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.

Product | JTI Launches Ploom AURA Teal Electric Pop in South Korea, Its First Dual-Color Edition
Product | JTI Launches Ploom AURA Teal Electric Pop in South Korea, Its First Dual-Color Edition
JTI Korea launched the Ploom AURA Teal Electric Pop limited edition in South Korea on September 1, 2026, marking the first dual-color design in the Ploom AURA range. The device combines a dark green body with teal accents and is accompanied by matching Front Panel, Back Cover and Pocket Bag accessories. The standalone device is priced at KRW 29,000, with three additional device-and-accessory bundles available. The release continues JTI Korea's use of limited colorways and interchangeable accessories to expand the Ploom AURA portfolio without introducing a new hardware platform.
Sep.03
PMI Q2 Revenue Rises 10.4% as IQOS and VEEV Expand, U.S. ZYN Growth Slows
PMI Q2 Revenue Rises 10.4% as IQOS and VEEV Expand, U.S. ZYN Growth Slows
Philip Morris International’s second-quarter net revenues rose 10.4% to a record $11.19 billion, as heated tobacco and e-vapor expanded across international markets. IQOS remained the main smoke-free growth engine, while VEEV shipments jumped 55.1%. In the United States, however, ZYN shipments increased just 1.8% and consumer offtake was broadly flat to slightly higher. Cigarette volumes also rose, showing that PMI’s transformation is advancing, but growth is becoming increasingly uneven across categories and markets.
PMI
Jul.22
EU Tobacco Rules Face Pushback as Analysis Says 90% of Consultation Responses Raised Objections
EU Tobacco Rules Face Pushback as Analysis Says 90% of Consultation Responses Raised Objections
An analysis by We Are Innovation says more than 90% of over 82,000 responses to the European Commission’s public consultation on the Tobacco Products Directive revision raised at least one substantial objection to the proposed regulatory direction.
Jul.13
UK HMRC Urges Public to Report Suspicious Vape Shops in Crackdown on Tax Fraud, Money Laundering and Illicit Tobacco Sales
UK HMRC Urges Public to Report Suspicious Vape Shops in Crackdown on Tax Fraud, Money Laundering and Illicit Tobacco Sales
HM Revenue & Customs is urging members of the public to report vape shops, barber shops and other high-street businesses suspected of tax fraud, money laundering or other illegal activity, with informants not required to provide personal details. HMRC plans more than 30,000 interventions in 2026-27 targeting tax fraud, organised crime and illicit activity, including the sale of illegal vapes and tobacco. The push forms part of a broader UK effort to tackle organised crime on high streets, backed by a £30 million government enforcement programme.
Regulations
Aug.17 by 2Firsts Perspectives
2FIRSTS EXCLUSIVE|China Breaks Up $6.8 Million Illegal Hookah Tobacco Operation as Market Expands
2FIRSTS EXCLUSIVE|China Breaks Up $6.8 Million Illegal Hookah Tobacco Operation as Market Expands
Chinese authorities have dismantled an illegal hookah tobacco operation worth more than 46 million yuan ($6.8 million), detaining five foreign suspects and seizing over 500,000 boxes of tobacco paste. The case comes as hookah expands across China’s nightlife sector and attracts overseas operators, including former vaping entrepreneurs. It also raises a central regulatory question: whether waterpipe tobacco will follow China’s private-sector e-cigarette licensing model or be reserved for the state tobacco system, as with nicotine pouches, in the years ahead.
Jul.31
JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
JAMA has published a Special Communication offering systematic recommendations for U.S.-based clinicians on the use of nicotine e-cigarettes in adult smoking cessation. Developed by the Harm Reduction Workgroup of the Society for Research on Nicotine and Tobacco’s Treatment Research Network, the paper recommends including e-cigarettes alongside FDA-approved cessation medications in risk-benefit discussions. It cites high-certainty evidence that nicotine e-cigarettes achieve higher quit rates than nicotine replacement therapy and evidence suggesting efficacy comparable to highly effective medications such as varenicline and cytisine. For adults who choose vaping to quit, the authors recommend FDA-authorized products, sufficient nicotine delivery and a rapid, complete transition away from cigarettes rather than prolonged dual use.
Aug.13