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 Commissioner Stresses “Predictability” as Science Chief Addresses Industry Uncertainty
FDA Commissioner Stresses “Predictability” as Science Chief Addresses Industry Uncertainty
FDA Commissioner Marty Makary briefly appeared at the February 10 PMTA roundtable, underscoring the importance of regulatory predictability. At the close of the session, Office of Science Director Matthew Farrelly responded to industry concerns over review uncertainty, stating the agency will issue a written summary of feedback, while reiterating that no fixed quantitative risk benchmark governs authorization decisions.
Feb.11
Belarus opts for stricter regulation instead of full e-cigarette ban
Belarus opts for stricter regulation instead of full e-cigarette ban
Belarus rejects full e-cigarette ban, opts for stricter regulation. Officials plan to restrict wholesaling and strengthen import and production permits.
Mar.04 by 2FIRSTS.ai
Louisiana lawmaker pushes bill to ban vape product sales within 300 feet of schools
Louisiana lawmaker pushes bill to ban vape product sales within 300 feet of schools
A Louisiana lawmaker has introduced HB 302, which would prohibit businesses from selling vapor products within 300 feet of schools. The bill would measure the distance by a person walking on the sidewalk from the nearest point on school property to the nearest point of the business. It would also give the commissioner authority to modify how the distance is calculated, while maintaining the 300-foot limit.
Feb.26 by 2FIRSTS.ai
Russia’s Rostov Region Eyes Full Vape Sales Ban, Signals Tighter Tobacco Retail Rules
Russia’s Rostov Region Eyes Full Vape Sales Ban, Signals Tighter Tobacco Retail Rules
Russia’s Rostov region is preparing to pursue a region-wide ban on vape sales and is also signaling support for broader regional powers to tighten tobacco retail rules. A regional lawmaker said the initiative aligns with a State Duma bill that would allow regions to impose vape sales bans—an initiative he said has presidential backing.
Jan.28 by 2FIRSTS.ai
South Africa health department agrees to exempt smokeless and non-combustible products from tobacco control bill
South Africa health department agrees to exempt smokeless and non-combustible products from tobacco control bill
At a parliamentary committee meeting in South Africa, Health Minister Aaron Motsoaledi said the health department has agreed to exempt non-combustible and smokeless products — including chewing tobacco, snus, nicotine pouches and e-cigarettes — from the Tobacco Products and Electronic Delivery Systems Control Bill. The department is prepared, at this stage, to exempt them from packaging and labelling requirements except for misleading or false claims.
Mar.06 by 2FIRSTS.ai
Isle of Wight councillors raise concerns about youth vaping; one says it may be seen “akin to asbestos”
Isle of Wight councillors raise concerns about youth vaping; one says it may be seen “akin to asbestos”
Concerns about the effects of vaping on young people and public health were raised at County Hall, the report said, with Cllr Chris Jarman saying it may one day be viewed as “akin to asbestos.” Jarman cited NHS-related research and a case highlighted by Hull University Teaching Hospitals NHS Trust: a 15-year-old admitted with chest pain and breathing difficulty who reported cannabis use and vaping about 500 puffs per day and was diagnosed via CT with “air leak syndrome.”
Feb.27 by 2FIRSTS.ai