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.

 Zyn Emerges as MAGA Cultural Symbol Amid FDA Policy Shift
Zyn Emerges as MAGA Cultural Symbol Amid FDA Policy Shift
According to The Wall Street Journal, nicotine pouch brand Zyn has rapidly gained popularity across the Trump administration and conservative political circles, including among U.S. Health Secretary Robert F. Kennedy Jr.
Business
May.20
ATF Cancels Webloc Contract, Raising Questions Over Commercial Location Data in Enforcement
ATF Cancels Webloc Contract, Raising Questions Over Commercial Location Data in Enforcement
The U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) has stopped using Webloc, a commercial phone-tracking tool, after lawmakers, a prosecutor and a judge raised legal and privacy concerns over warrantless use of ad-tech location data, a development that may affect data-use boundaries in U.S. enforcement against illicit tobacco, nicotine products and cross-border distribution networks.
Jun.29
Product | KT&G Expands lil AIBLE 3.0 Sales to Seoul Convenience Stores, Launches Two New AIIM Variants
Product | KT&G Expands lil AIBLE 3.0 Sales to Seoul Convenience Stores, Launches Two New AIIM Variants
According to South Korean media reports, KT&G has expanded sales of its heated tobacco device lil AIBLE 3.0 to convenience stores across Seoul starting May 13. The convenience-store version is offered in the exclusive OUD GRAY color. On the same day, KT&G also launched two new dedicated consumables for the lil AIBLE platform—AIIM REMIX and AIIM ICESPOT—at convenience stores nationwide, each priced at KRW 4,800.
Market
Jun.01
How AI Is Rewriting the Talent Playbook for the Nicotine Industry: JTI’s Case
How AI Is Rewriting the Talent Playbook for the Nicotine Industry: JTI’s Case
AI is moving from a back-office tool to a core organizational capability in the nicotine industry. Based on JTI’s responses, this 2Firsts feature examines how AI is reshaping talent strategy, internal mobility, decision-making and human accountability as global tobacco companies compete in the shift toward new nicotine categories.
Jun.17
Multi-State Coalition Urges F1 to End Nicotine Sponsorships, Citing Zyn and Velo
Multi-State Coalition Urges F1 to End Nicotine Sponsorships, Citing Zyn and Velo
Hawaii Attorney General Anne Lopez is co-leading a coalition of 19 states and jurisdictions urging the Fédération Internationale de l’Automobile (FIA) and Formula 1 to end sponsorships involving tobacco and nicotine products, including nicotine pouch brands such as Zyn and Velo.
News
Jun.09
The new regulations on nicotine in Argentina are creating caution, expectations, and doubts about the market, according to a local reference in harm reduction for smoking.
The new regulations on nicotine in Argentina are creating caution, expectations, and doubts about the market, according to a local reference in harm reduction for smoking.
The new Argentine framework for tobacco and nicotine marks a shift from prohibition towards registration, traceability, and health surveillance. Juan Facundo Teme told 2Firsts that adult consumers and some of the commercial sector are cautiously optimistic, although concerns remain about flavors, registration costs, and market access.
May.11