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CBD law expert calls for rethink over ‘horrendously slow’ novel foods process

Lawyer Sarah Ellson raised concerns about the new regulatory process being imposed by the Food Standards Agency

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An expert on CBD has called the rollout of the novel food regulations on the CBD industry ‘horrendously slow’.

Sarah Ellson, a lawyer at Fieldfisher, said policymakers should think again about how consumer CBD products are regulated.

The sector has been left reeling after the Food Standards Agency rejected over half of the 800+ applications from products seeking permission to remain on UK shelves.

Just 42 products have so far been validated and the process has slammed the breaks on an industry which had been growing rapidly in a light touch regulatory environment.

The FSA has confirmed to Cannabis Wealth it does not envision finishing the first round of checks until June and industry insiders expect the process for full authorisation to take up to a year for the products which make it over the first hurdle.

Asked if she thinks the small number of validations reveals more about the regulation than the quality of the sector at a Natural Health Forum online discussion, Ellson said: “It says more about the task of approving the dossiers and the validation process – and perhaps a huge underestimation of what was going to be involved in that.

“Congratulations to three or four companies that have got their products across the line but I don’t think it is a fair reflection of the marketplace.

“We’ve not been given any of the detail behind what’s within those several hundred applications reject for lack of information.

Hundreds of applications linked to CBD products have been turned down by the FSA.

“I think it’s very hard for those in the queue and for those stocking, supplying and investing in these products to know what to make of it other than the system look horrendously slow.

“It’s going to be another 12 months before we really know. This isn’t a market that wants that sort of slow pace and this is not an area where we have huge concerns about safety of products.”

The novel food application process results from the UK government’s decision to adopt the EU’s regulatory classification of CBD products despite leaving the bloc.

Companies which already had products on sale in the UK pre-February 2021 were given a March 31 deadline to submit detailed dossiers of quality and safety data.

Failure to comply would mean products being pulled from shelves and potential criminal action against company directors.

Ellson called for a rethink in the decision to follow Europe’s lead: “The EU made it very clear from its designation in 2019 that the argument was over, CBD is a novel food.

“But I wonder whether post-Brexit the UK will have the gumption to say ‘we don’t have to go down the same path’.

“That is supposed to be one of the upsides to Brexit, that we can diverge and we could abandon novel foods status.

“I’m just throwing that out there as an idea because this doesn’t look like it’s solving anyones problems.”

In a statement issued to Cannabis Wealth earlier this month, an FSA spokesperson said: “To date only 42 products have advanced onto the public list, these are linked to four validated applications.

“This reflects the complex nature of the industry, the quality of the evidence provided and the number of suitable applications at present.

“Many of the applications that have been received have been incomplete applications and do not provide enough information to assess acceptability.

“In a high number of cases we have had to ask for further information from companies before we can progress the validation process.

“We still expect that there could potentially be 100s of products on the list by the time it is complete later in the year.

“This list will reflect the products associated with companies that have taken the time to provide sufficient information to demonstrate the safety of their products.”

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180 Life Sciences collaborates with pioneer to develop CBD analogue

The company has collaborated with the “father of cannabis” Professor Raphi Mechoulam to identify of HUM-217.

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180 Life Sciences collaborates with pioneer to develop CBD analogue

Biotechnology company 180 Life Sciences has identified a CBD analogue that will move forward in clinical development for inflammation and pain. 

Born out of a merger of three companies, 180 Life Sciences is focused on the development of novel drugs that fulfil unmet needs in inflammatory diseases, fibrosis and pain. 

A continuing collaboration since 1998 between the “father of cannabis” Professor Raphi Mechoulam, Hebrew University, Jerusalem, co-founder Sir Marc Feldmann’s Laboratory in Oxford, and 180 Life Sciences’ scientists, has led to the identification of a CBD analogue – HUM-217 – which was selected based on a screen of derivatives of CBD and CBG made by Mechoulam and which will be will be advanced to clinical development for chronic pain and early arthritis.

According to the company, the analogue has a novel composition of matter which would enable patent protection, robust preclinical efficacy in several established mouse models for treating pain and inflammation in vivo, and ease of scalability for GMP manufacturing.

Industry veteran and 180 Life Sciences CEO, Dr Jim Woody, commented: “180 Life Sciences is the merger of three companies – one in Israel with Dr Mechoulam, who was working on cannabinoids, one in Oxford, UK, that was working on anti-inflammatory agents, primarily anti-TNF, and one here in the US that works on a nicotinic acid receptor agonist. 

“A long time ago, Dr Feldmann and I were working together and we were the first ones to ever invent an antibody against TNF. We showed it worked in rheumatoid arthritis and Crohn’s disease, psoriasis and ulcerative colitis, and it is now one of the standards of care called Remicade. There are probably 40 million people treated with anti-TNF so there are now no patients with rheumatoid arthritis in wheelchairs because of that drug and the follow on drugs. 

“However, there are problems with anti-TNF’s because the drug is saving the joints but the pain doesn’t totally go away. So, what we are focusing on is making synthetic cannabinoids that will have the ability to be anti-inflammatory and anti-pain. 

“We have now been able to do that – we selected our lead compound to move ahead and go through IND-Enabling studies. We have already tested our compound in inflammation models – there are animal models of inflammation that can give a good readout on whether this works or not – and we know that the compound is effective in those models. With the way it is constructed, it won’t be psychogenic and it is easily absorbed, so we can actually take enough of it or make it into a pill so, people could use it as opposed to regular cannabis that is made up of maybe 100 or more compounds. 

“We will treat patients who have arthritis and receive anti-TNF, but it doesn’t quite make their pain go away, as you do not want your patients to have to use opioids, which is not very satisfactory. Steroids are another problem because of their side effects – a lot of them cause kidney problems, for example. This pill will be non-addictive, and also quite favourable for the pain. 

“It turns out that there are two TNF-receptors, and one of them is inflammatory and the other one is anti-inflammatory so, down the road, we are going to make specific drugs against each of those to try to get away from the infectious disease complications. So, it is a whole new novel area but Dr Feldmann and I and others are very familiar with the TNF field.”

Dr Woody says that the anlaogue would be added to the regimen of doctors prescribing anti-TNFs as a large clinical trial, possibly all over Europe. Additionally, he says 180 Life Sciences are licensing more compounds from Oxford that have unique abilities to help tissue regrow after is damaged.

“In the cannabinoid area, I think this class of drugs probably has a lot of uses. Certainly, it’s being used in paediatric seizures and things like post-traumatic stress disorder, but these are not clean compounds, they are very complicated. 

“So, I think for the field to move ahead, we need to do what we are doing – making very specific medicines and molecules, so we know what they are, we know how they work, and then we can address many of these other problems because there is a whole range of therapeutics there that will be quite helpful that I think will be tailored for different diseases.”

The company recently raised $15m through private placement, which will fund general corporate purposes, working capital, and the research and development of its programmes which are not funded by grants.

“We raised the funds to accelerate these programmes moving forward. It will almost all go into the projects themselves. We don’t have an office because we’re scattered between Israel and Oxford and Palo Alto and so, we plan to put almost all the money into the programmes and get them to move more quickly.”

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Analysis shows 90 per cent of CBD brands third-party test products

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Analysis shows 90 per cent of CBD brands third-party test products

A new analysis of CBD product testing has shown that 90 per cent of brands third-party test their products.

With the growing number of CBD products available in stores across Europe and the US, there are concerns among consumers regarding regulatory oversight. A new analysis by industry watchdog, CBD Oracle, has demonstrated that of 520 companies and 20,000 products in Europe and the US 90 per cent of brands carry out third party testing.

The analysis also shows an increase in certified-USDA organic companies, indicating a higher level of self-regulation in an unregulated industry.

Alisdair Mans Cornwell, senior editor at CBD Oracle, commented: ”Despite consumer apprehension being a huge problem, our analysis suggests an industry so conscious of its regulatory shortcomings; it’s taking appropriate steps to fix them.”

“Testing evaluates CBD and THC levels, as well as the presence of pesticides, heavy metals, and solvents. 90% of CBD companies conduct independent, third-party testing on their products and publish all-important Certificates of Analysis as proof. 25 companies are also certified USDA Organic, up by 24 since 2019.

“Third-party testing and USDA certifications aren’t required by law. It’s great to see companies taking the initiative to legitimise the industry, instill confidence in consumers, and ensure product safety and transparency despite the clear lack of federal oversight.”

The analysis highlights, however, that celebrity-owned brands and companies selling CBD drinks are the least transparent, noting that Mike Tyson’s Dwiink brand and Ivan Moody’s Moody’s Medicinals fail to provide extraction method, hemp source, or third-party testing information.

Likewise, the majority of companies specialsing in CBD drinks and beverages don’t disclose their extraction methods or third-party testing.

“The CBD industry certainly isn’t in the clear yet, but this analysis shows it’s doing way better than most expected,” Alisdair concludes.

View full report: https://cbdoracle.com/cbd/cbd-companies-list/

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World’s first medical-grade vapouriser now available in the UK

Kanabo’s VapePod can now be purchased on Handpicked CBD.

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World’s first medical-grade vapouriser now available in the UK

The world’s first medical-grade vapouriser – the VapePod – is now available to UK customers. 

Customers in the UK can now purchase Kanabo’s VapePod on Handpicked CBD, which enables tracking of exactly how much CBD is best using metered dosing.

UK-based Kanabo, which has carried out extensive R&D in order to develop innovative medical-grade vapourisers and various non-smoking consumption solutions, has enabled the vape to be used with its three new proprietary formulas: Reload, Relax and Repair.

The high-quality pure hemp distillate CBD formulas contain up to 86% cannabinoids and the vapourisation of CBD means it is fast-acting compared to other products like tinctures or edibles. Each cartridge that goes into the VapePod contains 360mg of CBD and has a blend of terpenes, give more than 300 doses lasting between six to eight weeks.

Kanabo CEO, Avihu Tamir commented: “We are delighted to offer our CBD wellness line through Handpicked CBD. 

“Consumers now have access to the strongest yet non-intoxicating CBD formulas with only the highest quality of ingredients. Kanabo’s R&D team has created these fast-acting formulas with the health and wellness of consumers in mind.”

HandPickedCBD, a Materia asset, currently features more than 50 brands and more than 500 different products, all of which must satisfy a list of quality and safety criteria before they are featured on the platform. It is The Marketplace for the best of all CBD products available online in the UK. 

The platform highlights the benefit of the proposed partnership between Kanabo and Materia that will make Kanabo the largest medicinal cannabis company in Europe.

Kanabo intends to add more to its portfolio of products as the brand grows.

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