19 Jun, 2020

 

The ACI Responds to Global Regulatory Calls for Evidence of CBD Safety by Launching Study Consortium

The Association for the Cannabinoid Industry (The ACI) today announces it will spearhead a CBD Safety Study Consortium to generate data to assess the safety of CBD and to discern exactly what the recommended daily dose should be. This move is in response to calls from regulators around the world who are highlighting the lack of evidence relating to the safety of CBD. The ACI sees this as the most comprehensive and cost effective option available.

In the UK these safety concerns have been highlighted in public statements from the FSA, the Committee of Toxicology and the MHRA. Internationally, requests for more evidence are coming from national food safety agencies alongside calls from EFSA, the FDA and the UN.

The ACI’s CBD Safety Study Consortium will grant the opportunity for companies to provide the evidence these organisations are calling for whilst sharing the burden of costs of such studies. The study will identify data gaps and generate analytics based accordingly. The goal is to generate data to be used across a broad range of secondary (finished) products.

This safety data is required to successfully gain novel foods approval from regulators. Answers that need to be gathered include whether CBD causes potential drowsiness, liver toxicity or has any interaction with other drug substances. Once complete, The ACI’s Regulatory and Compliance Unit will be able to integrate this data into the novel foods application of our members. 

The study will assess different modes of delivery and bioavailability, for example ingestion, absorption and inhalation. The study will also assess if there are any potential vulnerable groups (for example children, adolescents or pregnant and lactating women). We will also identify any overlap of therapeutic dose levels from approved drug products, with potential exposure from other uses including food, dietary supplement or cosmetics. The outcomes will help define a maximal acceptable daily intake of CBD for all products.

The ACI is combining forces with Advanced Development & Safety Laboratories (ADSL) to meet the safety and toxicity challenges of assessing CBD. ADSL is a leading regulatory and compliance company with full scale laboratory and analytical testing capabilities.

CBD isolate has been identified as the first primary product for this work. This will provide a baseline for finished product assessment. The same approach can then be applied for all primary CBD products; including isolate, narrow spectrum, broad spectrum or full spectrum.

Timeline

  • July 2020 – deadline for consortium members
  • August 2020 – testing and equivalency reports sign off
  • September 2020 – share protocol with regulators 
  • December 2020 – submission of scientific dossier for CBD isolate

Quotes

Dr Parveen Bhatarah, Regulatory and Compliance Unit Lead, The ACI
“Regulators in the UK and internationally are looking for evidence about CBD safety, toxicity, dosing and the cumulative effect of ingesting CBD. Along with safety issues related to other known cannabinoid impurities present in the CBD products and possible associated harms.  ACI is assisting the CBD industry to generate this data in a most cost effective manner.”

Dr Paul Duffy, Toxicologist, The ACI
“The ultimate aim of the work is to support the continued use of CBD products by providing the necessary data for the FSA/EFSA to approve the required novel food application. Sharing the effort in a consortium is the most efficient way to do it.”

Mark Richard Bowes-Cavanagh, Managing Director, ADSL
“ADSL offers full regulatory compliance and safety testing at every stage of the process; from when the crop is in the soil, through to harvest and extraction and onto the consumer’s shelf. Proudly working with the ACI, and leading professionals, we are able to provide an efficient and competitive safety toxicity protocol that meets the requirements of the EFSA whilst promoting the innovative benefits of the CBD industry.”

Steve Moore, The ACI Founder and Strategic Counsel
“As the industry has struggled to get to grips with the data requirements for a successful novel food submission, our toxicological proposal provides the most comprehensive and cost-effective solution for CBD businesses. We have strengthened our team and partnered with best-in-class laboratories, meaning we are able to deliver on this huge undertaking. We have prioritised the long-term commercial success for any organisation wishing to join our consortium, whilst also minimising the financial burden as we look to make this as an attractive proposition for SMEs.”

About The Association for the Cannabinoid Industry 
The ACI is an industry body which is committed to nurturing a safe, legal and well regulated CBD market in the UK. Our vision is to create an innovative, sustainable sector that meets the highest standards in product quality, consumer satisfaction and environmental stewardship.