Press Release – 12 October 2023 7:30am BST
Response to UK Food Standards Agency updated recommendation for daily consumption of CBD.
Mile High Labs is a market pioneer and leader in the CBD industry and upholds the highest standards of quality, service, and integrity across its range of cannabinoid ingredients and finished goods. We treat food safety and consumer protection with the utmost seriousness and always deliver the safest and highest quality product to our customers.
We acknowledge today’s press release by the UK’s Food Standards Agency (the “FSA”) which has given new precautionary advice recommending that healthy adults do not consume more than 10mg of CBD per day.
We share the FSA’s desire to maintain food safety in relation to CBD products. It is important to note that Mile High Lab’s toxicology data has not been included in the FSA’s risk assessment process and subsequent COT report as only 3 applications were chosen for the assessment of the Acceptable Daily Intake (“ADI”).
If we consider Mile High Labs’ proprietary data set and apply the same criteria as the committee’s approach, this will lead to an ADI of significantly more than the 10mg per day recommended.
We have requested an urgent meeting with the FSA to gain more transparency on the ongoing safety data assessment, and to understand why precautionary advice has been published without assessment of all applicable data.
As part of this process, we are encouraging the FSA to publish individual ADIs based on each application as it is known that different manufacturing processes can lead to different safety profiles and consequently, different ADIs.
Part2 – 13 October 2023 8:00am BST
Based on the FSA’s own criteria, Mile High Labs’ extensive safety data supports an ADI of 70mg or more.
Following on from our press release on 12 October 2023, Mile High Labs has again requested a meeting with the UK Food Standards Agency (the ‘FSA’) and further requested the publication of individual acceptable daily intake (‘ADI’) data for each CBD manufacturer’s Novel Foods application.
The FSA’s precautionary advice recommending that healthy adults do not consume more than 10mg of CBD per day is based on the opinions detailed in the Joint Committee position paper from the Advisory Committee on Novel Foods and Processes (ACNFP) & Committee on Toxicity (COT) published on 12 October 2023. We share the FSA’s desire to maintain food safety in relation to CBD products, but note the opinion is based only on three CBD Novel Food applications submitted to the FSA. Mile High Labs’ application and proprietary data set was not considered in this assessment. The opinion takes into account several uncertainties in these three applications which lowers the derived ADI (by 300 fold from that derived in safety studies).
If exactly the same criteria as set out in by the Joint Committee is applied to Mile High Labs’ CBD proprietary data set, an ADI of 35mg would be derived for Mile High Labs’ CBD. From a scientific perspective, the standard 100-fold uncertainty factor was applied to the 150mg/kg body weight (‘bw’)/day point of departure (‘POD’) alongside the additional uncertainty factor of three, giving an overall uncertainty factor of 300-fold which, when applied to the POD, would result in a putative ADI of 0.5 mg/kg bw (150 mg/kg bw/day POD / (10 x 10 x 3)). For a 70kg adult, 0.5 mg/kg bw x 70 kg would lead to an ADI of 35mg.
However and importantly, this set of criteria does not take into account the fact that Mile High Labs also conducted pharmacokinetic studies to assess bioavailability, which is considered an uncertainty factor. As an uncertainty is resolved, Mile High Labs’ CBD can be accordingly increased to an ADI of 70mg or more.
Mile High Labs acknowledges the FSA’s obligation to update precautionary advice as safety information emerges but equally the FSA also acknowledge in their announcement that their revised decision is only based on three Novel Foods applications. However, it is clear that different manufacturing processes can lead to different safety profiles and as a consequence different ADIs.
Mile High Labs’ highest quality standards ensures that we always deliver the safest and highest quality product to our customers. Based on the FSA’s own criteria, Mile High Labs’ extensive safety data supports an ADI of 70mg or more.
