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.

Special Report | Can Nicotine Be Replaced? 6-MN Is Already on the Market While Key Human Evidence Is Still Missing
Special Report | Can Nicotine Be Replaced? 6-MN Is Already on the Market While Key Human Evidence Is Still Missing
Nicotine analogues such as 6-methylnicotine are already appearing in e-cigarettes and oral pouches, even as key human evidence remains limited. A new Nixodine-S study adds nonclinical data showing differences from nicotine in cytotoxicity and receptor activity, while independent studies point to a more complex toxicological picture. With supply-chain activity growing and FDA seeking clearer authority over nicotine analogues, the industry now faces a larger question: what evidence is needed before these substances can credibly replace nicotine?
SCIENCE
Sep.23
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
InterTabac 2026: Further Sessions on Regulation, Market Access and Innovation Confirmed; 2FIRSTS to Host China Market Forum
InterTabac 2026: Further Sessions on Regulation, Market Access and Innovation Confirmed; 2FIRSTS to Host China Market Forum
InterTabac 2026 will bring together international experts to discuss European regulation, tax policy, Track & Trace, market access, retail impacts, consumer behavior and innovation. Sessions will also examine Poland’s tobacco-growing perspective and the growing fragmentation of Europe’s tobacco and nicotine market. Media partner 2FIRSTS will host the second “2FIRSTS Connect at InterTabac” on September 16, focusing on developments in China’s tobacco and nicotine industry.
Aug.06
South Korea Imports 12,126 Kg of Nicotine Analogues From April to August After Bringing Synthetic Nicotine Under Tobacco Law
South Korea Imports 12,126 Kg of Nicotine Analogues From April to August After Bringing Synthetic Nicotine Under Tobacco Law
South Korea's liquid-vape market is showing changes across raw-material imports, product types and sales channels after synthetic nicotine came under the Tobacco Business Act on April 24. Customs data show nicotine-analogue imports totaled 12,126 kilograms from April through August, while synthetic-nicotine imports over the same five months totaled 231,663 kilograms, just 39.3% of the amount imported in March alone. Physical liquid-vape stores tracked in Seoul and Gyeonggi Province fell 9.9%, unmanned outlets edged higher and online sales listings increased from 27,774 to 42,437. Government testing of 105 liquid inhalation products promoted as nicotine-free separately found nicotine in 13 and 6-methylnicotine in 12.
Sep.22
China Tobacco Zhejiang files patent for pressure-triggered, on-demand oral nicotine release
China Tobacco Zhejiang files patent for pressure-triggered, on-demand oral nicotine release
China Tobacco Zhejiang Industrial Co., Ltd. has filed a patent application for an oral nicotine delivery product designed to let users actively adjust nicotine release. The product embeds two types of nicotine reservoirs with different wall thicknesses and positions inside a deformable matrix. Pressure applied with the tongue or lips can rupture the reservoirs and accelerate nicotine release. In simulated oral tests, several patent examples showed sharply higher peak nicotine release rates as applied force increased from 0 N to 1 N and 3 N. The filing explores a shift from preset release profiles toward user-triggered nicotine delivery.
Sep.01
Product | OXVA Launches ONEO Pro in France, Upgrading Its Open-Pod Platform
Product | OXVA Launches ONEO Pro in France, Upgrading Its Open-Pod Platform
Vape brand OXVA has introduced the ONEO Pro, a refillable open-pod system that entered the French market in July 2026. The device features a 2,100mAh battery, up to 40W output, a 4ml refillable cartridge, multiple coil options and a 0.96-inch color TFT display. The launch reflects continued performance upgrades within the refillable open-pod segment, with brands adding higher capacity, adjustable output and smarter device interaction.
Aug.03