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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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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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