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.

China Tobacco Yunnan files patent for cellulose-free nicotine pouch scaffold to replace microcrystalline cellulose
China Tobacco Yunnan files patent for cellulose-free nicotine pouch scaffold to replace microcrystalline cellulose
China Tobacco Yunnan Industrial Co., Ltd. has filed a patent application for a cellulose-free scaffold material for nicotine pouches, proposing a combination of bioceramic material, polydextrose and sugar alcohols to replace conventional microcrystalline cellulose and cellulose derivatives. The filing aims to address issues including powdery mouthfeel, residue and limited release control, while also reducing reliance on existing cellulose-based patent portfolios. In patent examples, one fast-release formulation reached a nicotine release rate of 50% at 10 minutes and more than 90% at 20 minutes.
Sep.02
Nevada Considers Nearly Doubling Tobacco Taxes, With $65 Million in New Revenue Expected From Expanded Nicotine Levies
Nevada Considers Nearly Doubling Tobacco Taxes, With $65 Million in New Revenue Expected From Expanded Nicotine Levies
Health groups in Nevada are urging lawmakers to nearly double the state cigarette tax and extend similar tax changes to other nicotine products, including e-cigarettes and nicotine pouches.
Jul.17
FTC Scrutinizes Fifty Bar’s “Made in America” Claims as Vape Marketing Faces New Compliance Risk
FTC Scrutinizes Fifty Bar’s “Made in America” Claims as Vape Marketing Faces New Compliance Risk
The Federal Trade Commission sent a warning letter to Lucky Bar Holdings LLC over “Made in the USA” claims tied to Fifty Bar vape products, saying staff had reason to believe the products may be imported in whole or in significant part despite unqualified U.S.-origin marketing claims.
Jul.20
South Korea’s New Vape Rules Raise Bar for E-Liquid Makers and China-Linked Supply Chains, Expert Says
South Korea’s New Vape Rules Raise Bar for E-Liquid Makers and China-Linked Supply Chains, Expert Says
South Korea’s new vape regulations are reshaping the e-liquid market, raising compliance requirements for manufacturers, retailers and overseas suppliers. In an interview with 2Firsts, Korean nicotine products specialist Sam Kim discusses licensing barriers, inventory impacts, China-linked supply chains, and emerging regulatory challenges around nicotine analogues, nicotine-free products and DIY mixing. The Korean case may offer broader insights as governments worldwide adapt to rapidly evolving nicotine products.
Jul.16
Science | International Experts Propose a New Smoking Cessation Pathway, Citing Higher Quit Rates With E-Cigarettes Than Nicotine Replacement Therapy
Science | International Experts Propose a New Smoking Cessation Pathway, Citing Higher Quit Rates With E-Cigarettes Than Nicotine Replacement Therapy
A new expert paper in JAMA urges U.S. clinicians to include nicotine e-cigarettes in smoking-cessation discussions, citing higher quit rates than nicotine replacement therapy. It also stresses that products must deliver enough nicotine to replace cigarettes, dual use should be brief, and complete switching is the goal. 2Firsts argues the recommendations matter beyond clinics: public-health professionals should reassess relative risk, regulators should preserve sufficient product appeal for adult smokers, and manufacturers should focus on helping users quit cigarettes more sustainably.
SCIENCE
Aug.03 by 2Firsts Perspectives
UK Vape Tax Countdown: Retailer Vape HQ Estimates 100ml E-liquid Prices Could Rise From £12.99 to £39.39, While Pod Kits Increase Less Than 10%
UK Vape Tax Countdown: Retailer Vape HQ Estimates 100ml E-liquid Prices Could Rise From £12.99 to £39.39, While Pod Kits Increase Less Than 10%
The UK’s Vaping Products Duty (VPD), scheduled to take effect in October 2026, is prompting retailers to assess how different vape categories may be affected. UK retailer Vape HQ has estimated potential price changes under the new volume-based tax system, showing that 100ml shortfill e-liquids could see prices rise from around £12.99 to £39.39, a 203% increase, while 2ml prefilled pod vape kits could rise from £5.99 to £6.52, an increase of about 9%. The estimates highlight how a volume-based tax structure creates uneven cost impacts across product categories.
Aug.19