Archives: Agenda

Overview of FDA enforcement tools & actions

  • Brief overview of the regulation of tobacco products
  • Enforcement discretion & priorities
  • Compliance & enforcement tools
  • Recent enforcement actions by the agency
  • Pending lawsuits

Panel discussion: Key developments in the cannabis and hemp markets

  • Review of states that have increased legal access to cannabis and hemp products
  • States that are likely to be allowed to sell Hemp/Cannabis/CBD products in the future
  • Innovation in delta 8 products
  • The growth of cannabis vaping
  • Update on vaping CBD
  • Outlook for the category over the next 3-5 years
  • What’s going to be the next big thing in the cannabis/hemp category?

 

Interview: A Discussion with the Office of Science

1)         Recent Actions

  • Review Actions (MGO,MDO, Deficiency Letters, RTA, RTF, Flavored ENDS, Etc.)

2)         Additional resources/ Transparency

  • Memo posting
  • Searchable Products Database
  • Public meeting
  • Further discussion of APPH

3)         Questions FDA would like some feedback on

  • What do you need to hear from us?
  • What scientific guidance do you need the most?
  • How do you want to engage with us?

 

The Tobacco Control Act 15 Years Later: Is the Center for Tobacco Products Achieving the Act’s Goals?

  • The TCA was a landmark event that for the first time, established a comprehensive regulatory system with the goal of reducing tobacco-related death and disease as the proper framework for regulation
  • As we approach the 15th anniversary of the TCA’s enactment—and the inception of FDA’s Center for Tobacco Products—it’s time to reflect on what’s working well at the Center and where there are potential opportunities for improvement
  • Regulations and Guidance: Do stakeholders have clarity on the Center’s current thinking, expectations, and requirements?
  • Timely, Clear, and Consistent Application Review: Is the current application process fostering innovation and promoting tobacco harm reduction?
  • Compliance and Enforcement: Has the Center established a coherent compliance framework for responsible industry members that has resulted in a well-regulated marketplace?
  • Communication and Education: Has the Center provided clear, science-based, and relevant communications to public health and adult smokers on the continuum of risk and the misperceptions of nicotine?