Safety Assessment of Cannabidiol (CBD) as a Novel Food for Use in Food and Food Supplements (RP521)

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) received an application from TTS-Pharma Limited, UK (“the applicant”) for the authorisation of cannabidiol (CBD) as a novel food in March 2021. The novel food is seeking to use the novel food as an ingredient in beverages, chewing gum, gummies, preserves, sports gels and powders, and food supplements for adults (excluding pregnant and lactating women and other specifically identified vulnerable groups including those taking medication and the immunocompromised). To support the FSA and FSS in their evaluation of the application, the Advisory Committee on Novel Foods and Processes (ACNFP) were asked to review the safety dossier and supplementary information provided by the applicant. The Committee did not consider any potential health benefits or claims arising from consuming the food, as the focus of the novel food assessment is to ensure the food is safe and does not put consumers at a nutritional disadvantage. The novel food was assessed based on the data provided. This review indicated it was appropriate for the provisional Acceptable Daily Intake (ADI) for 98% purity or greater CBD to form part of the evidence for this assessment. For CBD, a provisional acceptable daily intake (ADI) of 10 mg/day has been published by the FSA and was considered in assessing this novel food. The provisional ADI (section 2.7) was recommended, subject to the existing advice to consumers that pregnant and breastfeeding women and people taking any prescription medication should avoid the consumption of CBD. Consumers on regular medications should seek advice from a medical professional before using any type of CBD food product. In addition, children and prospective parents trying for a baby are advised against consumption of CBD, as are those who are immunosuppressed, due to remaining data gaps and residual uncertainties concerning the safety of CBD for these groups of consumers. These contraindications would also apply to this novel food. The FSA and FSS concluded that the applicant had provided sufficient information to assure that CBD was safe under the intended conditions of use. The anticipated intake levels and the intended use in food and food supplements was not considered to be nutritionally disadvantageous. The safety assessment represents the opinion of the FSA and FSS.