CBD classified as narcotic in Italy, with products ordered off market

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[This decision has since been reversed: Read about it here]

CBD has been classified as a narcotic in Italy, with officials simultaneously banning the compound from the Italian market.

Under a recent decree issued by the Ministry of Health, CBD was officially added to the country’s list of medicines; a separate order from Italy’s Customs and Monopoly Agency, which quickly followed, warned retailers “not to hold and sell . . . inflorescences (flowers), oils and resins or other products containing substances derived from hemp sativa.”

Published in Italy’s Official Gazette, the decree adds CBD to the country’s table of medicines as “compositions for oral administration of cannabidiol (CBD) obtained from cannabis extracts.”

Authorization required

“This decree specifies that CBD for oral use extracted from cannabis is in the drug table and can only be produced with the authorization of AIFA (the Italian Medicines Agency),” Giacomo Bulleri, a lawyer who analyzes the Italian cannabis sector and serves as a board member at Federcanapa, an Italian hemp trade group, told the website Fanpage.it. “Therefore the oils on the market for undefined use are illegal,” Bulleri said.

The moves set up an apparent conflict in Italy following a separate recent decree from the Agriculture Ministry that listed hemp flowers for “extraction uses” as an agricultural product, and not a drug.

Epidiolex poised to enter market

Observers have noted that the decree establishing narcotic status for CBD is, in part, preparation for the introduction of Epidiolex, a CBD-based drug whose manufacturer, UK-headquartered GW Pharmaceuticals, has requested authorization to begin selling that product on the Italian market. GW is slowly expanding its distribution of Epidiolex in Europe, with rollouts also afoot in the U.K., Germany, Spain and France. 

Epidiolex has been found to be effective in patients who suffer Dravet Syndrome and Lennox-Gastaut Syndrome, two debilitating forms of epilepsy. GW made cannabis history in 2018 when it earned approval from the U.S. Food & Drug Administration (FDA) for Epidiolex, making it the first cannabis-derived prescription drug to gain federal approval in the United States.

What about smokable hemp?

It remains to be seen what will happen in Italy with smokable hemp, which is based on hemp flowers (“inflorescences”) and therefore not extracted, under the Customs and Monopoly Agency’s stop-sell order. Sold as pre-rolled cigarettes and loose in pouches, smokable hemp has rapidly grown in popularity in Italy and Switzerland over the past couple years.

Hemp inflorescences can also contain hemp seeds, which are technically legal in Italy, raising still further potential confusion. Roughly 80% of Italian hemp production is in food seed, according to a report published earlier this year by the Foreign Agricultural Service of the U.S. Department of Agriculture.

Clouds on Europe’s CBD horizon

The situation in Italy comes amid recent ominous signals in the European Union regarding CBD and other hemp extracts; the European Commission earlier this year issued a “preliminary conclusion” that hemp extracts, including CBD, are to be considered narcotics. While European stakeholders – who were blindsided by the EC decision last July – are known to be pushing back against the Commission’s conclusion, there’s been little indication so far that they’re having any success.

European hemp interests have said if the EC does not change its position on extracts, it could have a drastic negative effect on the CBD sector, and the hemp industry overall.

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