Your latest cannabis business info from Europe

Your latest cannabis business info from Europe

2023-02-05

Cannabidiol (CBD) as a novel food by EFSA

CBD as a food

The European Commission has determined to consider cannabidiol (CBD) as a so-called novel food (NF). According to definition, novel foods are foods which any significant extent of humans has not consumed in the European Union before May 15, 1997. This is a date when the first novel food regulation entered into force. “Novel food” can generally mean newly developed, innovative food or food produced using new technologies. But it can also mean food that is or has been traditionally consumed outside the European Union. 

The European Commission has decided that there are gaps in knowledge regarding the safety of CBD. The lack of this information needs to be addressed before any conclusions can be drawn. Therefore, EFSA has issued this statement, summarizing the safety of CBD consumption. They are also pointing out areas where they need more data.

Interpretation

Namely, the EC conducted a review to identify safety concerns. It is noted that researchers conducted several in vivo CBD toxicology studies (on mice, rats, dogs and monkeys), as well as a number of in vitro studies. More about what is in CBD products can be found HERE. But the main problems in interpreting many of these studies are different preparations or extracts containing different concentrations of CBD and other cannabinoids. In addition, the content of other substances rarely occurs in the descriptions. As such, there is some degree of uncertainty whether the reported effects for low-CBD products are usable solely to CBD. A result of conducting research with CBD extracts rather than the pure compound is that it is difficult to identify a CBD-specific benchmark.

CBD food side effects

Many human studies involved patients who required use of other medications, including Epidyolex®, a CBD drug approved for the treatment of refractory epilepsy. In the context of medical conditions, side effects are tolerable if the benefits outweigh the side effects. However, this is unacceptable if we consider CBD as NF. According to the European Commission, researchers should analyze also any interactions when considering CBD as a novel food. It is becasue of the complexity and importance of CBD receptors and pathways.

What researchers should look at now?

What researchers must clarify is the effect on drug metabolism. They also must look at toxicokinetics in different matrices, half-life and accumulation. The effects of CBD on the liver, digestive tract, endocrine system, nervous system, and psychological function need to be clarified. Animal studies show significant reproductive toxicity and the extent to which this occurs in humans in general and in females of childbearing potential in particular requires specific assessment. The panel identified several risks associated with CBD consumption and pointed out shortcomings in both animal and human experimental data. Given the significant uncertainties and data gaps, the panel concludes that they cannot establish the safety of CBD as novel food at this time.

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