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Irish entrepreneurs have had their CBD product recognised as an oral food supplement in a global regulatory first.

Pureis Ultra Pure CBD, which is produced by Chanelle McCoy Health, has had regulatory approval from the Saudi Food and Drug Authority.

The company has also received confirmation from EU drug regulators that Pureis is safe for use as a food supplement under the EU Novel Food guidelines, another global first. 

The product is lab-made and contains 0% THC, with co-founder Chanelle McCoy describing it as “designed to meet some of the toughest regulatory requirements in the world”.

The company said navigating these pathways involved “comprehensive clinical studies developed over several years” and cost “many millions,” adding that there are currently regulatory approvals pending in over 40 markets.

It is currently seeking strategic growth capital to support market expansion and research and development across a number of product categories, including wellness, cosmetics, medical devices and veterinary applications.

McCoy commented: “Building a new category in healthcare is a rare opportunity – one that brings the chance to shape something that has never existed before.

“CBD has become the most talked about ingredient globally because many people use CBD similar to other supplements to support their wellbeing, sleep, stress and balance.

“Our belief in the product, our perseverance and our commitment to giving people access to safe, high-quality CBD has led to this world-first approval of its kind for Chanelle McCoy Health.

“Today, we have shown that with the right science, the right standards and the right determination, a small Irish company can lead globally.”

Carole Coen, co-founder and chief scientific officer, said: "We made a conscious decision to develop our products to meet some of the toughest regulatory requirements in the world.

“That meant investing heavily in the science, safety and quality from day one. Approval by Saudi Arabia and confirmation from Europe that our CBD product is safety approved demonstrates that our rigorous science approach works”.