The ACI today welcomes the guidance issued by the Food Standards Agency today which fully validates our consortium approach to generating toxicology safety study data for novel foods applications for CBD in line with the requirements of the Government Committee on Toxicity.
Critical novel foods update: FSA Confirms that Valid CBD Novel Foods Applications Must Include Toxicology Safety Study Data
With just 6 months remaining, for CBD companies to have a valid novel foods application for each of their products, the ACI has received confirmation from the FSA that these dossiers must include toxicology safety study data and literature-based information is not sufficient.
The ACI will host their latest in a series of webinars on 22 September, in conjunction with the UK’s leading magazine for the FMCG industry, The Grocer and one of North America’s most established cannabis companies, Columbia Care.
The ACI will host a series of panels at the upcoming VOXPO virtual event which runs from July 31 to August 2. The ACI are educational partners for the event and our panels will discuss issues relevant to CBD companies and consumers.
The ACI Responds to Global Regulatory Calls for Evidence of CBD Safety by Launching Study Consortium
The ACI today announces it will spearhead a CBD Safety Study Consortium to generate data to assess the safety of CBD. 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 today welcomes five new hires to bolster our Regulatory and Compliance Unit. The unit, headed up by Dr Parveen Bhatarah, provides regulatory and compliance support to members of The ACI.
ACI in the media
A British trade group says it has formed a consortium that may spend up to £1million (€1 million; $1.27 million) to carry out trials aimed at demonstrating the safety of CBD. The Association for the Cannabinoid Industry (ACI) said the research intends to answer questions posed by the UK’s Food Standards Agency (FSA).
[The Cannavist] The Association for the Cannabinoid Industry (ACI) has announced details of a study that will assess the safety of CBD ahead of the March 2021 novel foods deadline
The ACI has teamed up with the Advanced Development and Safety Laboratory (ADSL) and a consortium of CBD companies who are ‘committed to building a sustainable, safe and fully compliant industry in the UK’.
Today (25 September 2020), the Association for the Cannabinoid Industry (ACI), in partnership with Advanced Development and Safety Laboratory (ADSL), has announced the launch of a landmark study with a consortium of CBD companies who are jointly committed to building a sustainable, safe and fully-compliant industry in the UK.
The trial, which has been organised by the Association for the Cannabinoid Industry (ACI), will involve toxicity tests on rodents – most probably rats – and will cost up to £1m.
With the Novel Food Validation deadline date of March 31, 2021, approaching, the research is designed to assure UK regulators, the Food Standards Agency, of the safety of the CBD products of the participating companies.
The UK’s Association for the Cannabinoid Industry has welcomed a clarification from the country’s Food Standards Agency concerning the need for new evidence as part of Novel Food applications for cannabidiol food supplements.
Published on the FSA website on 24 September, the new guidance (see below) “fully validates” the ACI’s approach to generating toxicology safety study data, the association told HBW Insight.
Building on its three-tier certification system launched earlier this year, the ACI has brought together a consortium of UK CBD players committed to compliance with recently introduced British and European Novel Food regulation for the ingredient. (Also see “CBD Self-Regulation? UK Trade Association Launches Three-Tier Certification System” – HBW Insight, 22 Apr, 2020.)
The consortium will be undertaking a study – in partnership with Advanced Development and Safety Laboratory (ADSL) – that the ACI said would address questions raised by the FSA’s Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT), such as whether CBD causes potential drowsiness, liver toxicity or has any interaction with other medicinal substances.
The FSA’s clarification means that the ACI’s efforts to get its members ready for 31 March 2021 – when only firms that have submitted validated Novel Food applications to either the UK authority or to the European Food Safety Authority will be able to continue to sell CBD – have not been in vain. (Also see “UK CBD Firms Given Deadline For EU Compliance” – HBW Insight, 13 Feb, 2020.)
“We acknowledge the FSA’s reference to advice that applicants should consult EFSA’s guidance on ‘the usual application process for all novel foods,’” the association continued. “This process includes the details of a 90-day rodent safety study.”
“The ACI’s Safety Study Consortia will undertake the necessary studies as stipulated by EFSA,” it explained. “Our group application will keep the necessary animal use to a minimum and reduce costs for participating companies.”
Further details of new consortium study would be revealed at a press conference later today, the ACI noted.
According to the ACI, there has been some confusion as to whether new studies were needed for Novel Food approval, or whether existing toxicology data available in the public sphere would suffice.
A recent FSA webinar had muddied the waters, the ACI’s strategic counsel, Steve Moore, told HBW Insight, and had led some of the association’s members to believe that neither a study nor a consortium was necessary.
The FSA had clarified in a conversation with Moore the position made public today, that such studies would in all likelihood be needed, he revealed. However, the FSA had subsequently not made this position public, nor confirmed this in follow-up correspondence.
A new page on the FSA website now makes clear that “with so little publicly available information on the safety of CBD we anticipate that directly relevant studies will be needed.”
“Only by including this directly relevant safety information will applications be able to progress and potentially be authorized,” the regulator added.
Great Britain has rejected the European Commission’s preliminary stance that hemp flower-derived CBD should be regulated as a narcotic, a key food safety regulator in the United Kingdom says.
[Nutra Ingredients] CBD Novel Foods deadline fast approaching as firms embrace regulatory challenges
With UK FSA (Food Standards Agency) setting 31 March as the deadline for firms to have validated novel foods application for its CBD products, how are firms responding to this challenge in the current climate?’
The ACI is pleased to announce a partnership with The CBD podcast by ReLeaf.
ReLeaf offers educational and informative content about CBD.
The partnership commences with an interview with members of The ACI’s Regulatory and Compliance Unit, which is headed up by Dr Parveen Bhatarah. The team, which includes several new hires, ensures that our members are fully compliant with laws relating to cannabinoids.
This week’s podcast consists of an interview with The ACI’s Dr Parveen Bhatarah, Isabel Alber and Marc Burbidge.
They discuss the importance of the work CBD companies need to do, in order to stay on the market after the FSA’s 31st March 2021 deadline, to have a validated novel foods application for each of their products. The discussion covered the ACI’s timeline of work which demonstrates how essential it is that CBD companies start this work now.
They also covered our recently launched novel foods CBD safety consortium and gave some specific examples of why this work is necessary as well as highlighting the commercial advantage brands gain from participating.
The deadline for CBD brands to join the consortium is 7th of July 2020.
The ACI looks forward to future collaborations with ReLeaf in the coming months.
For in depth discussions with The ACI and all things CBD subscribe to The CBD podcast by ReLeaf.
UK TRADE BODY THE ASSOCIATION FOR THE CANNABINOID INDUSTRY (THE ACI) WILL LEAD A NEW CBD SAFETY STUDY CONSORTIUM TO GENERATE DATA TO ASSESS THE SAFETY OF CBD AND EVALUATE DOSAGE IMPACTS.
The ACI says the initiative comes in response to calls from regulators around the world who, it says, continue to highlight a lack of evidence around the safety of CBD.
In the UK these safety concerns have been highlighted in public statements from the UK Food Standards Agency (FSA), the Committee of Toxicology and medicines regulator, the MHRA. Internationally, requests for more evidence have come coming from national food safety agencies alongside calls from European Food Safety Authority (EFSA), the US Food & Drug Administration (FDA) and the UN.
The focus on safety is likely to intensify as the deadline for the submission of validated novel food applications (31 March 2021) draws nearer. Earlier this year the FSA announced that, after this deadline, only products for which a valid novel food application has been submitted and approved will be able to remain on the market.
Detailed safety data is required to successfully gain novel foods approval from regulators, including information on whether CBD causes potential drowsiness, liver toxicity or has any interaction with other drug substances.
The ACI says its CBD Safety Study Consortium offers an opportunity for companies to provide the required evidence whilst sharing the burden of costs of such studies. It is collaborating on the project with with Advanced Development & Safety Laboratories (ADSL), 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, says the ACI, can then be applied for all primary CBD products; including isolate, narrow spectrum, broad spectrum or full spectrum.
The ACI is working on a four-stage 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
Commenting on the launch of the Consortium, Dr Parveen Bhatarah, regulatory and compliance unit lead, The ACI, said: “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.”
Steve Moore, The ACI founder and strategic counsel, committed: “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 a proposition for SMEs.”
In a question and answer session Mark Richard Bowes-Cavanagh, Managing Director, ADSL, said: “What everyone cares about here, is that CBD can get on, and remain on the market. We are offering a flexible and competitive way off getting CBD on the market, and at a fraction of the cost of undertaking this work individually”.