Two months before the deadline for novel food applications, smaller CBD brands describe feeling “completely disregarded” as the industry appears to take another step towards “shutting out” grassroots businesses.
This week, the Association for the Cannabinoid Industry (ACI) announced a partnership with Trading Standards.
Approved by the Secretary of State last week, the ACI is now the first UK cannabis industry to formalise a partnership with Trading Standards which will allow the ACI and its members to seek advice from the official body that will be enforcing the market from April onwards.
After the FSA’s 31st March 2021 deadline, any CBD product that does not have a validated novel foods application will be illicit.
As part of the agreement the ACI has agreed to run educational webinars and develop literature to enable Trading Standards officers to recognise non-compliant CBD products sold in the UK.
In exchange, the Trading Standards will provide webinars, training, general information and guidance on topics such as, labelling, advertising claims and food safety management plans to ACI members.
“We are thrilled to further support the sale of safe and compliant CBD in the UK through this partnership with Trading Standards,” Leila Simpson, ACI innovation director said at the time of the announcement.
“This will enable us to ensure our members are getting the best available advice to help raise the standards of the industry and more easily share intelligence with the regulator about non-compliant products after the novel foods March deadline.”
Although the ACI says the partnership hopes to raise the quality standards of CBD for sale in the UK, many CBD advocates and small businesses see it as another step towards “shutting out” smaller companies who are unable to afford the high membership fees.
Peter Reynolds from CannaPro, another UK trade association for the CBD sector, describes the fees as “outrageous” and cites companies that have withdrawn their membership for this reason.
In 2019, members of the ACI reported admission fees of £12,000 or £50,000 per annum.
The ACI confirmed to Cannabis Health that there is now just one fee, of £25,000 a year, but says this allows it to “hire the best people” in order to engage with those in the scientific and regulatory sectors on a “peer to peer” level.
According to Reynolds, CannaPro, which represents many of the UK’s smaller CBD companies, has not been provided with the same level of information as the ACI.
As a trade association, he believes both bodies should be treated on “exactly the same basis”.
“Essentially what the ACI is doing is setting up a club where the admission fees are tens of thousands of pounds,” Reynolds tells Cannabis Health.
“This is all about a campaign to destroy the small businesses that created the CBD market and seize control of it.
“These arrangements between Trading Standards and commercial organisations are not new. It has happened before but what these [partnerships] are usually trying to do is help retailers clarify what is going on.
“But when you have an organisation like the ACI, which is systematically engaged in trying to close down the majority of the market in favour of its members, it’s deeply shocking.”
Mike Peates, founder of CBD company Medivita, also fears the move will leave smaller businesses at a disadvantage.
“Whilst I understand the need to remove rogue traders from the industry and have helped Trading Standards with this, I can’t see how this will end up being impartial,” he says.
“The ACI has a membership paying huge fees for them to manipulate the decision makers. On the face of it this partnership means they will be both Gamekeeper and Poacher acting in the best interest of their membership.”
This echoes the sentiment of many smaller CBD companies that are feeling “cornered” by the events surrounding the FSA’s Novel Food Applications.
Speaking to Cannabis Health, director of Leafline CBD and All World Products, Paul Shrive, says: “As always, it’s monopolisation. We, the small guys, pave the way then big business comes in and takes over.
“Effectively what we have is a politician-fuelled trade body looking to monopolise and take over the cannabis sector. It’s as simple as that.”
Shrive believes the current situation extends back to 2016, when the UK “gave away” its cannabis sector.
“We gave it away by allowing American and Canadian companies to come over to the UK and influx the market with their products, whether they are isolates, whole-plant or full-spectrum,” Shrive says.
“We are now dealing with the consequences.”
Having first experienced the benefits of cannabis in the 1980s while living in Africa, Shrive has had a passion for the plant’s medicinal properties for over thirty years. Having launched his first CBD company in 2016, he says “it’s the most frustrating and soul-destroying situation to be in”.
Sam Connolly, owner of CBD oil brand, Bnatural is more understanding of the ACI’s actions.
“I get where [the ACI] is coming from,” Connolly says. “They want to police the industry because their members have forked out tens, if not hundreds of thousands to become members. They need to make sure they do what’s right for their members.”
Despite this, Connolly still feels that the UK’s CBD sector is under “systematic attack from all angles”.
Aside from its own brand, Bnatural has multiple other businesses relying on it to have its products available after the Novel Foods deadline. The company prepared itself early and took other routes to compliance without the help of consortiums such as the ACI.
“We have direct contact with the FSA and we’re getting information that way,” Connolly explains.
“But the [ACI] subscription is designed for the elite, isn’t it? It’s not designed for smaller [businesses] like us. Fees are way too high for most people.”
For CBD company, Karma Coast, the health of its customers is its primary concern.
As a producer of full-spectrum oils, the Newcastle-based company expects that many of its products will be deemed illicit after the March deadline, despite claiming that they are more effective than isolates.
Karma Coast’s founder, Dylan Mortimer says data from his company’s product development showed that an isolate product with a 50 percent concentration of CBD was less effective than a whole-plant product with just six percent CBD.
With many people now relying on Karma Coast’s products for managing their health conditions, the company is concerned about the future of the business.
“Our business is just a bit up in the air at the moment,” Mortimer says.
“We will look to supply something else, but unfortunately, it will be an inferior product.
“I feel like we’re being shut out and completely disregarded.”
In 2019, the ACI carried out the first major third party testing of CBD products in the UK. The report found only 38 percent of the products were within 10 percent of the advertised CBD content and 38 percent actually had less than half of the advertised CBD content, with one product containing no CBD at all.
According to the report the test exposed “regulatory gaps” and highlighted a need for “well-regulated, innovative and responsible industry” to protect consumers.
Speaking to Cannabis Health, Shomi Malik, external affairs director at the ACI, says: “This market has existed in a grey area for a long time and we in no way want to diminish the good work of a lot of the companies that have been around for a little while.
“We’ve got the same mission, we want to increase access to cannabinoids. We want to increase the levels of education and decrease the stigma and to see real mass adoption. If retailers can’t engage with the sector meaningfully [due to a lack of regulation] this will be harder to achieve.”
Malik admits that some of the events around the novel food applications have caused confusion in the sector and the situation has not been “ideal”.
He continues: “I understand that the novel food process is out of reach for a lot of companies, but the ACI didn’t push for novel foods, we pushed for consumer protection.
“We want safe CBD products out there and novel foods regulation is an imperfect model, but a happy compromise. If you look at any other food products, you have to prove it’s safe.”
However, he refutes the idea that the ACI is “in cahoots” with the FSA.
“We are supporting them and making this process simpler and smoother for companies. But we are diligent about what we want to achieve and won’t compromise on our quality standards and that gets used as a stick against us for favouring big business,” says Malik.
“Our membership fees allow us to hire an incredible team and carry out developmental work in science and policy, which in turn will make things more accessible for our members. We’ve made tremendous strides and the speed with which we’ve achieved clarity and a measure of quality controls can only be a good thing.”
He adds: “Not everyone can afford them, and we’re very open about that, but we’re also open about how smaller companies can work with the industry at large.
“We do have a lot of startups in our core cohort and we’re about to launch a project to help smaller brands work with larger companies.”
Cannabis Health has approached Trading Standards but they did not wish to comment.
Spain approves first cannabis based medicine
The approval for Epidyolex was based on the results of four randomised controlled Phase III trials
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.
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.
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
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.
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.
Dr Anthony Ordman, Consultant in Pain Medicine
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.
Alex Fraser, Patient Access Lead at GrowPharma
Alex 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
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
Dr Sally Ghazaleh, Consultant Pain Specialist
Dr 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.
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.
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.
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.”
In a survey, one-third of the Swiss population reported using cannabis at some stage with 200,000 reporting they use it frequently.
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.
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- Spain approves first cannabis based medicine
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