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Industry reacts to 0.03% THC recommendations for CBD products

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The ACI and CMC have recommended a safety limit of 0.03% THC in CBD products

The Association for the Cannabinoid Industry (ACI) has suggested to the Home Office a 0.03 percent THC Limit for CBD products in its latest review paper, but some industry professionals are sceptical.

The ACI and Centre for Medicinal Cannabis (CMC) have put forward recommendations to the Home Office advising a safety limit of 0.03 percent THC or 21 micrograms per day.

The advice is part of a safety review paper of THC called Health Guidance Levels for THC in CBD Products: Safety Assessment & Regulatory Recommendations.

In most European countries, maximum THC levels have been agreed for controlled cannabinoids in products for consumer use. This ranges from 0.001 mg/kg (European Food Safety Authority and Germany) to 0.007 mg/kg THC in consumer products (Switzerland and Croatia).

THC limits in CBD end products range from 0.05 percent in the Netherlands to <3 percent in Guernsey.

However, in the UK, there is confusion among the public and businesses when it comes to the control status of products containing hemp, CBD and other cannabinoids.

The ACI says it seeks to address the anomalies in UK regulation with its THC safety recommendations.

“We fully understand that tackling drug misuse, and the harm it causes, is a top priority for the UK Government,” says Dr Parveen Bhatarah, Regulatory and Compliance Associate, ACI and CMC.

“CBD is not a controlled drug, but any plant-derived CBD has potential to contain controlled cannabinoids.

The organisations says it independently considered all of the available data and reached the conclusion that 0.03% THC is “highly unlikely” to produce a positive THC drug test.

“This paper has taken into account the analytical challenges, testing methodology challenges and existing scientific evidence base data to propose the safe limit for controlled cannabinoids,” Dr Bhatarah continues.

“This approach can overcome the challenges the CBD industry is currently facing which is important for the sustainability of the industry. Meanwhile, the ACI team is generating further evidence-based data on the safety of CBD-based.”

For some industry leaders, however, the review paper poses more questions than it answers.

Kyle Esplin, chair of the Scottish Hemp Association, told Cannabis Health that the 0.03 percent safety limit is “not helpful to the industry” and wondered how the ACI reached the figure.

He says: “The rest of the industry would welcome a further explanation from the ACI as to how they came to that number because the study does not explain where 0.03 percent came from as a safety limit.

“The 21 microgram dosage per day of THC to not fail a drug test under any scenario makes sense and there’s data to back that up. But the 0.03% as a safety limit, I don’t understand where that comes from.

“That would mean, for example a 10ml bottle with 4mg of THC (0.04 percent) would be into the new band of a controlled substance, but if you had a one litre bottle you could have up to 299 milligrams of THC and that wouldn’t be a controlled product – I don’t see how the 0.03 percent fits the safety profile.”

The ACI also suggests in its review paper six key proposals for future research that will help fill the scientific knowledge gap.

These include further animal toxicology studies on the effects of purified cannabinoids, more studies into the dose-dependant effects of isolated cannabinoids in humans, randomised placebo-controlled trials, observational studies of CBD consumer behaviour, surveillance studies to monitor safety and tolerability and more trials to assess how CBD products may affect drug tests.

“This evidence-based initiative is important to allow a threshold for THC to be set in consumer CBD products that is safe for consumers and society, is enforceable by regulators and can be adopted by manufacturers,” says Dr Andy Yates, Scientific Associate for ACI and CMC.

Esplin believes that rather than more studies on the effects of isolated cannabinoids, more work is needed to examine the effects of whole plant extracts.

“This year some of the most cited papers on THC involves injecting volunteers with pure THC and then they come to the conclusions based on that,” Esplin adds.

“What we need is more human trials with hemp products.”

On the basis of the literature review, the ACI made six additional recommendations surrounding policy. It suggests that CBD products containing between 0.03 percent and 0.2 percent controlled cannabinoids should be classified under Schedule 5 of the Misuse of Drugs Regulations act of 2001, and should be lawfully available for over-the-counter supply in the UK.

It also states that the Home Office should consider exempting dried hemp leaves and flowers from drug controls where the hemp has been lawfully grown or imported into the UK, and suggests post-marketing surveillance measures, such as a consumer app, to better identify product health risks.

It adds: “By adopting these recommendations, the UK can establish itself as a leading jurisdiction in setting unambiguous, enforceable, evidence-based standards for CBD products, which the industry and the consumer has been calling for over the last few years.”

Peter Reynolds of CannaPro, the UK trade association for cannabis and hemp businesses, is critical of the report and claims that the ACI is not “acting in the interest of consumers” by “pushing” the sector towards isolate-based CBD products.

“The only result of it will be that the market will be pushed towards isolates and synthetic – millions of people in the UK, and elsewhere, who would benefit from whole plant CBD products,” Reynolds tells Cannabis Health.

“If the ACI and the FSA get their way, then people will no longer have access to the products that have given them immense benefits.”

In Reynold’s view, there is no need for any THC limit for products derived from industrial hemp and asserts that controlling industrial hemp is in breach of international law.

“Of course, what we need is a percentage limit rather than an absolute limit on THC,” he adds.

“But under the terms of the UN Convention on Narcotic Drugs in 1961, industrial hemp and anything derived from it is not controlled.

“The government chooses to control industrial hemp in breach of international law.”

The report, which was published by the ACI, CMC and Conservative Drug Policy Reform Group, will be further peer reviewed before being published as an academic paper later in the year.

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Six big cannabis sector stories you might have missed this week

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It’s been another week of big news in the cannabis world.

At Cannabis Health, our in depth coverage of the ongoing growth of cannabis as a medical and wellness product continues

Meanwhile, over at Cannabis Wealth, we’ve been following all the big industry and policy news in a week which has seen some important developments..

Been busy and want to get caught up in a hurry?

Here are the six things you need to read to stay in the loop this week.

1. Reprieve for medical cannabis patients

The Department of Health has reached an agreement with Dutch officials to extend the supply of medical cannabis oils to existing patients in the UK until 2022.

Medical cannabis patients, living with severe, life-threatening epilepsy were left without access to medication when the UK left the EU at the end of last year.

Medical cannabis

Families, whose children are prescribed Bedrocan oils in the UK but must obtain their prescription through the Transvaal pharmacy in the Netherlands, were given two weeks notice that their medication could no longer be dispensed following the end of the Brexit transition period on 31, December 2020.

Read the full story.

2. UK largest’s medical cannabis trial reports back

The first findings from the UK’s largest medical cannabis patient study show quality of life improved by more than 50 percent.

Preliminary results from Drug Science’s Project Twenty21 study, have found medical cannabis significantly improves quality of life for people with life-limiting conditions such as chronic pain, multiple sclerosis (MS) Tourette’s syndrome and post-traumatic stress disorder (PTSD).

Published on Tuesday 11 May, the report is the first real-world data to be collected on medical cannabis in the UK.

Read more here.

3. Harrowing first-hand account of medical cannabis user
Diagnosed with a personality disorder and experiencing debilitating anxiety which left him housebound, Craig – whose name has been changed – had exhausted all treatment options and was losing all hope.
He speaks about how medical cannabis helped save his life here.

4. CBD market set to shrink

The UK’s CBD sector looks set to shrink significantly as the roll out of new regulations continues to batter the industry.

The FSA has confirmed to Cannabis Wealth it received applications for 803 different CBD products – but only 42 have been advanced to the next stage of the process so far.

More than half of all applications (445) were ‘incomplete’ and a further 41 have been withdrawn altogether.

Read the full story here.

5. CBD not linked to single doping case

CBD has not been linked to a single failed drugs test in UK sport despite fears about the undeclared levels of THC in some products.

The World Anti-Doping Agency removed the cannabinoid from its banned substances list in 2017 and since then several high profile athletes have publicly endorsed CBD products.

Even though CBD – which has no psychoactive properties – is not banned, the UK Anti-Doping (UKAD) still warns athletes to be cautious with treatments.

Read our exclusive report here.

6. School’s out for cannabis class

The first class on a pioneering university medical cannabis course have concluded their first year of studies.

The research programme at the Humboldt-Universitat zu Berlin examines the medical and nutritional uses of cannabis, production and the legal and economic frameworks of the business.

It’s the latest sign that medical cannabis is becoming a part of the mainstream education offering and a positive indication that new industry leaders will emerge in the coming years.

Full story here.

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Science finds a way for medical cannabis to relieve pain without side effects

Researchers have developed a molecule that allows THC to fight pain without the side effects.

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Medical cannabis
Many people living with chronic pain have found that cannabis can provide relief. 

Scientists may have developed a molecule which could allow medical cannabis to provide pain relief without any side effects.

Many people live with chronic pain, and in some cases, cannabis can provide relief. 

But the drug also can significantly impact memory and other cognitive functions. 

Now, researchers have developed a peptide that, in mice, allowed THC to fight pain without the side effects.

According to the US Centres for Disease Control and Prevention (CDC) around 20 percent of adults in the states experienced chronic pain in 2019. 

In some studies, medical cannabis has been helpful in relieving pain from migraines, neuropathy, cancer and other conditions, but the side effects can present hurdles for widespread therapeutic use.

Previously, researchers identified two peptides [molecules which are made up of amino acids] that disrupt an interaction between a receptor that is the target of THC and another that binds serotonin, a neurotransmitter that regulates learning, memory and other cognitive functions. 

When the researchers injected the peptides into the brains of mice, the mice had fewer memory problems caused by THC. 

Now, this team, led by Rafael Maldonado, David Andreu and colleagues, has gone one step further to improve these peptides to make them smaller, more stable, orally active and able to cross the blood-brain barrier.

Based on data from molecular dynamic simulations, the researchers designed two peptides that were less than half the length of the original ones but preserved their receptor binding and other functions. 

They also optimised the peptide sequences for improved cell entry, stability and ability to cross the blood-brain barrier. 

Then, the researchers gave the most promising peptide to mice orally, along with a THC injection, and tested the mice’s pain threshold and memory. 

Mice treated with both THC and the optimised peptide reaped the pain-relieving benefits of THC and also showed improved memory compared with mice treated with THC alone. 

Importantly, multiple treatments with the peptide did not evoke an immune response. 

Reporting in the American Chemical Society’s Journal of Medicinal Chemistry, researchers say that these findings suggest the optimised peptide is an ideal drug candidate for reducing cognitive side effects from cannabis-based pain management.

The abstract that accompanies this paper can be viewed here.

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Dutch Government to supply medical cannabis for UK patients until 2022

The Department of Health has reached an agreement to continue the supply of Bedrocan oils

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The Dutch Government will supply medical cannabis to UK patients until 2022

The Department of Health has reached an agreement with Dutch officials to extend the supply of medical cannabis oils to existing patients in the UK until 2022.

Medical cannabis patients, living with severe, life-threatening epilepsy were left without access to medication when the UK left the EU at the end of last year. 

Families, whose children are prescribed Bedrocan oils in the UK but must obtain their prescription through the Transvaal pharmacy in the Netherlands, were given two weeks notice that their medication could no longer be dispensed following the end of the Brexit transition period on 31, December 2020. 

After outrage from campaigners, the Dutch government agreed to continue supplying the life-saving products until 1 July, 2021 while a more permanent solution was reached.

This waiver period has now been extended until 1 January, 2022.

Health ministers promised to work with officials in the Netherlands to find a “long-term” solution, but according to those at the forefront of the campaign, there is still “some way to go”.

Hannah Deacon and son Alfie Dingley

Hannah Deacon’s son Alfie Dingley, who is prescribed Bedrocan products for a rare form of epilepsy, recently celebrated one year seizure-free.

In a letter to Deacon on Thursday 13 May, the DofH said it was working with the Dutch government, Bedrocan and the Transvaal pharmacy to proceed as “quickly as possible” with the UK production of these medicines.

It added that domestic production is “complex” and that manufacturing “unlicensed herbal medicines” comes with “significant challenges”. 

Deacon said that the UK production of Bedrocan products was the “only solution”.

While other cannabis-based medicines are available in the UK, experts have warned that there is ‘significant variation’ from one product to the next and switching an epilepsy patient’s treatment could be ‘life-threatening’.

“With the 1 July deadline for Bedrolite supply to cease from the Netherlands looming ever closer, we made it clear we wanted an extension to the agreement to stop the situation becoming dangerous for Alfie and the other patients receiving this vital medicine,” commented Deacon.

“The long term solution of Bedrocan products being made in the UK still has some way to go, but it can be the only solution and we thank everyone who is working very hard to achieve this. 

“This is still a long way off from being okay, but for now we have the pressure taken off on the supply issue.”

With limited access to medical cannabis on the NHS, families are still calling for the Government to help fund their children’s prescriptions, which can cost thousands of pounds each month.

Deacon added: “The ever-pressing issue of financial burden on the many families and patients wishing to use medical cannabis in the UK remains and this is a huge issue which needs dealing with.

“There are many ways in which the Government could step in and help access for very vulnerable people and we will continue working as hard as we can to make things better for all.”

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