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.

Thai Police Seize 30,000 Illegal Vapes Worth Over US$270,000
Thai Police Seize 30,000 Illegal Vapes Worth Over US$270,000
According to Thai police, officers seized 30,000 illegal vapes worth over THB 10 million (US$270,000) and arrested two suspects linked to online sales via LINE account “VST Nuan Chan.” Raids were conducted in Bangkok and Samut Prakan, uncovering a main warehouse and residence. Both suspects confessed and face charges under the Product Safety Act and Customs Law for illegal import and sale.
Oct.30 by 2FIRSTS.ai
Dagestan Proposes Pilot Ban on E-Cigarette Sales, Submits Request to State Duma
Dagestan Proposes Pilot Ban on E-Cigarette Sales, Submits Request to State Duma
The head of Russia’s Republic of Dagestan has proposed a region-wide ban on the retail sale of e-cigarettes and has written to the State Duma seeking to designate Dagestan as a pilot region for a comprehensive e-cigarette sales ban.
Oct.21 by 2FIRSTS.ai
Product | Magnetic-attach design + mini display: FASTA’s new product goes on sale in the U.S., priced around $16
Product | Magnetic-attach design + mini display: FASTA’s new product goes on sale in the U.S., priced around $16
FASTA’s 40K Kit hits U.S. retailers: magnetic prefilled pods + reusable battery, mini display, two power levels; rated 20 mL/40,000 puffs/50 mg; some listings at $15.99.
Oct.15 by 2FIRSTS.ai
Portugal to Tax Nicotine Pouches from 2026 at €0.065 per Gram
Portugal to Tax Nicotine Pouches from 2026 at €0.065 per Gram
Portugal’s 2026 State Budget adds nicotine pouches to the IEC by inserting Article 104-D into the Excise Code’s tobacco chapter. A specific duty of €0.065/g applies from 2026, with rounding to whole grams. The Budget also defines pouches (natural nicotine, up to 12 mg, tobacco-free, oral mucosal absorption). Lusa projects €1.676B in tobacco excise for 2026; combined levies near €1.993B.
Oct.30 by 2FIRSTS.ai
Product | GEEK BAR and Canada’s STLTH Co-Launch 80,000-Puff Vape, Now Available Across Multiple Channels
Product | GEEK BAR and Canada’s STLTH Co-Launch 80,000-Puff Vape, Now Available Across Multiple Channels
Canada’s STLTH has teamed up with GEEK BAR to launch the disposable “STLTH X GEEK BAR 80K,” featuring 30 ml of e-liquid and up to 80,000 puffs. The device is now available across multiple retail channels in Canada, priced around C$44.99–48.99.
Oct.30 by 2FIRSTS.ai
10,800 Vape Cartridges Worth USD 175,000 Confiscated in Maldives
10,800 Vape Cartridges Worth USD 175,000 Confiscated in Maldives
The Maldives Customs Service has confiscated the largest single shipment of vapes since the national import ban took effect in November 2024. Officials searched a sea freight shipment on December 4 and seized 10,800 vape cartridges valued at approximately MVR 2.7 million (USD 175,000).
Dec.11 by 2FIRSTS.ai