Cannabis Derived Products in the Regulatory Spotlight

26/02/2020

CBD Products In The Regulatory Spotlight

The UK Food Standards Agency (FSA) has identified the need to regulate Cannabidiol (CBD) in food and oil which means that 2 human clinical trials will be required to prove content, efficacy and safety in future. The FSA is giving the CBD industry until March 31, 2021 to submit valid novel food authorisation applications aimed at ensuring foods containing CBD meet legal standards.

A daily limit at which the cannabis-derived compound is safe to consume has also been set by the FSA who state that “Healthy adults are  also advised to think carefully before  takingCBD, and the FSA recommends no more than 70 mg a day (about 28 drops of 5% CBD) unless under medical direction”.
Clinical trials are therefore a critical element in ensuring the efficacy and safety of CBD products. Onorach are highly experienced in managing clinical studies for nutraceutical and food products and can assist organisations involved in the development of CBD derived products with the necessary clinical trials, regulatory support and advice.

Related to this is the fact that during cultivation, cannabis and hemp absorb heavy metals from the soil and from contaminants in fertilisers, nutrients, pesticides as well as other environmental pathways. Moreover, the growing, cutting and grinding of the cannabis / hemp flowers for extraction can often cause the pick-up of elemental contaminants from stainless steel manufacturing equipment. Cannabinoid extraction risks differing amounts of heavy metals (depending on the solvent/extraction process used) ending up in the finished product.

Therefore there is a need for a comprehensive suite of tests to identify elemental contaminants and gather toxicological data on cannabis products. The FDA are moving towards regulating this and the FSA already has this on their radar for regulation. Many cannabis manufacturers have little or no experience using Inductively Coupled Plasma Mass Spectrometry (ICP-MS) which is required to generate the ultra-trace level data.

Onorach have developed a unique strategic partnership approach which means that the ICP-MS testing can be performed seamlessly hand-in-hand alongside the clinical trials which will need to be performed. This one-stop-shop approach has advantages for the client; reducing the time, complexity and cost of ensuring CBD products meet regulatory requirements as well as giving clients the data which demonstrates their products are efficacious and safe.

Client Testimonial

Prof. Leiper and her team at Onorach have demonstrated competencies in many areas in both working with the authorities and with the sites as monitors. They impressed us deeply with highly motivated, goal-oriented staff members of lively personality and creativity. It was always a pleasure to cooperate with Onorach Clinical.
A German Client