FDA Premarket Application Pathways for E-Cigarettes and Other New Tobacco Products

Duration: 60 Minutes
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.
Electronic Cigarettes For Sale
Instructor: Azim Chowdhury
Product ID: 500211

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. This webinar will focus on the potential FDA regulatory premarket application requirements that will apply to those products that are deemed to be within FDA’s authority. The instructor will discuss Family Smoking Prevention and Tobacco Control Act requirements, focusing on the premarket review of new and modified tobacco products under Section 910 of the Act.

Why Should you Attend:
It is critical for manufacturers and importers of cigars, pipe tobacco, electronic cigarettes, dissolvable tobacco and other novel tobacco products to be prepared to submit premarket applications to FDA to bring their products to the market.

This webinar will focus on the potential FDA regulatory premarket application requirements that will apply to those products that are “deemed” to be within FDA’s authority by the upcoming Deeming Regulation. The instructor will discuss Family Smoking Prevention and Tobacco Control Act requirements, focusing on the premarket review of new and modified tobacco products under Section 910 of the Act.

Objectives of the Presentation:
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.
  • Overview of the Family Smoking Prevention and Tobacco Control Act
  • Premarket Review of New and Modified Tobacco Products
  • Premarket Tobacco Applications
  • Substantial Equivalence Reports
  • Minor Modification Exemption
Who can Benefit:
  • General Counsel and Management of tobacco companies, e-cigarette companies, etc
  • Regulatory Compliance Associates and Managers
  • Medical professionals, public health and consumer advocates, and other individuals working in the smoking control/ harm reduction area
  • Regulatory affairs professionals and scientists who work in this area
  • Manufacturers and importers of e-cigarettes and other novel tobacco products
  • Suppliers to Tobacco Industry
$300
Recorded Session for one participant
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Instructor Profile:
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.
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