Cannabidiol: a legal food ingredient for 2021?

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Representing a seismic shift in policy, the European Commission (EC) has now accepted that extracts from Cannabis Sativa L. (CS) can be considered for assessment as a food rather than constituting a narcotic.

CS is a plant with over 5,000 years of history as a food, medicine and source of fibre for textiles.1 However, its place in modern-day nutrition has been reimagined since the identification of Cannabidiol (CBD), just one of over 600 biologically active metabolites that can effectively treat epileptic conditions. It has been over eight years since Charlotte Figi’s self-treatment for Dravet syndrome with CBD opened up the global cannabis extracts market. However, research as far back as 1980 recognised CBD’s potential.2 After what could be argued as a slow start, it now represents a compound worth an estimated $23.6 billion globally by 2025, with a CAGR of 22 percent.3 Europe alone will account for $16.14 billion of this market by 2025, with the UK anticipated as the biggest EU market worth an estimated $3.57 billion.4

That’s some fantastic potential, but there is a snag: CBD is novel in Europe, meaning it cannot be sold without prior authorisation and the submission of a toxicological dossier proving safe use. Also, extracts from the CS plant other than those from leaf, seed and mature stem have historically been viewed as narcotics. Nevertheless, the potential of this ingredient for use in foods across the EU has now opened up, thanks to opinions by the courts and regulatory authorities.

The Kanavape case

Case C-663/18 (Kanavape)5 revolves around two managers of a vape startup company using a CBD-based extract from the entire hemp plant. Under French law, products derived from any part of CS, other than the fibre and seed, are viewed as narcotics. 6
The French Court of Appeal asked the Court of Justice of the European Union (CJEU) if a cannabis-based CBD-containing extract (from the whole plant), which can be lawfully sold in one Member State (in this case the Czech Republic) yet considered as a narcotic and illegal in another (France), is an unlawful restriction of free movement rules.

UK law (Misuse of Drugs Regulations 2001 ‘MDR’) views extracts other than from the seed and mature stalk (fibre) as ‘controlled parts’ and thus scheduled substances (illicit drugs). The seed and stalk contain very little CBD, so access for food businesses to a CBD source from other parts of the plant would significantly impact any yield of CBD per gram of hemp (low in levels of Tetrahydrocannabinol ‘THC’ – the primary psychoactive in CS). Given the recent timing of the decision from the European courts, it is binding on the UK legislator as the case started before the end of the Brexit transition period.6

Following a view issued by the Advocate General (AG) in May 2020 that restrictions in the free movement of CBD would not be lawful and it is not deemed to be a narcotic,7 industry was hopeful that the final decision of the courts would mirror those of the AG. A literal interpretation of the law would indeed lead to a conclusion that ‘extracts from the entire plant’ is within the meaning of Schedule I of the Convention and subsequently they are deemed as drugs (Article 1(1)(j)).

However, the court ruled that a teleological interpretation of the Convention and its objectives should be taken into account, concluding “Since CBD does not contain a psychoactive ingredient in the current state of scientific knowledge […], it would be contrary to the purpose and general spirit of the Single Convention to include it under the definition of ‘drugs’ within the meaning of that Convention as a cannabis extract.”

The operative part of the judgement (that which has a legal effect) interprets free movement laws as precluding national measures that prohibit the marketing of CBD – even if extracted from the entire cannabis plant – and that any restrictions based on protecting public health must be proportionate and necessary. A win for industry!