Version 1
: Received: 30 July 2024 / Approved: 31 July 2024 / Online: 31 July 2024 (09:50:10 CEST)
How to cite:
Wisotzki, E.; Franke, H.; Sproll, C.; Walch, S. G.; Lachenmeier, D. W. Updated Risk Assessment of Cannabidiol in Foods based on Benchmark Dose-Response Modeling. Preprints2024, 2024072527. https://doi.org/10.20944/preprints202407.2527.v1
Wisotzki, E.; Franke, H.; Sproll, C.; Walch, S. G.; Lachenmeier, D. W. Updated Risk Assessment of Cannabidiol in Foods based on Benchmark Dose-Response Modeling. Preprints 2024, 2024072527. https://doi.org/10.20944/preprints202407.2527.v1
Wisotzki, E.; Franke, H.; Sproll, C.; Walch, S. G.; Lachenmeier, D. W. Updated Risk Assessment of Cannabidiol in Foods based on Benchmark Dose-Response Modeling. Preprints2024, 2024072527. https://doi.org/10.20944/preprints202407.2527.v1
APA Style
Wisotzki, E., Franke, H., Sproll, C., Walch, S. G., & Lachenmeier, D. W. (2024). Updated Risk Assessment of Cannabidiol in Foods based on Benchmark Dose-Response Modeling. Preprints. https://doi.org/10.20944/preprints202407.2527.v1
Chicago/Turabian Style
Wisotzki, E., Stephan G. Walch and Dirk W. Lachenmeier. 2024 "Updated Risk Assessment of Cannabidiol in Foods based on Benchmark Dose-Response Modeling" Preprints. https://doi.org/10.20944/preprints202407.2527.v1
Abstract
Cannabidiol (CBD), a non-psychotropic main component of the Cannabis plant, is approved as a drug in the European Union (EU) under the name “Epidyolex”. However, the approval process as a food ingredient under the Novel Food Regulation was paused by the European Food Safety Authority (EFSA) due to a lack of safety data. Nevertheless, there is a growing, unregulated market in which CBD is advertised with various health claims and different dosage instructions. Of particular concern is its toxic effect on the liver and possible reproductive toxicity in humans. Studies suitable for calculating a benchmark dose were identified from the available data. Animal studies yielded a Benchmark Dose Lower Confidence Limit (BMDL) of 43 mg/kg bw/day, which translates into a safe human dose of approximately 15 mg/day. Only a Lowest Observed Adverse Effect Level (LOAEL) of 4.3 mg/kg bw/day could be identified from the human data. This updated risk assessment confirmed the Health-based Guidance Value (HBGV) of 10 mg/day based on human LOAEL. Despite existing data gaps, preliminary regulation appears advisable as the current form of the gray CBD market is unacceptable from the standpoint of consumer safety and protection.
Medicine and Pharmacology, Pharmacology and Toxicology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
