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.

NYC makers turn discarded disposable vapes into “Vape Synth” mini digital instruments
NYC makers turn discarded disposable vapes into “Vape Synth” mini digital instruments
The report says disposable vapes are sold at more than 11 million units per month and often end up in landfills after flavored nicotine juice runs out, along with lithium-ion batteries, microcontrollers, and LEDs, increasing the risk of waste fires. A New York City maker trio known as Paper Bag Team has built “Vape Synth” by cracking open spent Elf Bar cartridges—specifically the EB BC5000—and hacking them into tiny digital instruments.
Feb.12 by 2FIRSTS.ai
Exclusive | China Releases E-Cigarette Regulatory “Status Report”, First Comprehensive Disclosure of Oversight Framework and International Cooperation
Exclusive | China Releases E-Cigarette Regulatory “Status Report”, First Comprehensive Disclosure of Oversight Framework and International Cooperation
As 2025 draws to a close, China’s State Tobacco Monopoly Administration has released a white paper–style “Status Report” on e-cigarette regulation, systematically outlining its oversight framework, enforcement outcomes and international cooperation. 2Firsts provides exclusive in-depth reporting and analysis, offering insight into China’s regulatory logic and governance direction.
Dec.29 by 2Firsts Perspectives
PMI Faces Setback in India: Global Regulatory Fragmentation Complicates Its Smoke-Free Transition
PMI Faces Setback in India: Global Regulatory Fragmentation Complicates Its Smoke-Free Transition
India has reaffirmed its 2019 ban on e-cigarettes and heated tobacco devices, effectively blocking Philip Morris International (PMI) from launching IQOS in the country despite years of lobbying. Together with Taiwan, China’s conditional opening of heated tobacco products, and Japan’s planned 2026 excise tax hikes, these moves highlight increasingly divergent national regulatory pathways—an external uncertainty shaping PMI’s smoke-free growth trajectory.
Feb.12
Singapore detected 59 large-scale vape smuggling cases in 2025, seizing about 230,000 items
Singapore detected 59 large-scale vape smuggling cases in 2025, seizing about 230,000 items
Singapore’s Ministry of Health said on Feb. 3 that authorities detected 59 large-scale vape smuggling cases in 2025 and seized about 230,000 vapes and accessories. Over the past two years, more than 10,000 online vape sale advertisements were removed, with about 99% linked to overseas platform posts. Enforcement includes bot-driven surveillance, public tip-offs, and site-blocking with partner agencies.
Feb.04 by 2FIRSTS.ai
PMI reports full-year 2025 results with net revenues of $40.6 billion and smoke-free net revenues were about $16.9 billion
PMI reports full-year 2025 results with net revenues of $40.6 billion and smoke-free net revenues were about $16.9 billion
Philip Morris International (PMI) released its Q4 and full-year 2025 results on February 6, 2026. PMI reported full-year net revenues of $40,648 million ($40.6 billion), reported diluted EPS of $7.26 and adjusted diluted EPS of $7.54. PMI said smoke-free net revenues were $16.9 billion and represented 41.5% of total net revenues, with smoke-free products available in 106 markets and over 43 million estimated adult consumers.
Feb.06 by 2FIRSTS.ai
Philip Morris International: Over $20 Billion Invested in the U.S. Since 2022; IQOS ILUMA to Launch Pending FDA Authorization
Philip Morris International: Over $20 Billion Invested in the U.S. Since 2022; IQOS ILUMA to Launch Pending FDA Authorization
Philip Morris International (PMI) said its U.S.-related investments have topped $20 billion since 2022, when it entered the U.S. market through its roughly $19 billion acquisition of Swedish Match. The company also said it plans to launch its heated tobacco product IQOS ILUMA in the United States pending authorization from the U.S. Food and Drug Administration (FDA).
Jan.16 by 2FIRSTS.ai