Female Founders Create World-First Approvals as Chanelle McCoy Health unlocks Multibillion CBD Category Across Europe and Middle East

Two female entrepreneurs have achieved a global regulatory first that could help shape the future of one of the fastest-growing sectors in health and wellness.

Chanelle McCoy Health, founded by UK-based Chanelle McCoy and pharmacologist Caroline Coen, has become the first and only company in the world to secure regulatory approval for CBD as an oral food supplement, with a recent approval by the Saudi Food and Drug Authority, while also becoming the first company globally to receive confirmation from European regulators that it’s CBD product is safe for use as a food supplement under the EU Novel Food guidelines.

The twin milestones position Chanelle McCoy Health at the forefront of a rapidly emerging global CBD market expected to grow from US$9 billion today to more than US$22 billion by 2030.

For the founders, these achievements mark the culmination of many years of scientific research and working with regulators. They have invested into transforming CBD from a misunderstood ingredient to a trusted, safe consumer product.

Chanelle McCoy Health’s brand called Pureis® Ultra Pure CBD is unlike any CBD products currently available. It is lab-made to the highest quality standards and contains 0% THC, designed to meet some of the toughest regulatory requirements in the world.

While the concept of “lab-made” ingredients may sound unfamiliar, it is already a well-established part of everyday health and wellness products. Circa 99% of the world’s Vitamin C is lab-made, manufactured to ensure consistent quality, purity and supply.

Chanelle McCoy, Founder and CEO of Chanelle McCoy Health, said:

“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”.

McCoy previously spent almost two decades helping drive international growth for Chanelle Pharma, Ireland’s largest indigenous pharma company, overseeing expansion into 96 global markets and more than 2,500 product registrations.

These CBD approvals are particularly significant given the regulatory hurdles involved. Unlike conventional food ingredients, novel foods must be supported by extensive clinical studies demonstrating safety, quality and consistency before regulators will permit their sale. Chanelle McCoy Health’s lab-made, 0% THC CBD was supported by comprehensive clinical studies developed over several years and costing many millions, ultimately securing approvals that position the company to be the first globally to have navigated such demanding regulatory pathways. The Saudi Food and Drug Authority is internationally recognised for its rigorous regulatory standards and precautionary approach to novel ingredients and consumer health products. Its decision to approve Chanelle McCoy Health’s CBD as an oral food supplement is therefore particularly significant, reflecting the strength of the scientific, safety and quality evidence supporting this product.

The company is now preparing for its next phase of growth, with regulatory approvals progressing across more than 40 markets.

With approvals now secured in key markets, the entrepreneurs are ideally positioned for future growth. As the business is now at an inflection point ready to significantly scale in multiple markets, they are seeking strategic growth capital to support market expansion and R&D across product categories, including wellness, cosmetics, food, beverages, medical devices, medicines and veterinary applications.

Caroline 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”.

As international demand for regulated wellness products continues to grow, the founders believe the company’s regulatory achievements place Ireland at the centre of an entirely new global category.