Co-written by Business of Cannabis and Cannabis Health
The UK’s Food Standards Agency (FSA) today published a shock update to its consumer guidance on the recommended daily dosage of CBD.
According to new ‘scientific evidence’, understood to have been gained from toxicological studies submitted by the industry itself, the FSA has dropped its recommended daily intake from 70mg to just 10mg.
Many single dose products such as CBD beverages, capsules and gummies will now contain levels of CBD over the new limit.
Industry stakeholders have already raised concerns about the lack of clarity from the FSA, which has stated it plans to ‘work closely with the industry to minimise the risk to consumers’.
What does this mean for businesses?
The FSA informed the market in a statement this morning that the change in advice is based on ‘new evidence from the industry and updated advice from our independent scientific committee’.
While it has been suggested that this updated guidance related only to CBD isolate products, the FSA informed us that ‘our consumer advice is for all CBD foods’.
As such, this means a swathe of products on the market will now contain more than the recommended daily intake of CBD in a single dosage.
CBD drinks brands including Trip (15mg per can), Medahuman (20mg per can) and Goodrays (30mg), some of the most prominent brands in the CBD space, will be impacted, but it is as yet unclear to what extent.
We have reached out to each of these brands but have not received a response at the time of writing.
According to the FSA, their update is ‘consumer advice’, and as such ‘no products need to be removed at this stage’.
ACI issues statement following the updated consumer advice on CBD from the UK's Food Standards Agency #CBD https://t.co/oMmVg8FGIf
— ACI (@ACIndustry) October 12, 2023
Many brands have also raised questions as to whether their labelling now needs to be updated to reflect the change in guidance, to which the FSA said: “We will consider any changes to our labelling guidance in due course. We encourage industry to include the most up to date consumer guidance in their labelling.”
This has been emphasised by a number of industry trade organisations, including the European Industrial Hemp Association’s (EIHA) Tony Reeves, who told us: “I would stress that the FSA have stated that there is no requirement to make any changes to packaging and other consumer communications with respect to this revised opinion; this is for guidance only and is not enforceable.”
As the Cannabis Trades Association (CTA) points out, this risks products being delisted by retailers, and may mean they are ‘hesitant to stock CBD products based on this advisory’, despite it not being ‘legally enforceable by Trading Standards or any other regulatory body’.
We have contacted a number of major high street retailers to inquire about how they intend to move forward and will update as we receive responses.
How the decision was made
In line with Novel Food requirements, the FSA was provided with toxicology data for hundreds of CBD products. As a result a new Advisory Committee on Novel Foods and Processes (ACNFP) & Committee on Toxicity (COT) Subgroup was established to review the evidence.
According to background provided by the FSA, the data was divided into three groups:
- those including using ≥98% pure CBD only and no other cannabinoids (derived from either plant-based extraction or synthetic sources)
- those ingredients using CBD and a mixture of cannabinoids (plant-based extraction and synthetic sources)
- and natural hemp or hemp-based extract ingredients containing a range of cannabinoids
These datasets were then used as the basis for determining a reliable toxicological Point of Departure (POD) and ultimately, a provisional acceptable daily intake (ADI) for pure form CBD.
The FSA provided us with background data for three ‘pivotal’ 90-day repeat dose toxicology studies, from which the average ADI was deemed to be 0.16 mg/kg bw x 70 kg.
Data from human studies on CBD was also used to perform a provisional risk assessment, which after considering the ‘chronic nature’ of general consumption of CBD as a food, as opposed to as a medicine, suggested that the maximum Health Based Guidance Value (HBGV) that could be supported was 11.7 mg/day.
Taking the average ADI from the three studies and the supporting human data, it was concluded that for pure form CBD (products containing ≥98% CBD) a provisional ADI of 10 mg/day for a 70 kg (0.15 mg/kg bw/day) healthy adult, could be established.
The value is said to be based on ‘observations of adverse effects in the liver’, with liver effects and somnolence (excessive tiredness) said to be the main areas of concern.
Due to ‘important data gaps’ and ‘uncertainties’ the subgroup has taken a ‘cautionary’ approach to account for the lack of human-based long-term evidence in humans and potentially vulnerable groups.
In its position statement, the FSA says: “It cannot be ruled out that long-term daily chronic use of pure form CBD (≥98% purity) at intake levels higher than 10 mg CBD/day could contribute to the development of adverse effects over time, most notably in the liver… Human evidence suggests that with oral intake levels above 70 mg CBD/day, in some individuals, adverse drug-drug interactions with some medications could occur…drug-drug interactions at doses lower than 70 mg/day cannot be ruled out.”
Conflicting recommendations?
A scientific review commissioned by US cannabis companies, Canopy Growth and Charlotte’s Web, to develop recommendations for oral doses of CBD isolate, found a maximum daily intake of 160mg to be generally safe for adults.
The review, published this month, used publicly available data from 28 human clinical trials and toxicity studies in animal models to set upper intake levels of CBD when taken as a dietary supplement.
A dose between 100-160 mg per day was determined to be generally safe for ‘healthy adults’ who are not trying to conceive, are pregnant or breastfeeding, in which case a maximum dose of 70 mg per day is recommended. In this case, ‘healthy adults’ were classed as those who have not been diagnosed with any medical condition, or are currently taking any medications.
The review stressed that these recommendations are based on the authors’ assessments and should not be taken as regulatory guidelines.
A previous study, which was supported by 12 major CBD brands, reportedly found ‘no evidence’ of liver toxicity in over 800 participants taking an average daily dose of 40-50 mg CBD.
Business of Cannabis will be delving into the industry response to the update imminently.
