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.

FDA Wins Default Entry in Case Against E-Cigarette Distributor, to Seek Permanent Injunction
FDA Wins Default Entry in Case Against E-Cigarette Distributor, to Seek Permanent Injunction
The U.S. Food and Drug Administration (FDA) has made procedural progress in its lawsuit against North Carolina-based e-cigarette distributor Dream Distro LLC and its owner. A federal district judge granted the government’s request for entry of default after the defendants failed to respond to the complaint within 21 days of service. The government will next seek a default judgment, including a permanent injunction.
Apr.09 by 2FIRSTS.ai
KT&G Integrates “lil Aible” Dedicated Stick Lineup Under the “AIIM” Brand
KT&G Integrates “lil Aible” Dedicated Stick Lineup Under the “AIIM” Brand
KT&G said it will integrate the Real, Granular and Vapor Stick product lines for its heated tobacco device “lil Aible” under the “AIIM” brand. The company said the brand integration is intended to organize the existing lineup more intuitively and improve consumer accessibility and convenience.
Mar.18 by 2FIRSTS.ai
U.S. Military Smoking Debate Spotlights E-Cigarettes and Nicotine Pouches as a “Bridge”
U.S. Military Smoking Debate Spotlights E-Cigarettes and Nicotine Pouches as a “Bridge”
At a policy forum hosted by The Hill and sponsored by PMI US, U.S. defense health officials, lawmakers and industry representatives discussed tobacco use in the military and explored the potential role of smoke-free nicotine products — including e-cigarettes and nicotine pouches — as transitional tools to help service members reduce reliance on combustible cigarettes.
PMI
Mar.23
Poland Seizes 223,688 Disposable Vapes Without Required Excise Marks
Poland Seizes 223,688 Disposable Vapes Without Required Excise Marks
Poland’s Customs and Tax Service in Łódź carried out an inspection at a property near Zgierz and seized 223,688 disposable e-cigarettes without the required excise markings.
Apr.07 by 2FIRSTS.ai
French Anti-Tobacco Group Contre-Feu Calls for Plain Packaging Across All Vaping Products
French Anti-Tobacco Group Contre-Feu Calls for Plain Packaging Across All Vaping Products
French anti-tobacco group Contre-Feu said in a statement released on April 14 that e-cigarette manufacturers are encouraging nicotine dependence among young people through targeted marketing and called for concrete measures to protect minors. The group asked for plain packaging for all vaping products, strict regulation of flavor names, and a ban on online sales.
Apr.15 by 2FIRSTS.ai
BAT faces London shareholder lawsuit over alleged disclosure failures tied to North Korea business
BAT faces London shareholder lawsuit over alleged disclosure failures tied to North Korea business
British American Tobacco is facing a shareholder lawsuit in London alleging it failed to properly disclose to markets information about breaches of U.S. sanctions linked to its North Korea-related business. BAT agreed in 2023 to pay more than $635 million to U.S. authorities after a subsidiary admitted conspiring to violate U.S. sanctions by selling tobacco products to North Korea and committing bank fraud from 2007 to 2017.
Mar.05 by 2FIRSTS.ai