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.

French Lawmakers Move to Extend Plain Packaging Rules to Vaping Product
French Lawmakers Move to Extend Plain Packaging Rules to Vaping Product
French lawmakers Nicolas Thierry and Pierre Cazenave said on April 15 that they will file a cross-party bill to extend plain packaging requirements to vaping products. Under the proposal, unit packs and outer packaging for vaping products, including those without nicotine, would become neutral and standardized in the same way cigarette packs have been since 2017.
Apr.16 by 2FIRSTS.ai
Namibia Moves to Tighten Laws on E-Cigarettes and Emerging Nicotine Products
Namibia Moves to Tighten Laws on E-Cigarettes and Emerging Nicotine Products
Namibia is moving to tighten regulation of e-cigarettes and other emerging nicotine products as part of broader tobacco control efforts. Deputy health minister Susan Ndjaleka said the government is reviewing the Tobacco Products Control Act to close regulatory gaps and address emerging tobacco products. Namibia is also working toward joining the Protocol to Eliminate Illicit Trade in Tobacco Products in order to curb the black market and protect public revenue.
Apr.17 by 2FIRSTS.ai
Turning Point Brands Reports Q1 2026 Net Sales of $124.3 Million as Modern Oral Net Sales Rise 133%
Turning Point Brands Reports Q1 2026 Net Sales of $124.3 Million as Modern Oral Net Sales Rise 133%
Turning Point Brands reported first-quarter 2026 results on May 7, covering the period ended March 31, 2026. Total consolidated net sales were $124.3 million, up 16.8% year on year. Gross profit was $68.3 million, up 14.6%, while net income fell 19.0% to $11.7 million. Adjusted EBITDA declined 6.5% to $25.9 million.
May.08 by 2FIRSTS.ai
FDA Adds 18 Tobacco Harmful Constituents and Seeks Comment on 3 More
FDA Adds 18 Tobacco Harmful Constituents and Seeks Comment on 3 More
U.S. Food and Drug Administration published a Federal Register notice finalizing the addition of 18 constituents to the established list of Harmful and Potentially Harmful Constituents in tobacco products. With the update, the list now contains 111 constituents. FDA also proposed adding three more constituents to the list and opened a public comment period ending at 11:59 p.m. ET on May 26, 2026.
Apr.24 by 2FIRSTS.ai
U.S. Senator Durbin Criticizes FDA’s First Flavored Vape Authorization, Says Trump Administration Conceded to Big Tobacco
U.S. Senator Durbin Criticizes FDA’s First Flavored Vape Authorization, Says Trump Administration Conceded to Big Tobacco
U.S. Senator Dick Durbin on May 13 criticized the Trump Administration’s Food and Drug Administration for approving the sale and marketing of fruit-flavored e-cigarettes for the first time, while also allowing some illegal vaping products to remain on the market. He also linked the regulatory shift to the departure of FDA Commissioner Marty Makary, saying White House pressure on regulators to approve tobacco product applications could create serious public-health consequences.
Regulations
May.15
FDA Renews Exposure Modification Authorization for IQOS Devices and Three HeatSticks Products
FDA Renews Exposure Modification Authorization for IQOS Devices and Three HeatSticks Products
U.S. Food and Drug Administration renewed modified risk granted orders for five IQOS products from Philip Morris Products S.A., including two IQOS system holders and chargers and three HeatSticks products. Under the renewed orders, the products may continue to be marketed with an exposure modification claim.
Apr.20 by 2FIRSTS.ai