CBD Products Still Available in the EU Must Be Considered Unsafe, Say Researchers
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Earlier this year, the European Food Safety Authority (EFSA) announced that it would be “stopping the clock” on CBD novel foods applications currently under consideration, after finding that significant data gaps had hindered EFSA scientists’ ability to assess the safety of CBD as a novel food.
Now, a new preprint (not yet peer-reviewed) study from food chemists and public health experts at the Chemical and Veterinary Investigation Office Karlsruhe, Germany, provides a deeper look into the available data on CBD safety.
The authors make several recommendations on how the EFSA may proceed in judging the risks presented by those CBD products that are already available on the commercial market.
EFSA’s stopped clock on novel foods applications
Novel foods are considered foodstuffs that were not commonly consumed by humans before 15 May 1997, the date when the first novel foods regulations came into being within EU member states. In order to be authorized and sold within the EU, CBD products are first required to have a novel food application approved by the EFSA. But before this, the EFSA must first establish the safety of CBD as a novel food.
In a statement published on June 7, the EFSA reported that there were “insufficient data on the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system and on people’s psychological well-being,” and so the agency would be pausing the processing of 19 applications for CBD products that had been received.
“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,” said Professor Dominique Turck, Chair of the EFSA’s expert Panel on Novel Foods and Allergens, in the statement. “It is important to stress at this point that we have not concluded that CBD is unsafe as food.”
Ana Afonso, head of nutrition and food innovation at EFSA, also said: “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.”
Reviewing available data on CBD safety
The new preprint paper looked at the studies and data presented alongside the full EFSA statement published in EFSA Journal.
From these studies, only three of the animal studies contained suitable dose-response data for benchmark dose modeling. A benchmark dose is defined as the dose that corresponds to a specific change in adverse effects, compared to the response in unexposed subjects. From these studies, the authors suggest using a benchmark dose lower limit (BMDL) of 20 milligrams per kilogram of bodyweight per day (mg/kg bw/day).
The authors found that none of the human studies examined by the EFSA contained sufficient data for dose-response modeling. However, one clinical trial involving 120 healthy participants did allow for the determination of a lowest observed adverse effect level (LOAEL) of around 4.3 mg/kg bw/day, based on the 300 mg CBD dose used. In this trial, four participants had elevated levels of certain liver enzymes after 28 days.
Based on the doses where a biological response was first seen in the animal and human studies, the preprint authors propose a reference dose – the daily exposure dose that is likely to not present risks over a lifetime – of around 10 mg/day. This is very similar to the reference dose already used for risk assessment by the Swiss Federal Food Safety and Veterinary Office, which recommends adults not exceed 12 mg of CBD per day.
Consequences of stopping the clock
Despite the overall lack of data, the CVUA authors believe that there is enough known for the EFSA to be making preliminary risk assessments.
They also note that many of the CBD products which currently remain on sale, despite the pausing of novel foods applications, exceed this estimated 10 mg/day reference dose. Given the adverse effects on the liver observed in both humans and animals, this is of particular concern to the authors. As they explain, medical products can strike some kind of risk-benefit balance, but the safety of food products must be guaranteed safe as these are not consumed under medical supervision.
Now the lack of data has been highlighted, the CVUA authors say that they would expect a risk management response, so CBD products still available on the EU food market would be assessed against Article 14 of the Basic Food Regulation No 178/2002. Under this response, if a food were to exceed the preliminary 10 mg/day reference dose it would be “unfit for consumption”, while those exceeding the LOAEL would be considered “injurious to human health.”
The authors also list three pathways through which they could see the EFSA choosing to proceed further:
- CBD products under the reference dose could be approved as foods on an intermediary basis and include relevant warning labels.
- Low-dose CBD products could become over-the-counter medicinal products, as a separate category to prescription-based high-dose CBD products.
- CBD products may become regulated outside the scope of foods or medicines, under a separate framework.
Given the growing consumer demand for CBD products, it is unlikely that the market will happily remain paused while additional safety studies are carried out to plug existing knowledge gaps. To protect consumers in the interim, the authors would like to see further action be taken.
“This is now a political decision to be made and the authors hope that the legislator does not again turn a blind eye to the problem as in the past,” they concluded.