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 First Look|China to End VAT Export Rebates on Vape Devices and Nicotine in April 2027, Following Earlier Removal for HTP Devices and Nicotine Vapes
2Firsts First Look|China to End VAT Export Rebates on Vape Devices and Nicotine in April 2027, Following Earlier Removal for HTP Devices and Nicotine Vapes
China's Ministry of Finance and State Taxation Administration announced on October 12, 2026, that value-added tax (VAT) export rebates for vape devices, nicotine and its salts, and certain non-combustible inhalation products will be eliminated from April 1, 2027. The measure adds four tobacco- and nicotine-related customs codes, including 8543400010, which covers vape devices and qualifying empty pods. China previously eliminated rebates for nicotine-containing vaping products and devices under code 8543400090 in April 2026. According to industry classification information held by 2Firsts, the latter currently corresponds to heated tobacco devices. Export excise tax refund and exemption arrangements will remain unchanged.
Special Report
Oct.12
FRE and ALP Push Modern Oral to 48% of Q2 Sales as Turning Point Brands Changes CEO and Lowers Profit-Guidance Ceiling
FRE and ALP Push Modern Oral to 48% of Q2 Sales as Turning Point Brands Changes CEO and Lowers Profit-Guidance Ceiling
Turning Point Brands said Executive Chairman David E. Glazek will become CEO on October 1, replacing Graham Purdy, who is stepping down for personal reasons. The company narrowed its 2026 adjusted EBITDA outlook to $70 million-$80 million from $70 million-$90 million while maintaining Modern Oral gross sales guidance of $330 million-$350 million and net sales guidance of $260 million-$270 million. In the second quarter, Modern Oral net sales rose 128% to $68.4 million and accounted for 48% of company-wide net sales. Adjusted EBITDA fell 50% year over year. TPB shares closed about 10% lower on September 21.
Market
Sep.22 by 2Firsts Perspectives
Altria’s USSTC Starts $250 Million Kentucky Expansion, Adding More Than 200 Jobs
Altria’s USSTC Starts $250 Million Kentucky Expansion, Adding More Than 200 Jobs
U.S. Smokeless Tobacco Company, an Altria Group company, has broken ground on an approximately $250 million manufacturing expansion in Hopkinsville, Kentucky. The roughly 270,000-square-foot facility is expected to create more than 200 jobs and absorb processing, manufacturing and packaging operations currently split between Hopkinsville and Nashville, Tennessee. USSTC previously said production at its Nashville facility is expected to wind down by early 2028. The project forms part of Altria’s broader effort to modernize and consolidate its U.S. smokeless tobacco manufacturing network.
Sep.10
Pennsylvania Vape Directory Enforcement Starts Oct. 19, Barring Retail Sales of Unlisted Products
Pennsylvania Vape Directory Enforcement Starts Oct. 19, Barring Retail Sales of Unlisted Products
Pennsylvania's Act 57 vape directory regime will reach the end of its 120-day inventory transition period on Oct. 19. Nicotine-containing e-cigarettes intended for retail sale in the state that are not listed on the Attorney General's ENDS directory will then be barred from retail sale and treated as contraband subject to seizure, forfeiture and destruction. Manufacturers face annual product certification, brand- and style-based fees and a minimum $50,000 surety bond, while retailers and wholesalers must source through licensed channels and monitor the directory.
Regulations
Oct.08
Athletes Back Skoka's $21.5 Million Nicotine Pouch Venture: Can Its Consumer Health Founder Make an FDA-Focused Strategy Pay Off?
Athletes Back Skoka's $21.5 Million Nicotine Pouch Venture: Can Its Consumer Health Founder Make an FDA-Focused Strategy Pay Off?
U.S. nicotine pouch startup Skoka Inc. has raised $21.5 million and committed $15 million to an FDA regulatory and scientific research program. Founder Dan Aziz previously built dietary supplement brand Premama, which was acquired by Dr. Reddy's Laboratories in 2023. Skoka is combining proprietary formulations, ingredient transparency and equity investment from professional athletes. The company submitted a bundled PMTA covering 55 products on October 1, 2026. Aziz said Skoka declined an opportunity to enter retail in 2025, prioritizing product research and regulatory submissions instead. It now targets a U.S. retail launch in 2027, subject to FDA requirements. Its products have not received marketing authorization.
Business
Nov.04
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