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CBD And Hemp Products Are ‘Over-The-Counter Medicines Or Novel Foods’ – Say Influential UK Trade Group

THE UK Government signalled its intent to support the country’s burgeoning CBD sector in January this year.

In a letter to the Advisory Council for the Misuse of Drugs (ACMD) the Home Office Minister Kit Malthouse asked it to determine a safe level of trace THC and other psychoactive cannabis compounds in retail CBD products.

In undertaking this task the Home Office asked the ACMD to consider the UK’s laboratory testing capabilities so that ‘responsible producers are able to produce CBD to this level of purity, and it is within the capabilities of the forensic science sector to quantify consistently and affordably’.

The ACMD subsequently asked the Government Chemist to undertake this work and it initiated a Ring Trial which involved over 30 laboratories – around half of these based in the UK.

Poor THC Detection Rates

This report has now been published and highlights how ‘cheaper’ testing machines struggle to identify the precise levels of THC and other psychoactive compounds in UK CBD products.

In a joint submission to the ACMD – earlier this year – sister bodies The Association for the Cannabinoid Industry (ACI) and the Centre for Medicinal Cannabis (CMC) raised a few eyebrows when they suggested that some CBD products should be classed as Schedule 5 under the Misuse of Drugs Regulations 2001 – effectively an over-the-counter medicine such as paracetamol.

And, this recommendation has also now made it way into the TIGRR report which was published earlier this month.

Speaking to BusinessCann the ACI’s Regulatory Lead Dr Parveen Bhatarah explained the thinking behind this – and how it related to the capabilities of the UK testing sector.

The dozens of UK testing laboratories will generally have two types of machines with the basic High Performance Liquid Chromatography (HPLC) coming in at around £50,000.

Less Cost, Less Pollution

Meanwhile, a more powerful Liquid Chromatography with tandem mass spectrometry (LCMS) is far more sensitive – and around three times the price of a HPLC machine.

Dr Bhatarah  said: “Establishing a level of up 0.03% allows companies who are using HPLC machines, which are not as sensitive, more leeway for their products to to achieve compliance.

“We already have the safety evidence at this level and on top of that it won’t require CBD companies to use an LCMS and add another cost burden to these companies.

“That means less cost, they will not pollute their environment and the THC level is well below safety levels. It would be great to go to a higher level but we do not have the safety data for that, yet.”

A Compliant UK Industry

Dr Bhatarah said the main focus of its submissions is to ensure that the UK delivered a compliant industry and that is why it recommended placing those CBD/hemp products, with higher THC levels into the Schedule 5 category.

She said: “This 0.03% level is a step in the right direction from where the law stands now at almost 0% – or 1mg per pack.”

In their submissions to the ACMD other UK trade groups have called for THC levels of 0.2% to be acceptable in UK hemp and CBD products.

So why does the ACI/CMC insist on the 0.03% level?

Dr Bhatarah continued: “Whether it’s a food supplement, a nutraceutical or a phytoceutical – whatever category there needs to be some compliance. Otherwise anyone – which was happening to the market before Novel Foods – could bring any products into the market.

“That was the dilemma for consumer. ‘I would like to have these CBD products but I don’t know if they are safe or not’ – but if compliant that’s great, it doesn’t matter what category they are in. Consumers should have the confidence.”

“While there is no enforcement, as such, a strict interpretation of the law, as it stands, would place any hemp or CBD products with any trace levels THC of psychoactive components in to the Schedule 1.”

She added: ”Whether over-the-counter or a food supplement the products should be regulated.”

For Dr Bhatarah, the ACI and the CMC the message is safety and compliance. In its ACMD submissions it has also suggested further animal toxicology studies on the effects of purified cannabinoids, such as CBD, Δ9-THC, Δ8-THC, and cannabinol (CBN).

And, for more studies into the dose-dependent effects of these isolated cannabinoids in humans.

While they have also suggested the Home Office ‘exempt dried hemp leaves and flowers from drug controls where the hemp has been lawfully grown or imported into the UK’.

More Safety Data Needed

Dr Bhatarah added: “We have the data to show that THC levels up to 0.03% in CBD products are safe.

“So food supplements that are able to show the THC levels are below this are fine to be sold through the Novel Food process.

“However we have no safety data on THC and other psychoactive compounds  between 0.03 to 0.2% and therefore such CBD products should be placed in Section 5.

“If we already have the equipment to test successfully at 0.03% then it’s an easy ride, using standardised technology, for the industry to be complaint. 

“But if we can secure the data up to 0.2% THC that it is safe then that would be great for the industry, too.”

@Cold-pressed hemp seed oil should be excluded from these regulations, explained Dr Bhatarah.

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