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.


This document has been generated through artificial intelligence translation and is provided solely for the purposes of industry discourse and learning. Please note that the intellectual property rights of the content belong to the original media source or author. Owing to certain limitations in the translation process, there may be discrepancies between the translated text and the original content. We recommend referring to the original source for complete accuracy. In case of any inaccuracies, we invite you to reach out to us with corrections. If you believe any content has infringed upon your rights, please contact us immediately for its removal.

FDA Says Flavored ENDS Must Show “Added Benefit” as Small Manufacturers Seek Clearer Switching Benchmarks
FDA Says Flavored ENDS Must Show “Added Benefit” as Small Manufacturers Seek Clearer Switching Benchmarks
During the FDA PMTA roundtable session on “Studies of Adult Benefit,” officials said flavored ENDS must demonstrate “added benefit” over tobacco-flavored products under the APPH standard, including sustained complete switching evidence. Small manufacturers questioned switching benchmarks, study duration, and bridging expectations.
Feb.11
USITC Issues Final Ruling in 337-TA-1392 Investigation, Imposes Limited Exclusion Order and Cease and Desist Orders
USITC Issues Final Ruling in 337-TA-1392 Investigation, Imposes Limited Exclusion Order and Cease and Desist Orders
USITC issues final ruling on oil vaporizing devices, components violating tariff law, with limited exclusion order and cease-and-desist orders.
Jan.21 by 2FIRSTS.ai
Exclusive|Suspected China Tobacco Nicotine Oral Film Product Surfaces on Social Media
Exclusive|Suspected China Tobacco Nicotine Oral Film Product Surfaces on Social Media
China Tobacco Jiangsu IC appears to have developed a nicotine oral film product under the "Nanjing" brand, according to images circulating on Chinese social media. If confirmed, this could potentially mark China Tobacco's first oral nicotine product targeting the domestic market. The product's authenticity has not been officially verified, and no nicotine pouch products have been approved for sale in China.
Special Report
Feb.09
Five Inner West Sydney shops shut for 90 days after 780,000 illicit cigarettes and 2,200 illegal vapes seized
Five Inner West Sydney shops shut for 90 days after 780,000 illicit cigarettes and 2,200 illegal vapes seized
NSW Health has shut down five Inner West Sydney stores for 90 days after a major seizure of illicit cigarettes and illegal vapes, with two additional premises in Northern NSW also served closure notices. The action forms part of a broader crackdown that has seen 66 stores closed since new laws took effect in late 2025, with NSW Health warning further enforcement — including prosecution — may follow.
Feb.09 by 2FIRSTS.ai
PMI says it submitted evidence to FDA panel backing ZYN bid for modified-risk status
PMI says it submitted evidence to FDA panel backing ZYN bid for modified-risk status
Philip Morris International said it presented scientific evidence to the U.S. Food and Drug Administration’s Tobacco Products Scientific Advisory Committee to support its ZYN nicotine pouches seeking a modified risk tobacco product designation, which would allow the company to communicate to adult smokers that switching completely to ZYN could reduce the risk of multiple smoking-related diseases.
Jan.26 by 2FIRSTS.ai
China Caps E-Cigarette Capacity and Requires Export Compliance Proof to Curb “Involution”
China Caps E-Cigarette Capacity and Requires Export Compliance Proof to Curb “Involution”
China’s top tobacco regulator has issued a directive aimed at preventing excess capacity and curbing “involution-style” competition in the e-cigarette sector. The notice tightens investment controls, formalizes verified capacity management and requires exporters to submit compliance proof for destination markets, signaling a push toward higher industry concentration and stricter cross-border oversight.
Special Report
Feb.13