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.


This document has been generated through artificial intelligence translation and is provided solely for the purposes of industry discourse and learning. Please note that the intellectual property rights of the content belong to the original media source or author. Owing to certain limitations in the translation process, there may be discrepancies between the translated text and the original content. We recommend referring to the original source for complete accuracy. In case of any inaccuracies, we invite you to reach out to us with corrections. If you believe any content has infringed upon your rights, please contact us immediately for its removal.

Kazakhstan: Over 131,000 vapes seized in Almaty and Pavlodar case; about $1.422 million cited
Kazakhstan: Over 131,000 vapes seized in Almaty and Pavlodar case; about $1.422 million cited
Kazakhstan’s financial monitoring authorities said a group is suspected of illicitly distributing vaping devices in Almaty and Pavlodar Region, using Telegram as a sales channel with courier delivery. During searches, investigators seized more than 131,000 vapes valued at 711 million tenge (about $1.422 million, using 1 tenge = $0.0020).
Mar.04 by 2FIRSTS.ai
Rethinking Nicotine Harm Reduction: A Neuroscientist’s Perspective on Scientific Gaps and Future Directions — By Dr. Xin-an Liu
Rethinking Nicotine Harm Reduction: A Neuroscientist’s Perspective on Scientific Gaps and Future Directions — By Dr. Xin-an Liu
After France’s ANSES report on nicotine products and harm reduction, Dr. Xin-an Liu wrote to 2Firsts reassessing the field’s foundations. She argues the debate reveals gaps in evidence on long-term behavioral substitution, addiction pathways and neurobiological impacts, and calls for longitudinal research, integrated behavioral science and neuroimaging, clearer risk assessment and stronger transparency to ensure policy and next-generation product development rest on solid evidence.
Industry Insight
Feb.24
FDA Says Flavored ENDS Must Show “Added Benefit” as Small Manufacturers Seek Clearer Switching Benchmarks
FDA Says Flavored ENDS Must Show “Added Benefit” as Small Manufacturers Seek Clearer Switching Benchmarks
During the FDA PMTA roundtable session on “Studies of Adult Benefit,” officials said flavored ENDS must demonstrate “added benefit” over tobacco-flavored products under the APPH standard, including sustained complete switching evidence. Small manufacturers questioned switching benchmarks, study duration, and bridging expectations.
Feb.11
Russia’s Duma Deputy Speaker Davankov calls for a total vape ban, citing drug sales disguised as vapes
Russia’s Duma Deputy Speaker Davankov calls for a total vape ban, citing drug sales disguised as vapes
Vladislav Davankov, deputy speaker of Russia’s State Duma, urged a nationwide ban on vapes, arguing it would help prevent drugs being sold under the cover of vaping products, including near schools. The remarks come as Russia prepares to enforce a separate ban on vape sales at public transport stops starting Sept. 1, 2026.
Feb.09 by 2FIRSTS.ai
Louisiana lawmaker pushes bill to ban vape product sales within 300 feet of schools
Louisiana lawmaker pushes bill to ban vape product sales within 300 feet of schools
A Louisiana lawmaker has introduced HB 302, which would prohibit businesses from selling vapor products within 300 feet of schools. The bill would measure the distance by a person walking on the sidewalk from the nearest point on school property to the nearest point of the business. It would also give the commissioner authority to modify how the distance is calculated, while maintaining the 300-foot limit.
Feb.26 by 2FIRSTS.ai
KT&G says lil reached about US$2.924 billion in cumulative sales and is expanding overseas
KT&G says lil reached about US$2.924 billion in cumulative sales and is expanding overseas
KT&G said its HNB brand lil has grown since launch, reporting KRW 7.8 billion (about US$5.304 million) in sales in 2017 and about KRW 4.3 trillion (about US$2.924 billion) in cumulative sales by last year’s third quarter, with KRW 5 trillion (about US$3.400 billion) described as within reach. KT&G said lil has entered more than 30 countries and supplies some products abroad via a partnership with PMI.
Jan.13 by 2FIRSTS.ai