Azim Chowdhury
Attorney, Keller and Heckman LLP
Azim Chowdhury is an Attorney at the law firm of Keller and Heckman LLP in Washington, DC. In this role, he advises domestic and foreign corporations in matters of FDA and international regulatory compliance. In particular, he 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 also developed expertise in tobacco product regulation and has experience representing tobacco manufacturers and suppliers, including electronic cigarette companies, in FDA regulatory matters. He is also a frequent contributor to the Food and Drug Law Institute’s (FDLI) Update Magazine, currently serves on the Editorial Advisory Board of the Food and Drug Law Journal, and is edited and co-authored FDLI’s first tobacco-exclusive publication, Tobacco Regulation and Compliance: An Essential Resource. Mr. Chowdhury received a BA and BS 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.
Upcoming Webinar
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Recorded Webinar
Product Standards, Menthol and FDA's Deeming Regulation
The Food and Drug Administration (FDA) has now proposed to deem products meeting the statutory definition of "tobacco product," except accessories of a proposed deemed tobacco product, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act gives FDA the authority to regulate the manufacturing, labeling, distribution, and marketing of tobacco products in the United States. Specifically, although a "tobacco product" is defined broadly, in pertinent part, as "any product made or derived from tobacco that is intended for human consumption," the law only provides FDA with authority to regulate, through its new Center for Tobacco Products (CTP), cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. However, any “other tobacco products," such as electronic cigarettes and their components may become subject to regulation if FDA "deems" such products to be subject to the new law.
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FDA Regulation on Tobacco Products, Deeming regulations and Impact on E-Cigarettes
The webinar on FDA Regulation on Tobacco Products, Deeming regulations & Impact on E-Cigarettes will mainly focus on Tobacco Control Act, impact of tobacco products.
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Are Electronic Cigarettes a Public Health Threat or Benefit?
In June 2009, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) became law, and amended the Federal Food, Drug and Cosmetic Act to give the Agency authority to regulate the manufacture, labeling, distribution, and marketing of tobacco products in the United States. Specifically, although a “tobacco product” is defined broadly, in pertinent part, as “any product made or derived from tobacco that is intended for human consumption,” the law only provides FDA with authority to regulate, through the its new Center for Tobacco Products (CTP), cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. However, any “other tobacco products,” such as electronic cigarettes and their components may become subject to regulation if FDA “deems” such products to be subject to the new law.
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FDA Premarket Application Pathways for E-Cigarettes and Other New Tobacco Products
FDA has indicated that the premarket application requirements set forth in the Tobacco Control Act will apply to the new tobacco products (including electronic cigarettes, cigars and dissolvable tobacco) that are captured by the Deeming Regulation. Learn about the different premarket pathways, including the Premarket Tobacco Application, the Substantial Equivalence Report and the Minor Modification Exemption.
Recorded Session Get life time access for one participant with download option!

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