News & Features

Brains Bioceutical is the first company to receive validation for a cannabidiol (CBD) that is sourced naturally from industrial hemp

UNITED KINGDOM, Feb. 17, 2022 /CNW/ – Brains Bioceutical Corp. (“Brains Bio” or the “Company”) through its wholly owned subsidiary BSPG Laboratories Ltd., is pleased to announce it has received novel food validation from the UK Food Standards Agency (FSA) for its natural, plant-based CBD active pharmaceutical ingredient (API). The FSA has received over 800 CBD Novel Food applications and it has rejected over 600 of these. Three applications have been fully validated to date; one has been placed in the on-hold section. This validation will be required for any CBD nutraceutical products placed on the market in the UK and Europe. Brains Bio is the first company to receive novel food validation for its naturally sourced CBD API. This strategic advantage will allow the company to be the only manufacturer on the market able to meet the demand for natural plant-based products.

“We are extremely proud to have secured the FSA’s validation after years of research and data analysis on our industry-leading, natural hemp-based cannabinoid API,” said Brains Bio CEO and Chairperson Ricky Brar. “This will allow Brains Bio to capitalize on our first mover advantage, being strategically positioned within the industry that will likely face supply constraints based on the vigorous requirements related to novel food. Brains Bio and our B2B partners are confident we will be able to meet this consumer demand and rapidly achieve market share on a path to developing the UK’s largest CBD brand. From its initial inception, Brains Bio has been part of the first group of approvals within the industry, and this includes the rarity of our EU-GMP and MHRA approvals.”

Securing novel food validation is a highly vigorous process that is costly and time-consuming for companies seeking to sell their products legally in the UK and European markets.  Since 2015, Brains Bio has significantly invested in the collection and analysis of data required by the FSA, including toxicology reports, stability data, product manufacturing data, genotoxicology studies, detailed information on typical CBD exposure and usage, risk assessment and risk mitigation plans, and additional supporting data. In addition to supporting the FSA’s strict criteria to ensure consumers receive the best quality products, Brains Bio is the only producer of natural hemp-based cannabinoid APIs in the UK to develop a fully verified submission, including a comprehensive data package, to the FSA. This distinction positions Brains Bio as a leader in the rapidly growing global cannabidiol market, which is projected to accelerate by nearly 20 per cent to $7.99 billion USD by 2027.¹

“The CBD sector has been growing rapidly over recent years within the UK. It is a huge relief to see a UK-based company innovating within this space to successfully navigate the new novel foods regulations now overseen by the FSA. Brains Bio is a fine example of how a UK-based company can lead the charge in science, research, and clinical data globally to find their way through the thicket of regulations being applied retrospectively on an existing industry.  As a non-synthetic product, their farsighted investment in Sandwich is likely to bring them a significant competitive advantage, delivering what the market wants, but consistent with the very highest standards of safety,” said Crispin Blunt, chairman of the Conservative Drug Policy Reform Group.

Brains Bio is committed to advancing the research and development of natural cannabinoid APIs. The company is actively involved in clinical and academic trials across the world, evaluating the efficacy and impact of cannabinoid-based pharmaceutical and nutraceutical products to enhance life and expand treatment options.

“We know that the key to unlocking the transformative power of cannabinoids in the health and wellness industries is robust, evidence-based research,” said Dean Billington, Chief Operating Officer of Brains Bio. Brains Bio is proud to be at the forefront of this movement, unlocking solutions to enhance life and provide alternative therapeutic options for consumers.”

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

For more information on Brains Bio, please visit www.brainsbioceutical.com.

ABOUT BRAINS BIOCEUTICAL CORP
Brains Bio is the leader in evidence-based cannabinoid and phytochemical active pharmaceutical ingredients (API) to enhance life and treatment options for consumers and patients. Headquartered in Vancouver, Canada with operations in the United Kingdom, Brains Bio is one of the only producers of natural hemp-based cannabinoid APIs in the world. Combined with the company’s unparalleled expertise and institutional knowledge in biotechnology, pharmaceuticals and cannabinoid-based product development, Brains Bio is strategically positioned to be a trailblazer in healthcare innovation across the world.

CAUTIONARY STATEMENT:
This news release contains forward looking statements or forward-looking information (“forward-looking statements”) within the meaning of securities laws.  Often, but not always, forward looking statements can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved.  All statements, other than statements of historical fact, in this news release are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release.  Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance are not statements of historical fact and may be forward-looking statements. Risks, uncertainties and other factors involved with forward-looking statements could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking statements. Although the Company believes that the assumptions and factors used in preparing the forward-looking statements in this news release are reasonable, there can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities laws.

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For further information: For media inquiries please contact: Rachael Marshall, Telephone: 1-888-321-8003, Email: [email protected]; For investor relations please contact: Email: [email protected], Website: www.brainsbio.com