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.

South Korea Extends Vape Rules to Unmanned Stores After Bringing Synthetic Nicotine Under Tobacco Law
South Korea Extends Vape Rules to Unmanned Stores After Bringing Synthetic Nicotine Under Tobacco Law
South Korea's Ministry of Gender Equality and Family said on September 14 that it plans to designate unmanned e-cigarette stores as businesses where minors are prohibited from entering or working. Operators would be required to verify customers' ages and display notices restricting access by minors. The proposal is open for public comment through October 6. The move follows an April expansion of South Korea's statutory tobacco definition that brought products made with natural or synthetic nicotine under the Tobacco Business Act. Nicotine-free liquids and products using nicotine analogues such as 6-methylnicotine, however, remain an emerging regulatory issue.
Sep.21
Couche-Tard Posts Double-Digit U.S. Same-Store Growth in Other Nicotine Products, Led by Pouches
Couche-Tard Posts Double-Digit U.S. Same-Store Growth in Other Nicotine Products, Led by Pouches
Alimentation Couche-Tard said U.S. same-store sales in its “other nicotine products” category grew at a double-digit rate in the first quarter of fiscal 2027, led by nicotine pouches, while overall U.S. same-store merchandise revenues increased 1.7%. The company also said its Canadian nicotine business continued to face regulatory pressure and illicit-market headwinds. The U.S. performance coincides with Couche-Tard's participation in efforts to reopen Canadian convenience-store access to authorized nicotine pouches, though the company has not established a direct causal link between the two.
Sep.14
PMI Global Communications Chief Moira Gilchrist: Why AI Matters More Than Ever in the Smoke-Free Transition
PMI Global Communications Chief Moira Gilchrist: Why AI Matters More Than Ever in the Smoke-Free Transition
Philip Morris International (PMI) Chief Global Communications Officer Moira Gilchrist said artificial intelligence is changing how companies understand audiences, manage owned information channels and communicate business transformation. PMI is using AI-generated audience personas to test messaging while optimizing its corporate website and other owned channels for large language models. As PMI continues its transition from cigarettes toward smoke-free products, Gilchrist said owned data and corporate channels are becoming increasingly important in demonstrating the scale of that transformation.
Aug.26
2Firsts Hosts China Market Forum at InterTabac as Global Industry Attention to China’s Tobacco Sector Deepens
2Firsts Hosts China Market Forum at InterTabac as Global Industry Attention to China’s Tobacco Sector Deepens
On September 16, 2Firsts hosted a China-focused industry forum during InterTabac in Dortmund, bringing together more than 30 participants from North America, Europe, India, South Korea and other markets. The session covered traditional tobacco, next-generation products, exports, technology, regulation and supply chains, while examining how China’s tobacco sector operates, where its transformation may be heading, and why its growing role matters increasingly to companies across the global tobacco and nicotine industry.
Sep.21
Canada Considers Easing Pharmacy-Only Nicotine Pouch Sales Rules, Potentially Reopening Convenience Store Channel
Canada Considers Easing Pharmacy-Only Nicotine Pouch Sales Rules, Potentially Reopening Convenience Store Channel
Canada's federal government is considering changes to current restrictions on where nicotine pouches can be sold, potentially allowing authorized products to return to convenience stores and other general retail channels, although no decision has been made. Since 2024, emerging nicotine replacement therapy products such as nicotine pouches have been largely restricted to behind-the-counter pharmacy sales. Health Canada, meanwhile, continues to recall unauthorized and higher-strength nicotine pouches, indicating that the current discussion concerns retail access for authorized products rather than a broad relaxation of nicotine pouch regulation.
Sep.14
UK Directors Banned After 352,688 Vapes Imported From China Were Misdeclared as Medical Nebulizers in £15 Million Tax Case
UK Directors Banned After 352,688 Vapes Imported From China Were Misdeclared as Medical Nebulizers in £15 Million Tax Case
The UK Insolvency Service said YSK Enterprises imported large quantities of vapes from China in 2023, with a shipment addressed to the company declared as medical nebulizers before Border Force found 352,688 vaping products. HMRC calculated nearly £15 million ($20.3 million) in unpaid VAT and customs duty, alongside about £437,000 in corporation tax. Two directors were disqualified for nine years. The case predates the UK's Vaping Products Duty, which will introduce vape-specific excise and duty-stamp requirements from October 2026.
Regulations
Sep.11