Azim Chowdhury

In 2009, Congress passed the landmark Family Smoking Prevention and Tobacco Control Act (TCA), amending the Food, Drug and Cosmetic Act (FDCA) to give the U.S. Food and Drug Administration (FDA) authority to regulate the manufacture, sale, distribution, and marketing of tobacco products. The enactment of the TCA coincided with the introduction of new, reduced-harm products—namely, e-cigarettes or Electronic Nicotine Delivery Systems (ENDS)—that have since transformed the tobacco industry. FDA… Show more

In 2009, Congress passed the landmark Family Smoking Prevention and Tobacco Control Act (TCA), amending the Food, Drug and Cosmetic Act (FDCA) to give the U.S. Food and Drug Administration (FDA) authority to regulate the manufacture, sale, distribution, and marketing of tobacco products. The enactment of the TCA coincided with the introduction of new, reduced-harm products—namely, e-cigarettes or Electronic Nicotine Delivery Systems (ENDS)—that have since transformed the tobacco industry. FDA also maintains authority to regulate nicotine-containing products, including ENDS, as drugs or medical devices if they are marketed in a manner that triggers such classification. This article explores how FDA might so as over-the-counter (OTC) nonprescription drugs. Show less

This paper, part of the Washington Legal Foundation's Critical Legal Issues Working Paper Series (Number 210, October 2018 edition) addresses how the Food and Drug Administration (FDA) can better implement the Tobacco Control Act’s Modified Risk Tobacco Product (MRTP) provisions to benefit the public health.

This article discusses FDA's Youth Tobacco Prevention Plan intended to curb rising underage use of certain types of e-cigarettes products.

Dual Markets - Comparative Approaches to Regulation analyzes dual markets for regulated substances and services and aims to provide a framework for effective regulation. A "dual market" refers to the existence of both a legal and an illegal market for a regulated product. The volume focuses on nine types of markets and examines the relationship between regulation, the emerging illegal market, and the resulting overall access to each product or service. Azim's chapter, "Regulation of… Show more

Dual Markets - Comparative Approaches to Regulation analyzes dual markets for regulated substances and services and aims to provide a framework for effective regulation. A "dual market" refers to the existence of both a legal and an illegal market for a regulated product. The volume focuses on nine types of markets and examines the relationship between regulation, the emerging illegal market, and the resulting overall access to each product or service. Azim's chapter, "Regulation of E-Cigarettes in the United States" focuses on the FDA regulation of e-cigarettes under the Deeming Rule, including the current pre-market authorization requirements that could result in an effective ban on e-cigarettes in the United States. Show less

Abstract: Besides nicotine replacement therapies, a realistic alternative for smoking cessation or for smoking substitution may come from electronic cigarettes (ECs), whose popularity has been steadily growing. As for any emerging behaviour associated with exposure to inhalational agents, there is legitimate cause for concern and many health organizations and policy makers have pushed for restrictive policy measures ranging from complete bans to tight regulations of these products… Show more

Abstract: Besides nicotine replacement therapies, a realistic alternative for smoking cessation or for smoking substitution may come from electronic cigarettes (ECs), whose popularity has been steadily growing. As for any emerging behaviour associated with exposure to inhalational agents, there is legitimate cause for concern and many health organizations and policy makers have pushed for restrictive policy measures ranging from complete bans to tight regulations of these products. Nonetheless, it is important to reframe these concerns in context of the well-known harm caused by cigarette smoking. In this article, we discuss key public health principles that should be considered when regulating ECs. These include the concept of tobacco harm reduction, importance of relative risk and risk continuum, renormalization of smoking, availability of low-risk product, proportionate taxation, and reassessment of the role of non-tobacco flavours. These public health principles may be systematically scrutinized using a risk assessment matrix that allows: (1) to determine the measure of certainty that a risk will occur; and (2) to estimate the impact of such a risk on public health. Consequently, the ultimate goal of responsible ECs regulation should be that of maximizing the favourable impact of these reduced-risk products whilst minimizing further any potential risks. Consumer perspectives, sound EC research, continuous post-marketing surveillance and reasonable safety and quality product standards should be at the very heart of future regulatory schemes that will address concerns while minimizing unintended consequences of ill-informed regulation. Int. J. Environ. Res. Public Health 2017, 14(4), 363; doi:10.3390/ijerph14040363 (registering DOI) - 31 March 2017 Show less

Tobacco and Nicotine: Regulation and Compliance provides a comprehensive guide to the regulatory landscape that is actively shaping the tobacco industry. Industry professionals, attorneys, regulators, and the public health community will find this desk reference indispensable for understanding regulatory compliance, informing business decisions, and engaging the implementation and development of tobacco regulation. This second edition covers the regulation of the manufacturing, marketing… Show more

Tobacco and Nicotine: Regulation and Compliance provides a comprehensive guide to the regulatory landscape that is actively shaping the tobacco industry. Industry professionals, attorneys, regulators, and the public health community will find this desk reference indispensable for understanding regulatory compliance, informing business decisions, and engaging the implementation and development of tobacco regulation. This second edition covers the regulation of the manufacturing, marketing, labeling, distribution, and sale of tobacco products, and reflects the impact of the final “deeming regulation” that brings all products as defined by statute under FDA jurisdiction, including electronic cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe tobacco, and dissolvable tobacco products.

Topics include premarket review of new and modified tobacco products, warning requirements, advertising and marketing rules, harm reduction, state authority, case law, and global regulation. Show less

On April 19, 2016, the House Appropriations Committee voted to include a bipartisan amendment, sponsored by Rep. Tom Cole (R - OK) and Rep. Sanford Bishop (D - GA), to the 2017 fiscal year Agricultural Appropriations bill that would amend the February 15, 2007 "grandfather date" for currently unregulated tobacco product categories, including nicotine-containing electronic vaping devices and the "e-liquid" used in them. The U.S. Food and Drug Administration (FDA) is expected to "deem" such… Show more

On April 19, 2016, the House Appropriations Committee voted to include a bipartisan amendment, sponsored by Rep. Tom Cole (R - OK) and Rep. Sanford Bishop (D - GA), to the 2017 fiscal year Agricultural Appropriations bill that would amend the February 15, 2007 "grandfather date" for currently unregulated tobacco product categories, including nicotine-containing electronic vaping devices and the "e-liquid" used in them. The U.S. Food and Drug Administration (FDA) is expected to "deem" such e-vapor products subject to its authority under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), pending finalization of the so-called "Deeming Regulation" (FDA-2014-N-0189). The inclusion of the Cole-Bishop Amendment in the appropriations bill has been hailed as a victory for the e-vapor industry, but there remains a long road ahead before this budget amendment can effectively change the statutory grandfather date for deemed products. Show less

Join Keller and Heckman Partners Azim Chowdhury and Marcus Navin-Jones for a complimentary one hour webinar as they discuss the regulation of e-vapor products under the new Tobacco Products Directive in the European Union. This webinar is intended for producers, suppliers and users of e-cigarette, e-liquid and vapor products in the European Union. Some topics this webinar will address:

• The background issues regarding regulation of e-vapor in the EU and the new TPD;
• The legal… Show more

Join Keller and Heckman Partners Azim Chowdhury and Marcus Navin-Jones for a complimentary one hour webinar as they discuss the regulation of e-vapor products under the new Tobacco Products Directive in the European Union. This webinar is intended for producers, suppliers and users of e-cigarette, e-liquid and vapor products in the European Union. Some topics this webinar will address:

• The background issues regarding regulation of e-vapor in the EU and the new TPD;
• The legal requirements under the new TPD regarding e-cigarette, e-liquid and vapor products;
• Problems and pitfalls producers and suppliers of e-vapor should be aware of; and
• Obtaining and retaining market access in the EU.
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The U.S. Consumer Product Safety Commission (CPSC) now has new authority to require child-resistant (CR) packaging ("special packaging") over certain packages of nicotine-containing "e-liquid."

This article discusses the need for a new "Grandfather Date" for deemed tobacco products like e-cigarettes, FDA's authority to establish such a new date, and potential alternative dates.

This article summarizes the Tobacco Control Act requirements that would apply to e-cigarette companies if the proposed Deeming Regulation is finalized.

The article was published in Vapor Voice Magazine and discusses how China is trying to determine the regulation of vapor products.

Keller and Heckman partner Azim Chowdhury provided a primer on the Tobacco Control Act and how it might specifically apply to e-vapor products in a webinar on Friday, May 15, 2015. During the webinar, Mr. Chowdhury explored the legal basis for FDA to impose regulatory requirements that are specific to such products, and how Congress may actually have intended the Agency do this, rather than blindly applying the statutory requirements to all deemed products. Mr. Chowdhury covered potential… Show more

Keller and Heckman partner Azim Chowdhury provided a primer on the Tobacco Control Act and how it might specifically apply to e-vapor products in a webinar on Friday, May 15, 2015. During the webinar, Mr. Chowdhury explored the legal basis for FDA to impose regulatory requirements that are specific to such products, and how Congress may actually have intended the Agency do this, rather than blindly applying the statutory requirements to all deemed products. Mr. Chowdhury covered potential alternative regulatory frameworks for e-vapor and component parts. Show less

The emergence of new tobacco products has created the need to examine tobacco regulation in the US and EU. Speakers within this break-out session will discuss harm reduction, and reduced-risk products. Speakers will address the proposed deeming regulations in the US, electronic nicotine delivery systems (ENDS), comments on the continuum of risk from FDA’s Center for Tobacco Products, and an overview of the World Health Organizations Framework Convention on Tobacco Control (WHO FCTC).

The purpose of this Primer is to provide members of the tobacco manufacturing industry and other stakeholders with an overview of the key statutory provisions of the Tobacco Control Act and FDA’s implementation of those provisions to date. While certain information provided in this Primer may change due to the frenetic pace of FDA’s implementation activities, the Primer should nonetheless provide readers with an understanding of the regulatory landscape for new and current tobacco products in… Show more

The purpose of this Primer is to provide members of the tobacco manufacturing industry and other stakeholders with an overview of the key statutory provisions of the Tobacco Control Act and FDA’s implementation of those provisions to date. While certain information provided in this Primer may change due to the frenetic pace of FDA’s implementation activities, the Primer should nonetheless provide readers with an understanding of the regulatory landscape for new and current tobacco products in the United States. In particular, this Primer addresses the statutory definition of “tobacco product” and the scope of FDA’s enforcement authority over entities engaged in the manufacture, distribution, and sale of regulated tobacco products. Additionally, this primer addresses the processes and requirements for FDA’s premarket review of new and modified tobacco products, including “modified risk” tobacco products as well as FDA’s authority over the labeling, marketing, and advertising of regulated tobacco products. Lastly, this primer will cover key issues in the regulation of tobacco products that remain open, including the potential regulation of menthol in cigarettes and tobacco products, the composition of the Tobacco Products Scientific Advisory Committee, Good Manufacturing Practices and, of course, FDA’s Deeming Regulation, which proposes to capture currently unregulated tobacco products within the agency’s authority. Show less

Azim Chowdhury presented at the Food and Drug Law Institute’s "Introduction to Tobacco Law and Regulation: How FDA Regulates the Tobacco Industry" seminar on October 20, 2014 on the topic of “Product Standards, Menthol and FDA’s Deeming Regulation”.

Azim Chowdhury attended the 2014 Global Tobacco Networking Forum (GTNF) at the Greenbriar in White Sulphur Springs, West Virginia on October 1-4, 2014. Along with John Dubeck and Evolv, Inc. co-founders Brandon Ward and John Bellinger, he presented the “Evolution of the e-Vapor Industry: Past, Present and What the Future Holds” during the GTNF field trip to Washington, D.C.

Azim Chowdhury was a panelist on the Food and Drug Law Institute’s webinar on “Deeming Tobacco Regulations: What’s Included…and What’s Not” that was held on June 3, 2014. He discussed the key points of FDA’s regulation which proposes to deem currently unregulated products such as cigars, e-cigarettes, pipe tobacco and hookah as regulated tobacco products.

This article describes how FDA could regulate currently unregulated tobacco products, specifically electronic cigarettes, once the Agency's Notice for its “Deeming Regulation” is published pursuant to the Family Smoking Prevention and Tobacco Control Act.

Electronic cigarettes will soon be regulated by FDA. How might the Agency go about doing this, and will you be prepared?

Nearly a decade after the U.S. Supreme Court determined in FDA v. Brown & Williamson Tobacco Corporation, 529 U.S. 120 (2000), that the FDA did not have jurisdiction over tobacco products under the Federal Food, Drug and Cosmetic Act (FFDCA), on June 12, 2009, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) became law, and amended the FFDCA to give the Agency authority to regulate the manufacture, labeling, distribution, and marketing of tobacco products in the… Show more

Nearly a decade after the U.S. Supreme Court determined in FDA v. Brown & Williamson Tobacco Corporation, 529 U.S. 120 (2000), that the FDA did not have jurisdiction over tobacco products under the Federal Food, Drug and Cosmetic Act (FFDCA), on June 12, 2009, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) became law, and amended the FFDCA to give the Agency authority to regulate the manufacture, labeling, distribution, and marketing of tobacco products in the United States. Specifically, although a “tobacco product” is defined broadly, in pertinent part, as “any product made or derived from tobacco that is intended for human consumption,” the law only provides FDA with authority to regulate, through the its new Center for Tobacco Products (CTP), cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Any “other tobacco products” become subject to regulation only after FDA deems such products to be
subject to the new law. Show less

Azim Chowdhury - FDLI Member Profile

FDLI’s first publication focused exclusively on tobacco, this book serves as an essential resource to stakeholders navigating the continually developing regulation of tobacco products by FDA. This book brings together experts in the field to explain and discuss where we are now in areas of tobacco product law and regulation, including: modified risk products, retailer compliance issues, court actions, harm reduction, regulatory science and labeling, marketing and advertising. Reflecting the… Show more

FDLI’s first publication focused exclusively on tobacco, this book serves as an essential resource to stakeholders navigating the continually developing regulation of tobacco products by FDA. This book brings together experts in the field to explain and discuss where we are now in areas of tobacco product law and regulation, including: modified risk products, retailer compliance issues, court actions, harm reduction, regulatory science and labeling, marketing and advertising. Reflecting the experience of these experts, the book covers multiple perspectives on these and more complex and disputed issues. Equally relevant to industry professionals, practicing attorneys, academics and the public health community, this book will become a go-to resource on the evolving landscape of tobacco product regulation and compliance. Show less

On February 9, 2012, the U.S. Food and Drug Administration (FDA) released a set of three draft guidance documents as one of the first major steps in the Agency's implementation of the abbreviated approval pathway for "biosimilar" biological products created by the Biologics Price Competition Act of 2009 (the "BPCA"). The BPCA was enacted as part of Section 351 of the Patient Protection and Affordable Care Act of 2010. FDA is accepting comments on these draft guidance documents, each of which is… Show more

On February 9, 2012, the U.S. Food and Drug Administration (FDA) released a set of three draft guidance documents as one of the first major steps in the Agency's implementation of the abbreviated approval pathway for "biosimilar" biological products created by the Biologics Price Competition Act of 2009 (the "BPCA"). The BPCA was enacted as part of Section 351 of the Patient Protection and Affordable Care Act of 2010. FDA is accepting comments on these draft guidance documents, each of which is discussed in detail below, until April 16, 2012. Show less