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.

Australia’s TGA Places Nicotine Pouches Under Therapeutic Goods Rules From July 24, Blocking Imports of Unapproved Products
Australia’s TGA Places Nicotine Pouches Under Therapeutic Goods Rules From July 24, Blocking Imports of Unapproved Products
Australia is strengthening controls on nicotine pouches under its existing therapeutic goods regulatory framework. According to the Therapeutic Goods Administration (TGA), nicotine pouch products must meet regulatory requirements, and unapproved products cannot be legally imported. The move follows Australia’s broader approach of maintaining strict oversight of nicotine products, including nicotine-containing vapes. As nicotine pouches expand globally, Australia’s regulatory approach highlights growing differences in how countries manage emerging smoke-free nicotine products.
Regulations
Jul.27
Korean component maker ITM Semiconductor says Indonesia unit starts e-cigarette device output as related Q1 revenue rises 55.4%
Korean component maker ITM Semiconductor says Indonesia unit starts e-cigarette device output as related Q1 revenue rises 55.4%
South Korea’s KOSDAQ-listed electronics-component maker ITM Semiconductor said its Indonesia subsidiary has begun full-scale mass production of e-cigarette devices, with first-quarter revenue from the business rising 55.4% year on year to 42.1 billion won, Maeil Business Newspaper reported.
Jul.08
From Nicotine Pouches to Soft Candy Forms: China Tobacco Hubei explores adjustable-release oral nicotine products
From Nicotine Pouches to Soft Candy Forms: China Tobacco Hubei explores adjustable-release oral nicotine products
China-based China Tobacco Hubei Industrial Co., Ltd. has filed a patent application covering an oral nicotine product and its preparation method. The patent proposes a soft candy-shaped oral nicotine product containing nicotine ingredients, gelling agents, sweeteners and alkaline pH regulators. Through formulation adjustments and homogeneous or dual-layer structures, the technology aims to achieve different nicotine release profiles. The filing reflects exploration of new oral nicotine product formats and controlled nicotine delivery approaches.
Aug.06
Iowa Enforces Vape Registry Law as Retailers Warn Product Limits Could Increase Store Pressure
Iowa Enforces Vape Registry Law as Retailers Warn Product Limits Could Increase Store Pressure
Iowa has begun enforcing its vape registry law, requiring vape products to be registered before they can be legally sold in the state. The move follows a decision by the U.S. Court of Appeals for the Eighth Circuit to lift an injunction that had blocked enforcement. Retailers have warned that tighter product availability rules could increase pressure on vape shops. One Iowa retailer said that if only a limited number of products remain available, many stores could face significant business challenges.
Aug.06
Exclusive: China Tobacco Launches Locally Made MODEN FREE Nicotine Pouches in Indonesia
Exclusive: China Tobacco Launches Locally Made MODEN FREE Nicotine Pouches in Indonesia
2Firsts exclusively reports that China Tobacco Zhejiang Industrial has launched MODEN FREE nicotine pouches in Indonesia. The locally manufactured product is sold through Sixhill, a next-generation tobacco channel under CFU Group, at about $1.80 per 18-pouch can. The launch moves China Tobacco’s nicotine pouch activity beyond trade-show displays and testing into local production and public retail.
Jul.16
Dutch NVWA Seizes Record 277,000 Illegal Vapes; Video Shows “AL FAKHER” Cartons
Dutch NVWA Seizes Record 277,000 Illegal Vapes; Video Shows “AL FAKHER” Cartons
The Dutch Food and Consumer Product Safety Authority, known as the NVWA, seized more than 277,000 illegal vapes near Rotterdam and nearly 150,000 boxes of nicotine pouches in Utrecht and Rotterdam, calling them the largest batches of such products it has found to date. Video footage released by the NVWA shows some cartons in the warehouse bearing the “AL FAKHER / الفاخر” name, though the agency did not identify brands.
Jul.10