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.

China Tobacco International (HK) Announces FY2025 Results: Revenue Reaches HK$14.58 Billion, Up 11.5% Year-on-Year
China Tobacco International (HK) Announces FY2025 Results: Revenue Reaches HK$14.58 Billion, Up 11.5% Year-on-Year
China Tobacco International (HK) Company Limited announced its audited results for the year ended December 31, 2025. Revenue was HK$14.58 billion, profit before taxation was HK$1.28 billion, and profit attributable to owners of the Company was HK$0.98 billion, with basic and diluted EPS of HK$1.42. The Board proposed a final dividend of HK$0.33 per share; together with an interim dividend of HK$0.19 per share, the full-year dividend totaled HK$0.52 per share.
Mar.06 by 2FIRSTS.ai
Spain’s Galicia Moves First: Under-18 Vape and Energy Drink Sales and Use Banned
Spain’s Galicia Moves First: Under-18 Vape and Energy Drink Sales and Use Banned
Galicia will implement a new “Minor Health Protection and Addictive Behaviors Prevention” law this Saturday, becoming the first region in Spain to ban the sale and use of vapes for people under 18.
Mar.09 by 2FIRSTS.ai
Goyang City Urges Relevant Sellers to Apply for Tobacco Retailer Designation by April 23
Goyang City Urges Relevant Sellers to Apply for Tobacco Retailer Designation by April 23
Goyang Special City in South Korea said it has informed local sellers about the revised Tobacco Business Act, which will take effect on April 24, 2026, and urged them to apply for tobacco retailer designation.
Mar.13 by 2FIRSTS.ai
State Attorneys General Urge Visa, Mastercard and Others to Stop Processing Illicit E-Cigarette Transactions
State Attorneys General Urge Visa, Mastercard and Others to Stop Processing Illicit E-Cigarette Transactions
Fourteen U.S. state attorneys general sent a joint letter dated April 14, 2026 to Visa, Mastercard, American Express and Discover, asking them to immediately help stop the sale of illicit e-cigarette products by cutting off payment access.
Apr.17 by 2FIRSTS.ai
Japan Tobacco Releases Three Ploom AURA Collaboration Panels Inspired by “Sake”
Japan Tobacco Releases Three Ploom AURA Collaboration Panels Inspired by “Sake”
Japan Tobacco announced that it will sponsor “CRAFT SAKE WEEK 2026,” to be held at Roppongi Hills Arena, and set up a dedicated smoking area called “Ploom LOUNGE.” Three Ploom AURA collaboration front panels inspired by the theme of “sake” will be offered at the venue, along with trial use, sales, and related original content.
Apr.13 by 2FIRSTS.ai
FDA and IKE Tech Hold Formal Listening Session on Youth Access and Illicit ENDS Products
FDA and IKE Tech Hold Formal Listening Session on Youth Access and Illicit ENDS Products
U.S. Food and Drug Administration’s Center for Tobacco Products held a formal listening session with IKE Tech LLC to discuss youth prevention at the point of use for ENDS products, the circulation of illicit products in the supply chain, and the regulatory treatment of software in tobacco products.
Apr.10 by 2FIRSTS.ai