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.

Nicaragua’s Health Ministry reaffirms Resolution No. 334-2021, maintaining a total ban on vaping and e-cigarette sales
Nicaragua’s Health Ministry reaffirms Resolution No. 334-2021, maintaining a total ban on vaping and e-cigarette sales
Nicaragua’s Ministry of Health (MINSA) issued an official statement on January 2, 2026 reaffirming the validity of Ministerial Resolution No. 334-2021, which absolutely bans the use and commercialization of electronic nicotine delivery systems known as “vapeadores” or e-cigarettes.
Jan.04 by 2FIRSTS.ai
South Korea’s appeal court again sides with KT&G, Philip Morris Korea and BAT Korea in $36.24 million case
South Korea’s appeal court again sides with KT&G, Philip Morris Korea and BAT Korea in $36.24 million case
South Korea’s National Health Insurance Service (NHIS) has again lost on appeal in its damages lawsuit against KT&G, Philip Morris Korea and BAT Korea, seeking ₩53.3 billion (about $36.244 million).
Jan.15 by 2FIRSTS.ai
2Firsts Interview | Bengt Wiberg: Why the Oral Health Risks of Nicotine Pouches Merit Further Study
2Firsts Interview | Bengt Wiberg: Why the Oral Health Risks of Nicotine Pouches Merit Further Study
As nicotine pouches gain global traction as a lower-risk alternative to smoking, questions are emerging about their potential oral health effects. In a 2Firsts interview, Stingfree AB founder Bengt Wiberg discusses why gum irritation and oral lesions warrant closer scrutiny within the broader framework of tobacco harm reduction.
Jan.06
Special Report| Vuse Gains as U.S. Cracks Down on Illegal Vapes, But a $590 Million China Export Shadow Looms
Special Report| Vuse Gains as U.S. Cracks Down on Illegal Vapes, But a $590 Million China Export Shadow Looms
The payoff is here: BAT’s Vuse has seized a rare regulatory vacuum to reverse its U.S. slide, capitalizing on a crackdown that seemingly compressed the illicit market to 54%. But the victory is fragile. A record $590 million export shock in October signals the gray market is striking back—pitting a fleeting compliance dividend against a massive inventory wall.
BAT
Dec.09
Philip Morris Japan launches new IQOS SENTIA “Icy Red” flavor with icy menthol and red berry notes
Philip Morris Japan launches new IQOS SENTIA “Icy Red” flavor with icy menthol and red berry notes
Philip Morris Japan has announced the launch of a new SENTIA Icy Red tobacco stick for its IQOS ILUMA i and IQOS ILUMA heated tobacco devices, featuring an intense menthol profile with red fruit notes. The new product will roll out in stages from December across physical IQOS outlets, online channels and tobacco retailers nationwide in Japan, priced at 530 yen (approx. USD 3.4) per pack.
Dec.01 by 2FIRSTS.ai
Kazakhstan’s Astana Baikonur District Fines Illegal Smokeless Tobacco Sales Over USD 5,800
Kazakhstan’s Astana Baikonur District Fines Illegal Smokeless Tobacco Sales Over USD 5,800
Authorities in Astana’s Baikonur District have intensified enforcement against illegal smokeless tobacco and related products in 2025. Police conducted 59 inspection raids, identifying 63 cases of illegal sales of smokeless tobacco (nasvay). Total fines imposed reached KZT 3,096,450(approximately USD 5,880). Officials said inspections and preventive outreach will continue.
Dec.29 by 2FIRSTS.ai