Access to cannabidiol without a prescription : A cross-country comparison and analysis
Iain S. McGregor, Elizabeth A. Cairns, Sarah Abelev, Rhys Cohen, Mat Henderson, Daniel Couch, Jonathon C. Arnold, Natalie Gauld
International Journal of Drug Policy, 2020, 85, 102935
Doi : 10.1016/j.drugpo.2020.102935
A B S T R A C T
Background : Recent legislative change has allowed increased access to cannabis products in many jurisdictions. In some locations, this includes over-the-counter (OTC) and/or online access to products containing cannabidiol (CBD), a non-intoxicating cannabinoid with therapeutic properties. Here we compared the availability of CBD products and the associated legislative and regulatory background in nine selected countries.
Methods : Accessibility of CBD products was examined in the USA, Canada, Germany, Ireland, United Kingdom, Switzerland, Japan, Australia, and New Zealand as of May 2020. Regulatory and other relevant documents were obtained from government agency websites and related sources. Relevant commercial websites and some physical retailers were visited to verify access to CBD-containing products and the nature of the products available.
Results : A range of CBD products appeared to be accessible without prescription in seven out of nine countries reviewed. Australia and New Zealand were the exceptions where clinician prescription was required to access any CBD-containing product. CBD products commonly available without prescription included oils, gel capsules, purified crystal and topical products. The daily recommended doses with orally administered non-prescription products were typically well below 150 mg and substantially lower than the doses reported to have therapeutic effects in published clinical trials (e.g., 300-1500 mg). The legal foundations enabling access in several countries were often unclear, with marketed products sometimes failing to meet legal requirements for sale. There was an obvious disparity between federal directives and available products in both the USA and European countries examined.
Conclusions : There are a variety of approaches in how countries manage access to CBD products. Many countries appear to permit OTC and online availability of CBD products but often without legislative clarity. As consumer demand for CBD escalates, improved legislation, guidelines and quality control of CBD products would seem prudent together with clinical trials exploring the therapeutic benefits of lower-dose CBD formulations.
Keywords : Cannabidiol, Cannabinoid, Medicinal cannabis, Cannabis, Access to treatment, Government regulation
Cannabidiol (CBD) is a non-intoxicating cannabinoid found in the Cannabis sativa plant. Scientific and community interest in CBD has expanded dramatically in recent times (Leas, et al., 2019) with preclinical and clinical studies demonstrating efficacy in the treatment of conditions such as epilepsy (Devinsky, et al., 2017; Thiele, et al., 2018), anxiety (Linares, et al., 2019; Zuardi, et al., 2017), psychosis
(Leweke, et al., 2012; McGuire, et al., 2018) and chronic pain (Costa, Trovato, Comelli, Giagnoni, & Colleoni, 2007). Despite their striking chemical similarity, CBD lacks the distinctive psychotropic and
intoxicating effects of Δ9-tetrahydrocannabinol (THC), and serious side effects involving CBD appear rare (Chesney, et al., 2020; Larsen & Shahinas, 2020; Millar, et al., 2019; Spindle, et al., 2020; Taylor, Crockett, Tayo, Checketts, & Sommerville, 2020; Therapeutic Goods Administration, 2020).
The various therapeutic actions of CBD reported in clinical trials are typically seen at oral doses of 300-1500 mg (Millar, et al., 2019) with doses of up to 6000 mg reasonably well-tolerated (Taylor, Gidal, Blakey, Tayo, & Morrison, 2018).
Many countries now permit over-the-counter (OTC) or online access to a variety of CBD products. These products are often extracts of the flowering heads of CBD-dominant “industrial hemp” cultivars that are also grown for seed and fibre. These products come in multiple forms and commonly include CBD oils and tinctures, gel capsules, purified CBD crystal, and balms and lotions for topical application. Other accessible CBD products include chewing gum, lozenges, “gummy bears”, sports drinks and pet products. Some European countries also have retail outlets selling CBD-dominant cannabis plant material known as “light cannabis” that is smoked or vaporised in the same way as traditional cannabis (Pichini, et al., 2019). High concentration CBD “vape oils” for use in e-cigarette devices are also available in some countries (Table 1). It should be noted that these CBD-containing products are distinct from hemp seeds, hemp seed protein and hemp seed oil, which usually contain negligible THC/CBD concentrations, reflecting the absence of cannabinoids in cannabis seed (although cannabinoid contamination of hemp seed products from the surrounding hull can sometimes occur (Ross, Mehmedic, Murphy, & Elsohly, 2000)).
Non-prescription CBD products appear to involve relatively low daily doses of CBD as would be obtained with products such as capsules containing 10-50 mg CBD or oils of 50-100 mg/mL concentration that are dosed at a few drops per day. This would suggest that use of nonprescription products produces doses that are well below those identified as effective in clinical trials (Millar, et al., 2019). However, it is also worth noting that the accuracy of the labelling of such products has been called into question by several recent analyses meaning that the actual CBD doses taken by patient may sometimes be larger (or smaller) than intended, and that other cannabinoids, particularly THC, may be present in greater quantities than labelling suggests (Bonn-Miller, et al., 2017; Hazekamp, 2018; Lachenmeier, et al., 2019; Liebling, Clarkson, Gibbs, Yates, & O’Sullivan, 2020; Pavlovic, et al., 2018).
At the same time as non-prescription products have proliferated, the prescription-only CBD medication Epidiolex™ has received marketing approval by regulatory agencies worldwide including the Food Drug Administration (FDA) and European Medicines Agency (EMA). Epidiolex™ is an oil containing 100 mg/mL CBD and is approved for the treatment of various rare forms of paediatric epilepsy following successful Phase 3 trials (Devinsky et al., 2017; Thiele et al., 2018). Epidiolex™ is typically administered at doses of around 20 mg/kg/day (e.g., 800 mg total daily dose of CBD in a 40 kg child) (Thiele, et al., 2018). Many countries also have the THC/CBD containing buccal spray nabiximols (Sativex™) available on prescription for the treatment of spasticity in Multiple Sclerosis (MS). This is a 1:1 ratio formulation of CBD and THC and a typical daily dose for MS includes 8 – 16 sprays, delivering only around 20-40 mg CBD in total (Rice & Cameron, 2018).
In January 2019, the World Health Organization (WHO) via its Expert Committee of Drug Dependence proposed changes to the scheduling of CBD-containing and other non-THC containing cannabis preparations (Adhanom, 2019; WHO, 2019). Specifically, it was stated that CBD preparations should not be subject to international drug control as CBD is not intoxicating, is generally well tolerated, with no evidence of problematic use or associated public health concerns (WHO, 2017b; WHO, 2019). The therapeutic value of CBD in childhood epilepsy was also recognised (WHO, 2019). Clarification regarding the absence of scheduling of CBD is proposed to be achieved through a footnote to the “Cannabis and Cannabis Resins” section of the International Drug Control Conventions as follows: “preparations containing predominately cannabidiol and not more than 0,2 percent of delta 9-tetrahydrocannabinol are not under international control”. This proposal was later further clarified to state that “the percentage of CBD to be used in practice could be left to individual Member States”. The United Nations (UN) has delayed voting on the recommendation (Somerset, 2019), while acknowledging that CBD products are available in many countries, and that “Member States can regulate its availability using their own national legislation”.
There has been an obvious transition in the regulation and availability of CBD products in many countries. In a WHO survey of member states published in 2017 (WHO, 2017a), only four of 45 respondents (countries unspecified) reported that CBD was being used as a nonmedical product (e.g., dietary supplement or food product) in their country. Three years later, it is evident that a wide variety of OTC and online CBD products can be accessed in many jurisdictions, although the legality of such products is not always clear. For example, at the time of writing, the website of well-known health food and nutraceutical retailer Holland and Barrett allowed the instant online purchase and delivery of numerous CBD products to 29 different European countries. A cross-country policy analysis of CBD has been lacking, despite the obvious worldwide escalation in CBD use (Brightfield Group, 2019; Gibbs, Yates, & Liebling, 2019), with forecasts of a global market worth $US17 billion by 2026 (Fior Markets, 2019). Here we systematically investigated betweencountry variations in the legislative approach to CBD and its availability without prescription. Our focus was on a number of developed countries selected from the European, North American and Asia-Pacific regions.
We also examined the nature of available products, the likely dose that they supply, and the evidence supporting therapeutic benefits of such doses.