Does Cannabidiol (CBD) in Food Supplements Pose a Serious Health Risk? Consequences of the European Food Safety Authority (EFSA) Clock Stop Regarding Novel Food Authorisation
2. Materials and Methods
- Continuing with the current form of regulatory prohibition (i.e., proceeding with the current form of an unregulated market). This is probably the worst option as the prohibition approach has not worked in the past in similar areas of drug policy . It is not expected that enforcement could be strengthened to the extent that CBD products could be completely removed from the market. Prohibition will only reduce consumer protection as the products will mostly drift into areas of completely unregulated and uncontrolled non-food products (such as CBD air fresheners), and effective enforcement of the novel food regulation also seems generally impossible in other areas .
- Approving low-dose CBD food supplements (up to 10 mg/day and less than 300 mg/package) on an intermediary basis (see also the post-Brexit UK approach), including warning labels about potential toxic effects. This option may give consumers easy access to low-dose CBD supplements, despite the uncertain risk. However, warning labels about potential toxic effects and maximum daily doses may deter some consumers from using the products and increase the safety margin. Additionally, the lack of strict regulation may lead to variations in the quality and safety of CBD products between manufacturers.
- Regulating low-dose CBD products as over-the-counter medicinal products available only in pharmacies, as an additional category to the already available prescription-based high-dose CBD medicinal products (see the suggestion by Health Canada ). This option may ensure that consumers have access to safe and high-quality CBD products. However, limiting the availability of low-dose CBD products to pharmacies may reduce their accessibility to consumers, and hence still allow for unregulated markets specifically on the internet.
- Regulating CBD products outside the scope of foods or medicines in a separate framework, e.g., within the currently planned controlled distribution of cannabis to adults for recreational use in licensed stores in Germany. This option may ensure that CBD products are subject to strict regulation, labelling, and quality control standards. Additionally, it may provide consumers with accessibility to CBD products only through licensed stores. However, the potential for more or less unrestricted use of CBD products for recreational purposes may arise, leading to public health concerns.
- The currently available data for CBD do not allow a conclusive assessment of its safety as a novel food.
- Benchmark dose (BMD) response modelling of several bioassays provides an alternative POD for toxicological risk assessment.
- The authors suggest that certain CBD products still available on the EU market as food supplements despite the lack of authorisation must be considered “unsafe”: Products exceeding a health-based guidance value of 10 mg/day must be considered “unfit for consumption”, while those exceeding the human LOAEL must be considered “injurious to health”.
- This risk assessment could only be superseded if further dose–response data become available, such as those expected from the novel food applicants.
- By encouraging risk managers to take a more active role in communicating about CBD-containing products, public health outcomes could be improved and the potential for harm reduced.
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
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|Study, Animal Model||Study Design, CBD Doses||Endpoint||Sex||Model a||p-Value b||BMD c (mg/kg bw/day)||BMDL d (mg/kg bw/day)|
|GWTX1412 , rats||26-week oral at doses of 0, 15, 50, and 150 mg/kg bw/day (n = 15/sex/group)||Liver, centrilobular hypertrophy e||Males + females combined f||Dichotomous Hill||0.9989||41||20|
|GWTX1413 , dogs||39-week oral at doses of 0, 10, 50, and 100 mg/kg bw/day (n = 4/sex/group)||Liver, hepatocyte hypertrophy e||Males + females combined f||Log-Probit||0.5771||(3) g||(2) g|
|Marx et al. , rats||90-day oral at doses of 0, 25, 90, and 180 mg/kg bw/day (n = 10/sex/group) h||Liver weight||Males i||Exponential 2||0.5235||(52) j||(43) j|
|Females i||Polynomial 3||0.9771||(52) j||(34) j|
|Dziwenka et al. , rats||90-day oral at doses of 0, 6.3, 22.7 and 81.6 mg/kg bw/day (n = 10/sex/group) k||Relative liver weight||Females||Exponential 2||0.1941||(39) j||(26) j|
|CBD||Animal Data||Human Data|
|Type of point of departure (POD)||BMDL, see Table 1||LOAEL [7,17]|
|Value of point of departure (POD)||20 mg/kg bw/day|
(1400 mg/day a)
|4.3 mg/kg bw/day|
(300 mg/day a)
|Uncertainty factor (UF)||100 b||30 c|
|Health-based guidance value (HBGV)||0.20 mg/kg bw/day|
(14 mg/day a)
|0.14 mg/kg bw/day|
(10 mg/day a)
|% CBD||Number of Samples||Intake Amount [g] to Exceed LOAEL||Number of Drops to Exceed LOAEL a|
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Lachenmeier, D.W.; Sproll, C.; Walch, S.G. Does Cannabidiol (CBD) in Food Supplements Pose a Serious Health Risk? Consequences of the European Food Safety Authority (EFSA) Clock Stop Regarding Novel Food Authorisation. Psychoactives 2023, 2, 66-75. https://doi.org/10.3390/psychoactives2010005
Lachenmeier DW, Sproll C, Walch SG. Does Cannabidiol (CBD) in Food Supplements Pose a Serious Health Risk? Consequences of the European Food Safety Authority (EFSA) Clock Stop Regarding Novel Food Authorisation. Psychoactives. 2023; 2(1):66-75. https://doi.org/10.3390/psychoactives2010005Chicago/Turabian Style
Lachenmeier, Dirk W., Constanze Sproll, and Stephan G. Walch. 2023. "Does Cannabidiol (CBD) in Food Supplements Pose a Serious Health Risk? Consequences of the European Food Safety Authority (EFSA) Clock Stop Regarding Novel Food Authorisation" Psychoactives 2, no. 1: 66-75. https://doi.org/10.3390/psychoactives2010005