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ACI completes landmark CBD study

Posted: 16 February 2021 | | No comments yet

Following the submission of its novel food application, New Food gets exclusive insight from three experts integral to the study…

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The Association for the Cannabinoid Industry (ACI) has submitted its novel food application on behalf its CBD Safety Study Consortium members to address potentially dangerous data gaps.

The novel food deadline for CBD

In 2019, CBD was classified by the European Food Standards Agency (EFSA) as a ‘novel food’. Novel foods are those which haven’t been widely consumed before May 1997 by people in the UK or EU. If deemed as ‘novel’, further research into the safety of consumption is required.

With so many CBD products already on UK shelves, the Food Standards Agency (FSA) set a deadline of 31 March 2021 for the industry to respond to the EFSA’s classification.

For CBD companies wishing to remain in the UK market, their application needs to be validated by the FSA by this date.

“Irrespective of compliance, there is very little quality data to categorically state that CBD is safe for consumption as a food,” Dr Paul Duffy, Toxicology Associate, ACI, told New Food’s Editor. “This is the first step towards CBD, and cannabinoids in general, being normalised as an ingredient, rather than an offshoot of cannabis and all the implications that that brings.” 

The ACI partners with ADSL

Following the FSA announcement, ACI partnered with Advanced Development and Safety Laboratory (ADSL) and launched a landmark study, with the aim of building a sustainable, safe and fully compliant industry in the UK.

The study specifically addresses existing data gaps identified by the Government’s Committee on Toxicology (COT). For example, whether CBD has the potential to cause drowsiness, liver toxicity or interact with other drugs. It also aimed to provide the safety information required by the novel foods application process.

Dr Paul Duffy

Dr Paul Duffy

Commenting on this, Dr Duffy quoted the risk assessor’s (ACNFP) reading of the COT report: “The Committee noted that the main health concerns highlighted by the COT were hepatotoxicity, immunotoxicity, reproductive toxicity and drug metabolism interactions.”

He explained that the overlap in data requirements meant they could “meet all the guidelines set out by the FSA, as well as meeting the concerns from COT directly”.

“A lot of the focus is on compliance for products on the market now,” added Mark Bowes-Cavanagh, CEO, ADSL. “As the market evolves, and consumers look for products that are more in keeping with their lifestyles, our approach allows for this.”

He clarified that the goal of creating a “sustainable” sector refers to the growth of the CBD category. “If we just looked at today, then innovation in the space would be harder to achieve.”

Working with the competition

This submission is the culmination of months of hard work from ACI and its members. It marks a pivotal moment in the UK CBD industry, as competing companies chose to collaborate in order to share costs and data. 

“A consortium approach was welcomed by these companies due to the financial burden being reduced significantly,” added Dr Parveen Bhatarah,

Dr Parveen Bhatarah

Dr Parveen Bhatarah

Regulatory and Compliance Associate, ACI. “The challenge wasn’t necessarily getting the companies to work together, but rather the study architecture; there is no precedent for a consortium approach whereby the data generated by one sample can be applicable for multiple product types, at the ingredient (primary product) and finished product (secondary product) level.

“This study had to cover a number of strategic objectives: allow for supply chain variability, protect IP when sharing proprietary information in a group setting, and allow for NPD for future innovations. The expertise within the team allowed us to design this innovative data generation strategy, which was further ratified by the FSA’s risk assessment unit, the ACNFP.”

The future of CBD

As we move into the first regulated over the counter market for cannabinoids, Dr Bhatarah acknowledged her excitement for the future.

“Consumers will have access to products that go through rigorous safety studies and can be safe in that knowledge. Furthermore, as retailers can now engage this sector clear of ambiguity, the chance of mass adoption increases, giving more consumers access to quality, safe products that are being relied on for a number of therapeutic reasons.

Mark Bowes-Cavanagh

Mark Bowes-Cavanagh

“Our product testing exercise showed a number of consumer protection issues aside from safety; over a third of products tested had less than 50 percent of the advertised CBD content, and one product for £90 had 0 percent.”

“In the near-term, retailers can begin to have meaningful conversations with brands,” added Bowes-Cavanagh. “Our partnership with Trading Standards ensures that products that have not gone through this process will be removed from retail channels, allowing consumers access to products from companies that have their best interests in mind – safe and fairly labelled products.”

He concluded: “Looking further into the future, the industry can look at the other exciting areas of growth, whether that’s in NPD or the numerous other cannabinoids with therapeutic potential.”  

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