Slide Deck 230905

Natural Medicine Division

Listening Sessions
SB 23-290 Overview & Introduction

Dominique Mendiola, Senior Director, Department of Revenue Natural Medicine Division
Allison Robinette, Director of Policy & Regulatory Affairs, Department of Revenue Natural Medicine Division

Agenda
September 5, 2023

1. Introduction to Natural Medicine Division (Division)

2. Presentation of SB 23-290

   • Statutory Responsibilities Assigned to DOR

3. Overview of Priority Focus Areas presented to the Natural Medicine Advisory Board

4. Anticipated Implementation Timeline

5. Q&A Opportunity - Priorities & Implementation

6. Listening Session Overview & Schedule

   • Topics
   • September Schedule

7. Q&A Opportunity - Listening Sessions

Natural Medicine Division

Introduction

Heidi Humphreys, State Licensing Authority (Interim DOR Executive Director)
Dominique Mendiola, Senior Director
Kyle Lambert, Deputy Senior Director
Allison Robinette, Director of Policy & Regulatory Affairs
━━━━━━━━━━━━━━━━━
Cash Funded Program
Staffing - Leveraging Existing State Resources & Subject Matter Expertise
Coordination with Other State Agencies
Programming - Integrating New Licensing Functions into Existing Platforms

DOR-MED Areas of Expertise

• Cultivation & Manufacturing Oversight: Security requirements; permitted and prohibited chemicals; waste management; packaging & labeling; keeping pace w/innovation

• Inventory Tracking: Manifest requirements

• Health & Safety Protocols: Adverse Health Event Reporting

• Data Driven Strategies: Market data monitoring, risk-based intervention strategies

• Licensing Application Development & Procedures: Licensing processes for cultivation, manufacture, transport, and testing operations

• Laboratory Testing Program Oversight: Testing standards & Certification processes

• Regulatory Oversight Involving Schedule I Controlled Substances: Experience navigating challenges with federal law and opportunity to inform a federal framework

• Social Equity Considerations: Lessons learned / Impacts from the War on Drugs

Prop 122 to SB 23-290

Signed May 23, 2023

Natural Medicine Defined

• Psilocybin & Psilocyn (Initially)
• Ibogaine (Prior to 2026)
• DMT, Mescaline (2026)

Primary Code Changes

• Title 12
• Title 25
• Title 44
• Titles 16 & 18

Outline of Provisions

• DORA Regulatory Program
• DOR Regulatory Program
• CDPHE Regulatory Role
• Personal Use Provisions

Implementation Timeline Extended

• Extended Timeline for Rulemaking & Applications

SB 23-290

Regulatory Program - DOR

The Department of Revenue (DOR) is responsible for licensing and regulating healing centers, cultivations, manufacturers, and testing facilities under a new Natural Medicine Division.

Other responsibilities include:

• Testing Program (coordination with CDPHE)

• Data collection (LE incidents, adverse health events, healthcare system impacts, consumer protection claims, behavioral health impacts)

• Public education campaigns

• Training materials for first and multi-responders

• Annual Reporting (in coordination with DORA)

State Licensing Authority

Powers & Duties

• Application Intake: On or before December 31, 2024

• Licensing and Enforcement powers

• Reporting, Public Education, & Training duties

• Other Duties & Limitations:

  • Establish an equitable and inclusive program

  • Measures to prevent youth access

  • Production management

  • Measures to prevent exploitation & commercialization

State Licensing Authority

Rulemaking Authority

Mandatory Rulemaking: The State Licensing Authority shall promulgate rules…

• General licensing requirements; qualifications and eligibility requirements for licensure; permitted and prohibited financial interests; testing program; regulation of licensed premises; transportation requirements; production management; record keeping; etc.

Other Requirements & Limitations:

• SLA shall consult with the Natural Medicine Advisory Board when considering and promulgating rules

Priority Focus Areas

Presented to the Natural Medicine Advisory Board

Priority Focus Areas

• Data Collection

• Develop and promote training materials for first responders and multi-responders

• Permissible / Prohibited Financial Interests in a License

• Regulation of Licensed Premises

• Product Requirements and Restrictions

• Develop and promote public education campaigns

• Natural Medicine Cultivation

• Manufacturing of Natural Medicine Products

• Storage and Transport

• Licensing Standards & Qualifications

Anticipated Implementation Timeline

Q & A Opportunity

Focus Areas & Implementation

Listening Sessions Schedule

September

• September 12th: First & Multi-Responder Training Meeting #1

  • 2:00 pm - 3:00 pm (MDT)

• September 22nd: Public Education Campaign Meeting #1

  • 2:00 pm - 3:00 pm (MDT)

• September 27th: Testing Program Meeting #1

  • 10:00 am - 11:00 am (MDT)

• October 3rd: Cultivation & Manufacturing Practices Meeting #1

  • 10:00 am - 11:00 am (MDT)

Q & A Opportunity

Listening Sessions