The Food Safety Authority has finally acted against CBD products, writes Dr Des Corrigan
IIt has taken far too long, but finally, the Food Safety Authority of Ireland (FSAI) has bestirred itself and taken regulatory action against a range of CBD-containing products. As a result, certain batches of 14 named products must be removed from sale and consumers have been warned not to purchase or consume any of them. The full list is available on the FSAI website (www.fsai.ie).
The reasons for the intervention are set out in an FSAI report dated February 2020, Regulatory Issues with Hemp-based Food and Food Supplements on the Irish Market. Environmental Health Officers from around the country collected 38 samples of CBD products that were subsequently analysed at the Public Analysts Lab in Dublin. The results showed that 84 per cent of products were positive for THC, with 37 per cent having levels above the acute reference dose of 1 microgram/Kg of bodyweight, as set by the European Food Safety Authority in 2015. According to EFSA, this represents the highest dose of THC consumed in a sitting or in a day that is unlikely to have an adverse effect.
The report draws attention to the implicatons for consumers of these products because of the risk of an inadvertent positive drug test, with all of the consequences for athletes and for those in employments where drug testing is frequent. Sport Ireland recognised this issue by publishing an advisory on social media, warning athletes of the risk from consuming CBD products containing undeclared THC. Some products had only trace levels of CBD, despite label claims of significant concentrations. Over 40 per cent of the samples contained CBD levels that differed from the declared content by a factor of 50 per cent.
The report noted, “some of the discrepancies identified in this survey suggest a significant problem with the general quality control of these products”. Nobody should be surprised at this comment, as similar results were reported from the US and the UK. A 2017 paper in JAMA recorded THC present in 21 per cent of CBD products and only 31 per cent of them were accurately labelled as to CBD content. A 2019 study by a UK cannabis industry group reported that only 38 per cent of 29 products tested were within 10 per cent of the advertised CBD content, while another 38 per cent had less than 50 per cent of the claimed amount. One product sold by a high-street pharmacy chain at £90 for 30ml had zero CBD. Nearly half (45 per cent) had detectable levels of THC, making the products technically illegal. General EU food law does not permit the inclusion of any narcotic or psychotropic substances in food. Since THC is a psychotropic substance under the 1971 UN Convention, its presence in food or food supplements is illegal.
The FSAI reiterates the point that extracts of cannabis sativa and derived products containing cannabinoids are considered ‘Novel Foods’ under EU law, meaning that they must be pre-authorised by the EU Commission and EFSA before being marketed. The report found that 34 per cent of the products tested were considered ‘Novel Foods’. No CBD product has yet been granted such status at EU level.
Over half of the samples surveyed by FSAI made unauthorised nutrition and health claims on the packaging or online. Some medicinal claims for CBD are mind-boggling, such as teething pain and earaches in children, while others are more weighty, such as in anxiety, insomnia, psychosis, IBD, inflammation and cancer. There is some evidence of efficacy for these, but no conclusive proof other than in treatment-resistant epilepsies in childhood, where the evidence is rated as moderately good and been accepted by both the EMA and FDA. Both have licensed a CBD oral product (Epidyolex) as an adjunctive therapy in conjunction with clobazam for patients two years of age and older with either Lennox-Gastaut Syndrome or Dravet Syndrome.
The FSAI survey coincided with the release of an advisory from the British Food Standards Agency to the effect that consumers should think carefully before taking any CBD products. They went on: “We do not recommend CBD for people in vulnerable groups unless under medical direction. These include pregnant and breastfeeding women or people taking any medication.” Because liver injury is possible, healthy adults should not take more than a recommended maximum dose of no more than 70mg per day (compared to a maximum medical dose of 20mg daily for Epidyolex). The 70mgs, according to the FSA, is equivalent to approximately 28 drops of a 5 per cent CBD preparation “unless a doctor agrees more”, which is a strange statement for a food safety body to make about a food/food supplement. The FSA states that its advice is based on the latest scientific research in an unpublished (and hence not in the public domain) report from the UK Committee on Toxicity of Chemicals in Food, etc.
What is in the public domain is clinical and pre-clinical data from the EMA’s Assessment Report on Epidyolex. Thus, I can tell you that CBD does cause liver injury that shows up initially as elevated liver enzymes, especially if patients are also taking valproate or clobazam to a lesser extent. Patients therefore should have their liver enzymes and bilirubin levels checked before using CBD and then after one, three, and six months. CBD should be stopped if the upper limit of normal (ULN) increases three-fold for serum transaminases or two-fold for bilirubin. The SPC on Epidyolex also states that studies of CBD in animals have shown reproductive toxicity and as a precautionary measure, it should not be used during pregnancy, unless the potential benefit to the mother clearly outweighs the potential risk to the foetus. The SPC goes on to say that patients should be advised not to drive or operate machinery, because CBD has a major influence on the ability to drive due to the drowsiness and sedation that is one of its commonest side-effects. This effect is more likely when clobazam, other CNS depressants and especially alcohol, are consumed as well. Contamination with undeclared THC will also affect driving ability.
In view of what is in the SPC and in the FSAI survey, it is difficult to see how CBD can continue to be classified as a food supplement. To my mind, pure CBD is clearly a medicinal psychoactive drug, albeit without the intoxicating psychotogenic and addictive properties associated with THC. In view of the food safety bodies’ advice and the evident disregard for fundamental quality assurance by some in the CBD industry, pharmacists need to check their stocks of CBD products to ensure compliance. They also need to question seriously the advisability of supplying products that are unapproved by FSAI or not licensed as medicines by the HPRA. I recognise that there is a very strong commercial imperative in tapping into a seemingly ever-expanding market segment, but given the FSAI warnings, the evidence of side-effects and the risks to drivers, athletes and vulnerable groups, then surely professional ethical considerations must take precedence over concern for the bottom line.