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.

U.S. FDA posts TPSAC meeting materials ahead of discussion on ZYN MRTP applications
U.S. FDA posts TPSAC meeting materials ahead of discussion on ZYN MRTP applications
On January 20, 2026, the U.S. Food and Drug Administration (FDA) posted meeting materials ahead of a virtual Tobacco Products Scientific Advisory Committee (TPSAC) meeting scheduled for January 22, 2026, to discuss modified risk tobacco product (MRTP) applications submitted by Swedish Match USA, Inc. for 20 ZYN nicotine pouch products.
Jan.21 by 2FIRSTS.ai
Alcohol, tobacco and cannabis use among Spanish students aged 14–18 hits historic lows
Alcohol, tobacco and cannabis use among Spanish students aged 14–18 hits historic lows
Spain’s 2025 Survey on Drug Use in Secondary Education (ESTUDES), presented by the Ministry of Health, reports historic lows in alcohol, tobacco and cannabis consumption among students aged 14 to 18. The survey shows past-30-day drinking fell from 56.6% in 2023 to 51% in 2025, tobacco use from 21.0% to 15.5%, and cannabis use from 15.5% to 11.6%.
Feb.09 by 2FIRSTS.ai
Thailand police seize 17,320 disposable vapes valued at over USD 22,330 in Nonthaburi
Thailand police seize 17,320 disposable vapes valued at over USD 22,330 in Nonthaburi
Thai authorities arrested a 31-year-old man in Bang Bua Thong, Nonthaburi, on January 20, 2026, and seized 17,320 disposable e-cigarettes and a pickup truck. The seized goods were valued at more than THB 7 million (about USD 223,349.62).
Jan.21 by 2FIRSTS.ai
Kyrgyzstan: Jogorku Kenesh committee sends draft vape ban bills back for revisions
Kyrgyzstan: Jogorku Kenesh committee sends draft vape ban bills back for revisions
Kyrgyzstan Jogorku Kenesh committee on labor, health, women’s affairs and social issues decided to withdraw for revision two draft laws related to banning electronic nicotine delivery systems and e-cigarettes in Kyrgyzstan.
Jan.14 by 2FIRSTS.ai
Korea’s MFDS sets 2026 plan to manage and disclose harmful constituents in tobacco products
Korea’s MFDS sets 2026 plan to manage and disclose harmful constituents in tobacco products
South Korea’s Ministry of Food and Drug Safety (MFDS) said it has established its 2026 work plan to systematically manage harmful constituents in tobacco products and disclose related information under the Tobacco Harmfulness Management Act, which took effect in November 2025.
Jan.16 by 2FIRSTS.ai
Fifth Circuit Upholds FDA’s 2021 PMTA Rule, Citing Statutory Health-Study Requirements
Fifth Circuit Upholds FDA’s 2021 PMTA Rule, Citing Statutory Health-Study Requirements
A Fifth Circuit panel upheld the U.S. Food and Drug Administration’s 2021 final rule requiring companies seeking premarket authorization for new tobacco products to include information on health-risk investigations. In a published opinion, the court found FDA satisfied the Regulatory Flexibility Act’s procedural requirements and reasonably relied on the economic analysis from the 2016 “deeming rule” as a factual basis to certify limited impact on small businesses.
Feb.27 by 2FIRSTS.ai