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.

WHO’s First Global Report on Nicotine Pouches: Harm Reduction Questions Remain Amid Global Regulatory Warning
WHO’s First Global Report on Nicotine Pouches: Harm Reduction Questions Remain Amid Global Regulatory Warning
Ahead of World No Tobacco Day 2026, WHO released its first global report on nicotine pouches, warning that rapid market growth, youth-oriented marketing and weak regulation are converging. 2Firsts views the report as an important warning, but not a complete risk assessment, with harm-reduction questions still unresolved.
Special Report
May.17
BP, Marathon and Valero Warn U.S. Gas-Station Stores: Illegal Vape Sales Could Bring Heavy Fines and Card-Processing Limits
BP, Marathon and Valero Warn U.S. Gas-Station Stores: Illegal Vape Sales Could Bring Heavy Fines and Card-Processing Limits
Fiserv and service station operators including BP, Marathon Petroleum and Valero have warned U.S. partners and gas-station convenience-store owners that selling illegal vapes could lead to heavy fines, breach brand agreements and even put stores’ card-processing access at risk, according to Reuters.
Regulations
Jul.07 by 2Firsts Perspectives
BofA: U.S. Nicotine Market Splits as Vapor Sales Fall 17.2% and Oral Tobacco Rises 5.8%
BofA: U.S. Nicotine Market Splits as Vapor Sales Fall 17.2% and Oral Tobacco Rises 5.8%
According to Investing.com citing Bank of America scanner data for the four weeks ending May 30, U.S. nicotine category performance was mixed, with cigarette, vapor and cigar sales declining while oral tobacco sales rose 5.8%.
Jun.10
Malaysia Nicotine Vape Market Faces Legal Uncertainty Over Tax and Poisons List Ruling
Malaysia Nicotine Vape Market Faces Legal Uncertainty Over Tax and Poisons List Ruling
Malaysia’s Finance Minister Anwar Ibrahim said duties and taxes on nicotine-containing vape products will be determined in line with the Court of Appeal’s ruling on whether liquid or gel nicotine can be exempted from the Poisons List under the Poisons Act 1952, a case that could affect the legal basis for vape taxation, retail sales and future ban policy.
Jun.29
Product | Geek Bar BURJ 80K Extends High-Puff Competition Into Hookah-Style DTL Use
Product | Geek Bar BURJ 80K Extends High-Puff Competition Into Hookah-Style DTL Use
2Firsts has noted that Geek Bar has added BURJ to its official product portfolio under the E-HOOKAH category. Public information shows that BURJ 80K is a hookah-style disposable vape featuring a 25ml e-liquid capacity, a 1500mAh battery, 0.4Ω dual coils and three operating modes: ECO, Regular and Pulse. According to publicly available product information, the device is rated for up to 80,000 puffs in ECO mode and uses a nicotine strength of 0.5% (5mg/ml).
Market
May.29
Pennsylvania Updates ENDS Certification List as Chinese-Linked Manufacturers Enter State Review
Pennsylvania Updates ENDS Certification List as Chinese-Linked Manufacturers Enter State Review
Pennsylvania’s June 26 Pending ENDS Certifications list includes 23 manufacturers under review, including Shenzhen Smoore, Shenzhen IVPS, YME Technology and China-linked Boulder International. The list shows state-level vape regulation moving beyond retail brands toward manufacturer-based market access alongside FDA oversight.
Regulations
Jul.06 by 2Firsts Perspectives