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EFSA publishes its opinion on the safety data of Cannabidiol as Novel Food

The EFSA has published its analysis of the literature data concerning the safety of Cannabidiol (CBD) as a novel food. EFSA has issued this statement, summarizing the state of knowledge on the safety of CBD consumption and highlighting areas where more data are needed.

According to EFSA Panel, many human studies have been carried out with Epidyolex®, a CBD drug authorized 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 Novel Food.

Given the complexity and importance of CBD receptors and pathways, interactions need to be taken into account when considering CBD as a Novel Food. 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.

Consequently, EFSA Panel considers the existence of significant uncertainties and data gaps and concludes that the safety of CBD as a Novel Food cannot currently be established.EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, 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 JR, Trezza V, van € Loveren H, Albert O, Dumas C, Germini A, Gelbmann W, Kass G, Kouloura E, Noriega Fernandez E, Rossi A and Knutsen HK, 2022. Statement on safety of cannabidiol as a novel food: data gaps and uncertainties. EFSA Journal 2022;20(6):7322, 25 pp.