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FSA: New CBD food assessments await new data

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On June 7, 2022, the European Food Safety Authority (EFSA) published a statement Summarize the state of knowledge about the safety of CBD consumption and highlight areas that require more data. The European Food Safety Authority said its scientists cannot currently prove the safety of cannabidiol (CBD) as a new food due to data gaps and uncertainties about potential risks related to ingesting cannabidiol.

The EFSA’s Expert Committee on Nutrition, New Foods and Allergens (NDA) has received 19 applications for CBD as a new food, with more in the pipeline.

NDA Chair Professor Dominic Türk said: “We have identified several risks related to taking CBD and have determined that many data gaps on these health effects need to be filled before these assessments can proceed. It is important to stress at this point that we We did not conclude that CBD is unsafe as a food.”

There is not enough data on the effect of CBD on the liver, digestive system, endocrine system, nervous system, and psychological well-being of people.

Animal studies show significant adverse effects, especially with regard to reproduction. It is important to determine if these effects also appear in humans.

Ana Afonso, Head of Nutrition and Food Innovation at the EFSA stated: “Stopping the clock in a new food assessment is not unusual when information is missing. It is the applicant’s responsibility to fill in the data gaps. We are reaching out to them to explain how to provide additional information to help in addressing uncertainties”.

As part of the follow-up, the FRA is holding an open information session for applicants and other groups or individuals interested in this issue and new food in general. The event will take place online on June 28. Applicants and stakeholders can registration To attend the event by June 17 at 17:00 Italian time.

in their own Statement on data gaps and uncertainties surrounding CBD as a new foodMembers of the European Commission Committee identify areas where more data is needed. Literature searches were performed for both animal and human studies to identify safety concerns. Several human studies have been conducted with Epidyolex®, which is a CBD medication approved for treatment of treatment-resistant epilepsy. In the context of medical conditions, adverse effects are tolerated if the benefits outweigh the adverse effect. However, this is not acceptable when considering CBD as a new food. Furthermore, most of the human data referenced in CBD applications investigated the efficacy of Epidyolex (or CBD) at therapeutic doses.

NOAEL could not be determined from these studies. Due to the complexity and importance of CBD receptors and pathways, interactions must be taken into account when considering CBD as a new food. Effects on drug metabolism should be clarified. The kinetics of toxins in the different matrices, half-life and accumulation should be examined. The effect of CBD on the liver, digestive system, endocrine system, nervous system, and psychological function should be clarified. Animal studies show significant reproductive toxicity, and the extent to which this occurs should be evaluated in humans in general and in women of childbearing age specifically. Given the significant uncertainties and data gaps, the committee concluded that the safety of CBD as a new food could not be demonstrated at this time.


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