Azim Chowdhury
Washington, District of Columbia, United States
4K followers
500+ connections
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Azim Chowdhury, a Partner at Keller and Heckman LLP in Washington, DC, is nationally…
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Delighted to be included on the Best Lawyers in America list along with some of my amazing colleagues.
Delighted to be included on the Best Lawyers in America list along with some of my amazing colleagues.
Shared by Azim Chowdhury
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As highlighted in my brief video below, new polling from Gallup shows tremendous progress on reducing smoking by young and old. But millions still…
As highlighted in my brief video below, new polling from Gallup shows tremendous progress on reducing smoking by young and old. But millions still…
Liked by Azim Chowdhury
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University of Maryland - Robert H. Smith School of Business
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Activities and Societies: Associate on the New Markets Growth Fund
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Volunteer Experience
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Washington, DC Delegate for Keller and Heckman LLP
Mackrell International
- Present 7 years 8 months
Mackrell International (MI) is a truly global network of independent law firms. With 90 members representing a total of 4500 lawyers and attorneys working out of 170 offices in 60 countries, MI effortlessly delivers global expertise and local influence. See http://www.mackrell.net/.
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Tobacco and Nicotine Products Committee; Editorial Advisory Board of the Food and Drug Law Journal
Food and Drug Law Institute (FDLI)
- Present 13 years 6 months
The Tobacco and Nicotine Products Committee ensures that FDLI's tobacco programs bring diverse stakeholders together to have high-level discussions on tobacco products regulation and policy.
Food and Drug Law Journal Editorial Advisory Board Member from 2011-2014. -
Advice and Referral Clinic Volunteer
DC Bar
- Present 14 years 6 months
The clinic provides individuals who do not have their own lawyer an opportunity to discuss with volunteer attorneys civil legal problems governed by D.C. law. For more information see: https://www.dcbar.org/for-the-public/help-for-individuals/advice.cfm.
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Pro Bono Attorney for asylum seekers
Human Rights First
- Present 7 years 3 months
Human Rights First is a non-profit, nonpartisan international human rights organization based in New York, Washington D.C., Houston, and Los Angeles. See https://www.humanrightsfirst.org/about.
Mr. Chowdhury also has an active pro bono practice through Keller and Heckman’s Pro Bono Program, and has been featured in the Baltimore Sun for successfully obtaining asylum in the United States for a family who fled their home country of El Salvador because of violence they faced from MS-13. -
Volunteer Lawyer
Council on American-Islamic Relations (CAIR) - Maryland Outreach Office
- 1 year
Civil Rights and Social Action
Provided legal advice on civil rights issues; advisor on Equality for Eid initiative to have Eid holidays recognized by Montgomery County Public Schools.
Publications
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Future Developments in the Regulation of Electronic Nicotine Delivery Systems: Potential Over-the-Counter Pathway
Food and Drug Law Institute
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…
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.
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Implementing the Continuum of Risk: Modified Risk Tobacco Products
Washington Legal Foundation
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.
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FDA's Youth E-Cig Blitz Could Go Much Further
Law360
This article discusses FDA's Youth Tobacco Prevention Plan intended to curb rising underage use of certain types of e-cigarettes products.
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Regulation of E-Cigarettes in the United States
Dual Markets - Comparative Approaches to Regulation by Springer
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…
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.
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A Risk Assessment Matrix for Public Health Principles: The Case for E-Cigarettes, Int. J. Environ. Res. Public Health 2017, 14, 363
International Journal of Environmental Research and Public Health
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…
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
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Tobacco and Nicotine Delivery: Regulation and Compliance, 2nd Edition
Food and Drug Law Institute
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…
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.Other authorsSee publication -
The Cole-Bishop Amendment to the Agricultural Appropriations Bill Amending the Grandfather Date for "Deemed" Tobacco Products Passes House Committee - What Next?
National Law Review
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…
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.
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Webinar: E-Vapor Products Under the New European Union Tobacco Products Directive: Problems and Pitfalls
Keller and Heckman LLP
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…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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CPSC Likely to Gain New Authority Over Some Nicotine-Containing E-Liquid Packages
National Law Review
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."
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The Grandfather Date - What are FDA's Alternatives?
Vape Magazine
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.
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FDA Regulation of E-Cigarettes, Are You Prepared?
Vape Magazine
This article summarizes the Tobacco Control Act requirements that would apply to e-cigarette companies if the proposed Deeming Regulation is finalized.
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The Deeming Dragon: E-Cigarette Regulation in China
Vapor Voice Magazine
The article was published in Vapor Voice Magazine and discusses how China is trying to determine the regulation of vapor products.
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Webinar - E-Cigarette Regulation: Key Priorities for FDA and Alternative Regulatory Frameworks
Keller and Heckman LLP
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…
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.
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Tobacco: Potential Reduced-Risk Products – an Examination of New Products and Regulations
Food and Drug Law Institute
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).
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FDA Regulation of Tobacco: A Comprehensive Guide - An FDLI Primer
Food and Drug Law Institute
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 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.
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Tobacco Product Standards, Menthol and FDA's Deeming Regulation
Food and Drug Law Institute
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”.
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Evolution of the e-Vapor Industry: Past, Present and What the Future Holds
Global Tobacco Networking Forum
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.
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Deeming Regulations: Impact on Electronic Cigarettes
Food and Drug Law Institute
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.
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What to Expect: FDA Regulation of E-Cigarettes
Tobacco Reporter
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.
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FDA Regulation of Tobacco Products Set to Expand: The Deeming Regulation
FDLI Update
Electronic cigarettes will soon be regulated by FDA. How might the Agency go about doing this, and will you be prepared?
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FDA Regulation of Tobacco Products Set to Expand
Mackrell International's "Regulatory Matters!" Newsletter
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…
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
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Food and Drug Law Institute Member Profile
FDLI Update - March/April 2012
Azim Chowdhury - FDLI Member Profile
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Tobacco Regulation and Compliance: An Essential Resource
Food and Drug Law Institute
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…
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.
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Are Electronic Cigarettes Drug Device Combination Products or 'Modified Risk' Tobacco Products?
Food, Drug and Law Institute Update
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How will the Family Smoking Prevention and Tobacco Control Act Impact the Electronic Cigarette Industry?
Food, Drug and Law Institute Update
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FDA Publishes Three New Draft Guidance Documents on Biosimilar Product Development
Martindale-Hubbell - Counsel to Counsel Biotech & Life Sciences Law Alert.
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…
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.
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Courses
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Guest Lecturer at Georgetown Law - "Understanding the Regulatory Framework for Tobacco and Nicotine"
Health Law and Regulation
More activity by Azim
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In this peer-reviewed publication in the Harm Reduction Journal, we report that accurate knowledge regarding the harm of nicotine is associated with…
In this peer-reviewed publication in the Harm Reduction Journal, we report that accurate knowledge regarding the harm of nicotine is associated with…
Liked by Azim Chowdhury
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I’m thrilled to join this panel of my friends, colleagues and fellow OWNIT members to start the policy discussion at #GTNF2024. See you in Athens!
I’m thrilled to join this panel of my friends, colleagues and fellow OWNIT members to start the policy discussion at #GTNF2024. See you in Athens!
Liked by Azim Chowdhury
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Keller and Heckman LLP is thrilled to announce that the following attorneys have been selected by their peers for inclusion in The Best Lawyers in…
Keller and Heckman LLP is thrilled to announce that the following attorneys have been selected by their peers for inclusion in The Best Lawyers in…
Liked by Azim Chowdhury
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On the left is the FDA infographic communicating results of the CDC National Youth Tobacco Survey. On the right, is EXACTLY THE SAME DATA. I am…
On the left is the FDA infographic communicating results of the CDC National Youth Tobacco Survey. On the right, is EXACTLY THE SAME DATA. I am…
Liked by Azim Chowdhury
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One of those weeks - no summer camp and traveling spouse. But I am so thankful to be part of Sheppard Mullin Richter & Hampton LLP's DC office where…
One of those weeks - no summer camp and traveling spouse. But I am so thankful to be part of Sheppard Mullin Richter & Hampton LLP's DC office where…
Liked by Azim Chowdhury
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LinkedIn community - over the past year, since leaving NJOY, I have written articles and spoken at conferences on a number of important topics…
LinkedIn community - over the past year, since leaving NJOY, I have written articles and spoken at conferences on a number of important topics…
Liked by Azim Chowdhury
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After 18 years of dedicated service with my previous firm, I’m thrilled to announce my decision to join McGuireWoods. This new opportunity marks an…
After 18 years of dedicated service with my previous firm, I’m thrilled to announce my decision to join McGuireWoods. This new opportunity marks an…
Liked by Azim Chowdhury
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I am pleased to share (link here: https://lnkd.in/eMmKe67E) my recent paper, titled Proposed Redefinition of “Tobacco and Nicotine Industry”: An…
I am pleased to share (link here: https://lnkd.in/eMmKe67E) my recent paper, titled Proposed Redefinition of “Tobacco and Nicotine Industry”: An…
Liked by Azim Chowdhury
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This is maybe my favorite podcast episode yet. Katie Skaggs and I chat with Tony Pavel about “economic adulteration” (food fraud) and the…
This is maybe my favorite podcast episode yet. Katie Skaggs and I chat with Tony Pavel about “economic adulteration” (food fraud) and the…
Liked by Azim Chowdhury
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Keller and Heckman LLP's Food & Chemicals Unpacked Podcast is out with its latest episode: Economic Adulteration: Secrets in the Sauce. Mark…
Keller and Heckman LLP's Food & Chemicals Unpacked Podcast is out with its latest episode: Economic Adulteration: Secrets in the Sauce. Mark…
Liked by Azim Chowdhury
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