The European Commission has determined that cannabidiol (CBD) can be considered as a novel food (NF), and currently, 19 applications are under assessment at EFSA. While assessing these, it has become clear that there are knowledge gaps that need to be addressed before a conclusion on the safety of CBD can be reached. Consequently, EFSA has issued this statement, summarising the state of knowledge on the safety of CBD consumption and highlighting areas where more data are needed. Literature searches for both animal and human studies have been conducted to identify safety concerns. Many human studies have been carried out with Epidyolex®, a CBD drug authorised to treat refractory epilepsies. In the context of medical conditions, adverse effects are tolerated if the benefit outweighs the adverse effect. This is, however, not acceptable when considering CBD as a NF. Furthermore, most of the human data referred to in the CBD applications investigated the efficacy of Epidyolex (or CBD) at therapeutic doses. No NOAEL could be identified from these studies. Given the complexity and importance of CBD receptors and pathways, interactions need to be taken into account when considering CBD as a NF. The effects on drug metabolism need to be clarified. Toxicokinetics in different matrices, the half-life and accumulation need to be examined. The effect of CBD on liver, gastrointestinal tract, endocrine system, nervous system and on psychological function needs to be clarified. Studies in animals show significant reproductive toxicity, and the extent to which this occurs in humans generally and in women of child-bearing age specifically needs to be assessed. Considering the significant uncertainties and data gaps, the Panel concludes that the safety of CBD as a NF cannot currently be established.

Statement on safety of cannabidiol as a novel food: data gaps and uncertainties / Turck, D.; Bohn, T.; Castenmiller, J.; De Henauw, S.; Hirsch-Ernst, K. I.; Maciuk, A.; Mangelsdorf, I.; Mcardle, H. J.; Naska, A.; Pelaez, C.; Pentieva, K.; Siani, A.; Thies, F.; Tsabouri, S.; Vinceti, M.; Cubadda, F.; Frenzel, T.; Heinonen, M.; Marchelli, R.; Neuhauser-Berthold, M.; Poulsen, M.; Prieto Maradona, M.; Schlatter, J. R.; Trezza, V.; van Loveren, H.; Albert, O.; Dumas, C.; Germini, A.; Gelbmann, W.; Kass, G.; Kouloura, E.; Noriega Fernandez, E.; Rossi, A.; Knutsen, H. K.. - In: EFSA JOURNAL. - ISSN 1831-4732. - 20:6(2022), pp. e07322-e07347. [10.2903/j.efsa.2022.7322]

Statement on safety of cannabidiol as a novel food: data gaps and uncertainties

Vinceti M.;
2022

Abstract

The European Commission has determined that cannabidiol (CBD) can be considered as a novel food (NF), and currently, 19 applications are under assessment at EFSA. While assessing these, it has become clear that there are knowledge gaps that need to be addressed before a conclusion on the safety of CBD can be reached. Consequently, EFSA has issued this statement, summarising the state of knowledge on the safety of CBD consumption and highlighting areas where more data are needed. Literature searches for both animal and human studies have been conducted to identify safety concerns. Many human studies have been carried out with Epidyolex®, a CBD drug authorised to treat refractory epilepsies. In the context of medical conditions, adverse effects are tolerated if the benefit outweighs the adverse effect. This is, however, not acceptable when considering CBD as a NF. Furthermore, most of the human data referred to in the CBD applications investigated the efficacy of Epidyolex (or CBD) at therapeutic doses. No NOAEL could be identified from these studies. Given the complexity and importance of CBD receptors and pathways, interactions need to be taken into account when considering CBD as a NF. The effects on drug metabolism need to be clarified. Toxicokinetics in different matrices, the half-life and accumulation need to be examined. The effect of CBD on liver, gastrointestinal tract, endocrine system, nervous system and on psychological function needs to be clarified. Studies in animals show significant reproductive toxicity, and the extent to which this occurs in humans generally and in women of child-bearing age specifically needs to be assessed. Considering the significant uncertainties and data gaps, the Panel concludes that the safety of CBD as a NF cannot currently be established.
20
6
e07322
e07347
Statement on safety of cannabidiol as a novel food: data gaps and uncertainties / Turck, D.; Bohn, T.; Castenmiller, J.; De Henauw, S.; Hirsch-Ernst, K. I.; Maciuk, A.; Mangelsdorf, I.; Mcardle, H. J.; Naska, A.; Pelaez, C.; Pentieva, K.; Siani, A.; Thies, F.; Tsabouri, S.; Vinceti, M.; Cubadda, F.; Frenzel, T.; Heinonen, M.; Marchelli, R.; Neuhauser-Berthold, M.; Poulsen, M.; Prieto Maradona, M.; Schlatter, J. R.; Trezza, V.; van Loveren, H.; Albert, O.; Dumas, C.; Germini, A.; Gelbmann, W.; Kass, G.; Kouloura, E.; Noriega Fernandez, E.; Rossi, A.; Knutsen, H. K.. - In: EFSA JOURNAL. - ISSN 1831-4732. - 20:6(2022), pp. e07322-e07347. [10.2903/j.efsa.2022.7322]
Turck, D.; Bohn, T.; Castenmiller, J.; De Henauw, S.; Hirsch-Ernst, K. I.; Maciuk, A.; Mangelsdorf, I.; Mcardle, H. J.; Naska, A.; Pelaez, C.; Pentieva, K.; Siani, A.; Thies, F.; Tsabouri, S.; Vinceti, M.; Cubadda, F.; Frenzel, T.; Heinonen, M.; Marchelli, R.; Neuhauser-Berthold, M.; Poulsen, M.; Prieto Maradona, M.; Schlatter, J. R.; Trezza, V.; van Loveren, H.; Albert, O.; Dumas, C.; Germini, A.; Gelbmann, W.; Kass, G.; Kouloura, E.; Noriega Fernandez, E.; Rossi, A.; Knutsen, H. K.
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