Chanelle McCoy Health claims to have become the first CBD supplier to secure approval for an oral CBD supplement.
Its Pureis Ultra Pure CBD has last month received regulatory approval from the Saudi Food and Drug Authority, and confirmation from European regulators that it is safe as a food supplement under EU novel food guidelines.
Pureis Ultra Cure CBD is lab-made and contains 0% THC content. It was also among the first cohort of products to move past the “risk assessment” phase of the UK novel foods application process, run by the Food Standards Agency (FSA).
“We made a conscious decision to develop our products to meet some of the toughest regulatory requirements in the world,” said Caroline Coen, co-founder and chief scientific officer at Chanelle McCoy Health. “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”.
Chanelle McCoy Health said that – following the twin approvals – it was now “preparing for its next phase of growth, with regulatory approvals progressing across more than 40 markets”.
It was also seeking “strategic growth capital to support market expansion and R&D across product categories”.
Possible NPD could include “wellness, cosmetics, food, beverages, medical devices, medicines and veterinary applications”, it added.
It comes with the UK regulatory environment for CBD facing uncertainty due to government SPS realignment negotiations with the EU.
Last month, The Grocer revealed suppliers may have to launch fresh novel food applications into Europe, with the FSA set to hand over responsibility as a result of the regulatory reset.
There are currently 12,000-plus products on the list linked to novel food applications, and barring a few “frontrunners” most are unlikely to be approved before responsibility switches to the EU, the FSA has admitted.
However, leading CBD companies remain hopeful the agency will secure them an exemption that will allow them to continue to be sold in the UK.
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