A First-Tier Framework for Assessing Toxicological Risk from Vaporized Cannabis Concentrates

Area of Science:

• Toxicology
• Risk Assessment
• Cannabis Science

Background:

• Vaporization is a common cannabis consumption method.
• Lack of clear guidance exists for evaluating cannabis concentrate additive safety.
• Existing regulations often exclude additive safety assessments.

Purpose of the Study:

• To present a first-tier risk assessment framework for cannabis concentrate additives.
• To guide regulators and manufacturers lacking extensive toxicological expertise.
• To prioritize additives for acceptance, elimination, or further evaluation.

Main Methods:

• Framework excludes complex assessments of cannabinoids and contaminants.
• Utilizes toxicological risk assessment steps: hazard assessment, dose-response, exposure assessment, and risk characterization.
• Proposes a standardized daily consumption of 100 mg for first-tier risk assessment, informed by new and existing consumption data.

Main Results:

• Provides a preliminary methodology for health risk evaluation of additives.
• Incorporates novel consumption data from over 54,000 smart vaporization devices.
• Establishes a practical approach for additive safety assessment.

Conclusions:

• The proposed framework offers a practical solution for additive safety evaluation.
• Empowers regulators and manufacturers to make informed decisions on additive acceptance.
• Aims to enhance consumer safety in the growing cannabis concentrate market.