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.

Philippine Local Governments Urge Marcos to Prioritize Smoke- and Vape-Free Bill
Philippine Local Governments Urge Marcos to Prioritize Smoke- and Vape-Free Bill
The League of Municipalities of the Philippines (LMP) has urged President Ferdinand Marcos Jr. to prioritize the Smoke- and Vape-Free Bill, seeking a nationwide legal framework for tobacco and vape regulation. Local government leaders said national legislation would help standardize enforcement and strengthen public health measures. The proposal remains at the advocacy stage and has not yet become law.
Jul.29
China Discloses First Criminal Case Over Counterfeit Vapes Disguised as “Medical Nebulizers” and “Zero-Nicotine” Products
China Discloses First Criminal Case Over Counterfeit Vapes Disguised as “Medical Nebulizers” and “Zero-Nicotine” Products
Chinese authorities have disclosed the country’s first reported criminal case involving counterfeit vapes marketed as “medical nebulizers” and “zero-nicotine” products. Authorities determined that the products involved were counterfeit vapes and pursued criminal charges for producing and selling counterfeit goods. According to the report, the case resulted in the seizure of 347,000 counterfeit vape pods and 53,700 vape devices, with physical goods valued at 22.13 million yuan.
Aug.04
FIFA Bans Vaping in 2026 World Cup Stadiums, Putting Nicotine Rules in Event Compliance Focus
FIFA Bans Vaping in 2026 World Cup Stadiums, Putting Nicotine Rules in Event Compliance Focus
FIFA’s 2026 World Cup stadium rules prohibit smoking, vaping and the use of any tobacco products or electronic smoking devices inside stadiums, including inner and outer perimeters, while electronic smoking devices, tobacco products, lighters and matches are listed as prohibited items, bringing nicotine-product management, venue compliance and cross-border legal differences into focus at a major global sporting event.
Jul.06
ATF Cancels Webloc Contract, Raising Questions Over Commercial Location Data in Enforcement
ATF Cancels Webloc Contract, Raising Questions Over Commercial Location Data in Enforcement
The U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) has stopped using Webloc, a commercial phone-tracking tool, after lawmakers, a prosecutor and a judge raised legal and privacy concerns over warrantless use of ad-tech location data, a development that may affect data-use boundaries in U.S. enforcement against illicit tobacco, nicotine products and cross-border distribution networks.
Jun.29
Russia Adds Vapes to “Strategic Goods” List, Illegal Cross-Border Trade Faces Up to Five Years in Prison
Russia Adds Vapes to “Strategic Goods” List, Illegal Cross-Border Trade Faces Up to Five Years in Prison
Russia will place e-cigarettes and related nicotine products under its “strategic goods” framework from August 20, 2026. According to TVP World’s report published on August 19, the newly listed items include e-cigarettes, electronic smoking devices, vape liquids and nicotine salts. Individuals who illegally move these products across Russia’s customs border or its state border with other Eurasian Economic Union (EAEU) members could face up to five years in prison if shipment values exceed 100,000 rubles (about €1,000), provided all elements of a criminal offence are established.
Aug.20
Dutch NVWA Seizes Record 277,000 Illegal Vapes; Video Shows “AL FAKHER” Cartons
Dutch NVWA Seizes Record 277,000 Illegal Vapes; Video Shows “AL FAKHER” Cartons
The Dutch Food and Consumer Product Safety Authority, known as the NVWA, seized more than 277,000 illegal vapes near Rotterdam and nearly 150,000 boxes of nicotine pouches in Utrecht and Rotterdam, calling them the largest batches of such products it has found to date. Video footage released by the NVWA shows some cartons in the warehouse bearing the “AL FAKHER / الفاخر” name, though the agency did not identify brands.
Jul.10