Version 1
: Received: 11 August 2022 / Approved: 12 August 2022 / Online: 12 August 2022 (09:00:49 CEST)
Version 2
: Received: 3 September 2022 / Approved: 5 September 2022 / Online: 5 September 2022 (04:34:49 CEST)
Version 3
: Received: 23 November 2022 / Approved: 24 November 2022 / Online: 24 November 2022 (02:53:03 CET)
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, 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, 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, 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
Abstract
In the European Union (EU), cannabidiol products require pre-marketing authorisation under the novel food regulation. Currently, 19 CBD applications are under assessment at the European Food Safety Authority (EFSA). During the initial assessment of the application files, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) located several knowledge gaps in their 07 June 2022 statement on safety of cannabidiol as a novel food that need to be addressed before the evaluation of CBD can be concluded. Namely, the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system, psychological function, and reproductive system needs to be clarified. Nevertheless, the available literature allows a benchmark dose (BMD)-response modelling of several bioassays, resulting in a BMD lower confidence limit (BMDL) of 20 mg/kg bw/day for liver toxicity in rats. Human data in healthy volunteers found increases in the liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in a study at 4.3 mg/kg bw/day, which was defined by EFSA NDA panel as a lowest observed adverse effect level (LOAEL). The EFSA NDA panel currently concluded that the safety of CBD as a novel food cannot be evaluated, leading to a so-called clock stop of the applications until the applicants provide the required data. Meanwhile, the authors suggest that CBD products still available as food supplements on the EU market despite the lack of authorisation must be considered as “unsafe”. Products exceeding a health-based guidance value of 10 mg/day must be considered as being “unfit for consumption” (Article 14(1) and (2) (b) of Regulation No 178/2002), while the ones in exceedance of the human LOAEL must be considered “injurious to health” (Article 14(1) and (2) (a) of Regulation No 178/2002).
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.
Commenter: Dirk W. Lachenmeier
Commenter's Conflict of Interests: Author