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.

PMI Q2 Call: ZYN Growth, IQOS Pricing and a Diverging Global Tobacco Market
PMI Q2 Call: ZYN Growth, IQOS Pricing and a Diverging Global Tobacco Market
Philip Morris International’s second-quarter earnings call offered new detail on its smoke-free strategy. Management said it would increase U.S. investment behind nicotine pouch brand ZYN, keep IQOS focused on volume before stronger pricing, and use SENTIA, DELIA, LEVIA, VEEV and ZYN to manage tax and regulatory pressure across Japan and Europe. Analysts from Goldman Sachs, Morgan Stanley, UBS and other firms also pressed PMI on profitability, market share, cigarette resilience and the durability of its global transformation over coming quarters.
Jul.24
AIR Invests $20 Million in Greentank, Deepening Capital Ties Across the Vape Supply Chain
AIR Invests $20 Million in Greentank, Deepening Capital Ties Across the Vape Supply Chain
Nasdaq-listed AIR Global has invested $20 million in preferred shares of Canadian vaporization technology company Greentank, deepening a partnership established in 2023. AIR gains a board nomination right, access to new technologies, enhanced commercial terms and long-term supply assurances, while retaining an option to increase its stake. Greentank’s Quantum Chip platform powers Crown Switch and forms part of AIR’s planned U.S. PMTA dossier, linking capital investment more closely with product technology, regulatory evidence and supply-chain control.
Special Report
Jul.29
Ohio Supreme Court Weighs Whether State Consumer Law Can Restrict Flavored Vape Sales
Ohio Supreme Court Weighs Whether State Consumer Law Can Restrict Flavored Vape Sales
The Ohio Supreme Court is hearing a case involving flavored vape sales and whether state authorities can use consumer protection laws to take action against retailers selling unauthorized vape products. Ohio officials argue that selling unauthorized flavored vapes may constitute consumer deception, while retailers argue that tobacco product regulation falls under federal Food and Drug Administration (FDA) authority and that states cannot impose additional restrictions through consumer laws. The case could affect the scope of state-level vape regulation across the United States.
Aug.06
U.S. Fifth Circuit Vacates NicQuid Vape MDO, Says FDA Comparative-Efficacy Standard Violated APA Procedures
U.S. Fifth Circuit Vacates NicQuid Vape MDO, Says FDA Comparative-Efficacy Standard Violated APA Procedures
According to VitalLaw on August 27, 2026, the U.S. Court of Appeals for the Fifth Circuit vacated an FDA marketing denial order (MDO) against NicQuid LLC, ruling that the agency’s comparative-efficacy standard for electronic nicotine delivery system (ENDS) applications had become a substantive rule requiring notice-and-comment rulemaking under the Administrative Procedure Act (APA). The court did not reject FDA’s authority to compare the public health benefits and risks of flavored vapes, but held that the agency could not establish a broadly binding standard through informal adjudications. The case was remanded to FDA for further proceedings.
Aug.28
BAT Expands ITC Infotech Partnership Across Poland, Romania and India to Advance AI
BAT Expands ITC Infotech Partnership Across Poland, Romania and India to Advance AI
ITC Infotech has expanded its multi-year strategic technology partnership with British American Tobacco (BAT), providing technology services across Poland, Romania and India while continuing to support BAT's newly launched Future Capabilities Centre in India and existing technology hubs in Malaysia and Mexico. The companies said the agreement will focus on AI-enabled innovation, technology capability building and greater operational efficiency. The partnership also aligns with BAT's broader Fit2Win transformation programme, under which the group is expanding the use of external technology and business-services partners to simplify its global operating model.
Aug.13
Special Report | China Opens Draft Mandatory Heated Cigarette Standard for Comment, Multiple Heating Technologies Remain in Scope
Special Report | China Opens Draft Mandatory Heated Cigarette Standard for Comment, Multiple Heating Technologies Remain in Scope
China’s State Tobacco Monopoly Administration (STMA) has released a draft mandatory national standard for heated cigarettes, setting out detailed requirements for tobacco sticks, heating devices and aerosols. The proposal treats the stick and device as parts of the same product system, focuses on minimum safety and quality requirements, and leaves several heating architectures within scope.
Special Report
Jul.29