Recent EFSA Decision Highlights Real World Data’s Importance
by Dr Michael Winlo, Emyria Managing Director
When it comes to keeping citizens healthy and safe, major regulators have consistently demonstrated (rightly) that they will err on the side of caution.
Consider this most recent example.
Recently, the European Commission requested the European Food Safety Authority to table an opinion on whether cannabidiol could qualify as a ‘novel food’ – i.e., a substance that could be newly considered as a food product, ingredient or supplement.
This request was off the back of more than 150 applications to consider CBD as a novel food, 19 of which are currently being assessed.
As part of the assessment, the EFSA asked its Panel of Nutrition, Novel Foods and Food Allergens experts to consider the currently available data on the safety of CBD and, importantly, identify if there were any information gaps that existed regarding its safe use.
In their work, the NDA identified several data gaps that would prevent CBD being considered appropriate as a food ingredient effectively “stopping the clock” on all applications.
Some of the issues they identified were:
- Studies that had been conducted were not conducted with chemically pure CBD
- Human studies that had been performed were with patients that were treated with high therapeutic doses or on other medications
What that means is that significantly more data must be obtained on the safety of pure CBD in real world environments for CBD to ever be considered safe as a food ingredient.
That is work that Emyria is already carrying out via its development of an ultra-pure CBD capsule as well as its recognised commitment to real-world data gathering via its innovative clinics.
The standard for CBD as a food is of course much higher than CBD as a medicine. It must be proven to have no adverse effects (as opposed to minor effects that are outweighed by the therapeutic benefits).
It’s another reminder of how high-quality evidence is going to be the secret ingredient in any regulatory approval of new substances, formulations, or in this case, foods – and why evidence remains at the centre of everything we do and, as we are seeing, positioning us to be leaders in the industry.