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Brains Bioceuticals announce FSA validation for its CBD as a novel food

Home » Brains Bioceuticals announce FSA validation for its CBD as a novel food

Estimated reading time: 5 minutes

Cannabis wealth speaks to the chief commercial officer of Brains Bio, Bill Purves about CBD, FSA and novel foods and industry growth.

Anticipation is growing as the novel food list from the Food Safety Authority (FSA) is set to be released in the coming weeks.  Some companies have been celebrating their validation from the FSA which will allow their products to continue being sold on the market.

Brains Bioceutical, a plant-based pharmaceutical company, has just announced its validation ahead of embarking on a new trial that will see its products used as a potential treatment for opioid addiction.

Bill said: “There are a number of reasons why we are seeing the market growth for CBD. The world is becoming a more stressful place and people are far more self-aware of the importance of mental health. This is coupled with the concept of personal care and an increase in the need for naturally derived products as well. It’s the perfect storm brewing which is contributing to a lot of the CBD market drive.

“It’s hard to find a consistent source for the numbers on the market size as there is a huge disparity from data analyst companies. There is very strong double-digit growth anticipated over the next five to eight years in the global market.”

Regulations and CBD industry

Although the industry is growing, industry regulations have been progressing at a slower speed. Bill highlighted that Brains Bio are supportive of regulations but clarity is needed.

Bill said: “We are very supportive of the process and we were very happy to work on it. We do recognise that there were challenges for the FSA as I think they had an excess of 1000 applications that need processing. A lot of those could not be validated easily or quickly so have been placed on hold which all takes up regulator review time.

“It would be nice to have a little more clarity around timelines but in terms of what the FSA is doing, we are broadly supportive of the efforts. When you are ingesting any medication, you need a regulatory framework to ensure the quality and safety of  the products.”

Bill highlighted that recent reports have revealed the difference between what products claim and what is actually in the bottle. Such studies are deeply concerning as they could have huge effects on consumer confidence in CBD products.

“The Swiss Pharmacy Association did a study where there were a huge number of CBD products that did not even meet the specifications on their own labels. In that case, they recalled up to 74 different products that needed to be taken off the market. This is not helpful for the industry as a whole because regulations are really the only sort of mechanism to bring credibility and ensure there is a level playing field,” he said.

Brains Bio data delivery

Brains Bio products have taken a pharmaceutical approach to the generations of data and evidence as one of their primary targets is the pharmaceutical industry. They provide products that can be included in clinical trials such as their upcoming opioid study.

The Icahn School of Medicine at Mount Sinai in New York, NY is initiating the study with Brains Bio’s oral drug formulation of CBD, in a hard gelatin capsule. This preliminary data will be used as a foundation for potential future clinical trials in opioid addiction studies. This study is just one of thirteen clinical trials that Brains Bio has participated in across the world.

Bill is confident that the public list will help to bring confidence to consumers when it is finally released.

Bill said: “The million-dollar question is when? I’ve seen reports saying February and others saying it could take longer. We just don’t know when it’s going to happen. We are one step towards approval as we have been validated and can now go onto the risk assessment part of the evaluation process.”

He added: “What it will mean is that those who are on the public novel foods list can continue to sell products on the market that were available prior to the 13th of February 2020. We had product available prior to that date so we will probably look to bring the product back to the market in the not too distant future. We are taking it one step at a time as our ultimate aim was to get approval from the FSA so we can move forward with confidence.”

Bill Purves, CCO, Brains Bioceutical

Novel foods and CBD – what’s next?

So with the list on its way, where does Bill see the wellness industry heading in the next few months?

“The regulatory environment is going to be a critical factor in how quickly the industry moves forward and where it goes. Once products start getting approved and others drop off then it is still going to be murky because of the on-hold list. If we get to the point where products are being taken off the market then we may start to get a consolidation of the market. I see a scenario playing out where companies that have really focused on the quality of the product and data will start to consolidate their market position,” he explained.

“The pharmaceutical sector will get more actively involved in CBD and cannabinoid research in general. We supply products to sponsors of clinical trials globally. That data will contribute to the growth of the market but will support a consumer that is more informed and is searching for an evidence-based product.

“It should play out over the next three to five years not just because the pharmaceutical development timelines are so long. It’s exciting for us at Brains Bio because we come from a pharmaceutical background. We really want to push this evidence-based cannabinoid science approach to bring more products to market.”

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