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.

KT&G Aims to Accelerate Launch of New Heated Tobacco Innovation Platform
KT&G Aims to Accelerate Launch of New Heated Tobacco Innovation Platform
KT&G Chief Executive Officer Bang Kyung-man said at the annual shareholders meeting on March 26 that although the company expects a challenging environment marked by stronger protectionism and a high exchange rate, it will continue on a stable growth path through strategic choice and focus.
Mar.26 by 2FIRSTS.ai
Singapore Health Minister Ong Ye Kung receives SEATCA award for tobacco control and anti-vaping push
Singapore Health Minister Ong Ye Kung receives SEATCA award for tobacco control and anti-vaping push
SEATCA has honoured Singapore Health Minister Ong Ye Kung with its inaugural Trailblazer Award, citing Singapore’s long-standing vaping ban, stepped-up enforcement and regulatory measures, and the city-state’s role in sharing tobacco-control policy experience across ASEAN.
Feb.06 by 2FIRSTS.ai
Philip Morris Korea Launches New IQOS ILUMA i “Electric Purple” Color Edition
Philip Morris Korea Launches New IQOS ILUMA i “Electric Purple” Color Edition
Philip Morris Korea said it has launched a new color edition of its heated tobacco device brand IQOS, called “IQOS ILUMA i Electric Purple.” The new color has been added to the IQOS ILUMA i series and applies to the Prime, standard, and One variants. The product is being sold through the IQOS website and nine IQOS directly operated stores across South Korea.
Mar.12 by 2FIRSTS.ai
2Firsts Interview with Glas |Why a California ENDS Company Believes Its Age-gated Flavored Vape Could Be Next in Line for FDA Authorization
2Firsts Interview with Glas |Why a California ENDS Company Believes Its Age-gated Flavored Vape Could Be Next in Line for FDA Authorization
As the FDA advances efforts to streamline its PMTA review process, including support for small businesses, expectations are rising that additional product authorizations may follow. Age-verification technology is emerging as a key consideration in future approvals.In this interview, California-based Glas discusses its G2 platform, integrating smartphone-based identity verification, proximity controls and anti-counterfeit systems, and outlines its positioning under the FDA’s PMTA framework.
Mar.02
Special Report|Reynolds’ 337 Patent Case Ends, but a Harsher 337 Compliance Battle Now Targets the Entire Vape Supply Chain
Special Report|Reynolds’ 337 Patent Case Ends, but a Harsher 337 Compliance Battle Now Targets the Entire Vape Supply Chain
The U.S. International Trade Commission (ITC) has terminated Investigation 337-TA-1410 after invalidating key vape patent claims asserted by R.J. Reynolds Vapor Company, removing the immediate risk of import bans for dozens of companies. However, a new case—337-TA-1486—has already opened a more consequential legal front, shifting the focus from patent disputes to regulatory compliance across the vape supply chain, including PACT Act reporting, tax compliance, and FDA marketing authorization.
BAT
Mar.11
Illegal Trade in Tobacco and E-Cigarettes Continues to Rise in Germany, BVTE and BDZ Call for Enforceable Regulation
Illegal Trade in Tobacco and E-Cigarettes Continues to Rise in Germany, BVTE and BDZ Call for Enforceable Regulation
BVTE and BDZ said at a joint press conference in Berlin on March 10 that illegal trade in tobacco products, e-cigarettes and other nicotine products continues to grow in Germany, posing challenges to the rule of law, youth protection, consumer protection and state fiscal authority. The groups said there is still no reliable overall statistic for the illegal trade in tobacco products, e-cigarettes, nicotine pouches and oral nicotine products.
Mar.12 by 2FIRSTS.ai