EFSA Admits Novel Food CBD Applications Will Require ‘Complicated and Massive’ Human Studies

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Following the European Food Safety Authority’s (EFSA) controversial decision to halt the processing of Novel Food applications for CBD last month, the regulator addressed the industry in a virtual public forum last week.

As part of what EFSA called an effort to engage in “an open dialogue with stakeholders”, the “briefing session” sought to shed light on the reasoning behind its decision, which seen dozens of European applications for CBD products end up in regulatory limbo.

While a panel of experts from EFSA and the European Commission answered many questions posed by the CBD industry directly, they did not provide any concrete information on two key points: the likely duration of the process and the design of human trials.

Like its UK counterpart, the Food Standards Agency (FSA), which published the final version of its public list of CBD products just days after the speech, EFSA pointed to the wrong quality of many of its claims as a key reason for what could be a long delay in regulating the sector.

Where are the demands for CBD in the EU?

As Susanne Caspar, CEO of Swiss herbal extraction company Linnea, explained last week, many companies have already waited years, sometimes more than a decade, for their products to be approved under the European novel food process.

In the wake of this recent statement, many in the CBD industry are now eager to find out if it will push back regulatory deadlines even further, and by how long.

Panel host Ana Afonso did not provide a forward-looking timeline and offered little hope that the process could be completed in the near future.

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

“This is the main principle on which EFSA operates. The question of time is less relevant, even if it is not unrelated to our commercial operators and to the innovation that we want to promote on the European market. But our main concern is safety. »

“It would be difficult to answer this question. There is no timetable, it is about having enough data. What we can assure you from the EFSA side is that we will continue to work very hard with our panel of experts. We are also counting on the public to contribute to the success of these studies so that we can make a final decision. »

Another point of confusion for those who will be tasked with filling these “gaps” is exactly how these human studies must be structured for EFSA to consider them valid.

Again, the panel was unable to provide much clarity, with Dr Inge Mangelsdorf saying EFSA was “still in the developmental stage for what we think we need”.

She added: “We are sure, or rather we admit, that it will be a very complicated study and a huge study. »

Professor Harry McArdle, who is a member of both EFSA’s Novel Foods Task Force and the UK’s Advisory Committee on Novel Foods and New Processes (ACNFP), was able to provide some clarification on the length of the studies required by EFSA, explaining that “the studies that have been done were short term, and we need long term data”.

“We’ve thought long and hard about what constitutes long-term data, and I think six-month data would answer most of the concerns we have. »

The panel added that it expects the production process between synthetic CBD and naturally-derived CBD to “impact the final product,” so “each will be evaluated separately.”

Asked whether stopping CBD applications will impact other food applications of novel cannabinoids for compounds such as CBG and CBC, EFSA replied that it would depend on whether whether they will be supplied alone or mixed with CBD, adding that this is a “very complicated” consideration.

She also explained that, although she does her best to “work on many files simultaneously”, requests are not processed on a “first in, first out” basis, but on the quality of the data. submitted.

Why was the statement made?

Professor McArdle said the decision to suspend applications indefinitely was taken following “extensive research” into the current scientific literature.

This literature, which consists of numerous toxicological studies conducted on animals and humans, has often been carried out with “wide variety mixtures” of CBD, containing different compounds and other cannabinoids.

He explains that this became a “real problem when it became clear that the contents of these other components and their identities are rarely described, at least in sufficient detail for us to understand their contribution to the problems”.

Professor McArdle adds that it is very important to understand the “interactions between these chemicals and the human body”.

The few studies that focused 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 used drugs. additional.

“This really complicates our assessment of the effect of CBD. This became so important when we looked at the efficacy of Epidyolex, where adverse effects were sometimes observed but tolerated, where we could not derive any NOAEL (no-observed-adverse-effect level). »

Additionally, EFSA said there was little data on whether these “complex” interactions would still occur at expected dosage levels when CBD is taken for wellness use, rather than in a clinical setting.

Finally, Catalina Manieu, EFSA’s Chief Scientist, addressed issues relating to the quality of the applications she has already received, a reason repeatedly cited by the FSA for delays in its own process.

After assessing more than 40 applications as part of the initial suitability check, Ms Manieu said applicants often fail to fully identify the new food that will be placed on the market, specifying whether the compound is a “simple mixture or a complex mixture”, or whether the formulation is a crystal or an oil.

She added that EFSA received dossiers in which only 10% of the novel food had been characterized, while other important information such as the identity of the raw material, the geographical location, the taxonomy, the details of the production process and identity verification according to international methodologies were “often missing”.

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