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.

South Korea Publishes List of Major Tax Delinquents: Vape Wholesaler Owes Over USD 15.5 Million
South Korea Publishes List of Major Tax Delinquents: Vape Wholesaler Owes Over USD 15.5 Million
The Korea Customs Service (KCS) has released a list of 236 habitual and large-scale customs tax delinquents with total unpaid taxes amounting to approximately USD 917 million. Among them, a vape wholesaler tops the individual list, owing about USD 15.57 million, while another vape-related company owes roughly USD 12.02 million.
Nov.11 by 2FIRSTS.ai
Product | GEEKBAR Launches HOOKAH X on Its Official Website, Featuring Stepless DTL “Infinite Control”
Product | GEEKBAR Launches HOOKAH X on Its Official Website, Featuring Stepless DTL “Infinite Control”
GEEKBAR has launched the disposable hookah-style e-cigarette HOOKAH X on its official website. According to the product page, the device claims to feature “Stepless/Infinite Control,” enabling continuous adjustment across different airflow and draw-resistance ranges. HOOKAH X has also begun selling through online channels in the U.S., with pricing around US$21.99.
Dec.08 by 2FIRSTS.ai
Scottish Retailers Urge Government to Fast-Track Nicotine Pouch Regulations
Scottish Retailers Urge Government to Fast-Track Nicotine Pouch Regulations
The Scottish Grocers’ Federation (SGF) is calling on the government to clarify the regulatory framework for nicotine pouches in order to prevent high-strength and illegal products from entering the market, stressing that these products should not be targeted at minors.
Dec.04 by 2FIRSTS.ai
BAT Pauses U.S. Launch of Unlicensed Vuse One Vape amid FDA Crackdown — Reuters
BAT Pauses U.S. Launch of Unlicensed Vuse One Vape amid FDA Crackdown — Reuters
British American Tobacco has paused the U.S. pilot launch of its unlicensed Vuse One vape amid intensified FDA enforcement.
Oct.28 by 2FIRSTS.ai
Russian Police Seize Over 150,000 Counterfeit E-Cigarettes Worth More Than USD 1.65 Million
Russian Police Seize Over 150,000 Counterfeit E-Cigarettes Worth More Than USD 1.65 Million
Russian police in Tambov have detained a man for storing and selling unmarked e-cigarettes. Over 150,000 counterfeit e-cigarettes, cartridges, and e-liquids were seized, valued at more than 126.5 million rubles (approximately USD 1.65 million). Tests revealed that the nicotine content of the seized products exceeded the levels stated on their packaging. A criminal case has been opened under Article 171.1, Part 6 of the Russian Criminal Code.
Dec.09 by 2FIRSTS.ai
JTI UK Expands Nordic Spirit Line, Launches 17mg Nicotine Pouch
JTI UK Expands Nordic Spirit Line, Launches 17mg Nicotine Pouch
JTI UK has launched Nordic Spirit’s highest-strength variant—Frosty Mint Max, delivering 17mg of nicotine per pouch—and introduced a refreshed, darker packaging design for the brand.
Oct.31 by 2FIRSTS.ai