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.

Special Report | Vape bans and tougher rules: the South Caucasus takes different paths
Special Report | Vape bans and tougher rules: the South Caucasus takes different paths
Azerbaijan's sweeping e-cigarette ban has raised concerns over enforcement errors and the emergence of illicit sales, while neighboring Armenia is tightening technical rules and preparing higher excise taxes. Georgia, meanwhile, has resisted calls for broader vape restrictions and introduced preferential taxes for some domestically produced cigarettes. The divergent approaches across the South Caucasus highlight a regional policy dilemma: how to curb nicotine use and protect public health without encouraging black markets or creating unintended economic consequences for businesses and consumers.
Nov.03
STIIIZY Redesign Fails to Escape PAX Labs Patent Import Ban as Section 337 Case Also Involves China ALD
STIIIZY Redesign Fails to Escape PAX Labs Patent Import Ban as Section 337 Case Also Involves China ALD
U.S. Customs and Border Protection ruled that STIIIZY had not shown that the redesigned cannabis-vape products covered by its latest request fall outside an ITC limited exclusion order tied to PAX Labs patents. CBP accepted some of STIIIZY’s claim-construction and non-infringement arguments, but the company did not address two additional claims in the same patent. Earlier STIIIZY redesigned cartridges and certain associated components imported with them had received separate CBP clearance.
Sep.16
Ukraine Raises Excise Stamp Fees for Tobacco, Heated Tobacco and Vape Liquids by 30.5% as Parliament Backs E-Excise Delay to 2027
Ukraine Raises Excise Stamp Fees for Tobacco, Heated Tobacco and Vape Liquids by 30.5% as Parliament Backs E-Excise Delay to 2027
Ukraine's Cabinet of Ministers adopted Resolution No. 1259 on October 15, 2026, increasing excise stamp production fees for tobacco products and e-cigarette liquids by approximately 30.5%, from UAH 0.1643 to UAH 0.2144 per stamp. Fees for alcoholic beverages rose by about 30.2%. Separately, Ukraine's parliament passed Bill No. 15532 on October 13, proposing to postpone the full implementation of electronic excise stamps and traceability for alcohol, tobacco and e-cigarette liquids from November 1, 2026, to July 1, 2027. Parliament cited additional testing, configuration and integration requirements. The bill was sent to the president for signature on October 19.
Regulations
Oct.21
South Korea's Tobacco Plan Excludes 6-Methyl Nicotine as Customs Tightens Import Controls and Analog Liquid Imports Fall 83%
South Korea's Tobacco Plan Excludes 6-Methyl Nicotine as Customs Tightens Import Controls and Analog Liquid Imports Fall 83%
South Korea's government unveiled its first Tobacco Harm Management Basic Plan for 2027–2031 on October 29, 2026, proposing broader testing of vaping and heated tobacco products while excluding nicotine analogs such as 6-methyl nicotine. Synthetic nicotine came under tobacco regulation on April 24, and a June investigation found 6-methyl nicotine in 12 liquid inhalation products marketed as nicotine-free. Customs data released in September showed that imports of nicotine analog solutions fell 83.3%, from 12 metric tons in January–April to 2 metric tons in May–August. By September 20, imports had reached approximately 15 metric tons for the year, with 99.99% originating from China. Customs authorities have tightened pre-clearance testing and supply-chain documentation requirements, while the MFDS expects to complete its assessment of nicotine analog hazards by the end of 2026.
Regulations
Nov.04
Russia’s Vape Device Labeling Regime Enters Force: Registration Starts in September, Mandatory Coding in December
Russia’s Vape Device Labeling Regime Enters Force: Registration Starts in September, Mandatory Coding in December
Russia's digital labeling regime for reusable e-cigarettes and similar personal vaping devices entered its first mandatory phase in September 2026. From September 1, manufacturers, importers and other market participants must register with the national Chestny ZNAK tracking system. From December 1, newly manufactured and imported covered devices will be required to carry digital identification codes and be reported as entering circulation. Russia has also issued new operational guidance for imports, marking the transition from a voluntary pilot to phased mandatory implementation.
Sep.15
JTI Liggett Puts U.S. Value Cigarette Brands in Spotlight at 2026 NACS Show
JTI Liggett Puts U.S. Value Cigarette Brands in Spotlight at 2026 NACS Show
At the 2026 NACS Show in Las Vegas, JTI Liggett highlighted its value-priced cigarette portfolio, including LD and Montego, following JT Group's acquisition of Vector Group. The company's U.S. business reported market share gains, with LD sales volume rising 32.6% in the first half of 2026. Meanwhile, Ploom was displayed separately at Altria's booth under an existing partnership. JTI Liggett booth staff told 2Firsts that the company had not yet launched nicotine pouch products in the United States.
EXPO
Oct.09