Regulation (EU) 2015/2283 (Novel Food Regulation) sets out the applicable rules for the placing on the market of novel foods in the EU. At the heart of these rules is a detailed approval procedure by the European Commission with the involvement of the European Food Safety Authority (EFSA). In this process, EFSA evaluates all characteristics of the novel food that may pose a safety risk to human health. For products containing cannabidiol (CBD), EFSA has already received over 150 applications for evaluation, of which 19 applications are currently undergoing in-depth assessments (see Insight, 25 April 2022). On 7 June 2022, EFSA published a statement that evaluations on CBD as a novel food are suspended pending new data. This means that the approval procedures for products containing CBD are at a standstill for the time being.
What were the reasons?
EFSA's reasoning for suspending the assessments is that the safety of CBD as a novel food cannot be established based on current evidence. A number of safety risks to human health associated with the ingestion of CBD have been identified. However, due to data gaps and uncertainties, an adequate assessment of these risks is currently impossible. For example, there is a general lack of sufficient data on the effects of CBD on the liver, gastrointestinal tract, endocrine system, nervous system, and psychological well-being. The human studies that have been conducted werde not fully conclusive given the parallel medication or, in the case of Epidyolex, even its own therapeutic use. In addition, it was still unclear whether the adverse reproductive effects observed in animal studies occur in the same way in humans.
How should the decision be assessed?
EFSA's decision to suspend assessments in the case of unclear data is not unusual and is probably also related to the strict standard of review. While any undesirable effects can still be tolerated when CBD is used in medicinal products if a medical benefit outweighs them, a different standard applies to CBD in (novel) foods: the consumption of novel foods must not be associated with any safety risks. However, the latter determination was not yet possible for the EFSA experts on the basis of the current data situation.
Where do we go from here?
EFSA's decision to suspend the assessment is not to be equated with the classification of CBD as an unsafe novel food. Rather, EFSA is now playing the ball back to the applicants. It is their responsibility to fill existing data gaps and respond to EFSA's requests. Nevertheless, EFSA's decision is initially met with disillusionment in the industry. Because of the extensive data gaps, it will take some time before any research is initiated and clinical studies are carried out. However, EFSA's willingness to cooperate with the applicants gives reason for hope. And, the classification of CBD as a novel food remains possible!
Authors: Dr. Daniel Tietjen, Christoph Behm
