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Largest human trial seeks to prove safety of full-spectrum CBD

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Current European guidelines on THC are based on two small studies conducted in 1993 and 2011

The European Industrial Hemp Association (EIHA) has launched the largest human trial on the toxicological effects of trace amounts of THC in food products – but will it be enough to persuade regulators to approve full-spectrum CBD?

With an investment of 1.6 million Euros, the EIHA will assess 200 participants across a 30-day period in an effort to demonstrate to European regulators that trace THC is safe to consume.

Results from the study are expected to be released in the summer of this year.

Last month, the EIHA submitted three novel food applications on behalf of its members to both the European Food Safety Association (EFSA) and the UK’s Food Standards Agency (FSA).

These included an application for isolate-based, synthetic and full-spectrum CBD products.

Although the EIHA are in full agreement with the European Commission that isolate-based CBD should be classed as a novel food, it argues that full-spectrum products should not fall under the same regulations.

Lorenza Romanese, managing director at EIHA

Managing director at EIHA, Lorenza Romanese, told Cannabis Health: “When it comes to low levels of cannabinoids in food, this has been sold on the market for 25 years.

“It is not novel. For us, these do not deserve any novel food application prior to putting them on the market.”

According to Romanese, the full-spectrum application will be the organisation’s biggest challenge. Full-spectrum products contain the entire range of compounds found in the hemp plant, including trace amounts of THC.

In some cases, full-spectrum CBD products contain a larger concentration of THC than what is permitted under current guidelines.

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However, Romanese believes that these guidelines are “wrong, old and outdated”.

European guidelines on THC are based on just two studies. The first was conducted in 1993 with a cohort of thirty-one HIV patients. The second study, conducted in 2011, involved just eleven participants.

“They are completely ignoring 30 years of literature around cannabis,” she said.

“If we really believe that the full spectrum is the right product for the market, we need to tackle THC.”

With its ground-breaking study, the EIHC aims to fill the gap in scientific research surrounding the psychoactive compound found in hemp and cannabis.

“Full-spectrum is a challenge because there are some studies that are missing,” Romanese said.

“This is why we have decided to stick together and invest this money on behalf of our members, and in the name of the sector, to dig into this scientific topic that deserves toxicological studies.”

To ensure the results of the study are as safe and reliable as possible, the researchers will multiply its findings for uncertainty factors.

This number is fixed for certain substances.  For example, alcohol requires no multiplication. Meanwhile, Nicotine has an uncertainty factor of 4.4 and codeine has a factor of 5.

The uncertainty factor for THC, on the other hand, is between 20 and 40, almost ten times higher than nicotine and codeine.

Romanese hopes that the ongoing toxicological study will make regulators more comfortable with the concept of full-spectrum CBD and allow for its members to continue producing and selling products containing trace THC.

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However, if its full-spectrum application is not accepted, the association says it will not stop there. Following the initial decision is a nine-month period referred to as ‘assessment’ in which applicants can negotiate and debate with decision-makers.

“What I hope is that [regulators] will not reject full spectrum on principle. I will be very upset if they are not embracing science.

“The application takes a lot of work so it should not be refused on principle. They have to [explain why]. It will then be a negotiation with them to understand their decision.”

The EIHC was formed to support the three main families of the hemp sector: farmers, processing companies and traders.

Alongside its efforts to support companies through the novel food application, the organisation is also promoting hemp as an agricultural product and working to establish a clear legislative framework for the hemp plant.

In 2019, the European Commission launched the Green Deal, a project that aims to make Europe more sustainable while continuing to grow economically. Romanese says hemp can play an integral role in these ambitions.

“Climate change is here, and we need to tackle it. Hemp means no pesticides and little, if no, fertilizer. And on top of that, hemp helps the soil, the biodiversity, the pollinators and it stocks a lot of CO2 in the soil.

“The future of hemp could be bright. It’s super beneficial for the entire planet and I feel very proud to represent something that is very green, clean and supportive for the objectives of the Green Deal.”

Epilepsy

CBGA may be ‘more potent’ than CBD against seizures in Dravet syndrome

Dr Lyndsey Anderson said there is more to explore when it comes to creating more treatment options for Dravet syndrome.

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Dravet Syndrome: A row of test tubes containing CBGA oil with a doctors white gloved hand holding one up to the light

Scientists say they have found the ‘Mother of all cannabinoids’ which may help to reduce seizures in Dravet syndrome.

A new study on mice from the University of Sydney found that three acidic cannabinoids found in cannabis reduced seizures in Dravet syndrome, an intractable form of childhood epilepsy.

The three cannabinoids are cannabigerolic acid (CBGA), cannabidivarinic acid (CBDVA), cannabigerovarinic acid (CBGVA). All three but CBGA in particular “may contribute to the effects of cannabis-based products in childhood epilepsy” noted the researchers and were found to potentially have ‘anticonvulsant properties.”

The study marks the first time that three acidic cannabinoids were found to potentially help reduce seizures for Dravet syndrome.

Speaking with Cannabis Health News, the lead author of the study, Dr Lyndsey Anderson, said: “We found that CBGA exhibited both anticonvulsant and pro-convulsant effects. CBGA was more potent than CBD against febrile seizures in a mouse model of Dravet syndrome. We also found that a combination of CBGA and clobazam was more effective than either treatment alone. Additionally, we found that CBGA was anticonvulsant in the maximal electroshock acute seizure model, a model for generalized tonic-clonic seizures.”

She added: “CBGA did, however, present some proconvulsant effects. The frequency of spontaneous seizures in the mouse model of Dravet syndrome was increased with a high dose of CBGA. Also, CBGA was proconvulsant in the 6-Hz acute seizure model, a model of focal, psychomotor seizures.”

Although CBGA shows promise, Dr Anderson also stressed that it needs more research before it can replace CBD. She cautioned that Dravet syndrome patients may still need to proceed with caution.

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“Artisanal cannabis-based products are believed to reduce seizures in Dravet syndrome patients,” she said. “As these oils contain rare cannabinoids like CBGA, it is possible CBGA then contributes to the anticonvulsant effects of these artisanal cannabis oils. However, there were proconvulsant effects observed with CBGA, suggesting that Dravet syndrome patients may need to proceed with caution. The proconvulsant liability of CBGA would need to be addressed before it replaced CBD as an anticonvulsant.”

What is CBGA?

Sometimes referred to as ‘the mother of all cannabinoids,’ CBGA is the precursor molecule to many different cannabinioids including CBD and THC. It is thought to help some diseases such as colon cancer, metabolic disease and cardiovascular disease. It is a non-intoxicating cannabinoid much like CBD.

Dr Anderson explains that more research is needed to explain how the three cannabinoids work together.

“We don’t know how they work together yet,” she said. “We found that CBGA, CBDVA and CBGVA were all individually anticonvulsant against thermally induced seizures in the mouse model of Dravet syndrome. We did not investigate whether a combination of these three cannabinoids would result in a greater anticonvulsant effect than either cannabinoid alone. Future work will definitely explore this possibility.”  

CBGA future research

This isn’t the end of the research into CBGA for Dravet Syndrome. Dr Anderson said there is more to explore when it comes to creating more treatment options for Dravet syndrome.

 

She said: “Next on the horizon for this research is to explore whether the anticonvulsant properties of CBDVA and CBGVA translate to other seizure types including spontaneous seizures in the mouse model of Dravet syndrome. Additionally, we have extensively interrogated the anticonvulsant potential of individual cannabinoids and identified ten with anticonvulsant properties.”

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“We are now interested in investigating what happens when we combine these anticonvulsant properties. It remains an open possibility that greater anticonvulsant effects are achieved when the cannabinoids are administered in combination.”

The study was recently published in the British Journal of Pharmacology (DOI: 10.1111/bph.15661)

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New York regulators vote to allow home grow for medical cannabis patients

The new regulations would allow medical cannabis patients and carers in the state a safe, cost-effective way to access their medication

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New York: The statue of Liberty against a blue sky and the skyline of New York city

The proposed regulations would allow medical cannabis patients and carers in New York to grow up to six plants, indoors or outdoors, for therapeutic use.

New York cannabis regulators voted unanimously for the proposed regulations which would not only allow qualified patients to grow their own plants.

According to a slide from the Cannabis Control Board presentation, patients would be allowed six plants each but carers with more than one patient,  can “cultivate 1 additional cannabis plant for each subsequent patient.”

The new regulations would impose a duty on patients to ensure no one under the age of 21 can access the plants or any products cultivated from them.

Landlords would also have the option to prohibit their tenants from growing cannabis on their property if they chose. The products must not be processed using anything other than alcohol.

The regulations will now have a 60-day public commentary period before review.

Tremaine Wright, chair of the Cannabis Control Board (CCB) said: “We are proud to present those proposed regulations. The home cultivation of medical cannabis will provide certified patients with a cost-effective means of obtaining cannabis through personal cultivation while creating a set of standards governing the conduct and activities relating to the personal cultivation of cannabis.”

In a press release, the CCB also gave an update on the expungement of cannabis convictions. “Approximately 203,000 cannabis-related charges are presently being suppressed from criminal background searches and are in process of being expunged, adding to the approximately 198,000 records that were expunged as part of the first round of cannabis expungement following legislation enacted in 2019.”

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New York recreational market

Earlier this year, New York. It would become the 16th US state to legalise recreational cannabis creating thousands of jobs and tax revenue. The bill was signed into law by Governor Andrew Cuomo in March.

The law would allow for possession of up to three ounces of marijuana for personal use. It would allow licensed dispensaries to sell cannabis products to those over 21.

Neighbouring states who have already legalised marijuana, including New Jersey and Massachusetts, meant that New York citizens were leaving to access cannabis losing tax revenue in the process.

It is expected that home grow for recreational users will follow the proposed regulations for medical cannabis patients but only after the new market is established.

Read more: California governor signs Ryan’s Law to allow medical cannabis use in hospitals

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CiiTECH announces new CPD-accredited training course

It aims to support and encourage UK pharmacists, physicians and nurses.

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Ciitech academy
The course aims to support and encourage UK pharmacists, physicians and nurses.

Cannabis healthcare company CiiTECH has been awarded CPD accreditation for its academy course, which aims to support and encourage UK pharmacists, physicians and nurses.

CiiTECH’s Cannabis Science and Therapeutics course has had tremendous success after launching the course earlier this year.

The new and innovative course offers an interactive digital platform with a 12 chapter syllabus comprising of medical cannabis, CBD knowledge and information, specifically catered for healthcare professionals in the UK.

Industry experts in the UK could potentially face serious challenges if the trainers in question who are both recommending, and dispensing information are not up to the required standards in the field.

People currently working in the industry, such as pharmacy professionals will feel more secure and confident after taking the course. With such an array of knowledge from the experts, they are better able to recommend, treat and understand benefits and causes of their patients.

Besides all the learning and comprehensive information, simple FAQ questions by patients can be simply downloaded to have at hand as an ongoing reference.

The CBD industry is an extremely fast growing market, people are becoming more and more aware of benefits and common usage. It’s said that by 2025 the market in the UK only will be worth over £3 billion.

This means that clinics and pharmacies must be sourcing trustworthy information to their customers.

This course is aimed at filling an education gap in the market, by covering several points in intricate detail, from plant history to dosing, and patient care. A lot of occupations in the UK require an on going learning process each year, with positive results overtime, leading to a greater service in the industry.

“Through years of experience serving UK customers with our portfolio of CBD brands it was abundantly clear that the level of misinformation was enormous and confusing for everyone involved,” says Clifton Flack, CEO and founder of CiiTECH.

“Formal education is always important but with little to no existence in the UK we could not see a better way to help lead the industry than to establish our own online academy and give healthcare professionals the opportunity to not only learn about cannabis therapeutics but to earn further education points at the same time.”

Flack adds: “With the rise in UK cannabis prescriptions and CiiTECH’s long awaited move into the THC medical cannabis arena, now is the time to increase professional education and it is exactly why we have embarked on this education journey. CiiTECH is fast becoming the UK’s one stop shop for all your cannabis needs; research, education, consumer brands.”

CiiTECH collaborated with Medical Cannabis Mentor to produce the course and prepare it for CPD certification.

Joe Dolce, founder and CEO of Medical Cannabis Mentor, comments: “The course synthesises the most up-to-date scientific research and clinical guidelines in an engaging format to help professionals make informed treatment decisions.”

The course can be found on https://cpduk.co.uk/ or for pricing and registration visit:  https://ciitech.academy

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