On March 10, 2023, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule on Requirements for Tobacco Product Manufacturing Practice (TPMP), which sets forth proposed requirements for the manufacture, design, packing, and storage of tobacco products. The proposed requirements are essentially “good manufacturing practices” for tobacco products and are intended to minimize
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
FDA Files Civil Money Penalty Complaints Against Four Small Vape Shops for Alleged Premarket Review Violations
On February 22, 2023, the U.S. Food and Drug Administration (FDA) announced the filing of civil money penalty (CMP) complaints against four domestic e-liquid manufacturers, all of which appear to be small vape shops that were producing nicotine-containing e-liquids used in open-system electronic nicotine delivery systems (ENDS) devices. The four named companies are:…
California Votes “Yes” on Proposition 31 Banning the Retail Sale Non-Tobacco Flavored Tobacco Products; Keller and Heckman Files Supreme Court Amicus Brief in Case Challenging Los Angeles County Flavor Ban
On November 8, 2022, California voters approved the Referendum on 2020 Law That Would Prohibit the Retail Sale of Certain Flavored Tobacco Products (Proposition 31). The referendum, submitted in accordance with the provisions of Section 9 of Article II of the California Constitution, asked California citizens to vote on whether to uphold a 2020…
California OEHHA Adopts Safe Harbor Warning Regulations for Cannabis Smoke and Delta-9-THC
Recently, California’s Office of Environmental Health Hazard Assessment (OEHHA) adopted safe harbor warning regulations for cannabis smoke and delta-9-tetrahydrocannabinol (delta-9-THC) under California Proposition 65.
What is Proposition 65?
The Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65) requires the governor of California to publish, at…
FDA Files Permanent Injunctions Against Six Small Vape Shops for Alleged Premarket Review Violations
On October 18, 2022, the U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug Administration (FDA), filed complaints for permanent injunctions against six domestic e-liquid manufacturers across different federal district courts, all of which appear to be small vape shops that were producing nicotine-containing e-liquids used in open-system e-cigarette devices.…
Save the Date for Keller and Heckman’s 2023 E-Vapor and Tobacco Law Symposium
Save the date! Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium is back in person in 2023. Please join us on February 15-16, 2023, for a two-day comprehensive seminar focused on legal and regulatory issues critical to e-vapor, tobacco, and CBD industries.
This year’s program will feature new, timely topics specifically designed to help…
FDA’s Marketing Denial Order Issued to Bidi Vapor’s Non-Tobacco Flavored ENDS Products are Set Aside and Remanded by the 11th Circuit Court of Appeals for being Arbitrary and Capricious
Last year, Bidi Vapor LLC (Bidi or the Company), represented by Keller and Heckman LLP Partners Eric Gotting and Azim Chowdhury, petitioned the 11th Circuit Court of Appeals to review the Food and Drug Administration’s (FDA) order denying the Premarket Tobacco Product Applications (PMTA) for its non-tobacco flavored BIDI® Sticks, a disposable electronic nicotine…
A Closer Look at China’s New E-Cigarette Regulations
With the implementation of the Management Rules of E-cigarettes and the forthcoming effective date for the GB Standard on E-cigarettes (October 1, 2022), China has been regularly updating its e-cigarette regulations. Following up on our recent articles on China’s GB Standard and manufacturer license requirements, below we summarize various e-cigarette regulations recently promulgated by the…
Federal Court Rules That FDA Was Arbitrary and Capricious in Deeming Premium Cigars Subject to the Tobacco Control Act
Since it became effective in 2016, the cigar industry has mounted several challenges to the U.S. Food and Drug Administration’s (FDA) “Deeming Rule,” which extended the Agency’s tobacco product authority beyond cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco, to all products that meet the “tobacco product” definition in the Food, Drug and Cosmetic Act,…
FDA Denies Authorization to Market JUUL ENDS Products; Company Intends to Seek Stay of the Marketing Denial Orders
On June 23, 2022, the U.S. Food and Drug Administration (FDA) issued marketing denial orders (MDOs) to Juul Labs Inc. for all of the company’s JUUL electronic nicotine delivery system (ENDS) products currently marketed in the United States. After review, FDA determined that Juul’s Premarket Tobacco Product Applications (PMTAs), submitted more than two years…