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.

Italian Financial Police Seize 4.3 Million E-Cigarettes and Smoking Accessories; 28 Reported to Judicial Authorities Across Operations
Italian Financial Police Seize 4.3 Million E-Cigarettes and Smoking Accessories; 28 Reported to Judicial Authorities Across Operations
Italy's Guardia di Finanza announced on October 28 that officers in Latina province had seized approximately 4.3 million e-cigarettes and smoking accessories at an unauthorized warehouse in an operation involving restrictions on the possession and sale of tobacco-related products. Another 300,000 suspected counterfeit or unsafe items were confiscated during separate inspections, bringing total seizures across the operations to more than 4.6 million products. Twenty-eight people were reported to judicial authorities over suspected smuggling and counterfeiting offenses. Officials did not disclose separate vape quantities, the value of the merchandise or alleged violations associated with individual brands.
Enforcement
Oct.29
Australia Extends Illicit Tobacco Crackdown From Tougher Penalties to Customs and Logistics Supply Chains
Australia Extends Illicit Tobacco Crackdown From Tougher Penalties to Customs and Logistics Supply Chains
Australia's federal government introduced a new illicit tobacco enforcement bill on September 10 that would strengthen evidentiary presumptions, representative sampling, seizure and forfeiture procedures, proceeds-of-crime powers and obligations for customs and logistics operators. The proposal follows the Combatting Illicit Tobacco Act 2026, which took effect in August and increased penalties while expanding investigative and asset-recovery tools. Together, the reforms extend Australia's crackdown from tougher criminal sanctions into import, logistics and evidentiary enforcement.
Sep.14
Special Report | Altria's NACS Booth Raises Questions Over U.S. Tobacco Advertising Warnings
Special Report | Altria's NACS Booth Raises Questions Over U.S. Tobacco Advertising Warnings
During its coverage of Altria's booth at NACS Show 2026, 2Firsts documented product displays that prompted questions about U.S. tobacco advertising warning requirements. Following public comments from a former FDA official, 2Firsts sought responses from Altria and independently consulted U.S. regulatory lawyer Azim Chowdhury. Altria maintained that its B2B communications complied with applicable laws, while Chowdhury explained that federal warning rules provide no general trade-show exemption for e-cigarettes and nicotine pouches. The special report examines the broader regulatory implications.
Nov.04
Sweden Threatens EU Tobacco Tax Deal as Nicotine Pouch Duty Dispute Looms Over November 9 Meeting
Sweden Threatens EU Tobacco Tax Deal as Nicotine Pouch Duty Dispute Looms Over November 9 Meeting
Sweden is expected to oppose a European Union proposal to raise minimum tobacco excise duties, Law360 reported on October 26, 2026, citing an EU official. A provisional Council agenda dated October 23 confirms that the tobacco taxation package is scheduled for discussion at the November 9 finance ministers' meeting, where member states will seek a general approach. The proposed reforms would raise minimum taxes on conventional tobacco products and establish EU-wide excise rules for vaping liquids, heated tobacco and nicotine pouches. Sweden supports harmonising tobacco taxation rules but objects to requiring nicotine pouches to bear the same minimum tax burden as certain smoking tobacco products. As EU indirect tax legislation requires unanimous Council approval, Swedish opposition could block the proposal in its current form.
Regulations
Oct.29
GSTHR Estimates 200 Million People Use Non-Combustible Nicotine Products as 28 Countries Show Rising Use Alongside Falling Smoking Rates
GSTHR Estimates 200 Million People Use Non-Combustible Nicotine Products as 28 Countries Show Rising Use Alongside Falling Smoking Rates
The Global State of Tobacco Harm Reduction, a project operated by Knowledge·Action·Change, estimates that about 200 million people worldwide use non-combustible nicotine products including vapes, heated tobacco, nicotine pouches and snus. Its 2026 report says use of these products rose alongside declining smoking rates in 28 countries it analyzed. The data do not establish that all 200 million users have quit smoking, nor do they prove a direct causal relationship. GSTHR also says regulatory restrictions on the products continue to expand in many markets.
Sep.10
UK ONS Data: Vaping Rate Among Women Aged 25–34 Reaches 18.3%, Compared With 14.4% for Men
UK ONS Data: Vaping Rate Among Women Aged 25–34 Reaches 18.3%, Compared With 14.4% for Men
The vaping rate among women aged 25 to 34 in Great Britain reached 18.3% in 2025, up from 13.7% in 2024 and 8.3% in 2020, according to data from the Office for National Statistics (ONS). The figure was the highest for this group since records began in 2014 and exceeded the 14.4% recorded among men of the same age. Adults aged 25 to 34 also overtook those aged 16 to 24 as the age group with the highest vaping prevalence. Overall, about 5.4 million adults in Great Britain used e-cigarettes in 2025, broadly unchanged from the previous year.
DATA
Oct.13