FDA Premarket Review of New and Modified Tobacco Products

This training on FDA regulatory requirements for tobacco products will focus on the premarket review of new and modified tobacco products. It will also discuss the impact of FDA deeming regulation for of e- cigarettes and novel tobacco products on premarket authorization requirements.

Why Should You Attend:

On June 22, 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.

To bring a “new” tobacco product to the market will require obtaining FDA pre-market authorization by either demonstrating that the new product is substantially equivalent to a predicate product that was on the market as of the “Grandfather Date,” or submitting a new tobacco product application pursuant to Section 910 of the Tobacco Control Act. Companies looking to market their products with claims of either “reduced risk” or “reduced exposure” will need to prepare and submit a Section 911 Modified Risk Tobacco Product application to FDA. These premarket authorization requirements for now and modified risk tobacco products will also likely apply to currently unregulated products, such as e-cigarettes, once those products are captured within FDA’s authority pursuant to the upcoming Deeming Regulation.

This webinar will focus on FDA’s regulatory requirements of new and modified tobacco products. The instructor will discuss premarket authorization requirements including Section 910 new tobacco product application and Section 905(j) substantial equivalence report.

Areas Covered in the Webinar:

• Premarket Review of New and Modified Tobacco Products
• Section 910 New Tobacco Product Application
• Section 905(j) Substantial Equivalence Report
• Section 905(j)(3) Minor Modification Exemption
• Section 911 Modified Risk Tobacco Product Application
• What E-Cigarettes and Other Tobacco Products Can Expect

Who Will 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

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. You can follow Mr. Chowdhury on Twitter @ECIGattorney.