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No appeals process for CBD firms denied novel food status

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Companies denied novel food status face the prospect of launching a judicial review.

CBD producers faced with being told to cease trading in the coming days are weighing up their options.

Wednesday 31 March marks the deadline for applications to the Food Standards Agency (FSA) under the new novel foods approach to CBD products.

Businesses were told to apply for novel food status to keep trading under the new rules in mid-February after the UK adopted Europe’s categorisation of CBD in its post-Brexit regulations.

Successful companies will be added to a public register and allowed to keep trading in the UK.

The tight turnaround to turn over extensive data to the FSA has put companies under significant strain but another problem is looming: There is no established appeals process for companies denied validation. 

Companies which are unsuccessful and have to cease trading in the UK immediately under criminal law do not have a formal avenue to challenge the decision.

In circumstances where a validation is withheld and the FSA declines an informal request to reconsider a decision, the only avenue available to CBD companies will be a costly legal one.

Robert Jappie, partner at legal firm Ince and expert in cannabis regulations, told Cannabis Health the lack of route for redress was certain to be an issue over the coming weeks and months.

He said: “The fact there’s no appeals process suddenly means getting on the public list is the difference between having a trading businesses and not having one at all.

“You would expect there to be clear guidelines detailing what the FSA expects to see for validation, there should be very detailed information.

 “That would negate the need for an appeals process but we’re seeing information sent out two or three weeks before the deadline and some companies just don’t have the time to prepare.”

“You get the impression this has not been very well thought through. It seems to be reactive rather than proactive.”

Despite the deadline being on 1 April, the register will not be available until ‘later in April’ according to the FSA. A spokesperson for the agency was unable to provide a precise publication date to Cannabis Health.

On 29 March, Jappie addressed more than 200 CBD industry figures online alongside trading standards barrister Jonathan Kirk QC at an online event organised by major CBD marketplace Alphagreen.

A leading expert on consumer law, Kirk has represented several major retailers in cases against regulators – and he believes the novel foods issue could yet end up in court.

If informal mediation with the FSA fails, companies denied novel food status face the prospect of launching a judicial review, a costly and time-consuming process.

Jappie said: “[Kirk] was very clear that if you do no get validation you are talking about weeks and weeks of preparation so if a company is worried they should be taking action now.”

A group action undertaken by CBD companies against the FSA remains a likely avenue if several validations are refused, although Kirk speculated the threat of litigation may be enough to induce concessions from the regulator.

An FSA spokesperson said novel foods system ‘is an established process’ that has been used successfully in other sectors.

 They added that the ‘onus is on applicants to produce a good quality applications’, pointing to assistance offered to the CBD industry in recent months.

The spokesperson added: “While there is no appeal system built into the legislation, our risk assessment process includes an independent science committee and we consult on the applications so the process is open and transparent.”

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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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