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.

South Korea Fully Reviews Nicotine-Analog and Nicotine-Free Vape Liquid Imports, With Over 99% From China and Chinese Supply-Chain Documents Under Scrutiny
South Korea Fully Reviews Nicotine-Analog and Nicotine-Free Vape Liquid Imports, With Over 99% From China and Chinese Supply-Chain Documents Under Scrutiny
Korea Customs Service has tightened import controls on nicotine-analog and nicotine-free e-cigarette liquids, placing the products under 100% document review and subjecting all e-cigarette liquid import declarations to pre-clearance ingredient analysis. As of September 20, 2026, South Korea had imported about 15 metric tons of nicotine-analog liquids, 99.99% from China, and about 316 metric tons of nicotine-free liquids, including roughly 315 metric tons, or 99.7%, from China. The measures follow South Korea's April expansion of its tobacco definition to include synthetic nicotine products and include new checks on Chinese manufacturing, transaction and export documentation.
Sep.24
Product | VAPORESSO Launches PRIX MTL Pod, With NFC Version Linking Interchangeable Panels to On-Screen Animations
Product | VAPORESSO Launches PRIX MTL Pod, With NFC Version Linking Interchangeable Panels to On-Screen Animations
VAPORESSO introduced the PRIX MTL pod system in August 2026 in two versions, Filter and NFC. The Filter version allows users to switch between a conventional drip tip and a filter tip, while the NFC version links interchangeable panels to matching on-screen animations. PRIX features a 2,600mAh battery, a 5.5ml pod, a 0.87-inch TFT display and a maximum output of 40W, alongside Dual Mesh Impact Pods capable of operating at two resistance and power configurations. VAPORESSO's French website lists MSRP at $39.99 for the Filter version and $49.90 for the NFC version.
Market
Aug.24 by 2Firsts Perspectives
U.S. Military Could Test Nicotine Pouches and Vapes for Smoking Cessation as Washington Examiner Cites ZYN and Potential $4 Billion Reduction in Related Defense Costs
U.S. Military Could Test Nicotine Pouches and Vapes for Smoking Cessation as Washington Examiner Cites ZYN and Potential $4 Billion Reduction in Related Defense Costs
The House-passed FY2027 National Defense Authorization Act includes a provision authorizing the defense secretary to conduct a one-year smoking-cessation pilot for active-duty service members. Section 707 lists counseling, nicotine gum and patches alongside what the bill calls "electric nicotine delivery systems," nicotine pouches and heat-not-burn products. A recent Washington Examiner op-ed cited ZYN as an example in arguing for the provision, but the legislation does not name any commercial brand or supplier. ZYN is made by PMI-owned Swedish Match USA, with specified products holding FDA marketing authorizations and modified risk orders.
Sep.20
Malaysia Liquid Nicotine Returns to Poisons List, Leaving Vape Retail and RM354 Million Tax Collection in Legal Uncertainty
Malaysia Liquid Nicotine Returns to Poisons List, Leaving Vape Retail and RM354 Million Tax Collection in Legal Uncertainty
Malaysia’s withdrawal of its appeal in a landmark liquid-nicotine case has left a High Court ruling that struck down the 2023 nicotine exemption in force, bringing liquid and gel nicotine used in vaping products back under the Poisons Act 1952. At the same time, the Control of Smoking Products for Public Health Act 2024 continues to provide a regulatory framework for vaping products, creating uncertainty over retail sales, taxation and existing inventory. MPs are calling for nicotine vape sales and excise collection to stop, including refunds of more than RM354 million collected since 2023, while industry and consumer groups are asking the government to clarify the current legal position.
Sep.04
Product | Philip Morris Korea Launches TEREA Limona Pearl, Expanding Fresh Blend Capsule Lineup to Five
Product | Philip Morris Korea Launches TEREA Limona Pearl, Expanding Fresh Blend Capsule Lineup to Five
Philip Morris Korea launched TEREA Limona Pearl in South Korea on August 31, 2026, expanding the TEREA Fresh Blend capsule tobacco stick lineup from four variants to five. Designed for the IQOS ILUMA series, the new stick combines a capsule with what the company calls a Fresh Filter. Philip Morris Korea describes the product as offering an aromatic, refreshing flavor profile with a cooling sensation, with an additional fresh note released when the capsule is crushed. The recommended retail price is KRW 4,800 per pack, with sales through IQOS stores and convenience stores nationwide. No reliable evidence has been found that the same Limona Pearl SKU was previously officially launched in another major IQOS market.
Sep.01
Australia Adds 6-Methylnicotine to Schedule 9 Prohibited Substances, Effective October 1
Australia Adds 6-Methylnicotine to Schedule 9 Prohibited Substances, Effective October 1
Australia's Therapeutic Goods Administration published a final decision on September 25 to classify 6-methylnicotine as a Schedule 9 prohibited substance under the Poisons Standard, effective October 1, 2026. TGA said the chemical has been reported in e-cigarette liquids sold in Australia and marketed as nicotine-free or nicotine alternatives, while evidence also indicates its use in preparations such as oral pouches. The government originally proposed a Schedule 7 classification but ultimately adopted the stricter Schedule 9 designation, citing acute toxicity, dependence risk, use in unapproved consumer products and misleading marketing.
News
Sep.29 by 2Firsts Perspectives