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’s Heated Tobacco Tax Changes Reshape Consumer Choices, Survey Reveals Impact of Price and Income
Japan’s Heated Tobacco Tax Changes Reshape Consumer Choices, Survey Reveals Impact of Price and Income
A consumer survey by Japanese heated tobacco information platform RELAZO found that rising tobacco prices and planned heated tobacco tax changes may influence smoking decisions among Japanese consumers. The survey covered 49,879 men and women aged 20 to 69 nationwide. It found that around 40% of respondents cumulatively indicated they may consider quitting when a pack reaches ¥600 (approximately US$4.1), while nearly 90% expressed potential quitting intentions at a ¥1,000 (approximately US$6.8) price level. The survey also found significant differences by income level, with lower-income respondents showing greater sensitivity to price increases.
Jul.24
Product | IVG Pro 15K Enters European Retail Channels, Expanding High-Capacity Pod System Segment
Product | IVG Pro 15K Enters European Retail Channels, Expanding High-Capacity Pod System Segment
UK vape brand IVG has introduced the IVG Pro 15K, a high-capacity pod system combining a 2ml prefilled pod with a 10ml refill container to deliver up to 15,000 puffs. Unlike conventional high-puff disposable vapes, the IVG Pro 15K adopts a reusable device structure, reflecting a broader shift in the European vape market toward longer-use-cycle products and reusable hardware ecosystems.
Jul.14
U.S. Fifth Circuit Vacates NicQuid Vape MDO, Says FDA Comparative-Efficacy Standard Violated APA Procedures
U.S. Fifth Circuit Vacates NicQuid Vape MDO, Says FDA Comparative-Efficacy Standard Violated APA Procedures
According to VitalLaw on August 27, 2026, the U.S. Court of Appeals for the Fifth Circuit vacated an FDA marketing denial order (MDO) against NicQuid LLC, ruling that the agency’s comparative-efficacy standard for electronic nicotine delivery system (ENDS) applications had become a substantive rule requiring notice-and-comment rulemaking under the Administrative Procedure Act (APA). The court did not reject FDA’s authority to compare the public health benefits and risks of flavored vapes, but held that the agency could not establish a broadly binding standard through informal adjudications. The case was remanded to FDA for further proceedings.
Aug.28
Product | JNR Launches Crown Shisha 100K for International Wholesale, Pairing 58ml Capacity With Triple-Mesh DTL Design
Product | JNR Launches Crown Shisha 100K for International Wholesale, Pairing 58ml Capacity With Triple-Mesh DTL Design
JNR released the Crown Shisha 100K on August 14, 2026, positioning the ultra-high-capacity disposable around a direct-to-lung (DTL) e-shisha experience. The device combines a 58ml e-liquid capacity, triple 1.0Ω mesh coils and a 1,300mAh rechargeable battery, with JNR claiming up to 100,000 puffs. Adjustable airflow, battery and e-liquid status displays, a leather-style exterior and a shisha-inspired sound effect further differentiate the product. JNR is currently promoting the device through international wholesale and distribution channels, while a specific first retail market has not been disclosed.
Aug.31
Senate Democrat Wyden Probes Trump Administration Vape Policy Shift, Seeks Records From HHS and Reynolds American
Senate Democrat Wyden Probes Trump Administration Vape Policy Shift, Seeks Records From HHS and Reynolds American
U.S. Senator Ron Wyden, the Democratic ranking member of the Senate Finance Committee, has launched an investigation into flavored vape policy changes and requested records from the Department of Health and Human Services (HHS), Reynolds American and Botanic Tonics. The investigation focuses on a timeline involving Reynolds American’s $5 million donation to MAGA Inc. in April 2026 and subsequent vape policy developments. Wyden said the review aims to examine potential links between political donations, corporate communications and government decisions. The investigation does not represent a finding of wrongdoing.
Innovation
Aug.07 by 2Firsts Perspectives
UK HMRC Urges Public to Report Suspicious Vape Shops in Crackdown on Tax Fraud, Money Laundering and Illicit Tobacco Sales
UK HMRC Urges Public to Report Suspicious Vape Shops in Crackdown on Tax Fraud, Money Laundering and Illicit Tobacco Sales
HM Revenue & Customs is urging members of the public to report vape shops, barber shops and other high-street businesses suspected of tax fraud, money laundering or other illegal activity, with informants not required to provide personal details. HMRC plans more than 30,000 interventions in 2026-27 targeting tax fraud, organised crime and illicit activity, including the sale of illegal vapes and tobacco. The push forms part of a broader UK effort to tackle organised crime on high streets, backed by a £30 million government enforcement programme.
Regulations
Aug.17 by 2Firsts Perspectives