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.

FDA Says It Will Not Take Enforcement Action Against Zone Nicotine Pouches Until Lawsuit Is Resolved
FDA Says It Will Not Take Enforcement Action Against Zone Nicotine Pouches Until Lawsuit Is Resolved
The U.S. Food and Drug Administration has told vape manufacturer Fontem US that it does not presently intend to take enforcement action against the company’s Zone nicotine pouches while litigation over the agency’s handling of the application remains unresolved.
Apr.07 by 2FIRSTS.ai
Netherlands Plans Law to Ban Possession of Large Quantities of Vapes Intended for Trade
Netherlands Plans Law to Ban Possession of Large Quantities of Vapes Intended for Trade
Dutch Health Minister Hermans is drafting legislation that would also ban possession of larger quantities of vapes, allowing the Netherlands Food and Consumer Product Safety Authority to intervene earlier and seize stock before proving that trade has taken place.
Apr.13 by 2FIRSTS.ai
USITC Launches Section 337 Probe Into Disposable and Closed-System ENDS, Involving 16 Companies
USITC Launches Section 337 Probe Into Disposable and Closed-System ENDS, Involving 16 Companies
The U.S. International Trade Commission (USITC) voted to institute a Section 337 investigation into certain disposable and other closed-system electronic nicotine delivery systems (ENDS) devices and components thereof (Inv. No. 337-TA-1486). The investigation stems from a complaint filed on January 13, 2026 by R.J. Reynolds entities based in Winston-Salem, North Carolina, supplemented on February 3, 2026.
Mar.05 by 2FIRSTS.ai
UK Opens Applications for Vaping Products Duty and Duty Stamps Scheme From April 1
UK Opens Applications for Vaping Products Duty and Duty Stamps Scheme From April 1
HM Revenue and Customs announced that from April 1, 2026, UK vaping product manufacturers, importers and warehousekeepers can apply for approval under Vaping Products Duty (VPD) and the Vaping Duty Stamps Scheme (VDS). Under new GOV.UK guidance, Vaping Products Duty will take effect on October 1, 2026 and will apply to all vaping liquids, whether they contain nicotine or not.
Apr.02 by 2FIRSTS.ai
Cambodia’s tobacco industry association ATIC appoints JTI Cambodia GM as president
Cambodia’s tobacco industry association ATIC appoints JTI Cambodia GM as president
The Association of Tobacco Industry of Cambodia (ATIC) said JTI Cambodia General Manager Benjamin Cerletti has assumed the role of President following the completion of a two-year term served by his predecessor, Imperial Brands Plc.
Mar.05 by 2FIRSTS.ai
Metal Body + AMOLED Screen: KT&G Launches New Heated Tobacco Device Lil Aible 3.0
Metal Body + AMOLED Screen: KT&G Launches New Heated Tobacco Device Lil Aible 3.0
KT&G said it will launch the heated tobacco device Lil Aible 3.0 at four stores in South Korea on February 28. The device shortens charging and preheating time while keeping features such as pausing during use, mode switching, and three consecutive uses. It adopts a metal body and an AMOLED display, comes in four colors, and will expand to Seoul-area convenience stores and the online mall in April, and nationwide convenience stores in May.
Feb.27 by 2FIRSTS.ai