An integrated, iterative risk assessment framework for cannabis-containing products: Development and application

Area of Science:

• Toxicology
• Risk Assessment
• Cannabis Science

Background:

• The US market for cannabis products, particularly those with flavors, is expanding rapidly.
• A significant lack of consistent and aligned regulations currently exists for these products.
• This regulatory gap highlights the critical need for a standardized product evaluation framework.

Purpose of the Study:

• To develop a comprehensive product evaluation framework for cannabis-containing products.
• To adapt lessons learned from human health risk assessment in other industries.
• To provide practical guidance for manufacturers and regulatory bodies.

Main Methods:

• Developed an iterative, decision-based framework for product evaluation.
• Implemented the framework using a representative cannabis product for inhalation via an electronic cannabis delivery system (ECDS).
• Included formulation assessment and nonclinical product evaluation phases, encompassing chemistry and toxicology testing.

Main Results:

• The framework is adaptable for products intended for various exposure routes.
• Representative data illustrate the application of the framework to an ECDS inhalation product.
• Insights and limitations of applying current standardized methods to cannabis samples were discussed.

Conclusions:

• The developed framework provides an evidence-based approach to cannabis product risk assessment.
• It offers practical guidance for the responsible development of cannabis products.
• The framework supports the development of aligned regulatory guidance for the cannabis industry.