October 10 FDA Grand Rounds discusses why the IQOS heated tobacco product marketing was authorized. CE Credit is available.

FDA Grand Rounds

A discussion of why the FDA authorized the marketing of the IQOS heated tobacco product as “appropriate for the protection of the public health”

Thursday, October 10, 2019

12:00 p.m. - 1:00 p.m. EST

 

Register here for webcast (public attendees and FDA staff)

CE Credit Available

Presented 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.

What you’ll learn from this FDA Medical Officer:

1. Describe the Center for Tobacco Products and its’ responsibilities with respect to the Family Smoking Prevention and Tobacco Control Act
2. Explain the Premarket Tobacco Product Application review process
3. Describe the IQOS heated tobacco products
4. Discuss the scientific review process as it relates specifically to the IQOS products and explain why FDA believes marketing of IQOS products is appropriate for the protection of public health