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.

South Korea’s finance ministry to directly crack down on illegal high-nicotine vape liquids
South Korea’s finance ministry to directly crack down on illegal high-nicotine vape liquids
The report says South Korea’s Ministry of Economy and Finance (referred to as the finance ministry) will directly lead crackdowns on illegal distribution and “upward manipulation” of nicotine concentrations in liquid e-cigarettes, after cases of extremely high-strength nicotine liquids circulating at retail shops were highlighted.
Feb.28 by 2FIRSTS.ai
Indiana SB 185 Advances: Foreign-Made Vapes Would Be Barred, With Focus on China
Indiana SB 185 Advances: Foreign-Made Vapes Would Be Barred, With Focus on China
Indiana State Sen. Ron Alting is backing Senate Bill 185, which would ban vape shops in Indiana from selling any foreign-made vaping products and restrict retail shelves to U.S.-made items. Alting has framed the proposal as a consumer-safety measure and has singled out China, citing industry reporting that China produces more than 90% of the world’s vape hardware.
Jan.27 by 2FIRSTS.ai
Guam DOE: Police to respond to all school-campus incidents involving minors and nicotine products
Guam DOE: Police to respond to all school-campus incidents involving minors and nicotine products
According to the Guam Department of Education (GDOE), police officers will now assist in handling incidents involving minor students who vape or use tobacco products on public school campuses, and cases may be forwarded to the Office of the Attorney General.
Jan.15 by 2FIRSTS.ai
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
New Zealand’s largest vape retailer Shosha accused of using “hidden text” on its website
New Zealand’s largest vape retailer Shosha accused of using “hidden text” on its website
New Zealand vape retailer Shosha is accused of using hidden, white-on-white text on its website to promote refillable and disposable vapes. A Health Ministry spokesperson said it could not comment on individual businesses’ compliance status while matters are being assessed, and said the ministry continues to monitor digital advertising and promotional activity and will act where it considers there may be a breach.
Jan.12 by 2FIRSTS.ai
France’s ANSES Report Reframes the Vape Debate: Harm Reduction Confirmed, Regulatory Barriers Rising
France’s ANSES Report Reframes the Vape Debate: Harm Reduction Confirmed, Regulatory Barriers Rising
France’s top health agency has confirmed that vaping is less harmful than smoking — but not risk-free — reshaping the country’s regulatory trajectory. As Paris withdraws a proposed vape tax and debates stricter ingredient, emissions and youth-protection rules, the ANSES report signals not prohibition, but tighter technical oversight. For manufacturers, retailers and EU policymakers, France may be previewing Europe’s next phase of nicotine governance.
Special Report
Feb.23