Safety Assessment on the Safety of Cannabidiol (CBD) Isolate as a Novel Food for Use in Food Supplements (RP793)

An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in March 2021 from CBD Industries LLC. (“the applicant”) for the authorisation of cannabidiol (CBD) isolate as a novel food. The novel food is an isolated >97% pure form of CBD which is intended to be used as a food supplement for adults (excluding pregnant and lactating women, and other specifically identified vulnerable groups including those on medication and the immunosuppressed). 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. The FSA and FSS concluded based on the advice of the ACNFP that the applicant had provided sufficient information to assure the novel food, a CBD isolate as outlined in application RP793, was safe when used at 10 mg a day in food supplements. It was noted a higher use level of 24 mg/day was sought but when considered in the context of the wider data for 98% purity or greater CBD safety for the higher level could not be assured. The anticipated intake levels and the proposed use of this pure form of CBD in food supplements was not considered to be nutritionally disadvantageous. The views of the ACNFP have been taken into account in the regulatory assessment which represents the opinion of the FSA and FSS.