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Updated: Jun 10, 2025

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Updated Risk Assessment of Cannabidiol in Foods Based on Benchmark Dose-Response Modeling.

Eva Wisotzki1,2, Heike Franke1, Constanze Sproll2

  • 1Postgraduate Study of Toxicology and Environmental Protection, Rudolf-Boehm-Institut für Pharmakologie und Toxikologie, Universität Leipzig, Härtelstrasse 16-18, 04107 Leipzig, Germany.

Molecules (Basel, Switzerland)
|October 16, 2024
PubMed
Summary

Cannabidiol (CBD) poses risks, with animal studies suggesting a safe dose of 15 mg/day and human data indicating 10 mg/day. Preliminary regulation is advised due to safety concerns in the unregulated CBD market.

Keywords:
benchmark dosecannabidiolhealth-based guidance valuenovel foodrisk assessment

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Area of Science:

  • Pharmacology and Toxicology
  • Food Safety Regulation
  • Cannabinoid Research

Background:

  • Cannabidiol (CBD), a non-psychoactive cannabis compound, has drug approval (Epidyolex) but faces regulatory hurdles as a food ingredient.
  • An expanding, unregulated market offers CBD products with unverified health claims and dosages.
  • Concerns exist regarding CBD's potential liver toxicity and reproductive health effects in humans.

Purpose of the Study:

  • To conduct a risk assessment for CBD as a food ingredient.
  • To establish a health-based guidance value (HBGV) for safe human consumption.
  • To evaluate the need for preliminary regulation of the CBD market.

Main Methods:

  • Identification and analysis of studies suitable for benchmark dose (BMD) calculation.
  • Extrapolation of animal study data to determine a safe human dose.
  • Analysis of human data to identify the Lowest-Observed-Adverse-Effect Level (LOAEL).

Main Results:

  • Animal studies established a benchmark dose lower confidence limit (BMDL) of 43 mg/kg bw/day, suggesting a safe human dose of approximately 15 mg/day.
  • Human data yielded a LOAEL of 4.3 mg/kg bw/day.
  • An updated risk assessment confirmed an HBGV of 10 mg/day based on human LOAEL.

Conclusions:

  • The established HBGV of 10 mg/day provides a basis for consumer safety.
  • The current unregulated CBD market presents unacceptable risks to consumers.
  • Preliminary regulatory measures are recommended to address safety gaps and protect public health.