Securing Novel Foods Validation is a Highly Rigorous Process That is Both Costly and Time-Consuming for Companies

As the European Commission begins to release updates on CBD products that have made it through to the final stage of the Novel Food process, Dean Billington of Brains Bioceutical reflects on the impact of this lengthy process.

BRAINS Bioceutical’s executives started generating and evaluating data on its CBD molecule back in 2015 when investors and entrepreneurs were just starting to look to the cannabis industry as a potentially lucrative market. 

When others were merely scratching the surface of the emerging industry, this rigorous investment in the research and development of high-quality, pharma-grade, active- pharmaceutical ingredient (API) has given us a competitive advantage.

Brains has now spent up to £2m on gathering and analysing the data that the Food Standards Agency (FSA) requires for a Novel Foods validation. 

As part of the Novel Foods validation process, Brains Bioceutical submitted over 600 pages of data, including a full toxicology assessment, stability data, manufacturing data for a minimum of five batches, detailed information on typical CBD exposure and usage, risk assessment and risk mitigation plans and additional supporting data. 

The stability data alone takes three years to generate – which is a hurdle for companies entering the CBD space. 

They have to be extremely confident about the quality of their product before diving into the Novel Foods validation process and for a lot of cannabinoid companies, that quality is lacking. 

There are also challenges when it comes to the FSA processing the data and responding in a timely manner. 

While this complex regulatory process can be a challenge for new entrants on the market, Brains Bioceutical’s vision has always been founded on a desire to generate evidence-based data to validate the efficacy of its cannabinoid API. 

Acknowledging the challenges associated with decades of prohibition and stigmatisation of cannabinoids, there is a need for more data, clinical trials and verifiable research to validate its therapeutic potential. 

We are involved in clinical and academic trials around the world, evaluating the effectiveness of cannabinoid-based pharmaceutical products to treat major diseases and provide alternative treatment options for both human and veterinary use. 

As a UK-based API manufacturer we recently received confirmation of validation from the United Kingdom FSA for our natural, plant-based cannabidiol (CBD) as a novel food. 

The Novel Foods validation builds on Brains Bioceutical’s previous milestone accomplishment of validation that the company received last year from the European Commission and the European Food Safety Authority for its European Novel Foods application. 

Validation is the first step in receiving Novel Food authorisation, enabling Brains Bioceutical to continue to legally sell CBD nutraceutical products within the UK and Europe. 

Following the Novel Foods validation, the FSA will now go through a risk evaluation to ensure that the molecule is safe before Brains Bioceutical receives its official authorisation confirming that its CBD API is an approved Novel Food and can be legally sold, commercially to the public. 

Enforcement Challenge 

While the Novel Foods validation process will pave the way for a safe, sustainable and legally compliant CBD market, enforcement remains a challenge. 

Countries across Europe are beginning to withdraw products from shelves if they do not have the Novel Foods authorisation, but it will take some time before the FSA and other UK authorities actively begin prosecuting and fining companies. 

Brains Bioceutical knows how important it is for consumers to feel confident about the quality of products they are purchasing and consuming. 

This Novel Foods validation is further proof that the company’s pharma-grade CBD API is of consistent quality, providing consumers peace of mind that the products they are purchasing are safe and effective. 

What Are Novel Foods?

Novel Foods are foods that have not been widely consumed by people in the UK or the European Union before May 1997 and do not have a ‘history of consumption’.

Cannabidiol products fall under this umbrella, with the Novel Foods process providing much-needed regulation and quality control within the emerging CBD marketplace. 

The leadership team at Brains Bioceutical is committed to being part of that process; one which will help unlock the potential of cannabinoids in the health and wellness space. 

Brains Bioceutical, is a UK-based, globally-focused manufacturer of naturally-sourced active pharmaceutical ingredients (APIs).