The ACI Launches Its Own CBD Safety Studies to Help Satisfy UK Regulators
Many drug and health organizations around the world remain skeptical about the safety of CBD products.
In the US, the Food and Drug Administration (FDA) has said such products “have the potential to harm” consumers. And in the UK, the country’s Food Standards Agency (FSA) has advised anyone who is pregnant, breastfeeding, or taking medication not to consume CBD oils and foods.
To better prove the safety of CBD to such UK authorities, the Association for the Cannabinoid Industry (ACI) – which represents several of the largest CBD companies operating in the UK – has today launched a new safety study consortium.
Members of the industry group will be able to offer up their own CBD products for safety tests, which will range from contaminant analysis to experimental rodent studies.
Better safe than sorry
Working with Advanced Development & Safety Laboratories (ADSL), a formulated products consulting company in the UK, the ACI will assess whether CBD products can cause drowsiness and liver toxicity, and if they can interact with other drug substances to the detriment of a consumer’s health.
The study’s approach will divide CBD into four categories: CBD isolate, narrow spectrum, broad spectrum, and full spectrum.
Example products from the four groups will be analyzed with high performance liquid chromatography (HPLC) techniques, and their manufacturing data reviewed.
A 90-day-long rodent study will then be conducted, which will also assess the effects different means of delivery (ingestion, absorption, and inhalation) can have, and if there are any groups (children, adolescents, pregnant women) vulnerable to CBD’s effects. The ACI says the results could also help define a maximal acceptable daily intake of CBD for products.
All findings, data, and toxicology reports will then be shared with the FSA and other regulatory authorities.
“Regulators in the UK and internationally are looking for evidence about CBD safety, toxicity, dosing and the cumulative effect of ingesting CBD,” Dr Parveen Bhatarah, the ACI’s regulatory lead, said in a statement.
“ACI is assisting the CBD industry to generate this data in a most cost-effective manner.”
Part of this cost-effectiveness will be achieved by only testing one company’s CBD product for each of the four categories.
“Throughout this process, there will be, in effect, a lead registrant,” Mark Richard Bowes-Cavanagh, ADSL’s managing director, said during a virtual press conference.
“So, [for] isolates, you're going to have 99 percent CBD, but you would have a lead registrant, and the parties would go behind that particular registration of that particular product.”
The ASI say this streamlined strategy will help fast-track the data to the FSA, which, come March next year, will begin enforcing regulatory actions against any CBD oils, drinks, and treats sold without such safety data. To remain with retailers, all CBD companies producing these goods must apply for a novel food authorization with the European Food Safety Authority (EFSA) by March 31, 2021.
“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,” Dr Paul Duffy, a toxicologist at the ACI, said in a press statement. “Sharing the effort in a consortium is the most efficient way to do it.”
ACI members have until late July to become involved in the study.
“I still sense at the moment that the industry is still struggling to some to terms with the [regulators'] requirements,” Steve Moore, a founder of the ACI, said during the virtual press conference. “And I worry it will be too late before they do so. So there’s an urgency around this proposal.”
