EFSA: CBD Novel Food Evaluations on Hold Pending New Data

On June 7, 2022, the European Fooda Safety Authority (EFSA) published a statement summarising the state of knowledge on the safety of CBD consumption and highlighting areas where more data are needed. EFSA said that its scientists cannot currently establish the safety of cannabidiol (CBD) as a novel food due to data gaps and uncertainties about potential hazards related to CBD intake.

EFSA’s expert Panel on Nutrition, Novel Foods and Food Allergens (NDA) has received 19 applications for CBD as a novel food, with more in the pipeline.

Chair of the NDA Panel, Prof. Dominique Turck said: “We have identified several hazards related to CBD intake and determined that the many data gaps on these health effects need filling before these evaluations can go ahead. It is important to stress at this point that we have not concluded that CBD is unsafe as food.”

There is insufficient data on the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system, and people’s psychological well-being.

Studies in animals show significant adverse effects, especially in relation to reproduction. It is important to determine if these effects are also seen in humans.

Ana Afonso, Head of Nutrition and Food Innovation at EFSA, stated: “Stopping the clock on a novel food assessment is not unusual when information is missing. It’s the responsibility of applicants to fill data gaps. We are engaging with them to explain how the additional information can be provided to help address the uncertainties.”

As part of the follow-up, EFSA is holding an info session, open to applicants and other groups or individuals with an interest in this issue and novel food more generally. The online event takes place on 28 June.  Applicants and stakeholders can register to attend the event by 17 June at 17:00 Italy’s time EOB.

In their statement on data gaps and uncertainties surrounding CBD as a novel food, the panel members of the European Commission outline the 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 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. 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 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 the liver, gastrointestinal tract, endocrine system, nervous system, and 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 novel food cannot currently be established.