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First novel food list published as CBD products face being pulled from shelves

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CBD oil
An initial list of validated CBD products has been published by the FSA

CBD companies are learning their fates as the Food Standards Agency begins to validate products permitted to remain on shelves in the UK.

All UK CBD companies were required to apply for novel food status by 31 March, under new regulations announced last year.

Under the new system, any company selling a CBD product that was on the market prior to 13 February needed to submit sufficient quality and safety data to the regulator for each product.

Companies are now being informed whether or not their products have met required standards from the FSA directly, and decisions are also being made available online via a public register.

The FSA has today confirmed that this initial list is only provisional, with a full register of authorised products not due to be completed until June 2021.

The list distinguishes between validated products and ‘on hold’ applications in instances where sufficient data has not yet been received but companies have set out ‘set out robust plans to complete the risk assessment’.

Products which have not submitted application should be withdrawn from the market with criminal prosecutions possible for company directors who do not comply.

Emily Miles, chief executive of the FSA, said: “This is about bringing the CBD industry into compliance with the law. Consumers need to be able to trust that these products are safe and are what they say they are.

“Companies were given until the end of March  to submit their applications for safety assessment. Those who haven’t done this should take their products off the market.

READ MORE  Vitality CBD ‘leading the way’ with novel food application

“Products on the list that have been linked to a validated or on hold application will now undergo a full safety assessment so that a final decision can be made.

“When complete, the list can be used by suppliers and retailers to confirm the status of particular products and to help local authorities inform their enforcement decisions.

“The FSA is not endorsing the sale of any of these products, regardless of whether they are on the list or not and inclusion on the list is no guarantee of eventual authorisation; that will be determined on the strength of evidence of safety submitted by the companies.”

At time of writing, only 23 products manufactured by three companies (Pureis, 4MP and CBDex) are currently validated and none added to the ‘on hold’ list as of yet.

Cannabis Health has approached the FSA for clarity over when the register will be completed.

Validation is only the ‘first step in the process’, according to the FSA, and is granted to products where sufficient lab data has been submitted to allow the agency to carry out further checks pending full authorisation.

As previously reported, there is no appeals process for companies whose products have been denied validation but the register will be updated weekly according to the FSA.

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Spain approves first cannabis based medicine

The approval for Epidyolex was based on the results of four randomised controlled Phase III trials

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Spain cannabis: A Spanish flag in the air with an old building behind it

Spain has approved the first cannabis based medicine, Epidyolex for patients with severe conditions such as epilepsy.

Epidyolex, an oral cannabis-based medicine, has been approved in Spain by the Ministry of Health after a large two-year trial. The approval for Epidyolex was based on the results of four randomised controlled Phase III trials. The clinical development of the therapy was spread over 10 different hospitals.

The trial involved over 700 participants with severe forms of epilepsy.

Until recently, there was no distinction between recreational and medicinal cannabis use in Spain which made it difficult to obtain products with higher quantities of 0.02 percent THC.

The medicine will only be available in hospital pharmacies for the treatment of seizures caused by Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS).

Spain and medical cannabis

Speaking at a press conference, neurologist Vicente Villanueva, head of the Refractory Epilepsy Unit of the Hospital Universtiari i Politècnic La Fe de València said the trials have found a 40 percent reduction in seizures.  “As clinicians and researchers, we are satisfied to have these new options”, 

Antonio Gil-Nagel Rein, a neurologist and director of the Epilepsy Program of the Hospital Ruber Internacional de Madrid reported: “The potential improvement of the quality of life in an area where therapeutic options are very small is good news. Access to a new drug with a novel and clinically proven mechanism of action is a reason for hope for patients and satisfaction for specialists.”

Epidyolex received approval from the European Commission in September 2019. This made it the first cannabis-based prescription medicine to receive authorisation.

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Read more: Can cannabis reduce the side effects of anti-seizure medication?

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Royal Society of Medicine and Integro Clinics announce pain and cannabis medicines event

The event takes place on October 11 from 8:30 to 17:30. It will explore the potential of cannabis medicines in the field of pain medicine in the UK

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Event: The Royal Society of Medicine logo in green and red on a white background

The Royal Society of Medicine has announced a collaborative event, Pain and cannabis medicines: Everything you want to know (but were too afraid to ask) in association with Integro Medical Clinics.

The event takes place on October 11 from 8:30 to 17:30. It will explore the potential of cannabis medicines in the field of pain medicine in the UK

Since the legalisation of cannabis medicines on prescription in November 2018, patients and clinicians alike have been awaiting more data or information regarding these medicines. 

The event aims to provide those attending with a comprehensive understanding of the uses of cannabis medicines and the practicalities of using them in their own practice. It will consist of presentations on the history, regulatory environment and pharmacology of cannabis medicines including the use of different cannabis-based medical preparations in treating pain and related symptoms in a wide variety of clinical fields in the context of the current UK regulatory framework. 

Event presentations

The day will feature presentations from international leaders in cannabis medicines such as Professor Raphael Mechoulam, the chemist who discovered the endocannabinoid system and THC, Dr Anthony Ordman, Leading UK Consultant in Pain Medicine and previous President of the Pain Medicine Section of the Royal Society of Medicine and Dr Arno Hazekamp PhD, who worked as Head of Research and Education at Bedrocan, the first European company to produce EU GMP grade cannabis medicines.  

If you wish to sign up, please click here.

Event speakers
Dr Anthony Ordman, Consultant in Pain Medicine

Event: A black and white headshot of Dr Anthony Ordman Founder of the highly respected Chronic Pain Clinic at London’s Royal Free Hospital, he is one of the UK’s most experienced specialists in the treatment of pain. For his contributions to Pain Medicine, Dr Ordman was awarded a Fellowship of the Royal College of Physicians in 2005, and he is the Immediate Past President of the Pain Medicine Section of the Royal Society of Medicine. Dr Ordman is also Senior Medical Consultant and Lead Clinician at Integro Medical Clinics and has a special interest in the potential benefits of cannabis medicines in pain medicine.

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Alex Fraser, Patient Access Lead at GrowPharma

Event: A black and white headshot of guest speaker Alex FraserAlex Fraser is a leading medical cannabis patient advocate. He is a patient himself having been diagnosed with Crohn’s Disease in 2010 at 19 years old. In 2014 he founded the United Patients Alliance and has since appeared on mainstream media multiple times, including on the BBC and ITV, to highlight the urgent need for access to cannabis medicines for the many patients who may benefit from them. He has taken delegations of patients to parliament to give testimony to politicians at the highest levels and organised educational events, rallies and protests calling for law change on medical cannabis. In February 2019 Alex joined Grow Pharma, one of the leading suppliers of cannabis medicines in the UK, as their patient access lead. He utilises his extensive knowledge of medical cannabis, his understanding of patient needs and his network in the industry to ensure patient voices are heard and represented. His work includes informing top-level policymakers, educating healthcare professionals and conceiving and running projects that increase general awareness and provide practical help for patients.

Professor Raphael Mechoulam, Professor of Medicinal Chemistry at the Hebrew University of Jerusalem in Israel

Event: A black and white headshot Most well-known for the total synthesis of delta-9 tetrahydrocannabinol (THC) and the discovery of the Endocannabinoid System. Since the inception of his research in the 60s, Professor Mechoulam has been nominated for over 25 academic awards, including the Heinrich Wieland Prize (2004), an Honorary doctorate from Complutense University (2006), the Israel Prize in Exact Sciences – chemistry (2000), the Israel Chemical Society Prize for excellence in research (2009) and EMET Prize in Exact Sciences – Chemistry (2012

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Dr Sally Ghazaleh, Consultant Pain Specialist

Event: A black and white headshot of a guest speakerDr Sally Ghazaleh, is a Pain Management Consultant at the Whittington Hospital, and the National Hospital of Neurology and Neurosurgery, London. She qualified from the University of Szeged Medical School, Hungary in 2000, and then completed her specialist training in the Anaesthesia and Intensive Care Medicine at Semmelweis University in 2007. She went on a fellowship at University College Hospital, London, to gain her higher degree in Pain Medicine

During her time at the pain management Centre at University College Hospital, she gained extensive experience in dealing with and managing patients with complex multiple pain problems. She is accomplished at a variety of interventional and non-interventional treatments for this specific patient group. Sally specializes in managing patients with lower back pain, neck pain, neuropathic pain, abdominal pain, cancer pain, complex regional pain syndrome, post-stroke pain and Fibromyalgia. She has a particular interest in bladder and abdominal pain in women, and women’s health in general.

Sponsored post about British Cannabis Group

Read more: How Medical cannabis can help relieve the symptoms of migraine

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Zurich to launch recreational cannabis trial

Switzerland’s largest city announced a three and a half year pilot scheme that will allow the sale of cannabis products.

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Zurich: A red and white swiss flag against the blue sky of Zurich with mountains

Zurich is launching a new trial that will allow people to buy cannabis products from pharmacies and social clubs under controlled conditions from next year.

Zurich, Switzerland’s largest city, announced a three and a half year pilot scheme that will allow the sale of cannabis products. Products will be available with different combinations of THC and CBD.

Local manufacturers will need a production permit which will available from the Federal Office of Public Health. This will help to ensure quality and standards.

Zurich can

The scheme titled the Züri Can, cannabis with responsibility will start next year and is possible thanks to a change in the law that was introduced by the Swiss parliament in 2020. The law allows cities to conduct scientific studies on the effects of the cannabis market and of recreational use.

The trial will also be supervised by Zurich University’ psychiatric hospital.

In a statement, the City of Zurich, Zurich pharmacy network and Zurich University said: “For years, the City of Zurich and the Psychiatric University Clinic in Zurich have been committed to an objective and low-risk approach to cannabis use. In mid-May 2021, changes to the Narcotics Act came into force, which allow pilot tests for regulated cannabis sales. On this legal basis, the Psychiatric University Clinic Zurich, in cooperation with the City of Zurich, wants to research models of the regulated purchase of cannabis and its effects on the health and consumption behaviour of the consumer.”

“The aim of the Zurich study is to provide relevant knowledge on the best possible use of cannabis. The study is intended to promote public health, maintain public safety and support the protection of minors.”

Cannabis history

In a survey, one-third of the Swiss population reported using cannabis at some stage with 200,000 reporting they use it frequently.

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However, an initiative to decrinmalise cannabis for personal consumption was defeated in 2008 by almost two-thirds of the vote. This marked the second time there was a national vote on the issue of cannabis.

Zurich will be the first city in Switzerland to take part in the scheme but other cities may follow such as Bern or Geneva.

Read more: Ryan’s Law would allow cannabis use in California hospitals 

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