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.

EU Novel Tobacco Regulation Trends and Business Response | Guest Contribution by a European Legal and Compliance Expert
EU Novel Tobacco Regulation Trends and Business Response | Guest Contribution by a European Legal and Compliance Expert
Carlos Cabrera, founder of CabLab Law & Advocacy, contributes this article to 2Firsts, arguing that the EU’s evolving approach to novel tobacco regulation may unintentionally reinforce cigarette use by narrowing alternatives. He warns companies to watch signals on flavours, labelling, traceability, nicotine pouch rules and digital marketing, while grounding business decisions in realistic timelines, compliance planning and continuous monitoring.
Apr.22
Trump’s Tobacco Investments and Industry Donations Draw Scrutiny as FDA Eases Vape and Nicotine Pouch Rules
Trump’s Tobacco Investments and Industry Donations Draw Scrutiny as FDA Eases Vape and Nicotine Pouch Rules
A report by KFF Health News says that as the Trump administration pursued a series of policies favorable to the nicotine and tobacco industry, President Donald Trump increased his holdings in tobacco companies while benefiting from substantial industry-linked political donations, prompting questions from public health advocates about potential conflicts of interest and regulatory direction.
Jun.12
FDA Expands ENDS Market Access With First Authorization of Non-Tobacco and Non-Menthol Products
FDA Expands ENDS Market Access With First Authorization of Non-Tobacco and Non-Menthol Products
The U.S. Food and Drug Administration (FDA) announced on May 5, 2026 that it authorized the marketing of four Glas electronic nicotine delivery system (ENDS) products through the premarket tobacco product application (PMTA) pathway. The authorized products are Classic Menthol, Fresh Menthol, Gold and Sapphire pods, each containing 50mg/ml, or 5%, tobacco-derived nicotine.
May.06 by 2FIRSTS.ai
FDA Commissioner Marty Makary Resigns After Opposing Trump Administration’s Flavored Vape Push
FDA Commissioner Marty Makary Resigns After Opposing Trump Administration’s Flavored Vape Push
FDA Commissioner Marty Makary resigned on May 12 after opposing the Trump administration’s push to authorize fruit-flavored vaping products, according to reporting by The New York Times. Makary reportedly objected over concerns that flavored vapes could attract young people and refused to support broader approvals.
News
May.13
Product | ZYN Adds Tropical Flavor and Expands 1.5mg Nicotine Options in the Philippines
Product | ZYN Adds Tropical Flavor and Expands 1.5mg Nicotine Options in the Philippines
ZYN has expanded its nicotine pouch portfolio in the Philippines with the addition of Cool Breeze 1.5mg and Tropical in 3mg and 6mg strengths. Public information shows that 1.5mg is among the lower nicotine strengths offered by ZYN in the Philippine market and is positioned for adult nicotine consumers who are new to nicotine pouches.
PMI
Jun.08
Ukrainian Lawmaker Proposes Ban on Vapes, Heated Tobacco Devices and Hookahs for Under-17s
Ukrainian Lawmaker Proposes Ban on Vapes, Heated Tobacco Devices and Hookahs for Under-17s
Ukraine’s Verkhovna Rada has registered a bill that would ban the use of tobacco products, vapes, hookahs, herbal smoking mixtures and heated tobacco devices by people under 17. The bill was introduced by People’s Deputy Georgiy Mazurashu and has already been sent to the relevant parliamentary committee. The author said one reason for the initiative is the prevalence of vaping among adolescents.
Apr.28 by 2FIRSTS.ai