EFSA admits new food CBD applications will require ‘complicated and massive’ human studies – Newsweed

EFSA, Novel Food et CBD

Following the controversial decision by the European Food Safety Authority (EFSA) to stop processing new food applications for CBD last month, the regulator addressed the industry in a virtual public forum last week past 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 saw dozens of ‘European applications of CBD products ended in a regulatory limbo. Although a panel of experts from EFSA and the European Commission answered many questions raised by the CBD industry directly, they did not provide any concrete information on two key points: the likely length of the process and the design of the trials humans Like its UK counterpart, the Food Standards Agency (FSA), which released the final version of its public list of CBD products just days after the speech, EFSA pointed to the incorrect quality of many of his 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 process of new foods. In the wake of this recent statement, many in the CBD industry are now anxious to find out if and by how long it will further delay regulatory timelines. The panel’s host, Ana Afonso, did not provide a future 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 guarantee the safety of consumers. “This is the main principle on which EFSA operates. The question of time is less relevant, although it is not alien to our commercial operators and the innovation 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 calendar, it’s about having enough data. What we can assure you from EFSA is that we will continue to work very hard with our panel of experts. We also count 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 development stage of what we think we need”. He 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 Food Working Group and the UK’s New Food Advisory Committee food and new processes (ACNFP), was able to shed some light on the duration 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 expected the production process between synthetic CBD and natural CBD to “affect the final product”, so “each will be assessed separately”. When asked whether stopping applications of CBD will affect other food applications of new cannabinoids for compounds such as CBG and CBC, EFSA replied that it would depend on whether they are supplied alone or mixed with CBD, adding that it is a “very complicated” consideration. . He also explained that while he does his best to “work on many files simultaneously”, requests are not processed on a “first in, first out” basis, but based on the quality of the data submitted . Why was the statement made? Professor McArdle said the decision to suspend applications indefinitely was made after “extensive research” into the current scientific literature. This literature, which consists of numerous animal and human toxicological studies, has often been conducted with “broad-mix” CBDs, which contain 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 were rarely described, at least not in enough detail 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 on patients using additional medications . “This really complicates our evaluation of the effect of CBD. This became so important when we analyzed the efficacy of Epidyolex, where adverse effects were sometimes observed but tolerated, where we could not derive any NOAEL (level (no adverse effects observed).Furthermore, EFSA said there was little data on whether these “complex” interactions would still occur at expected dosage levels when CBD is taken for wellness, rather than in a clinical setting. Finally , EFSA Chief Scientist Catalina Manieu addressed issues related to the quality of the applications it 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 to be brought to market, specifying whether the compound is a “simple mixture or a complete mixture xa”, or if the formulation is a crystal or an oil. He 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, geographical location, taxonomy, details of the production process and the identity verification according to the data. international methodologies were “often lacking”.
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