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.

Canadian Court Allows Juul and Altria Vape Class Action to Move Forward Over Youth Marketing Claims
Canadian Court Allows Juul and Altria Vape Class Action to Move Forward Over Youth Marketing Claims
A Quebec Superior Court has allowed a class action lawsuit against Juul Labs and Altria Group related to vaping products to proceed, involving allegations concerning marketing practices, youth exposure and corporate responsibility. The ruling only allows the case to move forward and does not represent a finding that Juul or Altria are legally liable. The case highlights continued legal risks facing vape companies regarding product marketing, youth protection and corporate accountability.
Jul.28
JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
JAMA has published a Special Communication offering systematic recommendations for U.S.-based clinicians on the use of nicotine e-cigarettes in adult smoking cessation. Developed by the Harm Reduction Workgroup of the Society for Research on Nicotine and Tobacco’s Treatment Research Network, the paper recommends including e-cigarettes alongside FDA-approved cessation medications in risk-benefit discussions. It cites high-certainty evidence that nicotine e-cigarettes achieve higher quit rates than nicotine replacement therapy and evidence suggesting efficacy comparable to highly effective medications such as varenicline and cytisine. For adults who choose vaping to quit, the authors recommend FDA-authorized products, sufficient nicotine delivery and a rapid, complete transition away from cigarettes rather than prolonged dual use.
Aug.13
South Korea Rejects 16 Trillion Won Tax-Evasion Claim Over Chinese Synthetic Nicotine
South Korea Rejects 16 Trillion Won Tax-Evasion Claim Over Chinese Synthetic Nicotine
The South Korean government rejected allegations that Chinese synthetic-nicotine e-liquids were linked to about 16 trillion won in tobacco tax evasion, saying China does not ban synthetic nicotine exports and the estimate is difficult to verify, while acknowledging that pre-law synthetic-nicotine inventory is effectively difficult to tax.
Market
Jun.25
Kaival Brands Explores Nicotine Pouches as Smaller Nicotine Companies Seek Smoke-Free Growth
Kaival Brands Explores Nicotine Pouches as Smaller Nicotine Companies Seek Smoke-Free Growth
U.S. nicotine company Kaival Brands Innovations Group is exploring opportunities in nicotine pouches and other modern nicotine products, reflecting a broader shift among smaller nicotine businesses beyond traditional vaping products.
Jul.17
PMI Q2 Call: ZYN Growth, IQOS Pricing and a Diverging Global Tobacco Market
PMI Q2 Call: ZYN Growth, IQOS Pricing and a Diverging Global Tobacco Market
Philip Morris International’s second-quarter earnings call offered new detail on its smoke-free strategy. Management said it would increase U.S. investment behind nicotine pouch brand ZYN, keep IQOS focused on volume before stronger pricing, and use SENTIA, DELIA, LEVIA, VEEV and ZYN to manage tax and regulatory pressure across Japan and Europe. Analysts from Goldman Sachs, Morgan Stanley, UBS and other firms also pressed PMI on profitability, market share, cigarette resilience and the durability of its global transformation over coming quarters.
Jul.24
U.S. Appeals Court Says BAT Must Face Class Action Over Cigarette Labels
U.S. Appeals Court Says BAT Must Face Class Action Over Cigarette Labels
A U.S. appeals court ruled that British American Tobacco (BAT) must continue facing a consumer class action lawsuit over cigarette labels. The ruling allows the case to proceed but does not determine that BAT violated the law or is liable for damages. The case highlights ongoing legal risks facing major tobacco companies related to product labeling, consumer disclosures and product liability claims.
Jul.31