FDA Grand Rounds
The FDA Grand Rounds is an educational presentation that is webcast monthly to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute educational presentation is followed by questions from the audience. You can also view the presentation under Past Grand Rounds following the live webcast. #FDAGrandRounds.
Development and Testing of Warnings for Tobacco Products: Scientific and Regulatory Considerations
Thursday, January 13, 2022
12:00 p.m. - 1:00 p.m. EST
Webcast
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.
Past Grand Rounds
2021
- Closer to Zero
- The Development of Cellular-Level Structural and Functional Biomarkers of Eye Disease Enabled by Adaptive Optics
- Laboratory and Clinical Studies to Investigate Whether Ranitidine Converts to a Probable Carcinogen in Humans
- Immune System Responses to Therapeutic Proteins: Getting up close and personal
- SARS-CoV-2: Host-pathogen interaction, vaccines & variants of concern
- FDA's work with African Swine Fever from a policy and regulatory perspective
- Project Orbis: Global Collaborative Oncology Review Program
- Electrical Safety in CTP Regulated Products
- Studies of SARS-CoV-2 NSP1 and Envelope Protein
- Research and Development of Radioanalytical Capabilities for Detection of Radionuclides in Food
- FDA Grand Rounds: The CORE Network (or How I Learned to Love Lettuce…)
2020
- Assessment of Safety and Efficacy of Fecal Microbiota for Transplantation Products
- Facial Coverings During the COVID-19 Pandemic: How well do they flatten the curve?
- Bioequivalence of Complex Topical Generics: In Vitro and In Vivo
- Advancing the Science of Real-World Data to Address the COVID-19 Pandemic
- Nanotechnology: Over a Decade of Progress and Innovation at FDA
- A Pandemic and a Call to Action for One Health: The FDA One Health Initiative
- Artificial Intelligence for Regulatory Science Research
- Analysis of Per and Polyfluoroalkyl Substances (PFAS) in foods- Analytical method development, challenges and successes
- Modernization of Pharmaceutical Manufacturing through the Adoption of Advanced Technology
- Detection of Transmissible Spongiform Encephalopathy Agents in Biological Products Using Protein Aggregation Assays
- Quality Control: Stopping infections before they happen through safer endoscope reprocessing
2019
- Vet-LIRN – How FDA’s Network of Veterinary Diagnostic Laboratories advance animal food safety and public health by conducting outbreak investigations and monitoring resistance in animal pathogens
- Technical and Logistical Considerations for Examining FDA-Regulated Products at International Mail Facilities using Handheld and Field-Portable Analytical Devices
-
Cyclospora Cayetanensis: The Crossroads Between Scientific Advances and Knowledge Gaps
-
Uncertainty is the only certainty there is: Potential approaches for making public health decisions
2018
- Jerky Pet Treats and illness in dogs: a collaborative approach to investigating a mysterious outbreak
- Decomposition of Seafood Products by Mass Spectrometry with Sensory-Driven Predictive Modeling
- The Science to Inform a Tobacco Product Standard for the Level of Nicotine in Combusted Cigarettes
- Bisphenol A: Toxicology and Pharmacokenetic Data to Inform Ongoing Safety Assessments
- How Simulation Can Transform Regulatory Pathways
- FDA's Predictive Toxicology Roadmap: Implications and Opportunities for Stakeholders
- Are Stem Cells Ready for Prime Time? A Look at FDA Research Advances in Regenerative Medicine
- Ethnicity- and Gender-Related Differences in Alzheimer's Disease
2017
- Assessing the Safety and Effectiveness of New and Emerging Therapeutic Ultrasound Technologies
- Developing a Mechanistic Model-Based Approach to Assess Cardiac Safety of New Drugs
- Genome Trakr: How a Large Network of Sequencing Laboratories is Transforming Food Safety and Public Health
- Serious and Actionable Risks, Plus Disclosure: investigating an Alternative Approach for Presenting Risk Information in Prescription Drug TV Ads
- Vaccine adjuvants: New ways to evaluate their safety and effectiveness
- Developing Regulatory Methods for Characterizing Nanomaterials in FDA-Regulated Products
2016
- The Host Response to Whooping Cough Infection and Vaccination [Archived]
- Antibiotic resistance surveillance in the age of genomics: New answers to old questions [Archived]
- FDA Research into 3D Printing of its Regulated Products [Archived]
- Rapid Screening of Dietary Supplements for Undeclared Ingredients [Archived]
- Metabolomics and Proteomics Biomarkers: Discovery and Validation in Toxicity Studies [Archived]