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.

China’s Jinhua Tobacco Launches CNY 2.7 Million Procurement for E-Cigarette Violation Lead Monitoring Services
China’s Jinhua Tobacco Launches CNY 2.7 Million Procurement for E-Cigarette Violation Lead Monitoring Services
Jinhua Tobacco, a municipal tobacco company in China’s Zhejiang province, has launched a public tender for e-cigarette-related violation lead monitoring and consulting services. The project is valued at CNY 2.7 million and covers data resource integration and analytical consulting services for 36 months from contract signing. The procurement reflects the use of external data and analysis services to support local tobacco companies’ market oversight activities related to e-cigarettes.
Aug.07
UK Proposes Stricter Vape Packaging Rules as Retailers Warn of £330 Million Impact
UK Proposes Stricter Vape Packaging Rules as Retailers Warn of £330 Million Impact
The UK government has launched a nationwide consultation on vape packaging, appearance and retail displays, proposing tighter rules to reduce youth appeal while industry groups warn of significant compliance costs.
Innovation
Jul.20
WIRED Investigation: Chinese-Made Vapes Turn to 6-Methyl-Nicotine and Other Analogs, Challenging U.S. Regulation
WIRED Investigation: Chinese-Made Vapes Turn to 6-Methyl-Nicotine and Other Analogs, Challenging U.S. Regulation
U.S. technology and investigative publication WIRED has examined how nicotine analogs are emerging as a new challenge for the country’s vape regulatory framework. The article argues that after the U.S. expanded federal oversight of nicotine products in 2022, some manufacturers began using nicotine-like compounds such as 6-methyl-nicotine that may fall outside existing definitions. Researchers cited by WIRED said some nicotine analogs could be more potent than traditional nicotine, although human health impacts remain unclear. U.S. policymakers are considering broader definitions of nicotine to bring these compounds under federal oversight.
Jul.27
Spain Plans to Extend Smoking Ban to Terraces and Beaches, Bringing Vapes Under New Restrictions
Spain Plans to Extend Smoking Ban to Terraces and Beaches, Bringing Vapes Under New Restrictions
Spain is advancing a new tobacco-control reform that would expand smoking restrictions to additional public spaces, including restaurant terraces and beaches, while bringing vaping and other nicotine products into the same regulatory framework. The proposed measures aim to reduce secondhand smoke exposure, protect young people and expand smoke-free environments. The proposal remains under legislative development, and final implementation details have not yet been confirmed.
Jul.23
PMI Global Communications Chief Moira Gilchrist: Why AI Matters More Than Ever in the Smoke-Free Transition
PMI Global Communications Chief Moira Gilchrist: Why AI Matters More Than Ever in the Smoke-Free Transition
Philip Morris International (PMI) Chief Global Communications Officer Moira Gilchrist said artificial intelligence is changing how companies understand audiences, manage owned information channels and communicate business transformation. PMI is using AI-generated audience personas to test messaging while optimizing its corporate website and other owned channels for large language models. As PMI continues its transition from cigarettes toward smoke-free products, Gilchrist said owned data and corporate channels are becoming increasingly important in demonstrating the scale of that transformation.
Aug.26
2Firsts Data | China’s Vape Exports Rise 3.1% in H1 2026 as 6-Methyl Nicotine-Related Products Surge 65.2%
2Firsts Data | China’s Vape Exports Rise 3.1% in H1 2026 as 6-Methyl Nicotine-Related Products Surge 65.2%
China’s vape exports showed resilience in the first half of 2026 after a short-term shock from China’s export rebate adjustment. But customs data points to more than a simple recovery: the structure of growth is changing. Vaping devices and atomization hardware emerged as the strongest growth driver, while nicotine-containing vaping products remained broadly stable. Meanwhile, nicotine substitute-related products represented by 6-methyl nicotine expanded rapidly, becoming a new category to watch for both industry and regulators. After the U.S. market went through a cycle of shortages, replenishment and inventory rebuilding in 2025, China’s vape supply chain is entering a new phase of reallocation.
Special Report
Jul.20