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.


This document has been generated through artificial intelligence translation and is provided solely for the purposes of industry discourse and learning. Please note that the intellectual property rights of the content belong to the original media source or author. Owing to certain limitations in the translation process, there may be discrepancies between the translated text and the original content. We recommend referring to the original source for complete accuracy. In case of any inaccuracies, we invite you to reach out to us with corrections. If you believe any content has infringed upon your rights, please contact us immediately for its removal.

Peru Parliament Considers Imposing up to 100% Tax on E-Cigarettes
Peru Parliament Considers Imposing up to 100% Tax on E-Cigarettes
Peru Parliament discusses bill to impose up to 100% tax on e-cigarettes, citing public health concerns. Youth usage at 15.9%.
Mar.20 by 2FIRSTS.ai
New York Nicotine Pouch Tax Moves Forward as Critics Question Public Health Impact
New York Nicotine Pouch Tax Moves Forward as Critics Question Public Health Impact
New York Governor Kathy Hochul included in her FY 2027 budget proposal a plan to impose the same 75% wholesale tax on nicotine pouches such as Zyn that applies to cigarettes. The measure is expected to raise USD 18 million in FY 2027 and USD 44 million in FY 2028 after full implementation.
Mar.30 by 2FIRSTS.ai
Indonesian Health Ministry Says New Vape Rules Will Cover Age Limits, Advertising, and Product Standards
Indonesian Health Ministry Says New Vape Rules Will Cover Age Limits, Advertising, and Product Standards
Indonesia’s Ministry of Health is preparing to implement regulations on electronic cigarettes, as provided for in Government Regulation No. 28 of 2024. The ministry said e-cigarettes will be regulated under provisions equivalent to those applied to conventional cigarettes, including age restrictions, advertising controls, product content standards, pictorial health warnings, and bans on use in smoke-free areas.
Apr.16 by 2FIRSTS.ai
European Commission Publishes Tobacco Control Framework Evaluation, Says Smoking and Tobacco-Related Deaths Have Declined
European Commission Publishes Tobacco Control Framework Evaluation, Says Smoking and Tobacco-Related Deaths Have Declined
The European Commission has published its evaluation of the EU tobacco control framework, assessing the effectiveness, efficiency and relevance of the Tobacco Products Directive and Tobacco Advertising Directive in protecting public health and ensuring the smooth functioning of the internal market.
Apr.03 by 2FIRSTS.ai
FDA Adds 18 Tobacco Harmful Constituents and Seeks Comment on 3 More
FDA Adds 18 Tobacco Harmful Constituents and Seeks Comment on 3 More
U.S. Food and Drug Administration published a Federal Register notice finalizing the addition of 18 constituents to the established list of Harmful and Potentially Harmful Constituents in tobacco products. With the update, the list now contains 111 constituents. FDA also proposed adding three more constituents to the list and opened a public comment period ending at 11:59 p.m. ET on May 26, 2026.
Apr.24 by 2FIRSTS.ai
French Anti-Tobacco Group Contre-Feu Calls for Plain Packaging Across All Vaping Products
French Anti-Tobacco Group Contre-Feu Calls for Plain Packaging Across All Vaping Products
French anti-tobacco group Contre-Feu said in a statement released on April 14 that e-cigarette manufacturers are encouraging nicotine dependence among young people through targeted marketing and called for concrete measures to protect minors. The group asked for plain packaging for all vaping products, strict regulation of flavor names, and a ban on online sales.
Apr.15 by 2FIRSTS.ai