Neither the authors nor the sponsoring instiD.M.F. and E.R. are employed by PAX Labs, Inc. S.V. is an employee of True Terpenes and support for this work was captured in salary for employment and is not separately compensated. R.M.S. was supported by Portland State University. This study was funded by PAX Labs, Inc. and True Terpenes.
Vaping -- Toxicology, Electronic cigarettes -- Health aspects
Vaporization is an increasingly prevalent means to consume cannabis, but there is little guidance for manufacturers or regulators to evaluate additive safety. This paper presents a first-tier framework for regulators and cannabis manufacturers without significant toxicological expertise to conduct risk assessments and prioritize additives in cannabis concentrates for acceptance, elimination, or further evaluation. Cannabinoids and contaminants (e.g., solvents, pesticides, etc.) are excluded from this framework because of the complexity involved in their assessment; theirs would not be a first-tier toxicological assessment. Further, several U.S. state regulators have provided guidance for major cannabinoids and contaminants. Toxicological risk assessment of cannabis concentrate additives, like other types of risk assessment, includes hazard assessment, dose–response, exposure assessment, and risk characterization steps. Scarce consumption data has made exposure assessment of cannabis concentrates difficult and variable. Previously unpublished consumption data collected from over 54,000 smart vaporization devices show that 50th and 95th percentile users consume 5 and 57 mg per day on average, respectively. Based on these and published data, we propose assuming 100 mg per day cannabis concentrate consumption for first-tier risk assessment purposes. Herein, we provide regulators, cannabis manufacturers, and consumers a preliminary methodology to evaluate the health risks of cannabis concentrate additives.
Copyright: © 2022 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https:// creativecommons.org/licenses/by/ 4.0/).
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Vreeke, S.; Faulkner, D.M.; Strongin, R.M.; Rufer, E. A First-Tier Framework for Assessing Toxicological Risk from Vaporized Cannabis Concentrates. Toxics 2022, 10, 771. https://doi.org/10.3390/toxics10120771