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.

Malaysian Tobacco Control Groups Call for Annual 5% Tobacco Tax Hike
Malaysian Tobacco Control Groups Call for Annual 5% Tobacco Tax Hike
According to The Star and The Edge Malaysia, tobacco control groups in Malaysia have urged the government to raise tobacco taxes by at least 5% annually, saying the measure could reduce smoking rates and fund public health and social programmes.
News
May.26
BAT Shares Surge Nearly 6% as FDA Policy Shift Eases Pressure on Vuse and Velo
BAT Shares Surge Nearly 6% as FDA Policy Shift Eases Pressure on Vuse and Velo
British American Tobacco (BAT) shares rose sharply on May 12 after the U.S. Food and Drug Administration signaled it would deprioritize enforcement against certain unauthorized e-cigarette and nicotine pouch products with accepted premarket applications. Investors viewed the move as favoring established players such as BAT’s Vuse and Velo brands.
BAT
May.13
 NYT: Reynolds American Donated $5 Million Before FDA Vape Policy Shift
NYT: Reynolds American Donated $5 Million Before FDA Vape Policy Shift
According to The New York Times, Reynolds American donated $5 million to a Trump-backed super PAC shortly before the FDA introduced a new policy that could benefit major tobacco companies seeking to sell flavored vaping products.
News
May.21
Trump’s Tobacco Investments and Industry Donations Draw Scrutiny as FDA Eases Vape and Nicotine Pouch Rules
Trump’s Tobacco Investments and Industry Donations Draw Scrutiny as FDA Eases Vape and Nicotine Pouch Rules
A report by KFF Health News says that as the Trump administration pursued a series of policies favorable to the nicotine and tobacco industry, President Donald Trump increased his holdings in tobacco companies while benefiting from substantial industry-linked political donations, prompting questions from public health advocates about potential conflicts of interest and regulatory direction.
Jun.12
UK Vaping Products Duty to Raise £565 Million by 2030/31
UK Vaping Products Duty to Raise £565 Million by 2030/31
The UK will introduce Vaping Products Duty on all vaping liquids from October 1, 2026, with government revenue forecast to rise from £135 million in 2026/27 to £565 million by 2030/31.
Jun.18
Imperial Brands Pulls myblu Vape Business From U.S., Citing Prolonged FDA Approval Process
Imperial Brands Pulls myblu Vape Business From U.S., Citing Prolonged FDA Approval Process
Imperial Brands said it will phase out its myblu vaping business in the United States, citing prolonged FDA approval timelines for new vape products. The company said it will instead focus on modern oral nicotine products in the U.S., including the expansion of its Zone brand and new flavors. While overall next-generation product revenue continued to grow, revenue from the category in the Americas declined sharply.
May.12