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CBD Industry Set To Launch Joint Trials To Ease Regulators’ Safety Concerns

AS regulators on both sides of the Atlantic harry an untethered and ‘unsafe’ CBD industry, signs of a co-ordinated response are emerging.

The US Food and Drug Administration (FDA) was the first to hoist the regulatory red-flag when it expressed concerns over the ‘real-risks’ to health posed by CBD usage.

That was in November, 2019, and in February, this year the UK’s Food Standards Agency (FSA) shifted its position from CBD is safe, to ‘show us the evidence that CBD is safe’.

Now, the industry is under increasing pressure to deliver the data to show that regular CBD does not cause harm to the millions of people worldwide who use it.

Collaborative CBD Testing Consortium

Here in the UK, a consortium of companies is looking at delivering the scientific data needed to satisfy the FSA.

The talks also involve North American and Continental companies and consider the potential of delivering joint, laboratory-based, chronic-toxicity studies aimed at demonstrating the safety profile of CBD.

Hannah Skingle, Chief Operating, Officer Dragonfly Biosciences, said: “We know that the industry is looking collectively at how we can build a chronic toxicity database. I just don’t think it is possible for all companies to be doing their own chronic studies.” 

Dr Parveen Bhatarah, Director, Regulatory and Compliance Unit at the Association for the Cannabinoid Industry (ACI) is leading UK efforts to deliver a safe CBD industry.

She said: “The FSA are adamant you need to prove, and risk assess, and justify yourselves on the CBD safety data. 

“It’s the same with the FDA and EMA (European Medicines Agency). They cannot tell you categorically what they want, so everything is being done on a case-by-case basis, every product, by every company.” 

“There are teams here in the UK, France and the US all working on this and the ideal situation would be to work together to deliver a joint programme and share the costs.”

Efforts to drive forward these joint programmes have been hampered in recent weeks by the Covid-19 health pandemic, says Ms Bhatarah.

Industry Needs GW’s Epidyolex Data

The ACI says it is becoming increasingly clear in its conversations with UK regulators and Government agencies; the FSA, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Home Office that there is too much of a data gap on CBD safety.

However, there is one database that could provide many of the answers and it lies in the vaults of UK company GW Pharmaceuticals, makers of the global CBD drug Epidyolex.

“We really need that analytical data in the public domain, and we could really do with it, now,” said Ms Bhatarah.

Toxicology specialist Dr Paul Duffy.

The FSA changed its view on CBD after a report from the UK Committee on Toxicity (CoT) which included some aggregated data from GW.

The company made available summary information from its interactions with the FDA and EMA, but not its individual, final study reports.

Toxicology specialist Dr Paul Duffy said: “The CoT did a good evaluation of the data, identifying key aspects of the safety profile on animals and humans, of the Epidyolex submission.

“This develops a picture of its toxicity profile at higher dosages in animals and its side-effects on humans.

“But, when it comes to CBD use in food stuffs the question becomes one of the amounts in food, at a lower level, compared to risk?

“If that data were made available for CBD producers to compare their safety profile, and show it is comparable to Epidiolex, with the same synthesis pathways, that could open a lot of doors going forward.

“The FSA is adamant that unless you produce a CBD product by the same synthesis process as Epidiolex, to a very high purity, then you cannot use just their (GW’s) information. You can use it as a back-drop, to say you understand the profile of CBD, but you might need supplementary work.”

CBD – A Food Or A Drug?

A recent report found that almost two-thirds of UK high street products studied didn’t contain the CBD content promised on the label.

Dr Bhatarah: “There is a real lack of knowledge in the industry and many UK CBD consumers are being misled.”

Ms Bhatarah whose background is pharmaceuticals describes CBD as unique amongst the dozens of Novel Food authorisations she has studied, falling in a halfway house between a food and a drug.

This is the essential dilemma for regulators at in an industry, which has sprung up from a ‘grass’ roots base.

In fact, its acceptance as a food supplement in the UK in 2016 by the MHRA has now led to the industry, perversely, facing a tighter regulatory regime.

While the side-effect of a pharmaceutical drug may be tolerated when dealing with a primary condition, there is less regulatory leeway for a food supplement.

£250,000 Novel Food Process

In the UK and Europe regulators are asking CBD companies to validate their CBD products through the Novel Food process.

The FSA has set a deadline of March 31, 2021, for firms to apply for this.

This leaves a compressed timetable to undertake further safety tests, although the FSA has indicated it may be flexible in relation to additional toxicity studies, if they are aware of a timetable for completion.

The FSA has also indicated that smaller CBD brands, developing products from an authorised Novel Food SKUs can travel through, piggy-back as it were, on this.

This will be the case as long as additional test work is undertaken around issues such as absorption, distribution, metabolism and excretion, and the impacts on the perceived target population.

The key to a successful Novel Food dossier is to maintain an ‘on-going dialogue’ with the regulators, say Dr Bhatarah. 

Even before regulators unleashed their CBD broadsides Novel Food authorisations were proving costly and time-consuming process; the cost of one skew is now estimated at over £250,000.

This need to establish CBD’s safety has added an additional layer of complexity and concern for an industry, looking at ways of pursuing a collaborative approach.

Dr Bhatarah said the ACI is partnering with teams in Europe to deliver machine-learned trial data, but more real-world data is needed.

She added: “A lot of companies are looking to collaborate and share knowledge and data, as a lot of data needs to be assessed and risk-assessed. 

“This data is required by the FDA, the FSA and the EMA, and if we can come together and have a collaborative approach, that would be fantastic.”

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