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.

EUIPO Rejects Imiracle’s Opposition to ‘Crystal’ Trademark, Citing Lack of Proof of Actual Use in Slovakia
EUIPO Rejects Imiracle’s Opposition to ‘Crystal’ Trademark, Citing Lack of Proof of Actual Use in Slovakia
The EUIPO has ruled that Imiracle failed to demonstrate actual commercial use of its “Elfbar Crystal” brand in Slovakia, and therefore rejected in full the company’s opposition to Shenzhen SKE Technology’s application to register the “Crystal” trademark. The EUIPO noted that the sales records submitted by Imiracle were limited in scope and that the product packaging was in Ukrainian, which it found insufficient to prove that the products had been placed on the Slovak market.
Dec.10 by 2FIRSTS.ai
NZ Government Eyes Sale of Smokeless Tobacco; Critics Warn of “Backslide”
NZ Government Eyes Sale of Smokeless Tobacco; Critics Warn of “Backslide”
Associate Health Minister Casey Costello faced renewed scrutiny in Parliament’s health select committee over her handling of tobacco-related policy and alleged ties to the tobacco industry. The government is considering allowing smokeless nicotine products such as snus and nicotine pouches, provided they meet safety and youth-access regulations.
Dec.05 by 2FIRSTS.ai
Juul, NJOY and Altria Clash Over Use of UCSF Public Documents in U.S. Patent Litigation
Juul, NJOY and Altria Clash Over Use of UCSF Public Documents in U.S. Patent Litigation
Juul Labs has asked a U.S. federal court to prevent NJOY and Altria from using documents stored in a public UCSF database in an ongoing patent lawsuit, arguing they are protected by attorney–client privilege. The defendants say the files have long been public and may contain evidence relevant to Juul’s patent conduct.
Dec.29 by 2FIRSTS.ai
German Environment Minister Backs Ban on Disposable E-Cigarettes, Citing Safety Risks
German Environment Minister Backs Ban on Disposable E-Cigarettes, Citing Safety Risks
Germany’s Environment Minister Carsten Schneider has expressed clear support for banning disposable e-cigarettes, citing safety hazards, environmental damage, and waste management risks. While the ban has not yet been finalized, Germany’s parliament has instructed the government to examine the proposal. Several European countries, including Belgium, France, and the UK, have already implemented similar bans.
Dec.30 by 2FIRSTS.ai
Product | Claiming a “first multi-beverage vaporizer” with refillable juice/cocktail water chamber, PEAKBAR launches new device in the U.S.
Product | Claiming a “first multi-beverage vaporizer” with refillable juice/cocktail water chamber, PEAKBAR launches new device in the U.S.
PEAKBAR’s new H2O 40K has begun selling through U.S. online retailers including Vape Sourcing. Marketed as the “world’s first multi-beverage vaporizer,” the device is promoted as allowing users to add liquids such as juice and cocktails into a water chamber for pairing. Publicly listed specifications include 20 ml of e-liquid, a rated 40,000 puffs, 0.5% nicotine, a 1,000 mAh rechargeable battery, and two power modes at 22W and 12W.
Jan.22 by 2FIRSTS.ai
Special Report|Russia scales back anti-vaping drive, limits ban to single-region trial
Special Report|Russia scales back anti-vaping drive, limits ban to single-region trial
After months of debate, Russian lawmakers have retreated from plans for a nationwide vaping ban, opting instead for a single-region pilot. The shift reflects pressure from business groups and fiscal authorities, amid warnings that sweeping prohibitions could fuel illegal trade while undermining efforts to regulate the market.
Jan.22