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.

Bulgarian Police Seize More Than 56,500 Heated Tobacco Sticks in Sofia Operation
Bulgarian Police Seize More Than 56,500 Heated Tobacco Sticks in Sofia Operation
Bulgaria’s Interior Ministry said two men aged 48 and 50 were detained during a specialised police operation in Sofia’s Krasna Polyana district for distributing e-cigarettes and tobacco without excise stamps.
Mar.17 by 2FIRSTS.ai
China Tobacco International (HK) Announces FY2025 Results: Revenue Reaches HK$14.58 Billion, Up 11.5% Year-on-Year
China Tobacco International (HK) Announces FY2025 Results: Revenue Reaches HK$14.58 Billion, Up 11.5% Year-on-Year
China Tobacco International (HK) Company Limited announced its audited results for the year ended December 31, 2025. Revenue was HK$14.58 billion, profit before taxation was HK$1.28 billion, and profit attributable to owners of the Company was HK$0.98 billion, with basic and diluted EPS of HK$1.42. The Board proposed a final dividend of HK$0.33 per share; together with an interim dividend of HK$0.19 per share, the full-year dividend totaled HK$0.52 per share.
Mar.06 by 2FIRSTS.ai
Product | Claiming “U.S.-Made E-Liquid” and “80,000 Puffs,” VOOPOO Launches NAVI×Cyph 80K
Product | Claiming “U.S.-Made E-Liquid” and “80,000 Puffs,” VOOPOO Launches NAVI×Cyph 80K
VOOPOO’s website shows the company has introduced the NAVI×Cyph Kit 80K, an open-system, refillable vaping kit claimed to deliver up to 80,000 puffs. The device features a 1,500mAh battery with USB Type-C charging and comes in 12 flavors. A promotional image posted on VOOPOO’s official Instagram account includes the phrase “E-LIQUID BUILT IN THE USA.”
Feb.10 by 2FIRSTS.ai
Product | VOZOL launches new GEAR-series device in the UK and UAE, featuring a 2.1-inch colour screen and sound interaction
Product | VOZOL launches new GEAR-series device in the UK and UAE, featuring a 2.1-inch colour screen and sound interaction
Vape brand VOZOL has recently listed a disposable shisha-style product, the GEAR HOOKAH 40000, on its official website. Public information shows the device comes with a 26ml e-liquid capacity, offers 3mg/ml and 5mg/ml nicotine strengths, and is marketed at 25,000–40,000 puffs. It is currently available via selected online retail channels in the UK and the UAE.
Feb.04 by 2FIRSTS.ai
VCU Signs Letter of Intent to Buy Altria Building for USD 150 Million, Pending State Approval
VCU Signs Letter of Intent to Buy Altria Building for USD 150 Million, Pending State Approval
Virginia Commonwealth University has signed a letter of intent to acquire Altria Group’s 450,000-square-foot building in downtown Richmond for USD 150 million, but the deal still depends on approval from the General Assembly. The university said the facility would support expansion of the Massey Comprehensive Cancer Center and help grow enrollment in its new School of Public Health and School of Pharmacy. VCU also said constructing a comparable facility would cost about USD 715 million.
Mar.13 by 2FIRSTS.ai
Indiana SB 185 Advances: Foreign-Made Vapes Would Be Barred, With Focus on China
Indiana SB 185 Advances: Foreign-Made Vapes Would Be Barred, With Focus on China
Indiana State Sen. Ron Alting is backing Senate Bill 185, which would ban vape shops in Indiana from selling any foreign-made vaping products and restrict retail shelves to U.S.-made items. Alting has framed the proposal as a consumer-safety measure and has singled out China, citing industry reporting that China produces more than 90% of the world’s vape hardware.
Jan.27 by 2FIRSTS.ai