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.



Disclaimer

This article is provided solely for professional research, industry discussion, and informational purposes. Any references to brands, companies, products, technologies, or policies are made for factual reporting and analytical purposes only, and do not constitute endorsement, recommendation, promotion, or advertising by 2Firsts.

Nicotine-containing products, including but not limited to cigarettes, e-cigarettes, heated tobacco products, and nicotine pouches, carry significant health risks. Readers are responsible for complying with all applicable laws and regulations in their respective jurisdictions, including age restrictions and access limitations.

The information contained in this article should not be regarded as investment, legal, medical, regulatory, or commercial advice. While 2Firsts strives to ensure the accuracy and reliability of its content, it does not assume liability for any direct or indirect loss arising from errors, omissions, inaccuracies, or reliance on the information contained herein.

This article is not intended for individuals below the legal age for accessing tobacco or nicotine-related information in their jurisdiction.

 

Copyright Notice

This article is either original content produced by 2Firsts or content reproduced, translated, summarized, or adapted from third-party sources with attribution where applicable. The intellectual property rights of the original content remain with 2Firsts or the respective original rights holders.

No individual or organization may copy, reproduce, distribute, republish, modify, translate, or otherwise use this content without prior authorization. Any unauthorized use may result in legal action.

For copyright-related inquiries, corrections, or removal requests, please contact: info@2firsts.com.

 

AI-Assisted Translation and Editing Notice

Portions of this article may have been translated, edited, or reviewed with the assistance of artificial intelligence tools to improve efficiency and readability. Due to the limitations of AI-assisted translation and editing, discrepancies, omissions, or inaccuracies may exist when compared with the original source.

Where applicable, readers are advised to refer to the original source for the most complete and accurate information. If you identify any errors or believe that any content infringes upon your rights, please contact us at info@2firsts.com, and we will review and address the matter promptly.

Former ATF Official’s Claims on Chinese Vape Companies and 6-Methyl Nicotine Fuel US Regulatory Debate
Former ATF Official’s Claims on Chinese Vape Companies and 6-Methyl Nicotine Fuel US Regulatory Debate
Former ATF Deputy Director Edgar Domenech has warned that some Chinese vape companies may be using 6-methyl nicotine, a nicotine analogue, raising new questions over how US regulators should classify emerging nicotine compounds.
Jul.13
Special Report | Russia, Ukraine and Belarus Launch Fresh Push to Rein in Vaping
Special Report | Russia, Ukraine and Belarus Launch Fresh Push to Rein in Vaping
Russia, Ukraine and Belarus are tightening vape regulation through different tools, from Ukraine’s stronger enforcement push and Belarus’s proposed advertising restrictions to Russia’s new GOST standard and regional sales-ban mechanism. As black-market concerns persist, some Russian experts argue that China’s tightly controlled but legalised model — built around licensing, traceability and taxation — may offer a more effective alternative to blanket prohibition.
Jul.15
2Firsts Compliance Solutions Hosts PMTA Briefing on FDA Review Signals After JUUL2 Authorization
2Firsts Compliance Solutions Hosts PMTA Briefing on FDA Review Signals After JUUL2 Authorization
Following recent FDA authorizations for JUUL2 and ZYN ULTRA, 2Firsts Compliance Solutions held an online PMTA briefing on Sept. 4 to examine what the decisions may signal about review efficiency, scientific evidence and U.S. market access. Nearly 30 participants from brands, manufacturers, compliance service providers and investment firms joined the discussion.
2Firsts Events
Sep.06
BAT Regional Director Fred Monteiro Supports Spain’s Nicotine Rules but Opposes 0.99mg Nicotine Pouch Limit
BAT Regional Director Fred Monteiro Supports Spain’s Nicotine Rules but Opposes 0.99mg Nicotine Pouch Limit
Spanish newspaper El Confidencial interviewed Fred Monteiro, Regional Director for Americas and Europe at British American Tobacco (BAT). Monteiro said BAT supports setting regulatory limits for nicotine products but opposes Spain’s proposed 0.99mg nicotine-per-pouch limit, arguing that such a restriction could affect adult smokers’ transition to alternatives. He said nicotine regulation should be based on scientific evidence and harm reduction principles. Monteiro also said smoke-free products now account for around 25% of BAT’s Americas and Europe business and nearly 30% of its Europe business
BAT
Jul.30
Alaska Warns 1,500 Tobacco Retailers Over Unauthorized Vapes and Nicotine Pouches
Alaska Warns 1,500 Tobacco Retailers Over Unauthorized Vapes and Nicotine Pouches
Alaska Attorney General Stephen J. Cox has sent notices to more than 1,500 tobacco retailers and distributors warning them against selling vape and nicotine pouch products that lack authorization from the U.S. Food and Drug Administration (FDA). According to the Alaska Department of Law, businesses were advised to verify products against FDA authorization databases and avoid selling unauthorized nicotine products. The action highlights how state-level enforcement is increasingly extending federal product authorization requirements to retail channels.
Jul.24
Smoore Wins Three Heated Device Supply Lots in China Tobacco Jiangsu’s Overseas Market Project Covering Japan, South Korea and Southeast Asia
Smoore Wins Three Heated Device Supply Lots in China Tobacco Jiangsu’s Overseas Market Project Covering Japan, South Korea and Southeast Asia
China Tobacco Jiangsu Industrial Co., Ltd. (JSIC) has completed its 2026-2028 heated device procurement project, with Shenzhen Smoore Technology Limited securing final supply contracts for three lots: U1, C1 and C2. The project was launched through a public tender in June 2026 to support overseas markets and involved heated tobacco devices carrying JSIC’s “iRod” trademark. Candidate supplier results published on July 13 showed Smoore ranked first for the three awarded lots, while Shenzhen Yunxi Intelligent Technology Co., Ltd. and Shenzhen Bodi Technology Development Co., Ltd. participated in the bidding process.
Aug.03