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.

New York’s Lawsuit Against Puff Bar and Other Flavored Vape Companies Survives Key Court Challenge
New York’s Lawsuit Against Puff Bar and Other Flavored Vape Companies Survives Key Court Challenge
According to Law360, a federal judge ruled that makers and distributors of flavored vape brands such as Puff Bar cannot escape New York’s lawsuit seeking to hold them responsible for the youth vaping epidemic. The court found that the state had adequately alleged the companies misrepresented how safe vaping is.
Apr.07 by 2FIRSTS.ai
Trump Reportedly Signs Off on Plan to Fire FDA Commissioner Marty Makary
Trump Reportedly Signs Off on Plan to Fire FDA Commissioner Marty Makary
According to The Wall Street Journal, people familiar with the matter said President Trump has signed off on a plan to fire FDA Commissioner Marty Makary, though the plan is not yet final and could change. The report said Makary’s tenure has included clashes over vaping, abortion and drug policy, and that some senior administration officials view him as struggling to manage the agency.
May.09 by 2FIRSTS.ai
Nicokick and zone Extend NASCAR Collaboration for April 19 Kansas City Race
Nicokick and zone Extend NASCAR Collaboration for April 19 Kansas City Race
Nicokick.com said it will continue its collaboration with zone for a second year at the April 19 NASCAR race in Kansas City, appearing on Richard Childress Racing’s No. 8 Chevrolet driven by Kyle Busch. The 2026 race-weekend campaign for verified adult nicotine consumers aged 21 and older includes the exclusive launch of zone Cranberry and a limited-edition five-flavor mix pack selected by Busch.
Apr.16 by 2FIRSTS.ai
Product | 20ml E-liquid, Dual Modes with Up to 60,000 Puffs, Uwell Launches VALAYA AMP 60K Vape in the U.S.
Product | 20ml E-liquid, Dual Modes with Up to 60,000 Puffs, Uwell Launches VALAYA AMP 60K Vape in the U.S.
Uwell has recently launched its new disposable vape, the VALAYA AMP 60K, on its official website. The device features 20ml of pre-filled e-liquid and is rated for up to approximately 60,000 puffs. It is equipped with a 950mAh rechargeable battery and a 0.6Ω dual mesh coil. The product is now available through select online channels in the United States, with a listed price of $19.99.
Apr.09 by 2FIRSTS.ai
Moscow Police Seize About 65,000 E-Cigarettes Worth More Than RUB 30 Million
Moscow Police Seize About 65,000 E-Cigarettes Worth More Than RUB 30 Million
Russian Interior Ministry spokesperson Irina Volk said on May 6 that police in Moscow seized about 65,000 nicotine-containing products from a man during searches of residential and warehouse premises. The products were valued at about RUB 30 million, or about USD 395,727 based on an exchange rate of USD 1 = RUB 75.81.
May.11 by 2FIRSTS.ai
IMF Article Sets Out Three Principles: Cover All Harmful Products, Match Tax Rates to Harm, Improve Cross-Border Coordination
IMF Article Sets Out Three Principles: Cover All Harmful Products, Match Tax Rates to Harm, Improve Cross-Border Coordination
A March 2026 article in Finance & Development, “Taxing Harmful Habits,” argues that taxes on harmful products such as tobacco, alcohol and sugary drinks should better reflect the health harm they cause. The authors propose three principles: capture all harmful products, align tax rates with health harm, and strengthen cross-border coordination to reduce evasion and smuggling.
Mar.24 by 2FIRSTS.ai