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 Court Ends Six-Year Cigarette Excise Dispute, Rejecting Damages Claim
Italian Court Ends Six-Year Cigarette Excise Dispute, Rejecting Damages Claim
Italy’s Lazio Regional Administrative Court has dismissed an appeal by Italian Tobacco Manufacturing and Manifattura Italiana Tabacco over the cigarette excise calculation mechanism, upholding the minimum tax burden rules and excluding compensation for smaller tobacco operators.
News
Jun.26 by 2Firsts Perspectives
PMI Oral Products Chief Says Lack of Rules May Push Nicotine Pouch Market Into Illicit Trade
PMI Oral Products Chief Says Lack of Rules May Push Nicotine Pouch Market Into Illicit Trade
Nick Ricketts, President of Oral Products at Philip Morris International (PMI), told Logos Press that nicotine pouches should be brought under clear regulatory frameworks covering nicotine limits, flavor rules, age verification, sales controls and marketing standards, arguing that the absence of clear rules or blanket bans may push consumer demand into illegal or semi-legal channels.
Jul.06
Australian State Targets Illegal Tobacco Retailers With Tougher Closure Powers
Australian State Targets Illegal Tobacco Retailers With Tougher Closure Powers
According to Reuters, Australia’s state of Victoria introduced legislation to give police and the state tobacco licensing regulator stronger powers to shut businesses selling illegal tobacco, with non-compliant operators facing fines of more than A$2.4 million and up to 20 years in prison.
Jun.05
France Bans Zyn and Other Nicotine Pouches, Violators Face Jail and Fines
France Bans Zyn and Other Nicotine Pouches, Violators Face Jail and Fines
France has officially banned nicotine pouches and other oral nicotine products, including Zyn. The new regulation classifies such products as “toxic substances” and imposes criminal penalties on their use, possession, purchase, and sale. Violators may face up to five years in prison and fines of up to €400,000 (approximately $436,600).
Regulations
May.25
FIFA Bans Vaping in 2026 World Cup Stadiums, Putting Nicotine Rules in Event Compliance Focus
FIFA Bans Vaping in 2026 World Cup Stadiums, Putting Nicotine Rules in Event Compliance Focus
FIFA’s 2026 World Cup stadium rules prohibit smoking, vaping and the use of any tobacco products or electronic smoking devices inside stadiums, including inner and outer perimeters, while electronic smoking devices, tobacco products, lighters and matches are listed as prohibited items, bringing nicotine-product management, venue compliance and cross-border legal differences into focus at a major global sporting event.
Jul.06
Special Report|South Korean Lawmaker Queries China Tobacco Regulator Over Synthetic Nicotine as Export-Rule Gaps Emerge
Special Report|South Korean Lawmaker Queries China Tobacco Regulator Over Synthetic Nicotine as Export-Rule Gaps Emerge
A South Korean lawmaker has asked China’s tobacco regulator to clarify rules for e-cigarettes containing synthetic nicotine amid questions over product declarations and possible tax losses. The dispute exposes gaps between Chinese export requirements and destination-market rules, while underscoring the global impact of China’s licensing and traceability policies.
Jul.10