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Scottish hemp industry calls for cooperation over novel food regulations

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CBD companies must apply for novel food status by the end of March

Hemp and CBD companies have called on the authorities to ‘cooperate’ in coming to a solution over new novel food regulations.

Several Scottish companies, which say their place in the industry has been threatened by the introduction of novel food regulations this year, have appealed to Food Standards Scotland (FSS) to work with them to come to a solution.

CBD brands in England and Wales have until 31 March, 2021 to apply for Novel Food status from the Food Standards Authority (FSA), in line with European regulations.

At the end of last year, the FSA confirmed that all applications must include toxicology safety data and only products with this validation will be allowed on the market after this date.

However, FSS has not yet announced the deadline for those companies based over the border.

The Scottish Hemp Association, which represents more than 20 traders in the CBD and hemp sector – including manufacturers, producers and retailers – is hoping to reach an agreement which will allow whole-plant extracts to remain on the market.

While it agrees that CBD isolate should be considered a novel food, along with synthetically produced CBD, it claims that none of its members use isolates in their products.

The Association proposes that any products of under 95 percent purity – and therefore no longer pure single-molecule CBD – should be allowed to continue being used in food products.

“The information that has brought CBD to the attention of food regulators is based on clinical trials from GW pharmaceuticals using 99 percent purified isolated CBD,” said Kyle Esplin founder of Holistic Highland Hemp and chair of the Scottish Hemp Association.

“Concerns have never been reported about whole plant extracts.”

Esplin expects that as has happened elsewhere in Europe, CBD products which do not gain novel food status will be soon back on the shelves under the guise of cosmetics.

“If novel food regulation is enforced against hemp extracts, consumers who want the whole plant will be in the position of either consuming products labelled as cosmetics, or sourcing from the black market,” he argues.

The trade association was founded to bring together those in the Scottish hemp industry, after several companies felt “threatened” by the introduction of novel food regulations.

The cost of generating toxicology data, which must include a 90-day rodent trial, is estimated to be between £300,000 and £1million.

“We’re made up of small businesses, who felt threatened by the introduction of novel food regulation, which we feel is being unfairly pushed,” said Esplin.

“It’s not even just an issue of cost, it seems like it’s not possible to get some of these products through the novel foods process.”

He added: “If the concern is about people consuming these products, don’t remove them from the food standards system where we have regulation in place.

“We’re appealing to FSS not to exclude our products over the novel foods issue. There’s space for everybody.”

In a statement outlining its position to FSS the Scottish Hemp Association writes: “We want to cooperate and find a solution that works for Scotland.

“Failure to reach any agreement will result in a marketplace of known CBD brands – products that have been consumed for several years – then being sold as cosmetics, consumed by customers, and no food standards regulation can be applied which is extremely detrimental to consumer safety.”

None of the companies are considering the novel food application for their hemp based products and say they would rather drop out of the CBD food system all together if the regulation is enforced.

“Novel foods regulation opens the door to synthetically produced CBD being sold, something we as an industry have sought to keep out of the supply chain,” it argues.

“We are aware some companies in England are proceeding and the majority, if not all of them, are going to be made from CBD isolate, or CBD isolate plus CBG isolate. This does not satisfy the requirements of our whole plant consumers, they do not want isolated CBD they want hemp extracts.

“Synthetically produced CBD products could be sold with Hemp leaf artwork on the packet and no regulatory requirement to inform the consumer that it is synthetically produced.”

According to the Association some consumers have been “shocked” that this could be an outcome.

But some regulation of the market is needed and it has asked the FSS to work with it to introduce its proposed by an agreed transition date.

This includes ensuring that no CBD isolate or CBD extracts above 95 percent purity are used in food products and all CBD products contain less than 1mg THC per product.

“Hemp seed oil is not permitted in every country around the world, but Scotland has sold it for years with no enforcement over trace THC content, no public health issues or complaints, an established soft touch non enforcement policy it seems,” added Esplin.

“We are asking that FSS come to an agreement with Scottish Hemp Association that this soft touch policy of non-enforcement be extended to the CBD industry.”

While confirming that no deadline has been announced for novel food applications in Scotland, FSS urged businesses to lodge an application “without undue delay”.

In a statement to Cannabis Health, a spokesperson said: “At this time, there is no deadline for novel food application submissions in Scotland. However, it is important to note that all businesses intending to sell food items containing CBD should not place their products on the market until they have applied for, and received, authorisation from Food Standards Scotland and Food Standards Agency as part of the GB Application Service. Applications made to the EU prior to 1 January 2021 will also need to be submitted using the GB Application Service, which can be accessed here.

“We urge businesses with products already on the market to lodge an application for authorisation of a novel food without undue delay, and we would encourage Local Authorities to work with businesses in their area to facilitate this process.”

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Ireland to fund patient’s medical cannabis up front

Campaigner Vera Twomey described “relief” that her determination has finally paid off.

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Ava Barry medical cannabis patient
Vera Twomey's daughter, Ava Barry has a severe from of epilepsy which is helped by medical cannabis

Campaigner Vera Twomey has described her “relief” as the Irish Government agrees to fund medical cannabis patient’s prescriptions up front.

Eligible medical cannabis patients in Ireland will now have their medication paid for up front, after months of pressure on the Government from campaigners. 

Health Minister Stephen Donnelly announced on Monday 19 July that the refund system for patients who obtain their prescribed cannabis-based products from the Netherlands, will now be replaced by a direct payment system.

The HSE will pay the dispensing pharmacy in the Netherlands directly, rather than the burden falling to the patients and their families, who were then required to apply for a refund.

Vera Twomey, whose daughter Ava Barry, 11, has a severe form of epilepsy known as Dravet syndrome, is among 40 patients who have now been granted an individual ministerial licence to import Bedrocan oil to Ireland.

But the family were paying 10,000 Euros up front every three months for Ava’s prescription and waiting up to five weeks for it to be refunded.

Campaigner Vera Twomey is “delighted” by the news

Twomey, who has four other children, has previously spoken of the huge financial strain this system placed on her family.

Over the last 16 months she has relentlessly called for action, making dozens of phone calls daily to politicians and lobbying ministers on social media with the backing of thousands of supporters in Ireland and across the world.

Twomey, who received a phone call from Ireland’s Prime Minister, Micheál Martin on Monday confirming the news, says she is “delighted” that her determination has finally paid off.

“There’s a sense of relief that we have accomplished this, but also a little bit of shock because we have been trying to resolve it for so long,” she told Cannabis Health.

Twomey’s activism gained national attention in 2017 when she walked from her home in Cork to Leinster House in Dublin to ask former Health Minister Simon Harris to grant access to medical cannabis for her daughter. 

Initially having to travel to the Netherlands to collect the prescription herself, during the pandemic Twomey successfully campaigned to secure the permanent delivery of Bedrocan oils for Ava and other patients.

Now she says she is looking forward to focusing on her family and putting the phone down for a while.

“I don’t think anybody who has gone through this fight, seeing the injustice that we have had to deal with could ever walk away,” she said.

“But at the same time, I’ve made a lot of sacrifices and for the moment at least, I need to give 100 percent to my other children, to do normal things and be a family.”

But the fight in Ireland isn’t over.

The Irish Government announced the provision of funding for the Medical Cannabis Access Programme (MCAP) in January – almost two years after it was introduced – but only four low dose cannabis-based medicines are covered by the programme, for people living with one of three qualifying conditions.

“There are other issues – we still need expansion and improvement in medical cannabis access, the journey is over by any means, but we’re at the beginning and getting Bedrocan recognised as a medicine that is funded up front is very important.

“I think the Irish are actually miles ahead of the British on this one and I hope [politicians] will take notice and catch up.” 

She added: “The greatest gift you’ll ever receive is to lose your fear, then you can accomplish anything with focus and determination.

“If you have the determination to keep going you will get there. It’s not going to be easy, they are not going to make it easy but it can be done.”

Patients eligible for the direct payment system are those suffering from one of three stated conditions; spasticity associated with multiple sclerosis, intractable nausea and vomiting associated with chemotherapy and severe, refractory (treatment-resistant) epilepsy. 

The HSE says it will be contacting patients directly.

Health Minister, Mr Donnelly, commented: “I am delighted that the HSE and Transvaal Apotheek in the Netherlands are implementing a new process which will give peace of mind to the seventeen patients and their families who until now have been using the refund process.”

 

 

 

 

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Kanabo’s cannabis vaporiser for metered dosing launches in UK

The VapePod will give thousands of UK patients access to pain relief in a metered dose.

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Kanabo cannabis Vapepod
The VapePod can administer a measured dose of cannabis extract

Cannabis company Kanabo’s new extract formula and vaporiser will give thousands of UK patients access to pain relief in a metered dose.

UK patients will be the first in Europe to have access to Kanabo’s vaporiser, the VapePod, and its new extract formula when is it delivered later this month.

The deal, in conjunction with LYPHE Group, will see patient’s of LYPHE Group’s ecosystem, including The Medical Cannabis Clinic and Dispensary Green, able to access the VapePod under the brand name NOIDECS.

Under the agreement, PharmaCann and Kanabo established a customised production line for Kanabo’s VapePods cartridges.

An alternative to cannabis flower

The VapePod is a medical-grade, handheld vaporiser which enables accurate and precise micro doses of cannabis extract, dispensing 1mg of formula for each inhalation.

This will benefit to patients as inhaling extracts rather than tinctures and oils allows for faster onset and higher bioavailability.

It will also allow clinicians to more confidently prescribe and monitor a patient’s dosage, as well as providing more accurate patient data.

Previously, cannabis patients in the UK have only been able to access medical cannabis dry flower and oil tinctures for which the majority of patients consume via inhalation due to fast onset time.

Kanabo’s medical line aims to enable patients to move away from the harmful act of smoking medical cannabis flowers as they can now take their medicine without inhaling soot, tar and carcinogens into the lungs.

Kanabo founder, Avihu Tamir

Avihu Tamir, Kanabo’s CEO, said: “The VapePod is a world first allowing specialist consultants to prescribe a metered dose of medicinal cannabis that is healthier for patients than the alternative, which is typically smoking.

“Medical cannabis is a safer alternative to the conventional opiate solutions and other pain management treatments. This announcement ensures that thousands of UK patients have access to the most effective medicinal cannabis delivery system.

“The fact that the VapePod gives exactly 1mg on every inhalation is crucial for GPs because they can prescribe an exact dose which they haven’t been able to do before. For patients who want the similarity to smoking but know they are not inhaling soot and tar. There’s also the bioavailability factor too.

“The reason GPs haven’t been prescribing is the issue of dosing and flowers – they don’t feel comfortable asking patients to smoke. With Kanabo, they can prescribe exact dosing in a safe and consistent way.”

The medical extract formula, which is based on the Israeli medical cannabis pharmacopoeia as a recommendation for the treatment of pain management, has a purity of 70 percent THC with 15 percent minor cannabinoids and terpenes.

Earlier this year Kanabo became the second cannabis company to list on the London Stock Exchange.

Dean Friday, LYPHE’s CEO commented: “Kanabo are experts in novel delivery with their VapePod greatly improving onset times, and for our chronic pain patients we now have an alternative to flower vaporisation. This is the start of a revolution in medical cannabis application and we are delighted to be supplying it under the NOIDECS brand.”

 

 

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Mental health

Cancer survivors turn to cannabis for physical and mental health – study

Cancer survivors are more likely to use cannabis to help pain, anxiety, sleep and nausea. 

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cancer
Cancer survivors are more likely to use cannabis to help pain, anxiety, sleep and nausea. 

Cancer survivors are frequently using cannabis to manage physical and mental health symptoms, says a new study.

Research from the US indicates that cancer survivors are more likely to use cannabis for symptoms such as pain, anxiety, trouble sleeping and nausea. 

A team of investigators analysed results from a Covid-19 cannabis health study to examine changes to cannabis use, methods of cannabis delivery, and coping strategies among cancer survivors since the pandemic.

They found that individuals with a history of cancer are more likely to report cannabis use to manage mental health and pain symptoms.

This group of people were also more likely to report fear of a Covid-19 diagnosis, compared to adults without a history of cancer.

Data was collected from 158 responses between 21 March 2020 and 23 March 2021, from cancer survivors who identified as medicinal cannabis users.

These were then compared to medicinal cannabis users without a history of cancer of the same age.

According to the study, cancer survivors were more likely to report using cannabis as a way of managing nausea/vomiting, headaches or migraines, seizures, sleep problems or as an appetite stimulant.

Specifically, self-reported symptoms most frequently managed by medicinal cannabis among respondents included anxiety and pain. 

Sixty one percent of respondents with a history of cancer used cannabis to manage anxiety symptoms and 54 percent for chronic pain.

Forty eight percent said they used it to manage depressive symptoms and 25 percent for PTSD, while smaller numbers used it for symptoms of another autoimmune disease, and irritable bowel syndrome. 

While there were no differences in how often they used cannabis or their method of administration, cancer survivors were “more likely to have an advanced supply of cannabis”. 

The findings support the need for more conversations between doctors and their patients about the use of cannabis, say those behind the study.

The authors concluded: “Overall, we observed that cancer survivors are frequently reporting the use of cannabis to manage both physical and mental health symptoms associated with their cancer diagnosis and that cancer survivors are more likely to report fear of a Covid-19 diagnosis compared to those without a history of cancer. 

“Given the frequency of mental and physical health symptoms reported among cancer survivors during the Covid-19 pandemic period, clinician–patient interactions should include questions around cannabis use, particularly those with a history of cancer.”

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