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.

North Carolina Adds $1,000 Vape Shop Tax and 21+ Age Verification Requirement
North Carolina Adds $1,000 Vape Shop Tax and 21+ Age Verification Requirement
North Carolina’s new state budget introduces additional vape retail regulations, including a $1,000 tax on vape shops and mandatory age verification requiring customers to be at least 21.
Jul.08
FDA Foreign Tobacco Registration Proposal Could Strengthen ENDS Import Oversight, Azim Chowdhury Says
FDA Foreign Tobacco Registration Proposal Could Strengthen ENDS Import Oversight, Azim Chowdhury Says
FDA’s proposed rule requiring foreign tobacco manufacturers to register establishments and list products is more than routine paperwork, Keller and Heckman LLP partner Azim Chowdhury told 2Firsts. He said it could strengthen FDA’s import enforcement, inspections and market surveillance. Chinese e-cigarette OEM/ODM manufacturers, specification developers, brand owners and component suppliers may need to review their roles, product data and U.S. market authorization status.
Special Report
Jun.29
Product | Geek Bar Expands Meloso Lineup With the Launch of Meloso Max 2
Product | Geek Bar Expands Meloso Lineup With the Launch of Meloso Max 2
Geek Bar has added Meloso Max 2 to its official product lineup, further expanding its disposable vape portfolio. As the latest generation of the Meloso series, the new device introduces upgrades in endurance, device interaction and industrial design while reinforcing Geek Bar’s strategy of offering differentiated disposable products across multiple usage scenarios.
Jun.26
Altria’s USSTC to Close Nashville Plant and Shift Operations to Kentucky by 2028
Altria’s USSTC to Close Nashville Plant and Shift Operations to Kentucky by 2028
U.S. Smokeless Tobacco Company (USSTC), a subsidiary of Altria Group, announced plans to close its Nashville manufacturing facility by 2028 and consolidate production operations at a new facility in Hopkinsville, Kentucky.
Market
Jun.02
Italy Fines PMI €7 Million Over Misleading ‘Smoke-Free Future’ Marketing Claims
Italy Fines PMI €7 Million Over Misleading ‘Smoke-Free Future’ Marketing Claims
Italy’s Competition and Market Authority (AGCM) has fined Philip Morris Italia €7 million, finding that the company’s use of “smoke-free future” and related claims in promoting products such as IQOS, VEEV and ZYN could mislead consumers.
Jun.16
FDA 2025 NYTS: Youth E-Cigarette Use Declines but Unauthorized Disposables Remain Prominent; Nicotine Pouch Use Stays Low
FDA 2025 NYTS: Youth E-Cigarette Use Declines but Unauthorized Disposables Remain Prominent; Nicotine Pouch Use Stays Low
The U.S. Food and Drug Administration (FDA) released its 2025 National Youth Tobacco Survey analysis, saying about 2.01 million U.S. middle and high school students currently used any tobacco product; among current youth e-cigarette users, unauthorized disposable brands including Geek Bar, Elf Bar, Lost Mary and Raz had high reported shares, potentially making them a focus for future enforcement.
Jun.24