- October 10, 2019
- Organized By:
Priscilla Callahan-Lyon, MD
Deputy Director, Division of Individual Health Science
Office of Science, Center for Tobacco Products
About the Presentation:
The Center for Tobacco Products (CTP) is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act (TCA), which requires FDA premarket review of new tobacco products and determination about whether marketing the product(s) is “appropriate for the protection of public health”. Our mission is to protect Americans from tobacco-related death and disease by regulating the manufacture, distribution, and marketing of tobacco products and by educating the public, especially young people, about tobacco products and the dangers their use poses to themselves and others. After a brief introduction to CTP, this presentation will provide a description of the IQOS heated tobacco products and a summary of the applications. The specific requirements of the TCA and the criteria for denying marketing authorization will be described as well as a brief discussion of FDA’s understanding of what it means to be “appropriate for the protection of public health.” Finally, the presentation will conclude with an explanation of the rationale for FDA’s decision regarding IQOS and how this may impact future Premarket Tobacco Applications and tobacco control.
About the Speaker
After 20 years of private medical practice as an internist and pulmonologist, Dr. Priscilla Callahan-Lyon joined FDA in 2008 as a medical reviewer in the Center for Drug Evaluation and Research where she worked extensively on nicotine replacement therapies. She moved to the Center for Tobacco Products (CTP) in 2012 and currently serves as Deputy Director for the Division of Individual Health Science in CTP’s Office of Science. Dr. Callahan is a member of several FDA cross-center groups that are involved with nicotine policy and regulation. She also serves as the FDA contact on the Tri-Agency workgroup (CDC, NIH, and FDA) focusing on smoking cessation.