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.

Zhang Xiaotang Appointed Deputy Director of China’s Tobacco Regulator, Adding Another Finance-Background Official to Top Leadership
Zhang Xiaotang Appointed Deputy Director of China’s Tobacco Regulator, Adding Another Finance-Background Official to Top Leadership
China’s State Council has appointed Zhang Xiaotang as deputy director of the State Tobacco Monopoly Administration, with the regulator’s official website now listing him as a Party leadership group member and deputy director. Zhang previously led Hebei China Tobacco and earlier headed the STMA’s finance and audit department. His appointment follows the elevation earlier this year of former tax official Yao Laiying to head the STMA, adding another senior official with a strong fiscal or financial-management background to China Tobacco’s top leadership in 2026.
News
Sep.20
South Korea Constitutional Court Upholds Volume-Based E-Liquid Tax, With Challenged Rates at KRW 370 and KRW 628 per Milliliter
South Korea Constitutional Court Upholds Volume-Based E-Liquid Tax, With Challenged Rates at KRW 370 and KRW 628 per Milliliter
South Korea's Constitutional Court has upheld fixed taxes on nicotine-containing e-cigarette liquids based on solution volume, ruling that challenged provisions imposing KRW 370 per milliliter in individual consumption tax and KRW 628 per milliliter in tobacco consumption tax do not violate the Constitution. The cases stemmed from historical disputes involving importers that reported nicotine as being extracted from tobacco stems rather than leaves. South Korea has since broadened its tobacco definition to include synthetic nicotine, while current tax laws provide reduced rates for certain products not derived from tobacco.
Sep.18
Product | BAT Expands VELO Peach Ice Medium to FamilyMart Stores Nationwide in Japan
Product | BAT Expands VELO Peach Ice Medium to FamilyMart Stores Nationwide in Japan
British American Tobacco Japan (BAT Japan) expanded VELO Peach Ice Medium to FamilyMart stores nationwide in Japan from September 7, 2026. The oral tobacco product first launched on July 6 and had previously been sold through VELO's official online store, glo Store Ginza and tobacco retailers. It combines peach flavor with menthol cooling at a Medium strength level and is priced at JPY 360. Japanese tobacco retailers list 15 pouches per pack. The move adds the new SKU to an existing nationwide FamilyMart distribution network for VELO rather than marking the brand's first entry into the convenience-store chain.
Sep.15
Product | JT to Launch MEVIUS Tropical Option in Japan, Expanding Ploom Tobacco Stick Lineup to 32
Product | JT to Launch MEVIUS Tropical Option in Japan, Expanding Ploom Tobacco Stick Lineup to 32
Japan Tobacco (JT) will launch MEVIUS Tropical Option, a new tobacco stick for Ploom, nationwide in Japan from October 6, 2026. The capsule-format product combines mango-oriented sweetness with menthol cooling, adding a tropical flavor to the MEVIUS Ploom tobacco-stick lineup for the first time. Each pack contains 20 sticks and will launch at JPY 590. The product is compatible with all Ploom devices, and its addition will expand the Ploom tobacco-stick portfolio to 32 variants.
Sep.08
JUUL Purchasers Ask Ninth Circuit to Preserve Antitrust Classes in Case Over Altria’s $12.8 Billion Investment
JUUL Purchasers Ask Ninth Circuit to Preserve Antitrust Classes in Case Over Altria’s $12.8 Billion Investment
Private antitrust litigation stemming from Altria's 2018 $12.8 billion investment for a 35% economic interest in JUUL is advancing before the U.S. Court of Appeals for the Ninth Circuit. Direct purchasers, indirect purchasers and indirect resellers of JUUL products filed answering briefs this week seeking to preserve class certifications granted by a California federal court in February. Altria and JUUL argue that individual consumers and large distributors differ too much in purchasing terms to remain in a single direct-purchaser class, while a separate dispute concerns whether California antitrust law can apply to indirect purchasers across 27 jurisdictions. A September trial has been put on hold during the appeal.
Sep.23
FDA Authorizes JUUL2, Cites Adult Switching Amid Efforts to Speed PMTA Reviews
FDA Authorizes JUUL2, Cites Adult Switching Amid Efforts to Speed PMTA Reviews
The FDA authorized the JUUL2 device and tobacco- and menthol-flavored pods on Aug. 28, bringing the number of authorized e-cigarette products to 48. The agency highlighted complete switching among adult smokers, with six-week switching rates reaching 28.4%–49.3% for the menthol pod. The decision comes as FDA works to speed PMTA reviews, reduce application backlogs and expand authorized e-cigarette and nicotine-pouch products while maintaining enforcement priorities for unauthorized products.
Regulations
Aug.29