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.

Japan Health Ministry Cites Limited Evidence in Decision Not to Tighten Heated Tobacco Rules
Japan Health Ministry Cites Limited Evidence in Decision Not to Tighten Heated Tobacco Rules
Japan’s health ministry has proposed not tightening regulations on heated tobacco products to the same level as cigarettes as part of a review of passive smoking measures, with an expert panel broadly agreeing with the proposal, Jiji Press reported.
Jul.10
Scotland Plans to Remove Business Rates Relief From Vape Shops From 2027
Scotland Plans to Remove Business Rates Relief From Vape Shops From 2027
The Scottish Government plans to remove business rates relief from vape shops from April 1, 2027, saying the measure is intended to ensure vape retailers contribute to the high street and align rates relief with public health commitments, while the impact on convenience stores that sell vaping products remains unclear.
News
Jun.26 by 2Firsts Perspectives
State Registries Are Reshaping U.S. Vape Market Access 2Firsts Interview with U.S. Vapor Manufacturers Association President Allison Boughner
State Registries Are Reshaping U.S. Vape Market Access 2Firsts Interview with U.S. Vapor Manufacturers Association President Allison Boughner
As the U.S. vapor market faces FDA authorizations, import seizures and growing state-level restrictions, AVM President Allison Boughner told 2Firsts that state product registries and white-list systems are having the most immediate impact. She said distributors are placing greater weight on documentation, product origin and supply-chain transparency.
Special Report
May.26
Ireland Vape Bill Passes Dáil, Setting Limits on Flavours, Packaging and Retail Display
Ireland Vape Bill Passes Dáil, Setting Limits on Flavours, Packaging and Retail Display
Ireland’s Public Health (Tobacco Products and Nicotine Inhaling Products) (Amendment) Bill 2026 has passed final stage in the Dáil and will move to the Seanad, with measures to limit vape flavours to tobacco or unflavoured products and tighten rules on packaging colours, retail advertising, in-store displays and sales of nicotine pouches to minors.
News
Jun.26 by 2Firsts Perspectives
BAT Estimates U.S. Unauthorized Vape Market at $9.4 Billion, Plans New Vuse and Velo Launches After FDA Enforcement Shift
BAT Estimates U.S. Unauthorized Vape Market at $9.4 Billion, Plans New Vuse and Velo Launches After FDA Enforcement Shift
British American Tobacco (BAT) CEO Tadeu Marroco said the U.S. unauthorized vape market is worth about £7 billion, or US$9.43 billion. Following a shift in FDA enforcement policy, BAT plans to launch flavored Vuse products in the third quarter and an updated Velo pouch in August or September.
Jun.15
BofA: U.S. Nicotine Market Splits as Vapor Sales Fall 17.2% and Oral Tobacco Rises 5.8%
BofA: U.S. Nicotine Market Splits as Vapor Sales Fall 17.2% and Oral Tobacco Rises 5.8%
According to Investing.com citing Bank of America scanner data for the four weeks ending May 30, U.S. nicotine category performance was mixed, with cigarette, vapor and cigar sales declining while oral tobacco sales rose 5.8%.
Jun.10