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.

Sweden Becomes First EU Country to Reach Smoke-Free Status as Daily Smoking Falls to 4.8%
Sweden Becomes First EU Country to Reach Smoke-Free Status as Daily Smoking Falls to 4.8%
According to the latest CAN report and multiple media reports, Sweden’s daily smoking rate fell to 4.8% in 2025, below the commonly used 5% smoke-free threshold, making it the first EU country to reach that benchmark.
News
Jun.05
ITGA Americas Meeting Calls for Balanced Regulation as Tobacco Growers Warn of Pressure on Farms and Legal Supply Chains
ITGA Americas Meeting Calls for Balanced Regulation as Tobacco Growers Warn of Pressure on Farms and Legal Supply Chains
ITGA said tobacco grower organizations from five Americas countries called for stronger regional cooperation and balanced regulation, warning that restrictive policies could pressure farmers and legal supply chains. The article also provides data on major tobacco-producing countries in the Americas.
Special Report
Jun.02
PML Expands Its UK Smoke-Free Portfolio With LEVIA
PML Expands Its UK Smoke-Free Portfolio With LEVIA
Philip Morris Limited has launched LEVIA, a new range of zero-tobacco flavored nicotine sticks created for the IQOS ILUMA range. The product expands the company’s smoke-free portfolio in the UK and will initially be available in four variants, including Deep Mint and three capsule-based flavors. LEVIA has a recommended retail price of £5, or about $6.73, based on the European Central Bank’s April 28.
Apr.29 by 2FIRSTS.ai
FDA Launches Elsa 4.0 and Completes HALO Data Platform Consolidation
FDA Launches Elsa 4.0 and Completes HALO Data Platform Consolidation
The U.S. Food and Drug Administration announced on May 6 that it has advanced its modernization initiative by launching Elsa 4.0, an upgraded internal AI tool, and consolidating more than 40 application and submission data sources, systems and portals into a new platform called HALO. FDA said the integration of HALO and Elsa will allow staff to query data and build workflows without manually uploading documents in each chat.
May.07 by 2FIRSTS.ai
    Shenzhen Tobacco Monopoly Bureau Moves to Advance E-Cigarette Regulatory System 2.0
Shenzhen Tobacco Monopoly Bureau Moves to Advance E-Cigarette Regulatory System 2.0
The Shenzhen Tobacco Monopoly Bureau recently held the city’s 2026 e-cigarette regulation work conference to implement higher-level meeting requirements, review the city’s e-cigarette regulatory work in 2025 and during the 14th Five-Year Plan period, assess the current situation, and deploy the rollout of E-cigarette Regulatory System 2.0 across Shenzhen’s tobacco commercial system.
Apr.28 by 2FIRSTS.ai
Ispire Reports Fiscal Q3 2026 Revenue of $18.7 Million and Net Loss of $9.5 Million
Ispire Reports Fiscal Q3 2026 Revenue of $18.7 Million and Net Loss of $9.5 Million
Ispire Technology reported financial results on May 7, 2026, for the third quarter of fiscal 2026, covering the three months ended March 31, 2026. Revenue was $18.7 million, compared with $26.2 million in the third quarter of fiscal 2025 and $20.3 million in the prior quarter. Gross profit was $2.0 million, with gross margin of 10.7%. Net loss was $9.5 million, or $0.17 per share. The company said it held $18.0 million in cash as of March 31, 2026, up $468,000 sequentially.
May.08 by 2FIRSTS.ai