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

There is a growing market for cannabis-containing products in the US, many of which contain flavors, and a lack of consistent or aligned regulations. As such, the need for a product evaluation framework is critical. Building on decades of lessons in human health risk assessment in other industries, we developed a product evaluation framework for cannabis-containing products and implemented this with a representative cannabis product intended for inhalation with an electronic cannabis delivery system (ECDS). The framework is structured as an iterative, decision-based process that may be adaptable to evaluating products intended for different routes of exposure, in which each endpoint is integrated to guide additional testing and risk management decisions. Representative data on the formulation assessment and nonclinical product evaluation phases of the chemistry and toxicological testing are also provided for an inhalation product with discussion of limitations and insights of testing cannabis-containing samples with current standardized methods. Together, the framework and representative data exemplify use of an evidence-based risk assessment framework for cannabis products and offer practical guidance for manufactures seeking to responsibly develop products, as well as the development of regulatory guidance.