Italian and European hemp associations say they will jointly challenge a decree by Italy’s Ministry of Health that added CBD to the country’s list of medicines, essentially giving the compound narcotics status in all applications.
Federcanapa, the Italian Hemp Federation, and the European Industrial Hemp Association (EIHA) say they intend to fight the decree in Italy’s Regional Administrative Court, claiming it represents a sweeping ban that fails to recognize any distinction between CBD in industrial and medicinal applications.
Ban is unjustified
“The destinations for industrial hemp – food and cosmetics first of all – are in fact allowed by (Italian) law, within well-defined limits on the use of certain parts of the plant and within defined THC limits in the finished product (zero THC in cosmetics, and limits set by the Ministerial Decree on food of Nov. 4, 2019),” the groups wrote in a statement issued late last week. “The inclusion, without qualification, of hemp extracts in the (Italian) medicines table of the Single Text on Narcotic Drugs involves interpretative doubts that risk to also compromise extraction activities permitted by law.”
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The associations say they will challenge the recently published decree “to highlight the blatant contrast with EU legislation (on the free movement of goods and services) and with the intention of defining – once and for all – the clear distinction that exists between industrial hemp . . . products and narcotic cannabis.”
Ostensibly issued to prepare for the introduction to the Italian market of Epidiolex, a high-CBD medicine that is prescribed for specific debilitating forms of epilepsy, the decree mistakenly implies that CBD is to be considered a narcotic even in products where the compound is present in lower amounts.
The product, made by UK-based GW Pharma, was the first medicinal CBD product to be approved in the United States by the U.S. Food & Drug Administration, and is being introduced in Italy and several other European markets. It has been found effective in the treatment of Dravet Syndrome and Lennox-Gastaut Syndrome, two severe forms of epilepsy.
“GW’s focus has been on this high-dose medical class, and their strategy clear: (to make) Cannabinoid-based pharmaceuticals that come with a pedigree and a prescription, extensive clinical trials and federal approval, targeting specific conditions,” the groups noted in the statement.
While Federcanapa and EIHA agree that high-dose CBD remedies such as Epidiolex should be regulated as prescription-only medicinal products, they stress that non-medicinal CBD in food and supplements is allowed under Italy’s Industrial Hemp Law (242/2016), which has been in effect since 2017.
The lingering confusion
The situation in Italy reflects lingering confusion across the EU over CBD due to unclear guidance from the European Union, and comes after an alarming “preliminary conclusion” issued by the European Commission in August which, similar to the recent decree in Italy, suggests that CBD in all categories should be considered a narcotic.
“We will fight this totally unfair situation tooth and nail both in Italy and at the EU; fight it until we gain reasonable, logical laws that free up these products to benefit the health of EU citizens, and to allow the EU CBD market to thrive,” said Lorenza Romanese, EIHA Managing Director.
At the highest level, European CBD stakeholders point out that the 1961 United Nations Convention on Narcotic Drugs addresses only illicit farming and trafficking of psychoactive high-THC cannabis, which industrial hemp is not.
Additionally, Articles 2(9) and 28 of the 1961 Convention on Narcotic Drugs specifically exempt hemp from the scope of international narcotics controls; that exemption extends to the use of all “drug” compounds present in industrial, non-medical applications. In other words, as long as the flowering and fruit-bearing tops of the plant are not used to obtain high-CBD medicines, but only non-intoxicating products, they are not covered by the provisions of the Single Convention – which serves as guidance only in the medical sector, and not the food or cosmetics sectors.
EIHA’s three-tier proposal
On that basis, EIHA has a long-standing proposal for a three-tier EU regulatory framework for products containing CBD that aims to clear up the current tenuous patchwork of rules covering CBD and hemp extracts that imperil the food, supplements and cosmetics markets. Under EIHA recommendations:
• At high doses, CBD-laced products should be considered as medicinal and should be regulated as such.
• Products with medium levels of CBD should be regarded as over-the-counter products or food supplements, similar to rules governing substances such as valerian, glucosamine, chondroitin (sulfate), Ginkgo Biloba, some vitamins, and iron products.
• Products with low levels of CBD should be allowed in food products without any restrictions.
EIHA has said that classifying natural extracts as drugs will inevitably damage the whole industrial hemp sector and lead to proliferation of a grey market for substandard products that do not adhere to food safety standards and labeling regulations.