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.”
Study finds ‘one in four’ started using CBD during COVID-19
A new study has found that almost a quarter of CBD consumers in the US began using the cannabinoid during the coronavirus pandemic.
Newly released findings from a study of over 35,000 adults in the US highlights the age and gender divide in Covid-19’s impact on mental health.
According to the survey, almost seven in ten women have felt isolated from family and friends compared to just roughly half of men who have experienced the same.
Almost four in ten women also report feeling more depressed than usual compared to fewer than three in ten men. Sleep issues have also arisen at greater rates (32 percent) for women than for men (22 percent).
Gen Z and Millennials appear hardest hit by the economic fallout during the survey period. On average, one in four Gen Z and Millennial respondents reported having lost a job or taken a reduction to hours or pay.
However, most of the spending cutbacks are driven by older consumers, with respondents aged 40 years and over making up 65 percent of those who report reduced household spending due to Covid-19.
Market research company High Yield Insights ran the survey from September to October 2020, collecting data from over 35,000 adults aged 21 and over.
Respondents addressed how the pandemic has stirred mental health concerns, upended shopping habits, and sparked interest in new wellness products.
The study also delved deep into the use and interest in CBD as a source of relief for health issues associated with or exacerbated by the pandemic.
“Our findings capture an image of what some are rightly calling the mental health epidemic in America,” said Mike Luce, president of High Yield Insights and a 20-year veteran in consumer insights and market research.
“Consumers are thinking about wellness holistically today to encompass both mental and physical health. For product categories like CBD, which can address a range of conditions, the pandemic is having a historic knock-on effect. The growing popularity of CBD is evidenced by the number of people who started using one or more CBD products last year. For example, we discovered almost one in four US CBD consumers started using CBD in the six months leading up to our survey.”
UK retailers have also reported a rise in demand for CBD products since the start of the pandemic.
Newcastle based companies, Naturally North CBD and Karma Coast both told Cannabis Health that the vast majority of their customers are now using CBD to target anxiety and stress-related issues.
“This is not compassionate”: Ireland’s medical cannabis scheme ‘excludes thousands of patients’
Ireland’s government has finally announced funding for its Medical Cannabis Access Programme – but the scheme remains ‘extremely restrictive’, say campaigners.
Almost two years since the legislation was introduced on Thursday 21 January, Ireland’s Health Minister Stephen Donnelly announced funding for the Medicinal Cannabis Access Programme.
The programme is expected to commence later this year, with Donnelly claiming it will allow for “compassionate access” to cannabis medicines.
But campaigners have been quick to criticise the scheme, which only offers access to four low dose cannabis-based medicines to people living with one of three qualifying conditions.
These include intractable nausea and vomiting associated with chemotherapy, severe treatment-resistant epilepsy and spasticity associated with multiple sclerosis (MS).
But despite all of the patients who are currently being prescribed cannabis under a ministerial license, using Bedrocan products from the Transvaal pharmacy in the Hague, none of these have been approved for the programme.
This suggests children – including 11-year-old Ava Barry – who have had their quality of life significantly improved by Bedrocan oils, will have to switch products in order to have their prescriptions reimbursed.
As has been highlighted extensively by campaigners in the UK in recent weeks, in regard to the issues importing Bedrocan due to Brexit, changing treatments for epilepsy can lead to a worsening of seizures and could be life-threatening.
Alicia Maher is a patient and advocate who moved to Spain in 2019 in order to have better access to cannabis medicines, which she uses to manage chronic pain.
While she welcomed the news that the programme would finally be funded, she will still not be able to return to her hometown of Limerick.
“Many people have asked me whether this will impact me and whether I will be able to come home, but sadly the answer is no,” she said.
“Chronic pain is not one of the qualifying conditions, despite the Health Products Regulatory Authority (HPRA) acknowledging in their 2017 report that it is the most researched indication for cannabinoids, with the majority of reports concluding that cannabis is an effective treatment for chronic pain.”
According to Alicia, recent reports suggest that approximately 25 percent of the population suffer from chronic pain, with the condition affecting over 1.5 million people.
She was granted a ministerial licence to be legally prescribed medical cannabis last year, but would have to fund the costs of the prescription herself.
She continued: “I, along with many others that currently hold the ministerial licence and fall outside the three qualifying conditions, will not be allowed onto the access programme, even though our doctors are currently prescribing cannabis.
“We won’t have access to any of the cannabis products that have been approved and we won’t have our costs reimbursed.
Alicia added: “It is fiscally irresponsible as the cost of my cannabis prescription is less than my prescription was for 30 opioids per day, yet they were completely covered on my medical card.”
Campaign group, Cork Cannabis Activist Network said excluding patients from accessing these medicines is in no way “compassionate” or “acceptable”.
“The headlines are designed to paint a rosy picture favouring those in government, but this is not the truth, and most certainly for not the countless Irish citizens who consume cannabis daily for various medical reasons,” Nicole Lonergan spokesperson for the group, told Cannabis Health.
“Cannabis is complex and so are patients and their individual physiological needs. Yet the Irish government thinks it’s acceptable to offer limited access to four cannabis-based medicines and restrict access to three qualifying conditions.”
Nicole is among those who want to see cannabis legalised in Ireland, with thousands of patients still forced to access medication illegally.
The group has called for an education programme to improve understanding of the medicinal benefits of cannabis among healthcare professionals.
“Week after week, I receive hundreds of messages from people of all ages and backgrounds crying out for cannabis to be legalised,” she said.
“A comprehensive cannabis education programme needs to be urgently rolled out to GP’s and consultants in Ireland and the law needs to be changed so that no one is forced to continue relying on the illegal market for their medicine.”
Nicole added: “It is not ‘compassionate’ to exclude certain patients from accessing cannabis medicines, or to offer an extremely limited selection of products that do not suit the majority of patients’ needs. It is not ‘compassionate’ to condemn patients to rely on an illegal market or force patients to leave their homes and families to access cannabis legally.
“We deserve answers as to why the Irish government continues to uphold a law that ruins lives and prevents access to legitimate, effective medicine in all its forms.”
Announcing the provision of funding and delivery of the Medical Cannabis Access Programme, Minister Donnelly said: “The purpose of this Programme is to facilitate compassionate access to cannabis for medical reasons, where conventional treatment has failed. It follows the clear pathway laid out by the Health Products Regulatory Authority in their expert report ‘Cannabis for Medical Use – A Scientific Review’.
“Ultimately it will be the decision of the medical consultant, in consultation with their patient, to prescribe a particular treatment, including a cannabis-based treatment, for a patient under their care.
“It is important to state that there are no plans to legalise cannabis in this country.”
Vitality CBD ‘leading the way’ with novel food application
A UK CBD firm believes it is one of the first to submit its novel food application ahead of the March deadline.
Birmingham-based Vitality CBD confirmed it has submitted its novel food dossier for Food Standards Authority (FSA) approval.
The brand is widely distributed in UK high street retailers, stocked in the likes of Tesco, Boots, Lloyds Pharmacy, Sainsburys, Ocado and is listed on Amazon UK as part of its global trial of CBD.
In tandem with its raw material supplier, the company has submitted its Novel Food application for validation of its wide range of ingestible CBD products, assuring customers that it is ‘leading the way’ in helping to create a more regulated industry.
CBD products can remain on the shelves providing an existing CBD brand, which is defined as “on the market” prior to 13 February 2020, receives validation of its application before the 31 March deadline.
In the meantime, no new brands are permitted to launch in the UK until they have completed their Novel Food application and received full Novel Foods authorisation.
Vitality, which recently expanded and sources its CBD from Colorado in the US, supports the FSA’s move to better define the responsibilities of CBD retailers towards customers.
The company believes the new novel food guidance will end a ‘period of uncertainty’ and move the industry toward clearer and more concise regulation, ensuring consumers are provided with safer and higher quality CBD.
It expects the move will help to ‘legitimise its venture; and lead to greater consumer confidence in CBD.
Phillip Glyn, commercial director, commented: “It is important for our trade customers and consumers alike, to know that Vitality CBD, together with our raw ingredient provider, are one of the first in the UK CBD industry to submit a Novel Food dossier, and are therefore leading the way in future compliance and regulation.”
- Study finds ‘one in four’ started using CBD during COVID-19
- “This is not compassionate”: Ireland’s medical cannabis scheme ‘excludes thousands of patients’
- Vitality CBD ‘leading the way’ with novel food application
- Can CBD improve your mood?
- “Huge relief” as threat to children’s medical cannabis is resolved
- CBD shown to kill antibiotic resistant bacteria – study
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