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.

Philippine Anti-Smoking Groups Urge DTI Action Over Alleged Vape Law Violations by ZYN and IQOS
Philippine Anti-Smoking Groups Urge DTI Action Over Alleged Vape Law Violations by ZYN and IQOS
Several anti-smoking and health advocacy groups in the Philippines urged the Department of Trade and Industry to take action against tobacco companies accused of violating the Vape Regulation Act of 2022. The groups said three consecutive complaints had been filed involving nicotine pouch brand ZYN and heated tobacco product company IQOS Philippines.
Apr.27 by 2FIRSTS.ai
KT&G Aims to Accelerate Launch of New Heated Tobacco Innovation Platform
KT&G Aims to Accelerate Launch of New Heated Tobacco Innovation Platform
KT&G Chief Executive Officer Bang Kyung-man said at the annual shareholders meeting on March 26 that although the company expects a challenging environment marked by stronger protectionism and a high exchange rate, it will continue on a stable growth path through strategic choice and focus.
Mar.26 by 2FIRSTS.ai
Swedish Government Minister Visits Nicotine Pouch Factory, Calls Sector Important Export Industry
Swedish Government Minister Visits Nicotine Pouch Factory, Calls Sector Important Export Industry
Sweden’s Minister for Foreign Trade and Development Cooperation, Benjamin Dousa, visited nicotine pouch producer Another Snus Factory on Monday, calling the sector an important export industry as several European countries tighten regulation of the products.The company produces about 30 million cans of white snus annually and holds roughly 12% of Sweden’s domestic market.
Apr.16
BAT Shares Surge Nearly 6% as FDA Policy Shift Eases Pressure on Vuse and Velo
BAT Shares Surge Nearly 6% as FDA Policy Shift Eases Pressure on Vuse and Velo
British American Tobacco (BAT) shares rose sharply on May 12 after the U.S. Food and Drug Administration signaled it would deprioritize enforcement against certain unauthorized e-cigarette and nicotine pouch products with accepted premarket applications. Investors viewed the move as favoring established players such as BAT’s Vuse and Velo brands.
BAT
May.13
UK Tobacco and Vapes Bill Returns to House of Lords on April 20 for Ping Pong Consideration
UK Tobacco and Vapes Bill Returns to House of Lords on April 20 for Ping Pong Consideration
The UK Tobacco and Vapes Bill is set to return to the House of Lords on April 20 for consideration of Commons amendments in the parliamentary “ping pong” process. The bill aims to create the first “smoke-free generation” by ensuring that children turning 15 this year or younger can never legally be sold tobacco. It also seeks to enable product and information requirements to be imposed in connection with tobacco, vapes, and other products.
Apr.21 by 2FIRSTS.ai
Nicotine Beyond Tobacco? Cell Study Signals Emerging Shift in Production Systems
Nicotine Beyond Tobacco? Cell Study Signals Emerging Shift in Production Systems
Researchers at the Chinese Academy of Sciences reconstructed nicotine biosynthesis in non-tobacco plants and yeast systems, highlighting how advances in synthetic biology could gradually reshape future nicotine production technologies and challenge regulatory frameworks built around tobacco-derived definitions.
Special Report
May.07