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.



Disclaimer

This article is provided solely for professional research, industry discussion, and informational purposes. Any references to brands, companies, products, technologies, or policies are made for factual reporting and analytical purposes only, and do not constitute endorsement, recommendation, promotion, or advertising by 2Firsts.

Nicotine-containing products, including but not limited to cigarettes, e-cigarettes, heated tobacco products, and nicotine pouches, carry significant health risks. Readers are responsible for complying with all applicable laws and regulations in their respective jurisdictions, including age restrictions and access limitations.

The information contained in this article should not be regarded as investment, legal, medical, regulatory, or commercial advice. While 2Firsts strives to ensure the accuracy and reliability of its content, it does not assume liability for any direct or indirect loss arising from errors, omissions, inaccuracies, or reliance on the information contained herein.

This article is not intended for individuals below the legal age for accessing tobacco or nicotine-related information in their jurisdiction.

 

Copyright Notice

This article is either original content produced by 2Firsts or content reproduced, translated, summarized, or adapted from third-party sources with attribution where applicable. The intellectual property rights of the original content remain with 2Firsts or the respective original rights holders.

No individual or organization may copy, reproduce, distribute, republish, modify, translate, or otherwise use this content without prior authorization. Any unauthorized use may result in legal action.

For copyright-related inquiries, corrections, or removal requests, please contact: info@2firsts.com.

 

AI-Assisted Translation and Editing Notice

Portions of this article may have been translated, edited, or reviewed with the assistance of artificial intelligence tools to improve efficiency and readability. Due to the limitations of AI-assisted translation and editing, discrepancies, omissions, or inaccuracies may exist when compared with the original source.

Where applicable, readers are advised to refer to the original source for the most complete and accurate information. If you identify any errors or believe that any content infringes upon your rights, please contact us at info@2firsts.com, and we will review and address the matter promptly.

Product | PIXL Adds 6ml PIXL 5K in UK Alongside 12ml PIXL 8000 as Vape Duty Takes Effect
Product | PIXL Adds 6ml PIXL 5K in UK Alongside 12ml PIXL 8000 as Vape Duty Takes Effect
Vaping brand PIXL has introduced the PIXL 5K reusable prefilled pod device in the UK, featuring a 2ml prefilled pod and a 4ml refill container with a combined e-liquid capacity of 6ml. The device uses 20mg/ml nicotine salt e-liquid and is advertised to deliver up to approximately 5,000 puffs. Available through UK retailers by August 2026, the PIXL 5K sits alongside the existing 12ml PIXL 8000. The UK's Vaping Products Duty took effect on October 1 at £0.22 per millilitre, producing theoretical duty amounts of £1.32 and £2.64 for the two products' respective full refill sets.
product
Oct.10
How Many Nicotine Pouch Factories Does Europe Need? 2Firsts Interviews AIRSCREAM on the OEM Market
How Many Nicotine Pouch Factories Does Europe Need? 2Firsts Interviews AIRSCREAM on the OEM Market
At InterTabac 2026, nicotine pouch growth was visible not only in brands but across equipment, raw materials and OEM manufacturing. 2Firsts interviewed AIRSCREAM commercial head Steve Moore on how many pouch factories Europe may ultimately need and where manufacturers can differentiate, from formulation and flavour to pouch materials, production consistency and customer service. The category continues to expand, but questions remain over future capacity, consolidation and the long-term structure of the supply chain.
Sep.18
Sweden Threatens EU Tobacco Tax Deal as Nicotine Pouch Duty Dispute Looms Over November 9 Meeting
Sweden Threatens EU Tobacco Tax Deal as Nicotine Pouch Duty Dispute Looms Over November 9 Meeting
Sweden is expected to oppose a European Union proposal to raise minimum tobacco excise duties, Law360 reported on October 26, 2026, citing an EU official. A provisional Council agenda dated October 23 confirms that the tobacco taxation package is scheduled for discussion at the November 9 finance ministers' meeting, where member states will seek a general approach. The proposed reforms would raise minimum taxes on conventional tobacco products and establish EU-wide excise rules for vaping liquids, heated tobacco and nicotine pouches. Sweden supports harmonising tobacco taxation rules but objects to requiring nicotine pouches to bear the same minimum tax burden as certain smoking tobacco products. As EU indirect tax legislation requires unanimous Council approval, Swedish opposition could block the proposal in its current form.
Regulations
Oct.29
JAMA Study: U.S. Vape Directories Fail to Sustainably Curb Unlisted Sales as Product Shifts May Redistribute Brand Share 2Firsts Recommended
JAMA Study: U.S. Vape Directories Fail to Sustainably Curb Unlisted Sales as Product Shifts May Redistribute Brand Share 2Firsts Recommended
A study by CDC Foundation researchers found no sustained decline in e-cigarette sales across Alabama, Oklahoma and Louisiana, the first three U.S. states to implement e-cigarette directory laws. Louisiana initially saw a significant sales decline, followed by a rebound and a persistent reduction in product availability. Sales also shifted from nontobacco-flavored disposables toward prefilled cartridges, with Vuse Alto driving much of the increase in menthol cartridges. By April 2025, unlisted products still accounted for more than half of e-cigarette nicotine sales in all three states.
Sep.18
Spain Cigarette Volumes Fall 5.2% in August, BAT Drops 14.5%, JTI Gains Share; France Down 8.3% on Adjusted Basis
Spain Cigarette Volumes Fall 5.2% in August, BAT Drops 14.5%, JTI Gains Share; France Down 8.3% on Adjusted Basis
Spain's cigarette volumes declined 5.2% year over year in August 2026, according to government data cited by UBS and reported by Investing.com on October 7. British American Tobacco's volumes fell 14.5%, followed by Imperial Brands at 8.8%, Philip Morris International at 6.6% and Japan Tobacco at 4.6%. JTI was the only one of the four companies to gain cigarette market share, rising six basis points to 26.7%. In France, official customs data showed an unadjusted 3.7% decline in cigarette deliveries. Adjusting for the difference in delivery days produces a decline of approximately 8.3%, consistent with the UBS figure. The bank also estimated the earnings exposure of major tobacco companies to both markets.
Market
Oct.13
UK Extends Age-18 Rules to Zero-Nicotine Vapes and Nicotine Pouches From Oct. 29, Bans Vending Machines and Promotional Giveaways
UK Extends Age-18 Rules to Zero-Nicotine Vapes and Nicotine Pouches From Oct. 29, Bans Vending Machines and Promotional Giveaways
Key provisions of the UK's Tobacco and Vapes Act 2026 will take effect on Oct. 29, extending an age-18 sales restriction to all vaping and non-medicinal nicotine products. In England, Wales and Northern Ireland, the change brings zero-nicotine vapes within statutory age-of-sale rules and also covers products including nicotine pouches, strips and pearls. The law will also prohibit proxy purchasing for under-18s, consumer-facing vending machines, promotional giveaways and substantial discounts intended to promote vaping and nicotine products.
Regulations
Oct.10