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  5. Development and Testing of Warnings for Tobacco Products: Scientific and Regulatory Considerations - 01/13/2022 - 01/13/2022
  1. FDA Grand Rounds


Event Title
Development and Testing of Warnings for Tobacco Products: Scientific and Regulatory Considerations
January 13, 2022

January 13, 2022
12:00 PM - 1:00 PM ET

About the Speaker

David Portnoy, PhD
Supervisory Social Scientist
Division of Population Health Science (DPHS)
Office of Science (OS)
Center for Tobacco Products (CTP)

David Portnoy is Chief of the Social Science Branch 2 in the Division of Population Health Science, Office of Science at the FDA Center for Tobacco Products. He has a MA and PhD in Social Psychology from the University of Connecticut and an MPH from the Johns Hopkins Bloomberg School of Public Health.  Dr. Portnoy completed post-doctoral training through the National Cancer Institute’s Cancer Prevention Fellowship Program. In his current role, he leads a branch of Social Scientists focused on consumer perceptions and use of tobacco products, understanding communications about the harms of tobacco products (including warnings), and understanding and preventing youth use of tobacco products. His research interests include health risk perception and communication, consumer perceptions and use of tobacco products, and social psychological influences on health behavior and decision making. Dr. Portnoy was FDA’s scientific lead for the research to support a new cigarette health warnings rule starting in 2013.

About the Presentation

Warnings inform consumers about risks and are required on many FDA-regulated products. They are especially important for products which have inherent and unavoidable risks associated with their use, such as tobacco products. This presentation will discuss the current regulatory landscape of tobacco product warnings through CTP’s authority. We will examine the development and testing of warnings for cigarettes that resulted in the March 2020 final rule “Required Warnings for Cigarette Packages and Advertisements” with a focus on the scientific and regulatory considerations that went into that research and development plan for those warnings. 

Learning Objectives

After completion of this activity, the participant will be able to:

  • Recognize the scientific and regulatory issues considered by the FDA in developing new cigarette health warnings.
  • Discuss the steps in the research process used to develop, test, and refine the new cigarette health warnings.
  • Examine the requirements for the new cigarette health warnings final rule and its current status.

To Register

1. LMS Registration: *FDA Employees only.

2. Webcast Registration: *All participants MUST register for webcast to view FDA Grand Rounds!

FDA employees must register in both LMS and Webcast.

If you are not an FDA employee, register for the webcast only by clicking the Webcast Registration hyperlink above and then follow the instructions on the registration page. After Webcast registration, you will receive a link via email to access the live webinar. You must log in with the username and password created when you registered. Please pre-register at least two days before the event to ensure you receive the access link and outlook invitation for the session.

NOTE: Internet Explorer no longer supports the Adobe Connect platform. You must use MS Edge, Mozilla Firefox or Google Chrome as your browser.

For technical assistance please contact: Madison.Hanson@fda.hhs.gov


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