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.

EU ‘TPD3’ Enters Next Phase on Aug. 14 as Fragmented Vape and Nicotine Pouch Rules Push the Single Market Toward Regulatory Overhaul
EU ‘TPD3’ Enters Next Phase on Aug. 14 as Fragmented Vape and Nicotine Pouch Rules Push the Single Market Toward Regulatory Overhaul
A 12-week European Commission consultation on revising the Tobacco Products Directive and Tobacco Advertising Directive is due to close on Aug. 14, 2026. The Commission has identified e-cigarette flavours, disposable vapes, tobacco heating devices, nicotine pouches, nicotine-free e-cigarettes, packaging and digital marketing among areas for possible new EU rules. National regulations already vary significantly across the bloc, a fragmentation the Commission says creates internal-market barriers and distorts competition. No formal revised TPD/TAD legislative text has yet been published, with the Commission currently indicating December 2026 for the legislative initiative.
Aug.14
UK HMRC Plans 30,000 Retail Enforcement Actions as Illegal Tobacco and Vape Sellers Face Tougher Crackdown
UK HMRC Plans 30,000 Retail Enforcement Actions as Illegal Tobacco and Vape Sellers Face Tougher Crackdown
The UK government has announced that HM Revenue & Customs (HMRC) will carry out more than 30,000 interventions targeting businesses and retail premises during the 2026-2027 financial year. The actions will focus on tax fraud, illegal goods sales and businesses involved in unlawful activities through retail channels. The government said illegal tobacco and illegal vape sales remain areas of concern. The move shows that UK enforcement against illegal nicotine products is expanding from import and supply channels toward retail-level oversight, alongside the upcoming introduction of the Vaping Products Duty.
Jul.24
UK Councils Seize More Than 1.3 Million Non-Compliant Vapes One Year After Disposable Ban
UK Councils Seize More Than 1.3 Million Non-Compliant Vapes One Year After Disposable Ban
One year after the UK disposable vape ban came into force, local authorities continue to seize illegal and non-compliant vaping products. FOI data compiled by nicotine retailer Northerner shows more than 1.3 million products were seized between June 2025 and May 2026, with Bolton recording the highest number of seizures and Swansea reporting the highest estimated value.
Jul.21
From Border-Logistics Insiders to Retail Service Stations, Australia Mounts a Sweeping Crackdown on the Illicit Nicotine Trade as iGET Vapes Surface in A$80 Million Crime Networks
From Border-Logistics Insiders to Retail Service Stations, Australia Mounts a Sweeping Crackdown on the Illicit Nicotine Trade as iGET Vapes Surface in A$80 Million Crime Networks
Australian authorities have disclosed two major enforcement actions that go beyond product seizures and retail closures to examine how illicit tobacco and vape networks operate. On Aug. 14, the Multi Agency Strike Team said seven people had been charged and two criminal networks were valued by authorities at a combined A$80 million, or about US$56.8 million. Investigators allege the groups used bonded warehouses, freight businesses and “trusted insiders” in legitimate industries to circumvent border controls. In a separate operation on Aug. 11, more than 100 service stations were targeted as authorities sought information on illicit tobacco importation, distribution networks and the movement of sales proceeds.
Aug.17
Science | International Experts Propose a New Smoking Cessation Pathway, Citing Higher Quit Rates With E-Cigarettes Than Nicotine Replacement Therapy
Science | International Experts Propose a New Smoking Cessation Pathway, Citing Higher Quit Rates With E-Cigarettes Than Nicotine Replacement Therapy
A new expert paper in JAMA urges U.S. clinicians to include nicotine e-cigarettes in smoking-cessation discussions, citing higher quit rates than nicotine replacement therapy. It also stresses that products must deliver enough nicotine to replace cigarettes, dual use should be brief, and complete switching is the goal. 2Firsts argues the recommendations matter beyond clinics: public-health professionals should reassess relative risk, regulators should preserve sufficient product appeal for adult smokers, and manufacturers should focus on helping users quit cigarettes more sustainably.
SCIENCE
Aug.03 by 2Firsts Perspectives
IQOS Enters Kantar BrandZ Global Top 100 for First Time, Valued at $36.6 Billion and Ranked No. 74
IQOS Enters Kantar BrandZ Global Top 100 for First Time, Valued at $36.6 Billion and Ranked No. 74
Philip Morris International’s IQOS has entered the Kantar BrandZ Top 100 Most Valuable Global Brands for the first time, ranking No. 74 with a brand value of $36.634 billion and becoming one of only three newcomers to the 2026 ranking. Kantar said the combined value of the Global Top 100 reached $13.1 trillion, up 22% year on year, while the threshold for entry rose to a record high. PMI says IQOS has more than 35 million users worldwide and surpassed $10 billion in annual net revenues within a decade of launch.
Sep.03