Azim Chowdhury | Keller and Heckman

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/cannabidiol (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 acknowledged nationwide for his in-depth knowledge of 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 European Union (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 (U.S.), Canada, and the EU.

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.

I. Compliance obligations for vape companies | 1:00pm – 1:40pm

• Federal vs. state regulations: Key distinctions
• FDA marketing authorization and the PMTA process-flavored vs tobacco-flavored products
• FDA proposed rulemaking
• FDA enforcement and PMTA litigation update
• Labeling, advertising, and packaging and other Tobacco Control Act Requirements and Deeming Rule
• State laws including flavors bans and PMTA directory laws

II. Retail and online sales compliance | 1:40pm – 2:00pm

• Age verification and restrictions for online sales
• State-specific sales tax and licensing requirements
• Best practices to avoid illegal sales and enforcement actions

Break | 2:00pm – 2:10pm

III. Strategies for corporate counsel to reduce legal risks | 2:10pm – 3:10pm

• Creating internal compliance programs
• Responding to warning letters, regulatory audits and inspections
• Crisis management in the face of legal scrutiny