CBD-cannabidiol, extracted from hemp inflorescences-receives increasing attention from policy and government. In Italy, as in Europe and around the world, the circle is tightening. News and reflections.
CBD, a drug from narcotic active substance?
The Ministry of Health, by decree 1.10.20, inserts in the table of medicines, section B, of Presidential Decree 309/80 as amended – Testo Unico Stupefacenti (TUS) – ‘the following category of substances: compositions for oral administration of cannabidiol obtained from Cannabis extracts.’ (1)
Cannabidiol, CBD, is thus included in a table of ‘activenarcotic substances including active substances for pharmaceutical use, of current therapeutic use in human or veterinary use.’ More specifically, in Section B of the table where, among others, ‘Cannabis-based herbal medicines (herbal substances and preparations, including extracts and tinctures), with related non-repeatable prescription (RNR) supply scheme‘ are listed.
CBD, the drug on its way to approval
‘Compositions for oral administration of cannabidiol obtained from Cannabis extracts find use in the treatment of epilepsy,’ the ministry points out. And it is currently ‘in the process ofevaluating at the Italian Medicines Agency (AIFA) an application for authorization to begin marketing a medicine, in oral solution containing cannabidiol, which has already received centralized marketing authorization from the European Medicines Agency (EMA).’
The drug in question,
Epidyolex
, was in fact approved by the EMA on 9/19/19. (2) And it is made from natural CBD, extracted in supercritical CO2 from two proprietary genetics of Cannabis Sativa L. (not found in the Single European Catalogue of permitted varieties). Its use is controlled-under a compassionate use program notified to AIFA-for patients with Dravet syndromes (DS, severe myoclonic epilepsy of childhood) and Lennox-Gastaut syndromes (LGS, a rare severe epileptic encephalopathy that appears early in life).
CBD, a phytotherapeutic remedy for the United Nations
The UN (United Nations Organization) coordinates the implementation of international conventions on psychotropic substances:
– Single Convention on Narcotic Drugs (1961),
– Convention on Psychotropic Substances (1971),
– Convention against Illicit Traffic in Narcotic Drugs and Psychotropics (1988).
Its INCB(International Narcotics Control Board), in its report 16.11.18, actually describes CBD as a phytotherapeutic remedy. Attributing to it, based on solid scientific literature:
– almost irrelevant psychoactive effects, which are moreover of the opposite matrix to the psychotropic effects (instead proper to THC),
– Neuroprotective, anti-inflammatory and antioxidant health properties of cannabidiol.
‘CBD has few psychoactive effects. It may moderate the psychoactive effects of THC and has antioxidant, anti-inflammatory and neuroprotective effects‘ (3,4).
Stench of burning
Big Pharma
nevertheless persists in attracting CBD to its exclusive sphere of expertise. And so he moves his puppets to the top echelons of politics and public administration. A couple of examples, for good memory:
– the U.N.Expert Committee on Drug Dependence (ECDD) continues to unreasonably postpone the dutiful exclusion of natural CBD, extracted from Cannabis Sativa L., and its preparations (with THC content <0.2 percent) from the substances considered in the 1961 Convention, (5)
– the European Commission maintains firm applications for the authorization of CBD as an ingredient in foods and food supplements under the Novel Food framework. Theorizing, in blatant contrast to the scientific literature, that cannabidiol can be qualified as a narcotic substance, (5)
– the European Commission itself, after three turns in a few months, has come to exclude natural CBD from the list of cosmetic ingredients allowed in the EU(Cosing). Admitting instead the identical substance, when of synthesis.
Customs and Monopolies Agency, yet another hunchback blow to the hemp supply chain
The Customs and Monopolies Agency (ADM), with a directorial determination 13.10.20 signed by its director general Marcello Minenna, has scored the latest hunchback blow. (6) Prohibiting the marketing of hemp and hemp derivatives to holders of licenses to sell non-combustion inhalation products (consisting of liquid substances, with or without nicotine) to the public.
Since ‘it appears that products in the form of leaves, inflorescences oils, resins, and other products with the presence of substances derived from hemp sativa‘ arealsomarketed in certain establishments authorized for the sale of inhalation liquids,ADM’s senior executive elaborates a bureaucratic construct where they converge:
– the Consolidated Narcotics and Public Safety Texts (TUS, TUPS),
– the 10.4.18 opinion of the Consiglio Superiore di Sanità (devoid of any legal value, as we have seen), the enigmatic 30.5.19 ruling of the Supreme Court of Cassation in United Sections (already superseded by the lucid pronouncement of the Review Chamber of the Court of Genoa). (7)
The announcement of the Customs
The director general of the Customs and Monopolies Agency thus goes so far as to theorize that Law 242/16-in promoting the industrial hemp supply chain in Italy-defines its applications in an exhaustive list. (8) Above all, it neglects the necessary distinction between:
– Cannabis Sativa L. varieties included in the European Plant Varieties Database, the cultivation of which is eligible for aid under the Common Agricultural Policy (CAP), among other things,
– the various botanical species whose products instead qualify as psychotropic substances (in relation to a THC content >0.2%).
Customs, like former minister Matteo Salvini already, is making ‘all the grass into a lump’. To the point of prohibiting license holders (for the sale to the public of ‘‘non-combustion inhalation products consisting of liquid substances, with or without nicotine’, e.g. neighborhood establishments, pharmacies and parapharmacies) the sale of ‘leaves, inflorescences, oils, resins or other products containing substances derived from hemp sativa.’ (9)
Overview
La Cannabis Sativa L. represents a sustainable and promising crop, especially in Italy where its cultivation dates back to the Middle Ages. Its applications are many, from food to cosmetics, drug production but also that of bioplastics, green building materials, soil conditioners in agriculture, and biomass. In a circular economy logic that also reconciles with the EU Farm to Fork strategy. (10)
Natural CBD extraction is now the driving force in this supply chain because of its brisk demand in international markets. It can effectively add value to the agricultural production of industrial hemp, in compliance with EU rules. And yet it is subject to international competition with extracts that are not as guaranteed in terms of origin (natural or synthetic) and purity.
The tightening circle
The circle that tightens around CBD, variously framed as medicinal (without distinguishing the botanical species used) or as a narcotic (in a theorem divorced from the scientific literature), tends to exclude this substance-without any plausible justification-from the notion of food. (11)
With serious prejudice to the legitimate interest of agricultural and medicinal companies established in the EU in obtaining authorization for its use as an ingredient in food supplements (perhaps even in foods of current use, where appropriate with appropriate disclaimers), subject to scientific evaluation of its safety by theEuropean Food Safety Authority (EFSA). (12)
Amazon meanwhile starts selling CBD in England. (13) A market estimated to be worth 300 million pounds (€331 mln), with projected growth to GBP 1 billion (€1.1 billion) by 2025. (14) In turn, the Food Standards Agency has stated its intention to evaluate its food ingredient applications to ensure the best regulation of the industry and the most appropriate controls.
Dario Dongo
Notes
(1) Ministry of Health Decree 1.10.20. Update of the tables containing the indication of narcotic and psychotropic substances, referred to in Presidential Decree Oct. 9, 1990, no. 309, as amended and supplemented. Inclusion in the table of medicines, section B, of compositions for oral administration of cannabidiol obtained from Cannabis extracts’. (20A05476) (OJ General Series No. 255, 15-10-2020)
(2) The manufacturer of Epidiolex, GW Pharma International, also distributes
Sativex
(cleared by EMA on 2.12.06). Another cannabinoid drug (cannabidiol and delta-9-tetrahydrocannabinol, in equal amounts), used for pain and muscle spasms in patients with multiple sclerosis
(3) The report of International Narcotics Control Board for 2018. (UN, Geneva, 2019). ISBN: 978-92-1-148308-6, https://www.incb.org/documents/Publications/AnnualReports/AR2018/Annual_Report/Annual_Report_2018_E_.pdf. Chapter I, box 1, some key terms
(4) Bibliography cited in the report referred to in footnote 3:
– National Academies of Sciences, Engineering, and Medicine (2017). The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research (Washington, D.C., National Academies Press).
– WHO (2016). The Health and Social Effects of Nonmedical Cannabis Use.
– Leslie L. Iversen. The Science of Marijuana, 2nd ed. (Oxford, Oxford University Press, 2008)
(5) Dario Dongo. Natural CBD, delirium tremens in Brussels. GIFT(Great Italian Food Trade). 8.8.20. V. Note 3, at https://www.greatitalianfoodtrade.it/mercati/cbd-naturale-delirium-tremens-a-bruxelles
(6) Customs and Monopolies Agency, Director’s Determination 13.10.20, protocol 350874/RU, https://www.adm.gov.it/portale/documents/20182/5799260/20201013-350874RU-Determina+negotiations+liquids++13-10-2020.pdf/8c7aec5b-c003-4f15-9a76-0cafc0088313?version=1.4
(7) Dario Dongo. Industrial hemp, the bluff of the United Sections of Cassation. GIFT(Great Italian Food Trade). 12.7.19, https://www.greatitalianfoodtrade.it/consum-attori/canapa-industriale-il-bluff-delle-sezioni-unite-di-cassazione
(8) The theorem on the taxability of the list on closer inspection responds neither to the text of the law nor to its rationale. V. Dario Dongo. Industrial hemp, narcotic Cassation in United Sections. GIFT(Great Italian Food Trade). 5/31/19, https://www.greatitalianfoodtrade.it/mercati/canapa-industriale-stupefacente-cassazione-a-sezioni-unite
(9) The Customs and Monopolies Agency then requires holders of the cited licenses to submit a self-certification, by 13.11.20, pursuant to Law 445/00. With commitment to refrain from selling any product derived from hemp. Pending the ECJ’s ruling on the legality of the ban on the sale to the public of CBD legally placed on the domestic market (ECJ Case C-633/18. See footnote 4 to the article cited in footnote 5)
(10) The EU Farm to Fork strategy particularly insists on the need to increase the shares of UAA (Utilized Agricultural Area) devoted to organic farming. And this is one of the vocations of a resilient plant like Cannabis Sativa L. V. https://www.greatitalianfoodtrade.it/progresso/speciale-farm-to-fork-la-strategia-presentata-a-bruxelles-il-20-5-20
(11) Reg. EC 178/02, so-called General Food Law, in fact excludes from the notion of food both medicinal products and psychotropic substances (Article 2)
(12) Pursuant to reg. EU 2015/2283, so-called Novel Food Regulation
(13) Amazon Enters CBD Retail Market – But Only In One Country. BusinessCann. 12.10.20, https://businesscann.com/amazon-enters-cbd-retail-market-but-only-in-one-country/
(14) Blair Gibbs, Andrew Yates, Jon Liebling, Saoirse O’Sullivan (2019). CBD in the UK. Centre for Medical Cannabis. Executive Summary, %20Summary%
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.