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.

Gallup Tracks Nicotine Pouch Use for the First Time: 11% of U.S. Adults Smoke, 9% Vape and 4% Use Nicotine Pouches
Gallup Tracks Nicotine Pouch Use for the First Time: 11% of U.S. Adults Smoke, 9% Vape and 4% Use Nicotine Pouches
Gallup’s 2026 Consumption Habits survey tracked nicotine pouch use for the first time. The survey found that 11% of U.S. adults reported smoking cigarettes in the past week, 9% reported vaping, and 4% reported using nicotine pouches. Cigarette smoking remained near Gallup’s long-term low, while adult vaping rates stayed relatively stable in recent years.
Market
Aug.25 by 2Firsts Perspectives
2Firsts On-Site | PMI Brings IQOS, ZYN, VEEV and Marlboro Together at Its “Boulevard” at InterTabac 2026
2Firsts On-Site | PMI Brings IQOS, ZYN, VEEV and Marlboro Together at Its “Boulevard” at InterTabac 2026
At InterTabac 2026 in Dortmund, PMI is presenting multiple brands and products along “The PMI Boulevard,” including IQOS, ZYN, VEEV and Marlboro. On-site images captured by 2Firsts show dedicated spaces including the IQOS Boutique, ZYN Café, PMI Gallery and Marlboro Office
Market
Sep.16 by 2Firsts Perspectives
Australia Extends Illicit Tobacco Crackdown From Tougher Penalties to Customs and Logistics Supply Chains
Australia Extends Illicit Tobacco Crackdown From Tougher Penalties to Customs and Logistics Supply Chains
Australia's federal government introduced a new illicit tobacco enforcement bill on September 10 that would strengthen evidentiary presumptions, representative sampling, seizure and forfeiture procedures, proceeds-of-crime powers and obligations for customs and logistics operators. The proposal follows the Combatting Illicit Tobacco Act 2026, which took effect in August and increased penalties while expanding investigative and asset-recovery tools. Together, the reforms extend Australia's crackdown from tougher criminal sanctions into import, logistics and evidentiary enforcement.
Sep.14
Smoore Wins Three Heated Device Supply Lots in China Tobacco Jiangsu’s Overseas Market Project Covering Japan, South Korea and Southeast Asia
Smoore Wins Three Heated Device Supply Lots in China Tobacco Jiangsu’s Overseas Market Project Covering Japan, South Korea and Southeast Asia
China Tobacco Jiangsu Industrial Co., Ltd. (JSIC) has completed its 2026-2028 heated device procurement project, with Shenzhen Smoore Technology Limited securing final supply contracts for three lots: U1, C1 and C2. The project was launched through a public tender in June 2026 to support overseas markets and involved heated tobacco devices carrying JSIC’s “iRod” trademark. Candidate supplier results published on July 13 showed Smoore ranked first for the three awarded lots, while Shenzhen Yunxi Intelligent Technology Co., Ltd. and Shenzhen Bodi Technology Development Co., Ltd. participated in the bidding process.
Aug.03
Nicotine Pouches Gain Ground in U.S. Convenience Stores as Vape Unit Sales Fall 14%
Nicotine Pouches Gain Ground in U.S. Convenience Stores as Vape Unit Sales Fall 14%
According to convenience retail publication CStore Decisions, U.S. convenience store tobacco categories are undergoing a structural shift. Based on Circana OmniMarket Total U.S. Convenience data for the 52 weeks ending June 14, 2026, cigarettes remained the largest category with $50.8 billion in sales, but unit sales declined 5.3%. Electronic smoking devices and vaping products also declined, while modern oral nicotine products continued to grow, with nicotine pouch sales rising 29% in dollars and 17% in units. Retailers said changing consumer preferences are reshaping tobacco product assortments at convenience stores.
Regulations
Aug.07
PMI's IQOS Extends ZAMNA Electronic-Music Partnership to Spain as Vogue España Publishes Branded Content
PMI's IQOS Extends ZAMNA Electronic-Music Partnership to Spain as Vogue España Publishes Branded Content
Philip Morris International's IQOS has extended its partnership with electronic-music event brand ZAMNA to Spain, setting up a House of IQOS at ZAMNA Madrid. Vogue España and Time Out Madrid subsequently published branded content clearly labeled as collaborations with IQOS. PMI has also expanded its company-owned IQOS boutique network in Spain to seven cities this year. The company says IQOS's adjusted heated-tobacco market share in Europe reached 12.6% in the first quarter of 2026, with Spain among its stronger-performing European markets.
Sep.20