Azim Chowdhury advises domestic and international corporations on regulatory compliance with the U.S. Food and Drug Administration (FDA) and its global counterparts, particularly focusing on vapor, nicotine, tobacco product and cannabis/CBD regulation, as well as food-contact materials.
He counsels tobacco, e-cigarette, e-liquid and CBD manufacturers, distributors, retailers, suppliers, and trade associations on matters relating to regulatory compliance, as well as public policy initiatives. Azim is nationally recognized as an expert on the Family Smoking Prevention and Tobacco Control Act, which amended the Food, Drug and Cosmetic Act to give FDA authority over tobacco products, as well the Agency’s “Deeming Rule” which extended those authorities to previously unregulated products such as electronic nicotine delivery systems (ENDS), e-liquids, cigars, hookah/shisha, and heat-not-burn tobacco products. Azim also advises companies and trade associations on state and global law compliance, including in Canada, the United Kingdom, the EU, and China.
In addition to helping vapor, nicotine, and tobacco clients navigate federal and state regulatory complexities, Azim advises food and drug packaging companies in establishing food-contact regulatory clearances for their products in the United States, Canada, and the European Union.
Azim’s dedication to the practice of law has led to his involvement in activities such as Keller and Heckman’s Pro Bono program and Mackrell International. Notably, for a pro bono client, he successfully obtained asylum in the United States for a family who fled their home country of El Salvador due to violence they faced from an international gang. Additionally, Azim is a firm representative and Chair of the Next Generation group for Mackrell International, a global network of over 90 international law firms. His involvement in Mackrell International connects Keller and Heckman attorneys, and the clients they serve, with access to legal representation in all major world markets.
Azim is nationally recognized as a thought leader and frequently writes articles and speaks at industry conferences and public health events. He is the editor and primary contributing author to The Continuum of Risk, a law blog hosted by Keller and Heckman for vapor, tobacco, CBD and reduced-harm product companies. He also spearheads the firm’s E-Vapor and Tobacco Law Symposium, an annual conference focusing on the regulatory and business issues relevant to e-vapor, e-liquid, and tobacco product manufacturers, distributors, and retailers.
In addition, Azim has authored and edited articles and peer-reviewed publications, including Tobacco Regulation and Compliance: An Essential Resource; FDA Regulation of Tobacco: A Comprehensive Guide – An FDLI Primer, Tobacco and Nicotine Delivery: Regulation and Compliance, 2nd Edition, Regulation of Electronic Cigarettes in the United States; Future Developments in the Regulation of Electronic Nicotine Delivery Systems: Potential Over-the-Counter Pathway and A Risk Assessment Matrix for Public Health Principles: The Case for E-Cigarettes. He has served on the Editorial Advisory Board of the Food and Drug Law Journal, as well as on FDLI’s Tobacco and Nicotine Products Committee.
Prior to entering private practice, Azim served as a judicial law clerk on the Court of Special Appeals of Maryland, where he honed his legal research, writing and oral argument skills.
- Advised tobacco, e-liquid and ENDS product manufacturers on FDA compliance matters including Premarket Tobacco Product Applications (PMTAs), manufacturing establishment registration, product and ingredient listing, labeling, advertising and warning requirements, retailer and distributor compliance, and product testing and toxicity analysis.
- Assisted e-liquid and ENDS product manufacturers with resolving FDA Warning Letters, including developing and implementing corrective actions to ensure youth access prevention and targeted marketing to adult consumers.
- Assisted companies and state and national trade associations in drafting and submitting comments to FDA proposed rules and draft guidance, as well as filing Citizens Petitions.
- Advised roll-your-own (RYO), pipe tobacco and hookah tobacco manufacturers on Substantial Equivalence (SE) Reporting process. Provide guidance on FDA meeting requests and responding to deficiency letters.
- Met with FDA Commissioner, Director of the FDA Center for Tobacco Products as well as representatives from the Department of Health and Human Services and the White House to discuss matters relevant for small vaping businesses.
- Prepared and file Tobacco Product Master Files (TPMFs), Food Additive Master Files (FAMFs) and Drug Master Files (DMFs) for suppliers and manufacturers of tobacco, food, and food packaging products.
- Provided guidance and opinion letters regarding the FDA status of tobacco products, synthetic nicotine products, as well as CBD products.
- Conducted mock facility inspections as part of Keller and Heckman’s Audit and Inspection Program for Vapor and Tobacco Product Manufacturing Establishments.
- Maryland State Bar Association
- Food and Drug Law Institute (FDLI) 2021 Tobacco and Nicotine Products Committee
- Capital Area Muslim Bar Association
- Mackrell International (Washington D.C. Delegate)
- National Law Review Go-To Thought Leadership Award (2018) for The Continuum of Risk blog