Clinical Study On 200 People Aims To Establish ‘Safe’ THC Level In Full-Spectrum Hemp Extracts

The European Industrial Hemp Association (EIHA) is spending over €1.6m on the trial featuring 200 participants.

Taking place in Europe, EIHA believes the trial will help establish an evidence base for regulators to adjust the permitted levels of THC (tetrahydrocannabinol) in foods.

Free From Isolate Cocoon

And, in doing so, it believes it will free the European cannabinoid and hemp industries from the regulatory cocoon of processed CBD isolates.

Lorenza Romanese, Managing Director of EIHA, told BusinessCann: “This is the biggest study ever conducted in history into any potential toxicological impacts of THC in food on human beings – it could change the face of cannabis across the planet.

“This is the only way we can proceed if we want to demonstrate to regulators that it is safe for businesses to make and sell – and for consumers to take – real, full spectrum, hemp food supplements, containing all of the cannabinoids, and their acid forms.

“If we were to stick to the guidelines on THC in Europe at the moment then there will never be a future for whole plant extracts – which are considered illegal – and this needs to change.

“This will bring stability; it will be referenced worldwide and it will allow all governments to, at last, make science-based guidelines for all hemp foods and derivates.”

No Harm From Trace THC

Research into the impacts of cannabis and THC on humans is a rapidly-growing field and previous studies indicate some impacts on neurological function.

However, EIHA believes trace levels of THC, in combination with a recommended daily dose in a final product, will never produce extracts with any potential harm to humans.

Ms Romanese added: “We believe the current permissible THC limits are inadequate (see panel below), and we are pressing for higher levels based on science. No one is getting high on CBD or hemp oil and our aim is to prove it’s safe, even at higher doses, like elsewhere in the world.”

‘Vendetta on whole hemp plant Oil

Ms Romanese says the the study will allay regulatory concerns and end the ‘vendetta on whole hemp plant oil’.

She added: “Here at EIHA we have demonstrated that hemp extracts have been used across Europe for centuries and that whole plant extracts – especially when mixed into hemp seed oil, or initially extracted from hemp seed and leaves – are full of nutrients and support overall health. This voice needs to be heard.”

BusinessCann recently reported on EIHA’s attempts to permit the use of whole plant hemp and CBD extracts across Europe featuring over 30 historical records including evidence of a cannabis soup made for a Medieval Pope.

Once complete the results of the THC study will be included in its application to the European Food Safety Authority and the UK Food Standards Agency under their Novel Food pathways. It will be submitted for a ‘Regular’ – full spectrum, traditional, hemp food supplement.

EIHA is currently spending €2m on two Consortium Novel Food applications for a CBD isolate and synthetic CBD. It says the findings from the THC study will dovetail with the CBD toxicology data in these applications.

Ms Romanese added: “What we now aim to do is demonstrate with clinical studies that widely used, and popular full-spectrum CBD oils, are perfectly safe but even more important we will be able to recommend to regulatory bodies a science- based daily intake.”

MS ROMANESE ELABORATES ON THE STUDY

“Our THC study serves a double purpose. On the one hand, we aim at increasing the permitted level of THC in hemp derived food – dry food and oil derived from seeds. On the other hand, the goal is to obtain the approval of full spectrum extracts which inevitably contain higher levels of THC than the ones stated in the EFSA guidelines. EIHA believe the current values are outdated and unnecessarily strict and are based on a biased consideration of past studies. The European permitted levels of one microgram, per kg of body weight – 0.001 mg/kg bw – are particularly striking if compared to international competitors, like Canada (0.014 mg/kg bw), Switzerland (0.007 mg/kg bw) or Australia and New Zealand (0.006 mg/kg bw).”

As a matter of fact, the guidance value for THC recommended by EFSA, upon which the European Council will most probably base its decision on THC limits in food, is based on faulty conclusions of the data.
EFSA’s guidelines are based on three large clinical trials on HIV patients (Beal et al. 1995  and 1997, Struwe et al, 1993) to determine the LOAEL (Lowest Observable Adverse Effects Level), and one very small study – on 11 subjects – which was the only one to specifically and systematically investigate the psychoactive effects of delta9-THC.

In the UK, there is no limit set per kg/bodyweight for hemp foods, but an arbitrary amount of 1mg of a controlled substance, per product, irrespective of size. This was set in 1971 – 50 years ago – and bears has no relation to ordinary hemp foods which have been safely consumed for millennia, therefore we advocate for reasonable guidance values.

It’s important to note that only members of the EIHA Consortium will be able to sell products with higher levels of THC if the Novel Food application is approved. Consortium partners will own the intellectual property of this study for the following five years.”