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.

Dutch Watchdog Investigates Snapchat Over Minor Protection from Vape Sellers
Dutch Watchdog Investigates Snapchat Over Minor Protection from Vape Sellers
The Netherlands' ACM has opened an investigation into Snapchat for potentially failing to prevent its platform from being used to illegally sell vapes to minors, a possible breach of EU digital rules.
Sep.10
Joint law enforcement in Johor Bahru, Malaysia, seized 1,997 e-cigarette products and investigated eight violations
Joint law enforcement in Johor Bahru, Malaysia, seized 1,997 e-cigarette products and investigated eight violations
On September 27, the Johor State Health Department (JKNJ) and the Johor Bahru City Hall (MBJB) conducted a joint enforcement operation at a shopping mall in Johor Bahru, seizing 1,997 e-cigarette products. Ling Tianshun, Chairman of the Johor State Health and Environment Committee, reiterated that Johor has officially banned e-cigarettes since 2016 and will not issue sales licenses. He also warned businesses not to sell e-cigarettes.
Sep.29 by 2FIRSTS.ai
Cambodia Enforces Full Ban on E-Cigarettes and Shisha to Protect Youth
Cambodia Enforces Full Ban on E-Cigarettes and Shisha to Protect Youth
Cambodian Prime Minister Hun Manet signs order to strengthen enforcement of e-cigarette and shisha bans, citing health risks and youth usage.
Oct.23 by 2FIRSTS.ai
Product | 2× “2+10” configuration, rated 36,000 puffs — VOZOL launches NEON PLUG MAX
Product | 2× “2+10” configuration, rated 36,000 puffs — VOZOL launches NEON PLUG MAX
VOZOL has listed a new product, NEON PLUG MAX, on its official website, featuring dual 2 ml prefilled pods and dual 10 ml refill bottles (24 ml total), a claimed maximum of 36,000 puffs, and two-flavour switching. The device was previously shown at InterTabac 2025 and was listed by the UK MHRA in March 2025; however, as of publication it was not yet available on overseas retail sites.
Oct.22 by 2FIRSTS.ai
InterTabac 2025 Photo Gallery|Nicotine Pouch Exhibitors Surge: Booth Snapshot
InterTabac 2025 Photo Gallery|Nicotine Pouch Exhibitors Surge: Booth Snapshot
InterTabac 2025 in Dortmund has officially opened. At this year’s fair, numerous nicotine pouch brands are exhibiting, with their numbers rising significantly compared with last year.
Sep.19 by 2FIRSTS.ai
Danbury, Connecticut Conducts Raids on Four Vape Shops: Underage Sales and Suspected Illegal Cannabis Products Found
Danbury, Connecticut Conducts Raids on Four Vape Shops: Underage Sales and Suspected Illegal Cannabis Products Found
Police in Danbury, Connecticut, conducted surprise inspections with multiple agencies at four vape shops and found several violations, including selling tobacco products to minors and the alleged illegal sale of cannabis products. One store was ordered to close for violating labor laws. Mayor Roberto Alves said the city will continue to strengthen enforcement and zoning controls to curb threats to youth health.
Sep.16 by 2FIRSTS.ai