The report by DevelRx LTD and The Canna Consultants has raised concerns about the testing that businesses must take part in under the FSA guidelines.
DevelRx and The Canna Consultants have stated in the report that they believe the testing is ‘unethically acceptable’ and ‘scientifically unjust’ while drawing attention to the replicated animal testing for CBD products.
The Food Standards Agency (FSA) determined that all CBD products were to be classed as Novel Food in the UK and EU. They developed testing guidelines with guidance provided by the Committee on Toxicology (COT) in 2020 and declared that all businesses must submit scientific proof that their products were safe if they were to remain on sale. COT developed the guidance for their guidelines using data from GW Pharmaceuticals.
The report also draws attention to the ‘cherry picking’ of data given that the guidance is based on just one of 15 trials by GW Pharma for Epidiolex. The report stated that this is ‘superficial, scientifically flawed and has placed reliance in part on a biased data source that was part of a pharmaceutical company’s lobbying campaign to the US government to restrict the non-medical use of CBD by the US public.’
The authors developed a list of issues that they found within the data and testing which has formed the basis of the report.
Speaking with Cannabis Wealth, Steve Oliver, one of the co-founders of Canna Consultants raised his concerns about the testing CBD companies are forced to undertake.
“When the COT made their assessment, it was based on a document that GW Pharma supplied. That document is clearly a lobbying document. They highlighted adverse effects which didn’t stand up scientifically and contradicted their own efficacy and evidence of the safety of CBD at the levels we mention. So we have concerns and we have been raising this with regulators for 18 months and it’s been falling on deaf ears.”
He explained: “We got to access all of the clinical data then we asked them to conduct their own assessment and have it peer-reviewed. We found ten points where we demonstrate there are several statements in the COT document that contradicted the data they presented.
“They essentially cherry-picked some adverse events which were not representative of the much larger study they conducted. Those adverse events can be attributed to the other drugs that people were taking. We are very concerned that COT swallowed this and didn’t have the scientific experience, or was not prepared to drill down and test that. So they accepted the commercial organisation’s data.”
Some of the data from the Phase I GW trial raised concerns about the effect of CBD on the liver and potential reactions with other drugs. This led to the FSA suggestion that consumers keep within the recommended 70 mg per day despite the data showing no cause for concern on doses much higher than this.
The result of the new guidelines and increased testing has caused chaos for brands, in particular small to medium companies who may struggle to afford to test. This has led to every manufacturing company planning on making an application for their products having to conduct an extended 96-day, repeat dosing, rat toxicity study for each individual item. The effect for some brands has been devastating. Not only that, it has raised serious issues for brands that label their products as vegan or cruelty-free.
Animals are often forced to take CBD in these trials which are required for each ingredient. In May 2021, it had been reported that there were already over 800 applications to meet the deadline of 31 March. A high percentage of brands were forced to withdraw their applications due to costs or were rejected due to not being able to meet the high standards set.
Steve highlighted that there are a huge amount of companies who have tried but are unable to afford the fees causing them to ‘go to the wall’ as a result. He stressed that small companies are trying to do everything they can while the pharmaceutical companies already have their applications validated.
Steve said: “It forced people to go down the consortium route because some people who are selling wellness products brand them as vegan and cruelty-free. They are being corralled into sponsoring or contributing to animal testing which they don’t want to do. They have been told that if they don’t do that then they won’t have a business. Ethically, that is outrageous and morally it’s wrong.”
He added: “We are not against animal testing as required and needed for certain drugs but there is a requirement for that. Why would you go and retest on rodents when you already have the data for humans?”
The testing on animals raises serious ethical concerns for an industry that often carries products with cruelty-free or vegan labels. While some companies do publically make the choice, the report draws attention to the fact that many consumers may not know what is involved with this testing.
“It is important that people understand what is being tested. They are not sitting there cuddling these animals. They are being killed at the end of the trial and a necropsy takes place. Animals don’t naturally like to eat CBD oil or isolate so they are force-fed. It’s fundamentally wrong and we think it’s probably unlawful if it was put to the test.”
The effect for the industry if it were to gain a reputation for animal testing could be devastating. It raises further questions about how much retailers who supply a variety of brands know about what exactly is involved in the testing.
Steve said: “I’m not sure that some of these retailers know. If you have high-end retailers such as supermarkets or chemists selling a product that they thought was tested on animals then it would be removed. It’s very strange and damaging for our industry. So many people have gone down this route without challenging it.”
As the industry has moved to accept the regulations, guidelines and increased testing, is it now so far gone that it cannot change? If the guidelines were to change, how does this affect the companies that have already paid for extensive reports? The expense of testing for companies could mean companies would take issue with changes.
“We’ve got to realise that a lot of this testing isn’t taking place in the UK under good laboratory practices. The vast majority is taking place in America where you can go to places and as long as you have a chequebook, they will test it on whatever species you want. We hope someone will take notice because it’s wrong but the problem is, they have encouraged people to do this testing and now they have submitted it.”
He concluded: “They are tied up in knots now because if you are a company that spent a million pounds doing all of this testing, submitted your dossier then probably, quite rightly, you are going to have an issue with the regulator if they were to have a policy change. That can’t stop you trying to do the right thing and this is not the right thing on so many levels.”
Cannabis Wealth has reached out to the FSA and COT for comment.
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