THE European Industrial Hemp Association (EIHA) has responded to a number of criticisms from within the industry surrounding its Novel Foods toxicological studies.
Last week BusinessCann reported that hundreds of CBD businesses were expecting to have their products validated over the coming weeks after EIHA submitted completed CBD isolate and synthetic CBD applications for its consortia to the UK and European authorities.
Soon after its submission on November 4, questions were raised regarding the proposed 17.5mg daily Acceptable Daily Intake (ADI) of CBD, while a number of damning accusations were levelled against the organisation, spearheaded by The Canna Consultants (TCC).
In response, EIHA has said their assessment is ‘full of inaccuracies and propaganda’, and was not based on the full toxicology report, to which they have not had access.
The Toxicological Studies
BusinessCann understands that EIHA’s laboratories dosed rats with 25mg, 50mg, 75mg and 150mg of CBD isolate.
At a dose of 50mg per kg of bodyweight, a ‘bioaccumulation’ of isolate CBD was observed in the liver, kidneys, testes and ovaries of the rats, but this was not found at 25mg.
As there were no tests conducted between these two dose points, the 17.5mg ADI was calculated based on the lower 25mg dosage.
Chief Regulatory Officer at ADACT Medical Damien Bové, who leads a team of global regulatory compliance experts for the vaping, CBD and hemp industries, told BusinessCann that ‘this was not an adverse event, but it could lead to adverse events down the line. So it’s an observed event.’
An adverse event is defined as ‘any untoward medical occurrence associated with the use of a drug’, and according to a separate source also means the effects were considered reversible.
This means that the rats were not able to metabolise the CBD quickly enough to excrete it at 50mg doses.
Mr Bové added that there is a ‘pretty significant margin of error’ for testing in rats in terms of how it relates to human metabolism, and that pharmaceutical studies often test on more than one animal ‘to see if you get the same effect’.
“When you assess the results against human metabolism data in the literature, it may be decided that, actually, human beings are unlikely to see this effect, because they metabolise CBD at a faster rate.
“So, this is probably why the FSA have advised people not to change the labelling, to just continue until they have completed their risk assessment.”
IFS Laboratories’ General Manager Mark Jones added that ‘toxicological data derived from testing studies on rodents (mainly rats) in accordance with the OECD/OCDE Guidelines: TG 408: 2018 has been adopted and widely accepted.
“This study provides information on the major toxic effects, indicates target organs and the potential accumulation of the test chemical (Cannabidiol in this case), which in turn provides an estimate of a no-observed-adverse-effect level (NOAEL) of exposure which can be used when selecting dose levels and for establishing safety criteria for Human exposure.
“As with most biomedical research studies rats or mice are selected due to their anatomical, physiological and genetic similarities to humans. However, without toxicological data derived from Human studies there is no conclusive comparisons between them, therefore in my view regulatory bodies shouldn’t make any informed decisions on just this data alone, other considerations must be taken into account.”
What the FSA has said
In its submission, EIHA also encouraged members to change the labelling on their products to reflect the new suggested 17.5mg ADI.
The Cannabis Trades Association (CTA) confirmed to BusinessCann that its members had been informed ‘not to change their labelling from 70mg per adult per day whilst risk assessments into toxicological dosing levels are ongoing’.
“This has, of course, caused concern to CTA members who are licensees and sub-licensees of the EIHA Consortium toxicology data for their Novel Food dossiers.
“We should all hold together and wait for the final risk assessment reports, as there are other toxicology studies in process and the results may or may not be identical. The CTA is working with industry colleagues and directly with senior members of the FSA to define the risk to consumers of CBD products.”
Asked whether the FSA would make any amendments to the public list or to its overall guidance on CBD following the new data, as suggested by TCC, its Deputy Director of Food Policy, Natasha Smith, told us:
“Our independent scientific advisory committees are currently reviewing the safety data submitted to us by the industry as part of the approval process for CBD products. The committees will give advice based on this new toxicological information, and the FSA will consider if any action is needed, including an update to our safety advice.
“Our advice remains that consumers should think carefully about taking CBD. As a precaution, the FSA recommend that healthy adults do not consume more than 70mg a day (about 28 drops of 5% CBD) unless under medical direction. This advice doesn’t mean that these levels are definitely safe, but that there is evidence adverse health effects could occur at intakes above this level. At the moment, only limited data are available, which is why we need to continue to build our evidence base for these types of products.”
One of the key accusations made by TCC regarding EIHA’s submission is that, out of the 3,000+ products represented, its application is and only ever was suitable for around a third of them.
TCC stated that ‘months ago we saw EIHA documentation which indicated that the only products to be covered by the EIHA applications (and the respective toxicology submissions which would support each of them) were Hemp Oil Tinctures at a strength no greater than 10%’, thus disqualifying hundreds of products.
“This means that the toxicology and dossiers’ costs of the eligible products have been subsidised 2 to 1 by the two-thirds of products which could never have benefitted in any way.”
EIHA says that suggestions it only covered hemp oil were inaccurate, and that food categories were also included in its Novel Food application.
As to the 10% CBD cap, EIHA said this has been made clear since its annual general meeting in November 2019, and its partners were required to sign a contract with this specification clearly stated.
The association emphasised that all its members will have to comply with the specifications they signed, and nothing will change until the risk assessment is completed, as this will be the only legally binding report.