73rd Tobacco Science Research Conference (TSRC)

Posted On September 20, 2019

Highlights from “Tobacco Harm Reduction: Addressing Complexities Across the Risk Continuum” Opening Symposium with Matt Holman, Center for Tobacco Products Office of Science Director at FDA

Lansdowne Resort, Leesburg, VA September 15-18, 2019

Sept. 16, 2019 Opening Symposium: “Tobacco Harm Reduction: Addressing Complexities Across the Risk Continuum”

Speaker #1: Scott Ballin (Health Policy Consultant) “Is Civil Dialogue and Engagement Between Diverse Stakeholders with Respect to Tobacco Harm Reduction Feasible? A Review of the Past, Present and Future”

Speaker #2: Matt Holman presenting for Deirdre Kittner (FDA CTP) “FDA Regulating Tobacco Products Along a Continuum of Risk”

Speaker # 3: Brian Erkkila (Foundation for a Smoke-free World) “Tobacco Harm Reduction: Weighing the Evidence”

Speaker #4: Willie McKinney (Juul Labs) “Tobacco Harm Reduction: Addressing Complexities Across the Risk Continuum”

Discussion highlights from Matt Holman’s presentation:

  • Holman: Premarket Tobacco Applications (PMTA) Proposed Rule at OMB and should be coming out “very soon”
  • Holman: Modified Risk Tobacco Product Applications (MRTPA)- We are maximizing efficiency and productivity of TPSAC
  • Holman: Science is central to CTP’s public health goals
  • Questions from the audience:
    • Mike Ogden (RAI): What does the 1 year look like when CTP has 10-100s of thousands of products [PMTA applications] submitted? Holman response: Identify products with a positive impact on public health and are APPH. How exactly that will look like is unknown. Working and thinking creatively.
    • Michael Borgerding (RAI): What about MRTPA metrics [not shown during presentation] and how do they compare to SE metrics? Holman response: We know we aren’t meeting that metric, but we are putting things in place to meet that metric. There is a learning curve, and dialoguing with applicants. Shared goal to move them forward, but complicated issues we’re dealing with for the first time.
    • David Graham (NJOY): How additionally helpful will the proposed rule be? Holman response: There is overlap between the proposed rule and the draft guidance on ENDS. However, there will be some distinctly new information in the proposed rule. Draft guidance=Recommendation, while Rule=Requirement. In addition, will include broader types of policy issues and new information for PMTA and additional insights.

Panel Discussion highlights with Ballin, Holman, Erkkila and McKinney:

  • Questions from the audience:
    • Mike Ogden: There is a conflation of multiple issues, perhaps done unintentionally. Youth, flavors, illicit (an unintended consequence)? Holman: There are misperceptions and the agency is trying to distinguish. Can’t conclude its solely misuse of products. Addressing messaging and source.
    • Neil Sherwood: What are the components of tobacco harm reduction? An order or list from CTP? Erkkila: Harm reduction is a nonbinary approach. Reducing the harm of behavior of using nicotine. Ballin: Harm reduction with nicotine blown out of proportion. Ex: Obesity epidemic. There are 30,000 smokers dying from cigarettes (in reference to 6 vape deaths).
    • Ian Fearon: What about accountability for scientists publishing data that is factually incorrect (Ex: Publication drawing associations of vaping causing heart attacks), and the journals publishing these articles? Erkkila: Open science, making all data available, raises the bar. Willie McKinney: Single study becomes fact versus a weight of evidence.

Disclaimer: The following comments and questions were transcribed from notes taken during the symposium and may not be verbatim in all instances.