Industry leaders have responded to the findings of recent toxicology studies which suggest guidelines for the daily dosage of CBD isolate should be lowered.
Numerous cannabis industry groups have now published their positions on recent toxicological studies which suggest the average daily intake of isolated CBD should be well below current guidelines.
The Cannabis Industry Council (CIC) and Association for the Cannabinoid Industry (ACI) have both issued public statements in regards to ‘recent applications and toxicology studies’ submitted to the Food Standards Agency (FSA).
It came after the European Industrial Hemp Association (EIHA) submitted completed CBD isolate and synthetic CBD applications for its consortia to the UK and European authorities earlier this month, representing hundreds of businesses and thousands of products currently awaiting validation.
As part of its submission, EIHA included details of its toxicology studies which found that there was a ‘bioaccumulation’ of CBD in four organs of the rats which were tested upon.
In light of its findings, EIHA suggested an acceptable daily intake (ADI) for isolate CBD of 17.5mg per day, well below the 70mg currently recommended by the FSA.
Here’s what the industry had to say.
Jamie Bartley, chair of the Hemp Working Group, Cannabis Industry Council (CIC)
Bartley commented: “The Cannabis Industry Council notes the announcement of recent applications and toxicology studies submitted by other industry organisations to the Food Standards Agency.
“The CIC’s approach to these matters is guided by scientific and medical evidence. We are seeking clarification on the basis for some of the submissions, including the proposals in respect to the recommended daily intake of CBD.
“Within the medical sphere, the average daily dose of CBD recommended by clinicians for medical effect is 60-100mg. Any proposed deviation from this would have to be fully quantified with compelling evidence, which we are yet to see.
“At present, we are dealing with conjecture, and the CIC believes this is harmful to the success of the CBD industry. We will be engaging with the FSA as the detail of these third party applications is established.”
Dr Paul Duffy PhD, ERT, FBTS,FRSB, associate toxicologist – Association for the Cannabinoid Industry (ACI)
Since 4 November, when the ACI submitted its CBD toxicology safety study results to the Food Standards Agency, a number of pieces of commentary have been posted online regarding the status of our study and others.
In response to these posts our toxicologist Dr Paul Duffy has issued the following statement:
The widely shared details of the EIHA OECD408 rodent safety study with a CBD isolate material has elicited a range of responses on social media. The ACI position remains to provide no commentary on the data supporting that position nor the validity of any subsequent discussions between individuals taking place online.Nevertheless, it is important to remember and consider some key points that underpin the regulatory process supporting novel food applications.
- The primary aspect of the ‘novel foods’ process is the legal necessity for the food regulatory bodies (FSA, EFSA) to ensure, to best current scientific practice, the safety of the product intended for human consumption, in this case CBD. That safety evaluation is not concerned with any assertion of the efficacious nature of those products.
- The requirements of OECD chemical safety testing guidelines ensure that safety studies that comply with the OECD408 guidance should be comparable in terms of design, methodology and Good Laboratory Practice Standards. A variable that can be legitimately introduced is the chemical nature of the test material.
- Regulatory authorities are diligent in their evaluation of safety for any ‘novel food’ and will consider all submitted data and publicly accessible information that is available to them.
As it is not appropriate for ACI to speculate on the validity, or otherwise, of online discussions, it is also not appropriate for ACI to speculate on the outcomes of ongoing scientific evaluation of safety studies conducted by the FSA or other regulatory agencies.
We remain confident in our approach to the provision of toxicology safety data that our members require, the results that have emerged and in our ongoing interactions with the FSA.