Two female entrepreneurs have secured a landmark regulatory breakthrough that could help shape the future of one of the fastest-growing sectors in health and wellness.
Chanelle McCoy Health, founded by UK-based entrepreneur Chanelle McCoy and pharmacologist Caroline Coen, has become the first and only company globally to receive regulatory approval for CBD as an oral food supplement. The milestone follows a recent approval by the Saudi Food and Drug Authority, alongside confirmation from European regulators that its CBD product meets safety requirements under the EU’s Novel Food guidelines.
The twin achievements place the company at the forefront of a rapidly expanding global CBD market, forecast to grow from around US$9 billion today to more than US$22 billion by 2030.
For McCoy and Coen, the approvals mark the culmination of years of scientific research and close collaboration with regulators. Their work has focused on transforming CBD from a widely misunderstood ingredient into a trusted, regulated consumer product.
At the centre of the breakthrough is the company’s flagship brand, Pureis® Ultra Pure CBD. Unlike many products currently on the market, it is lab-produced to pharmaceutical-grade standards and contains 0% THC, enabling it to meet some of the most stringent regulatory requirements worldwide.
While lab-made ingredients may raise questions among consumers, they are already commonplace in the health and wellness sector. Around 99% of the world’s Vitamin C, for example, is manufactured in laboratories to ensure consistency, purity and supply.
Chanelle McCoy, Founder and CEO, said the achievement reflects both the scale of the opportunity and the persistence required to unlock it. “Building a new category in healthcare is a rare opportunity – one that brings the chance to shape something that has never existed before,” she said. “CBD has become one of the most talked-about ingredients globally, with many consumers using it to support 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. Today, we have shown that with the right science, the right standards and the right determination, a small Irish company can lead globally.”
McCoy brings significant industry experience, having previously spent nearly two decades at Chanelle Pharma, where she helped drive expansion into 96 international markets and oversaw more than 2,500 product registrations.
Securing approval for CBD as a food supplement has been particularly complex due to the stringent requirements applied to novel foods. Unlike conventional ingredients, these products must be supported by extensive clinical data demonstrating safety, quality and consistency. Chanelle McCoy Health’s 0% THC CBD has been underpinned by years of clinical development and multi-million-pound investment, ultimately enabling the company to navigate some of the most demanding regulatory pathways in the world.
The Saudi Food and Drug Authority is widely recognised for its rigorous standards and precautionary approach to consumer health products, making its approval especially significant. It signals strong confidence in the scientific evidence and safety profile underpinning the company’s CBD offering.
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Caroline Coen, Co-Founder and Chief Scientific Officer, said the company’s strategy was always to prioritise robust science. “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 science, safety and quality from day one. Approval by Saudi Arabia and confirmation from Europe that our CBD product is safe demonstrates that this approach works.”
With regulatory progress underway across more than 40 markets, the business is now entering a new phase of growth. The founders are seeking strategic investment to support expansion across a range of categories, including wellness, cosmetics, food and beverages, medical devices, medicines and veterinary applications.
As international demand for regulated wellness products continues to accelerate, the company’s achievements position it – and Ireland more broadly – at the centre of what could become a defining new global category.
