Fundamental flaws in FDA's tobacco regulation law: expert

Nov.16.2022
Fundamental flaws in FDA's tobacco regulation law: expert
Partner Azim Chowdhury of Keller and Heckman law firm criticizes the FDA's tobacco product regulation for allowing existing products to avoid scrutiny.

Azim Chowdhury, a partner at law firm Keller and Heckman, has criticized the implementation of the 2009 Family Smoking Prevention and Tobacco Control Act by the US Food and Drug Administration (FDA), which gave the agency the power to regulate tobacco products. Chowdhury wrote in Filter magazine that requirements for pre-market authorization of “new” products created almost insurmountable obstacles for potentially reduced risk products, while allowing existing products, including combustible cigarettes, to largely evade FDA scrutiny. Chowdhury proposed several ways in which the FDA could more effectively implement the law, including considering all evidence in pre-market applications for tobacco products, rather than conducting individual reviews. He also suggested that the FDA needed to halt the spread of counterfeit products, which posed greater risks to consumers and threatened small businesses and e-cigarette shops that were already struggling with FDA enforcement.


Finally, the FDA should allocate more resources towards developing reasonable safety, quality, and marketing standards for products.


Statement:


This article is compiled from third-party information and is intended for industry-related communication and learning purposes.


This article does not represent the views of 2FIRSTS, and 2FIRSTS is unable to confirm the authenticity and accuracy of the article's content. The compilation of this article is solely for exchanging and researching within the industry.


Due to limitations in translation abilities, the translated article may not fully express the original text. Please refer to the original article for accuracy.


2FIRSTS maintains complete consistency with the Chinese government's stance and statements pertaining to domestic, Hong Kong, Macau, Taiwan, and foreign affairs.


The copyrights of compiled information belong to the original media and authors, and in case of infringement, please contact for deletion.


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.

South Korea online purchasing fuels spread among younger groups; online drug cases share climbs
South Korea online purchasing fuels spread among younger groups; online drug cases share climbs
Police said detections of new drugs disguised as e-cigarettes reached 1,206 cases through September last year, up from 941 in 2022, and the number of detected drug types increased from 26 to 33 over the same period.
Feb.11 by 2FIRSTS.ai
2Firsts|Sesh Advances Nicotine Pouch PMTA to Filing Stage, Experts Highlight Regulatory Threshold and Market Window
2Firsts|Sesh Advances Nicotine Pouch PMTA to Filing Stage, Experts Highlight Regulatory Threshold and Market Window
Sesh said its Premarket Tobacco Product Application (PMTA) for 64 nicotine pouch SKUs has been accepted by the U.S. Food and Drug Administration (FDA) and advanced to the Filing stage, entering substantive scientific review. Industry experts say the development signals that the application has crossed a key technical and regulatory threshold, while also highlighting growing divergence in regulatory capability and market positioning within the nicotine pouch category.
Special Report
Mar.24 by 2FIRSTS.ai
Kuwait Bans Sale of Tobacco and E-Cigarette Products Through Delivery Platforms
Kuwait Bans Sale of Tobacco and E-Cigarette Products Through Delivery Platforms
Kuwait’s Minister of Commerce and Industry Osama Boodai has issued a decision banning the sale of tobacco, tobacco derivatives, all types of cigarettes, electronic cigarettes, and related tools, devices and accessories through delivery platforms or similar digital channels.
Mar.16 by 2FIRSTS.ai
GEEK BAR to Return to the European Market: Launches the SPARK Pod System
GEEK BAR to Return to the European Market: Launches the SPARK Pod System
GEEK BAR announced its return to the European market and the release of its pod-based product, SPARK, which will begin rolling out across select European countries starting in March. SPARK features a battery-status display interface and a fast-charging battery. It offers a 1.1Ω prefilled pod (up to approximately 1,000 puffs) and a 0.8Ω refillable pod, along with multiple new flavors tailored for Europe.
Mar.04 by 2FIRSTS.ai
Casey’s, the No. 3 U.S. C-Store Chain, Sees Nicotine Category Shift as Pouches Rise 31% and Vapor 12%
Casey’s, the No. 3 U.S. C-Store Chain, Sees Nicotine Category Shift as Pouches Rise 31% and Vapor 12%
Casey’s General Stores (NASDAQ: CASY) reported accelerating growth in modern nicotine products during its fiscal third quarter ended January 31, 2026. Nicotine pouch sales increased 31% year over year, while vapor products rose 12%. Although cigarette unit sales continued to decline, management stated that the rate of decline slowed compared to prior quarters.
Market
Mar.15
Panama Seeks Unified Regulation on E-Cigarettes and Heated Tobacco Products, Including Use Restrictions in Public and Private Spaces
Panama Seeks Unified Regulation on E-Cigarettes and Heated Tobacco Products, Including Use Restrictions in Public and Private Spaces
Panamanian authorities are seeking to establish a single regulatory framework aimed at prohibiting the use of e-cigarettes, vaporizers and heated tobacco products in public and private spaces, as well as restricting their advertising and promotion.
Mar.11 by 2FIRSTS.ai