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.

2Firsts Interview | Cigarette Sales Fall as Smokeless Alternatives Gain in U.S. Convenience Stores, NACS Says
2Firsts Interview | Cigarette Sales Fall as Smokeless Alternatives Gain in U.S. Convenience Stores, NACS Says
Ahead of the 2026 NACS Show, 2Firsts interviewed Chris Rapanick, NACS managing director of research, on changes reshaping the U.S. convenience-store tobacco and nicotine market. NACS data show cigarette sales declining while smokeless alternatives, including nicotine pouches, continue to grow. The interview also examines higher OTP margins, shifting backbar space, weaker store traffic, regulatory uncertainty and NACS’ outlook for 2027, offering a retailer-side view of one of the world’s largest nicotine markets.
Interview
Oct.03
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
China Tobacco Plans CNY 60 Billion Investment in ICBC, Agricultural Bank as Strategic Ties Extend Beyond Equity
China Tobacco Plans CNY 60 Billion Investment in ICBC, Agricultural Bank as Strategic Ties Extend Beyond Equity
China National Tobacco Corporation and several subsidiaries plan to invest a combined CNY 60 billion ($8.7 billion) in share placements by Industrial and Commercial Bank of China and Agricultural Bank of China as strategic investors. The agreements extend beyond equity investment to corporate governance, banking services and supply-chain finance. The filings also disclose 2025 data on China Tobacco’s tax and profit contributions and industry scale.
Sep.07
Iowa Enforces Vape Registry Law as Retailers Warn Product Limits Could Increase Store Pressure
Iowa Enforces Vape Registry Law as Retailers Warn Product Limits Could Increase Store Pressure
Iowa has begun enforcing its vape registry law, requiring vape products to be registered before they can be legally sold in the state. The move follows a decision by the U.S. Court of Appeals for the Eighth Circuit to lift an injunction that had blocked enforcement. Retailers have warned that tighter product availability rules could increase pressure on vape shops. One Iowa retailer said that if only a limited number of products remain available, many stores could face significant business challenges.
Aug.06
RLX Technology Dropped From FTSE All-World as International Business Reaches 68.5% of Q2 Revenue
RLX Technology Dropped From FTSE All-World as International Business Reaches 68.5% of Q2 Revenue
RLX Technology (NYSE: RLX) has been removed from the FTSE All-World Index, effective September 21. FTSE Russell records show RLX was already part of its global equity index universe by 2022, when its American depositary receipts were classified as China Large Cap securities. Trading volume rose to about 44.77 million shares on September 18, roughly 23 times the previous session's volume. RLX reported RMB1.0105 billion in second-quarter revenue, up 14.8% year over year, with international operations contributing 68.5%. The company also acquired a 51% stake in one of Western Europe's largest distributors of next-generation smoke-free and FMCG products in July.
Sep.22
Retail Case Study | Wisconsin Vape Market One Year After New Regulations: Johnny Vapes Reports 80% Sales Decline as Consumers Shift Online and Across State Lines
Retail Case Study | Wisconsin Vape Market One Year After New Regulations: Johnny Vapes Reports 80% Sales Decline as Consumers Shift Online and Across State Lines
According to WNCY on August 24, 2026, some independent vape retailers in Wisconsin say they have faced significant business pressure one year after new vape regulations took effect. Johnny Vapes, a retailer operating in northeast Wisconsin, said its store count fell from seven locations to four, sales declined by about 80%, and roughly 90% of its inventory was affected. Retailers said some consumers have shifted to online purchases or traveled to neighboring Michigan to buy vape products. The case highlights how local regulations can reshape retail operations, inventory management and consumer purchasing patterns.
Aug.28