European CBD Applications Will Require ‘Complicated And Huge’ Human Studies, Admit EFSA

FOLLOWING the European Food Safety Authority’s (EFSA) controversial decision to ‘stop the clock’ on all CBD novel food applications last month, the regulator addressed the industry in a virtual public forum last week.

In what EFSA referred to as an effort to begin ‘an open dialogue with stakeholders’, the ‘info session’ sought to shed some light on the reasoning behind its decision, which has seen dozens of European CBD applications thrown into regulatory limbo.

While a panel of experts from both EFSA and the European Commission directly addressed many of the questions posed by the CBD industry, they failed to provide any concrete information on two key points: how long the process was likely to take and what design these human trials should take.

Like its UK counterpart the Food Standards Agency (FSA), which published the final version of its CBD public list just days after the address, EFSA pointed to the poor quality of many of its applications as a key reason behind what could be a lengthy delay in regulating the sector.

Where Do EU CBD Applications Now Stand?

As detailed by Swiss botanical extraction company Linnea’s CEO Susanne Caspar last week, the EU novel foods process has already seen many companies wait years, some more than 10, to have their products approved.

Following the recent statement, many in the CBD industry are now anxious to know if this will push back the regulatory timeline even further, and by how long.

The panel’s host, Ana Afonso, failed to provide a prospective timeline and offered little hope the process could be completed in the near future.

“What this panel needs before expressing their opinion on the safety of these products is to have sufficient data to ensure the safety of the consumers is insured.

“This is the main principle on which EFSA operates. The question of time is less relevant, although by no means irrelevant to our commercial operators and to the innovation that we want to promote in the European market. But our main concern is safety.

“It would be difficult to answer that question. There is no timing, it’s about having sufficient data. What we can assure you from the side of EFSA is that we will continue working very hard with our panel of experts. We rely on the public as well to contribute to the success of these studies so we can reach a final decision.”

Another key point of confusion for those who will be tasked with filling these ‘data gaps’ is exactly how these human studies should be structured in order for EFSA to consider them valid.

Again, the panel were unable to provide much clarity, with Dr Inge Mangelsdorf stating EFSA was ‘still in a stage of development for what we think we’ll need’.

She added: “We are sure, or rather we are admitting, that this will be a very complicated study and a huge study.”

Professor Harry McArdle, who is a member of both EFSA’s novel foods working group and the UK’s Advisory Committee for Novel Foods and Processes (ACNFP), was able to shed some light on the length of the studies EFSA required, explaining that ‘studies that have been done have been short term, and we need long-term data.’

“We’ve been considering at some length what constitutes long-term data, and I think data over a six-month period would answer most of the concerns we have.”

The panel added that they expected the production process between synthetic and naturally derived CBD to ‘have an impact on the final product’, therefore ‘each will be assessed separately’.

Pressed on whether the ceasing of CBD applications will impact other cannabinoid novel food applications for compounds such as CBG and CBC, EFSA said this would depend on whether they will be provided alone or in mixtures with CBD, adding that this was a ‘very complicated’ consideration.

It also explained that while it was doing its best to ‘work on many dossiers simultaneously’, applications were not dealt with in a ‘first come, first treated’ manner, but based on the quality of data submitted.

Why Was the Statement Made?

Professor McArdle said that the decision to suspend applications indefinitely was made following ‘substantial searches’ of the current scientific literature.

This literature, which consists of numerous toxicology studies conducted on both animals and humans, was often carried out with ‘very varied mixtures’ of CBD, containing different compounds and other cannabinoids.

He explained that this became a ‘real problem when it was clear that the content of these other components and their identity are rarely described, certainly in enough detail for us to understand their contribution to problems’.

Professor McArdle added that the ‘interactions between these chemicals with each other and the human body are very important to understand’.

The few studies focusing on the effects of pure CBD in humans, such as those conducted with GW Pharmaceuticals’ Epidyolex, were also of little use for EFSA’s purposes, as they were conducted in patients who were using additional medications.

“That really complicates our assessment of the effect of CBD. This became so significant when we were looking at the efficacy of Epidyolex, where adverse effects were sometimes observed but tolerated, where we could derive no NOAEL (no-observed-adverse-effect level).”

Furthermore, EFSA said there was little data on whether these ‘complex’ interactions would still take place at the dosage levels expected when CBD is taken as a novel food, rather than in a clinical setting.

Next, EFSA Scientific Officer Catalina Manieu addressed the issues relating to the quality of applications it has already received, a reason cited numerous times by the FSA regarding delays to its own process.

After assessing more than 40 applications in the initial suitability check, Ms Manieu said that applicants often fail to fully identify the novel food that will be placed on the market, specifically whether the compound is a ‘simple mixture or a complex mixture’, or whether the formulation is a crystal or oil.

She added that EFSA has received dossiers where only 10% of the novel food has been characterised, while other important information such as the identity of the raw material, geographical location, taxonomy, details on the production process and verification of identity according to international methodologies was ‘often very scarce’.

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