When it comes to CBD, the European Union and the United States have something in common: they are grappling with its safety in food, despite widespread consumption.
This week, the European Food Safety Authority (EFSA), an entity that issues scientific advice to guide EU member states, held a listening session called “The safety of cannabidiol as a novel food: data gaps and uncertainties.” A handful of panelists covered topics like: the status of the safety assessment of CBD as novel food, CBD interaction with drug metabolism, neurological and psychiatric and psychological effects, endocrine and gastrointestinal considerations, and requirements and instructions for future applications. There were a series of Q&A periods, too.
The info session came at an interesting time for CBD in Europe. The EU Court of Justice ruled in 2020 that CBD cannot be regarded as a “narcotic,” citing that, unlike THC, it doesn’t appear to produce “any psychotropic effect.”
Because CBD shouldn’t be “considered” a drug under international drug agreements, the ruling read, it can “be qualified as food.”
Novel foods in the EU refer to any food that was not used for human consumption “to a significant degree” before 1997. Importantly, novel foods must be “safe,” and the evaluation of novel foods is “based solely on the analysis of the health risks and must conclude based on that basis alone,” according to EFSA.
While CBD is widely available for sale at shops and online, it largely falls into a regulatory area. The European Commission considers CBD a qualifying compound as a “novel food provided it meets the conditions of EU legislation on novel foods,” so the Commission asked the EFSA to issue an opinion on “whether CBD consumption is safe for humans.”
The opinion, released earlier this month, put applications for CBD under the novel food regulation “on hold,” citing “data gaps and uncertainties.”
“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,” said Dominique Turck, chair of the EFSA’s Panel on Nutrition, Novel Foods and Food Allergens.
During one of the sessions on research, Jose Vicente Terazona, who is head of the Pesticides Unit at EFSA, covered a number of CBD and animal studies. For example, a rat study showed that in utero exposure to Epidyolex resulted in litter loss and liver lobes, while a rabbit study showed lower birth weight. Also in rodents, exposure to this CBD formulation showed reproductive changes like a decrease in sperm quality. Epidyolex is a CBD-based drug extracted from cannabis plants, and is FDA-approved for patients with severe epilepsy in the U.S.
“Given how little we understand about the interaction of the microbiome and normal physiology, I think trying to extrapolate from animal studies to humans is definitely not possible,” said panelist Harry McArdle, who is a professor at the Rowett Institute, a food and nutrition research center. “I think it would be very difficult to be able to come to any conclusions about CBD and the safety of the microbiome.”
But, that doesn’t mean these CBD animal students aren’t worthwhile, he said.
“If it would help us understand the safety of CBD, that would also be very useful,” McArdle said.
Terazona also pointed out some data gaps: there isn’t enough literature with human data from healthy human volunteers, because many studies include patients that are taking other medications. Also, much of the human data in the EU is related to Epidyolex at “therapeutic doses.” There’s also the need for more studies on the potential long-term effects of repeated exposure to CBD.
“Studies that have been done have been short-term, and we need long-term data,” McArdle said. “So, we’ve been considering that at some length: what constitutes long term data? And I think that data over a six month period would answer most of the serious questions that we have or serious concerns that we have.”
Another panel led by Karen Ildico Hirsch-Ernst, of the German Federal Institute for Risk Assessment, focused on the liver, which has been shown in studies to be an area of concern for higher doses of CBD. For example, it could interact with the metabolism of common medications like bupropion (also known as Wellbutrin, a depression drug, in the U.S.) or propofol, an anesthetic.
During discussion of gastrointestinal effects of CBD, Hirsch-Ernst highlighted some data gaps, including why these digestive issues, like diarrhea, happen in the first place, and whether they’re present at lower doses. And also, will these issues get worse over time? Or resolve themselves? Officials pointed out that animal studies suggest that CBD accumulates in the system over time. Another data gap asks the question of whether CBD also accumulates in humans, and if so, whether the “harmful effects” are the same.
Some questions focused on cannabinoids other than CBD, like CBG or CBC.
Ana Afonso, a team leader on Emerging Risks for EFSA, replied that it was a “complicated” question.
“This cannot be replied to until this cannabinoid will be under assessment. So, it will depend on whether they would be provided alone in mixtures together with CBD,” Afonso said. “It’s very, very difficult to say something before we will dig into the data composition and also available data.”