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.

IVG Parent Secures HMRC Excise Warehouse and Duty Stamp Approvals Ahead of UK Vape Tax
IVG Parent Secures HMRC Excise Warehouse and Duty Stamp Approvals Ahead of UK Vape Tax
Acme Vape Ltd, the company behind UK vaping brand IVG, has received HM Revenue & Customs approval to operate an excise warehouse for vaping products and participate in the Vaping Duty Stamps Scheme. The UK's Vaping Products Duty will take effect on October 1, 2026, at a flat rate of £2.20 per 10ml of vaping liquid. Acme Vape Ltd says its approved warehouse in Preston will become operational under the new regime on the same date.
Regulations
Sep.18 by 2Firsts Perspectives
FDA Appoints Former Tobacco Enforcement Deputy Jessica Zeller as Director as Agency Weighs PMTA Framework Changes
FDA Appoints Former Tobacco Enforcement Deputy Jessica Zeller as Director as Agency Weighs PMTA Framework Changes
The U.S. Food and Drug Administration (FDA) has named Jessica Zeller director of the Center for Tobacco Products' (CTP) Office of Compliance and Enforcement (OCE), effective November 1, 2026. Zeller, the office's inaugural deputy director, returns from medical device manufacturer Edwards Lifesciences with more than 20 years of regulatory and legal experience. The appointment follows CTP leadership changes and adjustments to tobacco regulation. Bret Koplow became permanent CTP director in September; the FDA revised enforcement priorities for unauthorized e-cigarettes and nicotine pouches in May and announced faster PMTA review procedures. On September 28, the agency said it would evaluate changes to the existing PMTA regulatory framework, including potential rulemaking to replace it.
FDA
Oct.20 by 2Firsts Perspectives
China’s Vape-Related Exports Rose 4.5% in Q3 2026 as 21.6% Growth in Shipments to the UK Offset a Decline in Shipments to the US
China’s Vape-Related Exports Rose 4.5% in Q3 2026 as 21.6% Growth in Shipments to the UK Offset a Decline in Shipments to the US
China's vape-related exports rose 4.5% year over year to $2.86 billion in the third quarter of 2026, led by stronger shipments to the United Kingdom as exports to the United States declined. UK-bound shipments increased 21.6%, adding $81.9 million, while US exports fell 5.2%, or $53.6 million. Growth weakened through the quarter, with September exports down 6.3% globally and 37.8% to the US. Nicotine-containing vape products accounted for more than 82% of the quarterly net increase, while device exports were nearly flat. Nine-month exports totaled $7.82 billion, up 4.0%.
DATA
Oct.26
How Many Nicotine Pouch Factories Does Europe Need? 2Firsts Interviews AIRSCREAM on the OEM Market
How Many Nicotine Pouch Factories Does Europe Need? 2Firsts Interviews AIRSCREAM on the OEM Market
At InterTabac 2026, nicotine pouch growth was visible not only in brands but across equipment, raw materials and OEM manufacturing. 2Firsts interviewed AIRSCREAM commercial head Steve Moore on how many pouch factories Europe may ultimately need and where manufacturers can differentiate, from formulation and flavour to pouch materials, production consistency and customer service. The category continues to expand, but questions remain over future capacity, consolidation and the long-term structure of the supply chain.
Sep.18
Reynolds Seeks to Join Altria Lawsuit Challenging FDA PMTA Rule and Calculation of 180-Day Deadline
Reynolds Seeks to Join Altria Lawsuit Challenging FDA PMTA Rule and Calculation of 180-Day Deadline
Three R.J. Reynolds companies are seeking to intervene in a lawsuit filed by Altria subsidiaries Helix Innovations and NJOY challenging the FDA's 2021 PMTA final rule. The companies dispute how the agency uses Acceptance and Filing reviews and completeness determinations to establish when the Tobacco Control Act's 180-day decision period begins. Reynolds has also linked prolonged PMTA reviews to competition from unauthorized vaping products. The FDA, meanwhile, has been accelerating reviews and reducing its backlog.
Sep.14
Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
Sweden's Public Health Agency has found ingredient labels on ZYN nicotine pouches sold by Philip Morris International subsidiary Swedish Match to be noncompliant, according to Dagens industri. The products' packaging listed 10 to 13 ingredients, compared with 11 to 42 in regulatory submissions, with multiple flavoring ingredients grouped under the generic term "aromer." The agency ordered corrective action, warning of a conditional penalty of SEK 2 million per month for noncompliance. The order applies only to products manufactured after the decision becomes legally effective and does not require recalls. Swedish Match disputes the agency's interpretation and plans to appeal.
PMI
Oct.22