Azim Chowdhury

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Azim Chowdhury is a regulatory and public policy attorney with a focus on vapor, nicotine and tobacco product regulation. He is a Partner in Keller and Heckman’s nationally-ranked food and drug law practice.

Mr. Chowdhury advises domestic and foreign corporations in matters of Food and Drug Administration (FDA) and international regulatory compliance. In particular, he has developed expertise in tobacco and vapor product regulation relating to the implementation of the Family Smoking Prevention and Tobacco Control Act, and spearheaded the Tobacco and E-Vapor practice at Keller and Heckman. Specifically, Mr. Chowdhury has experience representing tobacco, e-cigarette and e-liquid manufacturers, distributors, retailers, suppliers and trade associations in matters of FDA, state and global regulatory compliance. He also assists corporations in establishing clearances for food and drug additives in the U.S., Canada, and European Union, with an emphasis on indirect additives used in food-contact materials.

Mr. Chowdhury has authored and edited numerous articles and publications, including Tobacco Regulation and Compliance: An Essential Resource, FDA Regulation of Tobacco: A Comprehensive Guide – An FDLI Primer and Tobacco and Nicotine Delivery: Regulation and Compliance, 2nd Edition. He is a frequent contributor to the Food and Drug Law Institute's (FDLI) Update Magazine and has served on the Editorial Advisory Board of the Food and Drug Law Journal.  In addition, he has been interviewed in the U.S. News and World Reports Best Lawyers Edition (2016) and was named one of “10 Names to Know in the Vape World” in the October 2015 issue of Vape Magazine. Mr. Chowdhury received the 2018 National Law Review Go-To Thought Leadership Award for his consistent coverage of the emerging issues surrounding vaping and e-cigarettes on Keller and Heckman’s law blog, The Continuum of Risk.  As an industry leader, Mr. Chowdhury frequently speaks at industry conferences and events.

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 an international gang.

Prior to entering private practice, he served as a judicial law clerk on the Court of Special Appeals of Maryland. Mr. Chowdhury received a B.A. and B.S. from Johns Hopkins University, a MBA from the University of Maryland Robert H. Smith School of Business, and a JD, cum laude, from the University of Maryland School of Law.

Education: Johns Hopkins University (B.A., B.S., 2003); University of Maryland Robert H. Smith School of Business (M.B.A., 2006); University of Maryland School of Law (J.D., 2006, cum laude).

Admissions: District of Columbia; Maryland

Latest Articles

Azim Chowdhury and Eric Gotting, partners at Keller and Heckman, will discuss the recent decision in the case American Academy of Pediatrics et al. vs. FDA, which struck down the extended premarket review compliance policy for deemed tobacco products.  Find out what the decision will mean to your business, both short and long term. All vapor and deemed tobacco product industry stakeholders should attend. See our previous blog posts on this case here and here.…
      Since the Child Nicotine Poison Prevention Act (CNPPA) became law in 2015, liquid nicotine in containers “from which nicotine is accessible through normal and foreseeable use by a consumer” (such as e-liquid bottles) have been required to utilize child-resistant packaging pursuant to the Poison Packaging Prevention Act (PPPA) and its implementing regulations. The Consumer Product Safety Commission’s (CPSC) guidance on these requirements for liquid nicotine containers has evolved – and become…
The Food and Drug Administration’s (FDA’s) recently published draft guidance, Modifications to Compliance Policy for Certain Deemed Tobacco Products (hereinafter, the “Revised Compliance Policy Draft Guidance”)[1], revises the Agency’s controversial “compliance policy” for new deemed tobacco products on the market when the Deeming Rule went into effect on August 8, 2016.  We describe FDA’s proposed changes to the policy below and what companies can do to remain in compliance. Compliance Policy Background: The…
Section 904(a)(3) of the Food, Drug and Cosmetic Act, as amended by the Tobacco Control Act, (FDCA) requires manufacturers and importers to report the quantities of Harmful and Potentially Harmful Constituents (HPHCs) found in their tobacco products, or in the smoke produced by their products, by brand and sub-brand.  21 U.S.C. § 387d(a)(3).  This requirement was extended to all deemed products such as e-cigarettes, e-liquid, cigars, hookah and pipe tobacco when the Deeming Rule…
On February 21, 2019, FDA released the second of two draft guidance documents related to the development of novel nicotine replacement therapies (NRT).  The first draft guidance document, Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry is available here, and the second draft guidance document,  Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products is available here. The draft guidance documents are one part of FDA’s efforts in…
A major study found that e-cigarettes were twice as effective in helping people quit smoking than nicotine replacement therapies—such as patches, gum, and nasal spray—when both methods were accompanied by behavioral support. The randomized study involved 886 adults who were attending the U.K. National Health Service stop-smoking services. Study participants were randomly given either nicotine-replacement products of their choice for up to 3 months or an e-cigarette starter pack, which consisted of a second-generation refillable…
As previously reported on this blog, on November 15, 2018, citing new data from the 2018 National Youth Tobacco Survey (NYTS) that showed a surge in e-cigarette use among youth, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. announced new steps aimed at curtailing illegal underage use of e-cigarettes by limiting where such products can be purchased.  More specifically, the Commissioner indicated that FDA would seek to limit the sale of flavored…
Keller and Heckman is pleased to announce the agenda for this year’s E-Vapor and Tobacco Law Symposium. This comprehensive 2-day course will provide you with guidance on how to stay in compliance with FDA’s recent announcements and much more. Click here to view the agenda. Topics that will be covered include: FDA and State law compliance, HPHCs and PMTAs, Advertising and Marketing, European Union and Global laws, Environmental, OSHA and CPSC compliance, CBD and cannabis-derived products, and…
As a reminder, the registration requirement for domestic U.S. tobacco product manufacturing establishments, including manufacturers of deemed products such as e-liquids and cigars, is a biannual obligation that requires each such establishment to “update” their Registration and Product Listing information with FDA by December 31 every year (product listing information must also be updated by June 30 every year). See Section 905(b) of the Food, Drug, and Cosmetic Act (FDCA) as amended by the Family…
Following a series of actions over the last several months, on November 15, 2018, the U.S. Food and Drug Administration (“FDA”) announced new steps aimed at protecting youth from tobacco, including, among other things, preventing access to flavored electronic nicotine delivery system (“ENDS”) sold in certain retail locations, and potentially banning menthol in combustible tobacco products.[1]  Spurred by the release of new data from the 2018 National Youth Tobacco Survey (“NYTS”) showing a…