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.

Cochrane 2026 Update Adds Nine Trials, Keeps High-Certainty Finding That Nicotine E-Cigarettes Improve Quit Rates Over NRT
Cochrane 2026 Update Adds Nine Trials, Keeps High-Certainty Finding That Nicotine E-Cigarettes Improve Quit Rates Over NRT
Cochrane’s 2026 update of its living review on electronic cigarettes for smoking cessation included 80 randomized controlled trials involving 29,861 adult smokers, with nine trials added in this update. The review retained its high-certainty conclusion that nicotine e-cigarettes increase smoking cessation rates compared with nicotine replacement therapy. In absolute terms, about 10 in 100 people using nicotine e-cigarettes may quit smoking for at least six months, compared with about 6 in 100 using NRT. The review found no clear difference in serious adverse event rates between the two groups, while longer-term safety and the relative effectiveness of newer device types remain less certain.
Sep.07
2Firsts Exclusive Analysis | RLX Q2 Revenue Rises 14.8%, Company Takes Control of Western European Distributor and Expands Multi-Category Strategy
2Firsts Exclusive Analysis | RLX Q2 Revenue Rises 14.8%, Company Takes Control of Western European Distributor and Expands Multi-Category Strategy
business accounting for 68.5% of sales. A new controlling investment in a Western European distributor and plans to scale modern oral nicotine pouches point to a broader international strategy spanning channels and multiple product categories.
Special Report
Aug.14
Elf Bar Vape Explosion and Amputation Claim Spurs Coverage Suit, U.S. Insurer MUSIC Seeks Ruling It Owes No Duty to Defend or Indemnify Distributor i5
Elf Bar Vape Explosion and Amputation Claim Spurs Coverage Suit, U.S. Insurer MUSIC Seeks Ruling It Owes No Duty to Defend or Indemnify Distributor i5
Mesa Underwriters Specialty Insurance Company has asked a federal court in Washington to declare that it has no duty to defend or indemnify vape distributor i5 Distribution in a product liability case involving an Elf Bar BC5000. The plaintiff alleges that the disposable vape caught fire and exploded in his pocket, causing severe burns and ultimately requiring an above-the-knee amputation of his left leg. MUSIC is relying on a tobacco, nicotine or nicotine replacement products exclusion and a premises limitation endorsement. The court has not ruled on the coverage dispute.
News
Sep.10
China Tobacco Zhejiang files patent for pressure-triggered, on-demand oral nicotine release
China Tobacco Zhejiang files patent for pressure-triggered, on-demand oral nicotine release
China Tobacco Zhejiang Industrial Co., Ltd. has filed a patent application for an oral nicotine delivery product designed to let users actively adjust nicotine release. The product embeds two types of nicotine reservoirs with different wall thicknesses and positions inside a deformable matrix. Pressure applied with the tongue or lips can rupture the reservoirs and accelerate nicotine release. In simulated oral tests, several patent examples showed sharply higher peak nicotine release rates as applied force increased from 0 N to 1 N and 3 N. The filing explores a shift from preset release profiles toward user-triggered nicotine delivery.
Sep.01
Earnings Analysis | CTIHK H1 2026 Revenue Falls 26.9% as Core Businesses Diverge and New Growth Drivers Remain to Be Proven
Earnings Analysis | CTIHK H1 2026 Revenue Falls 26.9% as Core Businesses Diverge and New Growth Drivers Remain to Be Proven
China Tobacco International (HK) reported a 26.9% revenue decline in H1 2026, while gross profit fell only 9.5%, revealing sharp divergence across its businesses. Tobacco leaf imports contracted, while leaf exports and Brazil operations expanded strongly. Cigarette exports faced China duty-free market transition, and new tobacco products remained small. Meanwhile, CTIHK continues to strengthen its role as an investment and financing platform, though major external deals have yet to emerge. 2Firsts examines what these shifts mean for its next growth drivers.
Capital Markets
Aug.24
South Korea Fully Reviews Nicotine-Analog and Nicotine-Free Vape Liquid Imports, With Over 99% From China and Chinese Supply-Chain Documents Under Scrutiny
South Korea Fully Reviews Nicotine-Analog and Nicotine-Free Vape Liquid Imports, With Over 99% From China and Chinese Supply-Chain Documents Under Scrutiny
Korea Customs Service has tightened import controls on nicotine-analog and nicotine-free e-cigarette liquids, placing the products under 100% document review and subjecting all e-cigarette liquid import declarations to pre-clearance ingredient analysis. As of September 20, 2026, South Korea had imported about 15 metric tons of nicotine-analog liquids, 99.99% from China, and about 316 metric tons of nicotine-free liquids, including roughly 315 metric tons, or 99.7%, from China. The measures follow South Korea's April expansion of its tobacco definition to include synthetic nicotine products and include new checks on Chinese manufacturing, transaction and export documentation.
Sep.24