06.08.22
The European Food Safety Authority (EFSA), Europe’s foremost authority on food safety, issued a statement that novel food evaluations for cannabidiol (CBD) ingredients will remain on hold as there are too many gaps in clinical safety data.
The response came after the European Commission announced that it considered CBD a novel food, so long as a product met the conditions of EU legislation on novel foods. The statement was issued in response to the Commission requesting that EFSA give its opinion on whether CBD consumption is safe for humans.
To date, 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.
“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.”
The EFSA panel in its statement broke down data insufficiencies relevant to the effects of CBD on the liver, gastrointestinal tract, endocrine system, nervous system, drug interactions, and psychological well-being in humans. Additionally, animal studies have yielded data suggesting significant adverse reproductive effects could be linked to CBD, and not enough research has been conducted to determine if these effects are also seen in humans. “In the context of medical conditions, adverse effects of CBD are tolerated if the benefits outweigh any adverse effect. However, adverse effects are not acceptable in foods. They must be demonstrated to be safe for normal consumption,” EFSA wrote in the statement.
The statement goes on to detail potential limitations in currently available data. Animal studies have been performed with non-chemically pure CBD, which could lead to confounding data. Additionally, several human studies were performed in patients that were, at the same time, treated with other medications and with high therapeutic doses, which may have impacted the data. Most of the human data is also sourced from trials that examined the efficacy of Epidiolex at therapeutic doses, at which adverse effects were sometimes observed. But, from the studies so far, no observed adverse effect level for CBD could be identified.
“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,” said Ana Afonso, head of nutrition and food innovation at EFSA.
On June 28, EFSA will take part in an information session intended for applicants or other groups with interest in CBD or novel foods generally.
The response came after the European Commission announced that it considered CBD a novel food, so long as a product met the conditions of EU legislation on novel foods. The statement was issued in response to the Commission requesting that EFSA give its opinion on whether CBD consumption is safe for humans.
To date, 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.
“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.”
The EFSA panel in its statement broke down data insufficiencies relevant to the effects of CBD on the liver, gastrointestinal tract, endocrine system, nervous system, drug interactions, and psychological well-being in humans. Additionally, animal studies have yielded data suggesting significant adverse reproductive effects could be linked to CBD, and not enough research has been conducted to determine if these effects are also seen in humans. “In the context of medical conditions, adverse effects of CBD are tolerated if the benefits outweigh any adverse effect. However, adverse effects are not acceptable in foods. They must be demonstrated to be safe for normal consumption,” EFSA wrote in the statement.
The statement goes on to detail potential limitations in currently available data. Animal studies have been performed with non-chemically pure CBD, which could lead to confounding data. Additionally, several human studies were performed in patients that were, at the same time, treated with other medications and with high therapeutic doses, which may have impacted the data. Most of the human data is also sourced from trials that examined the efficacy of Epidiolex at therapeutic doses, at which adverse effects were sometimes observed. But, from the studies so far, no observed adverse effect level for CBD could be identified.
“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,” said Ana Afonso, head of nutrition and food innovation at EFSA.
On June 28, EFSA will take part in an information session intended for applicants or other groups with interest in CBD or novel foods generally.
