Risk Assessment Suggests Safe Daily CBD Dose in Food May Be Around 10 mg Based on Liver Toxicity Data

Animal studies yielded a benchmark dose lower confidence limit (BMDL) of 43 mg/kg bw/day, translating to approximately 15 mg/day for humans. Human data identified a lowest observed adverse effect level (LOAEL) of 4.3 mg/kg bw/day. The confirmed health-based guidance value was set at 10 mg/day based on the human LOAEL, citing liver toxicity and possible reproductive toxicity.

Updated risk assessment using benchmark dose-response modeling of available animal and human safety data on CBD. Studies suitable for BMDL calculation were identified. Animal-to-human dose translation and standard safety factors were applied to derive a health-based guidance value for CBD in foods.

CBD is sold in a growing, largely unregulated food market with products often recommending doses far exceeding 10 mg daily. This risk assessment provides regulators with a scientifically derived safety threshold and highlights that many commercial CBD food products may exceed safe intake levels.

The contrast between CBD's therapeutic dose for epilepsy (5-20 mg/kg/day, i.e., 350-1,400 mg/day for a 70-kg person) and the safety threshold for daily food consumption (10 mg/day) illustrates the gap between medical and consumer contexts. What's acceptable under medical supervision may not be safe as a casual daily supplement.

Data gaps remain, particularly for reproductive toxicity and long-term exposure. The guidance value is conservative by design. Individual variation in CBD metabolism (especially related to concurrent medications) is not captured by a single threshold.