Reasons why UK government agencies are recommending a sharp reduction in daily cannabidiol intake
Due to
"important data gaps" and "uncertainties", a
"cautious" approach was taken to account for the lack of long-term
data from humans and potentially vulnerable groups.
The UK's Food
Standards Agency (FSA) has published a shocking update to its consumer guidance
on the recommended daily dosage of cannabidiol (CBD). The FSA has reduced the
recommended daily dose from 70mg to just 10mg, based on data supposedly derived
from toxicology studies.
What does this mean for the UK cannabinoid business?
The FSA told the
market in a statement that the change in advice was based on “new industry
evidence and updated advice from an independent scientific committee. Our
consumer recommendations apply to all CBD products.” Therefore, this means that
a number of products on the market will now contain more than the recommended
daily dose of cannabidiol in a single dosage.
On the one hand,
brands such as CBD drinks including Trip (15mg per can), Medahuman (20mg) and
Goodrays (30mg), some of the best known products in the UK cannabinoid market,
will be impacted new recommendations, but it is not yet clear to what extent.
On the other hand, the FSA says the update to the minimum amount of cannabidiol
is “consumer advice” and therefore “no products are required to be removed from
shelves at this stage.”
In turn,
cannabinoid manufacturers have raised questions about whether their labeling
needs to be updated to reflect changes in advice, to which the FSA said: “We
will consider any changes to our labeling advice in due course. We encourage
the industry to include the latest consumer guidance in its labeling.”
How the decision was made
Toxicological
data for hundreds of CBD products has been provided to the FSA as required by
Novel Food. As a result, a new Advisory Committee on New Foods and Processes
(ACNFP) and a subgroup of the Committee on Toxicity (COT) were created to
review the evidence.
According to
data provided by the FSA, the data was divided into three groups:
§ those
ingredients that include the use of only cannabidiol with a purity of ≥ 98% and
no other cannabinoids (derived from either plant or synthetic sources);
§ those
ingredients that use CBD and a mixture of cannabinoids (plant and synthetic
sources);
§ natural
ingredients from hemp or a plant-based extract containing a range of
cannabinoids.
These data sets
were then used as the basis for determining a reliable toxicological point of
intoxication and a preliminary Acceptable Daily Intake (ADI) for the pure form
of cannabidiol.
The FSA provided
raw data from three “pivotal” 90-day repeat dose toxicology studies, which
resulted in a mean ADI of 0.16 mg/kg body weight x 70 kg.
Data from human
studies of cannabidiol were also used to conduct a preliminary risk assessment,
which, after considering the "chronic nature" of overall CBD
consumption as food rather than as medicine, found that the maximum health
recommendation was 11.7 mg/day.
Taking the
average of three studies and supporting human data, it was concluded that for
the pure form of cannabidiol (products containing ≥ 98% CBD), the preliminary
acceptable daily dose is 10 mg/day for a 70 kg person (0.15 mg/day). kg body
weight/day).
This value is
said to be based on "observations of side effects", with the main
areas of concern being possible negative effects on the liver and drowsiness
(excessive fatigue).
Due to
"important data gaps" and "uncertainties", a
"cautious" approach was taken to account for the lack of long-term
data from humans and potentially vulnerable groups.
In its position
statement, the FSA said: “It cannot be ruled out that long-term daily chronic
use of a pure form of cannabidiol (purity ≥ 98%) at intake levels above 10 mg
CBD per day may contribute to the development of side effects over time,
particularly in the liver... Human data suggests that oral intake of more than
70 mg of cannabidiol per day may cause adverse drug interactions with certain
medications in some users.”
Commentary
from specialists of the Association “Ukrainian Industrial Hemp”
A scientific
review conducted by U.S. therapeutic cannabis companies to develop oral dosage
recommendations for CBD isolate found that a maximum daily dose of 160 mg is
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 establish upper intake levels
for cannabidiol when taken as a dietary supplement.
A dose of 100 to
160 mg per day has been found to be generally safe for "healthy
adults" who are not trying to become pregnant or are pregnant or
breastfeeding - in which case a maximum dose of 70 mg per day is recommended.
In this case, “healthy adults” were defined as those who had not been diagnosed
with any disease or were currently taking any medications.
The review
emphasizes that these recommendations are based on the authors' assessments and
should not be taken as normative recommendations.
The previous
study, which was supported by 12 major brands of cannabinoid products, found
"no evidence" of liver toxicity in more than 800 participants taking
an average daily dose of 40-50 mg of cannabidiol.
