"Beyond the Agency: From Oversight to Insight" PANEL HIGHLIGHTS

7th Annual Next Generation Nicotine Delivery USA Conference

"Beyond the Agency: From Oversight to Insight" PANEL HIGHLIGHTS

MODERATOR: Willie McKinney Ph.D., DABT

PANELISTS:

• Roxana Weil, PhD, DABT

• Angela Ho-Chen

• Melis Coraggio

• Gabriel Muniz

• David Oliveira

This panel featured former FDA/CTP employees who now operate within the industry or consulting sectors, offering insights on improving the relationship between the FDA and stakeholders.

KEY TAKEAWAYS regarding the future of the FDA's Center for Tobacco Products (CTP) and its relationship with industry stakeholders:

• BOLD LEADERSHIP: The new director of the CTP should establish a clear mission and direction with urgency, acknowledging past failures and the need for change within the agency.

• OPEN DIALOGUE: Establishing open lines of communication between the CTP and industry stakeholders is crucial. This includes encouraging dialogue to understand innovations and challenges in the market, thereby reducing the regulatory lag.

• TRANSPARENCY & TRUST: The panel emphasized the importance of transparency within the agency and with external stakeholders. Building trust is essential for effective regulation and collaboration.

• STREAMLINING PROCESSES: There is a call for a more efficient review process for applications including either abiding by the 180-day legal requirement or, potentially through a risk-based tiered approach that differentiates between low-risk and high-risk products.

• INDUSTRY RESPONSIBILITY: Industry stakeholders should approach the regulatory process with integrity, submitting applications in good faith and ensuring that their products meet safety and quality standards.

• SCIENTIFIC STANDARDS: The panelists stressed the importance of basing regulatory decisions on sound science and evidence, advocating for the use of reliable data in the evaluation of tobacco products.

• PUBLIC HEALTH FOCUS: The discussion underscored the need to prioritize public health, particularly in helping smokers transition to safer alternatives, and to communicate the benefits of tobacco harm reduction effectively.

• ADDRESSING INTERNAL SILOS: Breaking down internal silos within the CTP and fostering collaboration among different departments is necessary for improving the agency's effectiveness.

• PROACTIVE OUTREACH: The new director should actively engage with public health conferences and share research findings to promote understanding and support for tobacco harm reduction initiatives.