Regulatory approaches to cannabidiol in the European Union: are market developments sowing the seeds of confusion?

Abstract

The rapid growth in marketing cannabidiol poses a challenge to current European regulatory frameworks that can have important implications for consumer safety, public health, and established industries. Cannabis contains a variety of cannabinoids and the percentage of each depends on plant variety and growing conditions. The most studied are tetrahydrocannabinol (THC), that can cause intoxication, and cannabidiol (CBD). Cannabidiol was recently evaluated by the World Health Organization (WHO) Expert Committee on Drug Dependence (ECDD) as having “no potential for abuse and no potential to produce dependence” [2]. There is no explicit mention of cannabidiol in the United Nations (UN) drug conventions, leading to different interpretations on whether or not plant-derived CBD is an “extract of cannabis” controlled under the 1961 Convention. A THC limit for hemp crops was established by the European Economic Community in the mid-1980s to identify varieties of cannabis that could be subsidized if cultivated for industrial use (usually called “hemp”), and, therefore, lie outside the scope of the UN Convention. Today, cultivation may be subsidized by the EU if the top third of the plant contains no more than 0.2% THC [3, 4]. A number of significant developments have taken place during the last decade. In 2011, Switzerland increased their THC limit for hemp from 0.3% to 1%, and from mid-2016 onward hemp flowers and then hemp flower cigarettes became openly available [5]. From around 2017 a range of oils, creams, smoking, and ready-to-eat products have also become available more widely in the EU, in specialist and mainstream stores and in online shops. These are marketed in different ways, as containing cannabis extracts, CBD, and-or low THC [1]. Although some sellers claim that finished products containing less than 0.2% THC can be openly sold, the limit was not established for this purpose, nor was it intended to determine a safe dose for human consumption. Recent developments are putting considerable strain on existing regulatory approaches and there is increasing uncertainty as to whether certain products should be treated under EU regulations relating to drug control, medicinal products, food safety, tobacco and smoking products, or cosmetics. Importantly, legal definitions of “food” and “cosmetics” exclude cannabis because it is listed under the 1961 Convention. Because national regulatory authorities have to apply EU regulations within their own context, this can result in legitimate inconsistencies between countries’ approaches to particular products. In the EU, the ability or claim to prevent or treat a disease makes something a “medicinal product,” requiring a license to sell it and clear information on dosing and harms [6]. CBD does have an approved medical use; a plant-derived CBD oral solution, Epidyolex, has been approved by the European Medicines Agency to treat seizures associated with Lennox–Gastaut or Dravet syndromes. Nevertheless, despite marketing claims that CBD helps to alleviate various health problems including anxiety, insomnia, and pain, the available evidence of effectiveness for other conditions remains limited [7], and it has also been suggested that the low doses found in some of these products would limit any possible effect [8]. Reflecting this, CBD products are often marketed under the vaguer concept of “wellness” or complimentary health products rather than medicines. Under EU law, “food” may be sold provided the supplier ensures it is safe, but a designated “novel food” (one that has been introduced recently) requires evaluation by the European Food Safety Agency (EFSA) and subsequent authorization before sale [9]. CBD-containing products are considered as “novel”, and over 60 applications for novel food status for such products have recently been submitted to EFSA [10]. Product labeling has also raised concerns. THC content is usually presented as a percentage of the product (e.g. <0.2% THC), but this appears more focused on concerns about legality than safety. A 32 g Canadian cannabis chocolate bar, for example, contains 10 mg of THC [11], twice the proposed standard unit of THC of 5 mg [12], yet has a THC content of only 0.03%. Food safety information is usually expressed in μg/kg bodyweight of the consumer, such as the EFSA acute reference dose (ARf D) [13]. Production quality may also be inconsistent; studies suggest that products may contain THC levels above the legal limit [14] or have less CBD than declared [15]. Contaminants have also been noted as a possible cause for regulatory concern [16]. Recently, some countries have regulated smokable low THC cannabis as “herbal smoking products,”, which, under EU regulations, require health warnings and the reporting of ingredients [17]. The WHO's ECDD 2019 recommendation to delete the expression “extracts and tinctures of cannabis” from the 1961 Convention, and instead insert that “preparations containing predominantly CBD and not more than 0.2% THC are not under international control” [2] aimed to clarify this situation somewhat, but this was rejected at the Commission on Narcotic Drugs in December 2020. A recent European Court of Justice judgment on intra-community trade of CBD extract ruled however that CBD is not a narcotic under the UN Conventions [18], with possible implications for future regulatory approaches in areas like food and cosmetics. Reflecting on this growing complexity, greater conceptual clarity is needed in this area if we are both to reduce health and safety risks for consumers and to clarify the legal situation for producers. This may require developing an operational framework for all products containing “cannabis.” Important here will be the need to distinguish, among other things, between the predominant cannabinoid(s) present (THC, CBD); product form (seed, fiber, flower, resin, oil, crystals, and finished product); intended or expected use (recreational, food, cosmetic, medical, industrial etc.); product potency; intended mode of administration; and intensity of use. Although allowing space for different national interpretations, such a framework would aid future discussions that try to seek a balance between the need to allow legitimate commercial activity with the need to protect public health and clarify the boundaries of drug control and other regulatory frameworks. None Brendan Hughes: Writing Original Draft; Writing Review and Editing. Lisbeth Vandam: Writing Original Draft; Writing Review and Editing. Jane Mounteney: Writing Review and Editing; Supervision. Paul Griffiths: Writing Review and Editing; Supervision.

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