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.

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
NAS 2026 | Cliff Douglas: Risk Continuum Should Play a Central Role in Tobacco Policy
NAS 2026 | Cliff Douglas: Risk Continuum Should Play a Central Role in Tobacco Policy
Cliff Douglas, a veteran U.S. tobacco-control and public health policy figure, told NAS 2026 that the “continuum of risk” should play a central role in tobacco policy. He called for clearer market pathways, stronger risk communication, differentiated regulation and enforcement, and said possible FDA reforms to PMTA reviews could be a “welcome correction” if they create a more efficient, predictable route for scientifically substantiated lower-risk products. Read 2Firsts’ on-site coverage.
Sep.26
Product | HQD SiSA 80K Enters the U.S. Market With a Hookah-Inspired Approach to the High-Capacity Disposable Segment
Product | HQD SiSA 80K Enters the U.S. Market With a Hookah-Inspired Approach to the High-Capacity Disposable Segment
The HQD SiSA 80K Hookah Disposable Vape has appeared across U.S. and cross-border online retail channels. The device comes prefilled with 28ml of e-liquid, uses a 5% nicotine salt configuration and carries a brand claim of up to 80,000 puffs. Beyond puff count, the product differentiates itself through hookah-inspired features including adjustable airflow, a flowing-water sound effect and flavor options associated with traditional hookah consumption.
Aug.18
Huabao International Buys Indonesian HNB Manufacturer for RMB 90 Million, Adding OEM/ODM Capacity
Huabao International Buys Indonesian HNB Manufacturer for RMB 90 Million, Adding OEM/ODM Capacity
Huabao International Holdings Limited will acquire 100% of PT Broad Far Indonesia through two wholly owned subsidiaries for approximately RMB 90 million. The Indonesian company manufactures and sells heat-not-burn tobacco sticks and provides OEM/ODM services. The sellers are part of a related-party group controlled by Huabao International Chair and controlling shareholder Zhu Linyao. PT Broad Far Indonesia generated $4.37 million in revenue and $177,000 in profit after tax in the first half of 2026, while net assets stood at about $326,000 at June-end. An independent valuer assessed the company’s equity at approximately RMB 93.06 million. Following completion, the HNB manufacturing operation will be consolidated into Huabao International.
News
Sep.29 by 2Firsts Perspectives
JTI Proposes 25-Cent Irish Cigarette Tax Increase, Says It Could Raise €45 Million
JTI Proposes 25-Cent Irish Cigarette Tax Increase, Says It Could Raise €45 Million
Japan Tobacco International's Irish business has proposed a €0.25 tax increase on a pack of 20 cigarettes in its pre-Budget 2027 submission, below the €0.50-or-more increases typically imposed in recent Irish budgets. JTI says the proposal could generate around €45 million in additional Exchequer revenue while limiting further movement toward illicit and non-Irish-tax-paid tobacco. Revenue's existing estimate for a comparable €0.25 increase, including pro-rata rises on other tobacco products, is about €18 million for a full year.
JTI
Sep.18 by 2Firsts Perspectives
Product | PMJ Adds Bold Ruby to IQOS ILUMA i Lineup in Japan, Convenience-Store Rollout Starts Sept. 29
Product | PMJ Adds Bold Ruby to IQOS ILUMA i Lineup in Japan, Convenience-Store Rollout Starts Sept. 29
Philip Morris Japan (PMJ) launched Bold Ruby as a new regular color for the IQOS ILUMA i and IQOS ILUMA i ONE in Japan on September 16, 2026, priced at JPY 6,980 and JPY 3,980, respectively. Initial sales began through IQOS online and physical channels, with convenience stores and selected tobacco retailers set to follow from September 29. Bold Ruby is a regular rather than limited-edition colorway and is available for the ILUMA i and ILUMA i ONE, but not the ILUMA i PRIME. The release does not involve changes to the devices' core hardware or functions.
Sep.22