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.

Haypp Report: Women Emerge as a Key Growth Driver in the UK Nicotine Pouch Market
Haypp Report: Women Emerge as a Key Growth Driver in the UK Nicotine Pouch Market
According to Haypp’s 2026 UK Nicotine Report, women are a key growth driver in the UK nicotine pouch market. Overall sales for Haypp and Northerner rose 60% year‑on‑year in 2025, but purchases by women surged 202%, versus 25% for men. Women’s share of consumers jumped from 22% to 40%. The report attributes this to discretion, perceived health benefits, and more gender‑neutral product positioning, suggesting future growth will come from a broader range of adult nicotine users.
Jul.01
China Tobacco International HK Warns First-Half Revenue May Fall 25%-30%, Tobacco Leaf and Duty-Free Exposure Highlight Reliance on Traditional Tobacco
China Tobacco International HK Warns First-Half Revenue May Fall 25%-30%, Tobacco Leaf and Duty-Free Exposure Highlight Reliance on Traditional Tobacco
CTIHK expects first-half 2026 revenue to fall 25%-30%, mainly due to lower tobacco leaf imports and delayed cigarette shipments to China’s domestic duty-free market. Its 2025 revenue mix—nearly 90% from tobacco leaf-related businesses and less than 1% from new tobacco products—shows continued exposure to traditional supply chains and trade variables.
Jun.18
 Philip Morris Lowers Profit Outlook as Zyn Faces Competition and FDA Delays
Philip Morris Lowers Profit Outlook as Zyn Faces Competition and FDA Delays
According to Reuters, Philip Morris International (PMI) lowered its 2026 adjusted earnings-per-share forecast amid regulatory uncertainty around Zyn nicotine pouches, rising competition and shipment pressure in the U.S. market.
PMI
Jun.02
Reuters: Big Tobacco Emerges as Winner After FDA Regulatory Shift
Reuters: Big Tobacco Emerges as Winner After FDA Regulatory Shift
According to Reuters, major tobacco companies may emerge as key beneficiaries after the U.S. FDA loosened regulations on vaping and nicotine pouch products, a shift that has sparked debate over public health risks.
Industry Insight
May.26
PMI U.S. Launches America250 Initiative, Introduces Limited-Edition ZYN Patriotic Storage Can
PMI U.S. Launches America250 Initiative, Introduces Limited-Edition ZYN Patriotic Storage Can
PMI U.S. launched its America250 initiative on June 1 to commemorate the 250th anniversary of the United States. As part of the program, the company introduced a limited-edition ZYN Patriotic Storage Can and released an IQOS U.S. Edition device. Beyond product-related activities, the initiative also includes innovation funding, nationwide events and community engagement programs.
PMI
Jun.05
PMI Partners With Italian Tenor Andrea Bocelli to Launch “Believe. Further” Platform
PMI Partners With Italian Tenor Andrea Bocelli to Launch “Believe. Further” Platform
Philip Morris International (PMI) and Italian tenor Andrea Bocelli have launched “Believe. Further,” a multi-year communications platform targeting cultural, institutional and business audiences in Europe, as PMI says smoke-free products accounted for 43% of its net revenues as of the first quarter of 2026.
Jul.01