternative that contains no tobacco and involves no combustion. At the same time, social media discussion and media reporting indicate that Philip Morris International’s ZYN nicotine pouches are also being distributed through Argentine channels.
Jan.12 by 2FIRSTS.ai
Product | Full-screen display and 10K puffs: IVG launches new Pro-series pod vape in the UK
Product | Full-screen display and 10K puffs: IVG launches new Pro-series pod vape in the UK
E-cigarette brand IVG has recently rolled out the IVG Pro 2 across several UK online retailers. The device is compatible with IVG Pro pods and comes in 33 flavours with nicotine strengths of 0mg, 10mg and 20mg. Channel listings show a 2ml prefilled pod paired with a 10ml refill container, with pricing around £9.99.
Feb.02 by 2FIRSTS.ai