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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

Small businesses are facing serious compliance burdens as a result of the Consumer Product Safety Commission (CPSC)’s recent interpretation of the Child Nicotine Poisoning Prevention Act (CNPPA). Keller and Heckman partner Sheila Millar testified on behalf of the E-Vapor Coalition about the adverse impact at the Small Business Administration’s (SBA) regulatory fairness hearing held on

A coalition of state and national vapor trade associations[i] has moved to intervene in and appeal the District Court for the District of Maryland’s decision in American Academy of Pediatrics, et al. v. FDA, Case No. 8:18-cv-00883, which drastically accelerated the Premarket Tobacco Product Application (PMTA) deadline for vapor products to May 11,

Electronic cigarettes may soon become much more widely available in the world’s largest tobacco market: The People’s Republic of China. With over 300 million smokers, China has the world’s largest smoking population – which directly results in approximately 1 million deaths annually. [1] While the global e-cigarette market has experienced rapid growth over the last

As previously reported on this blog, earlier this year, the U.S. Consumer Product Safety Commission (CPSC) announced that it was now reading the Child Nicotine Poisoning Prevention Act (CNPPA) to require nicotine e-liquid bottles to meet the “restricted flow requirement” in 16 C.F.R. § 1700.15(d), in addition to having child-resistant closures. A wave of enforcement

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

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

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

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

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