Cannabidiol is classified as a narcotic in Italy, resulting in the ordering of products off the market
Under a recent decree from the Ministry of Health, CBD was officially added to the country's drug list; a separate decree from the Italian Customs and Monopoly Agency, which quickly followed, warned retailers not to own and sell flowers, oils and resins or other products containing substances derived from sativa hemp. As Epidiolex begins to enter the Italian market, the cannabinoid compound CBD has been considered a narcotic in Italy. According to a report published by HempToday earlier this week, Italy put CBD on the country's drug list.
While this may appear to be a positive development, it also has ramifications for retailers looking to sell the cannabinoid compound, with the Customs and Monopoly Agency advising retailers “not to own and sell… inflorescences (flowers ), oils, resins or other products containing substances derived from sativa hemp, ”reported HempToday.
The HempToday report goes on to quote Better Retailing, which claims that around 50% of the brands of CBD in Europe could disappear due to new laws surrounding the compound.
“From March 31, 2021, brands of CBD food, drink, oil and dietary supplements must be able to prove that products placed on the [EU] market before February 13, 2021 have done so. the subject of a validated novel food application to be legally authorized to be sold in stores. This provision only applies to ingested products, which means that the CBD vapor lines are exempt, ”Better Retailing said.
The retail ban on CBD products echoes similar moves New York City took last year, which banned CBD edibles due to companies' exaggerated claims about the benefits of their products. At the time, the FDA publié this declaration.
CBD has been classified as a narcotic in Italy as authorities simultaneously banned the compound from the Italian market
Published in the Italian official journal, the decree adds CBD to the country's list of drugs as “compositions for oral administration of cannabidiol obtained from cannabis extracts”.
“This decree specifies that CBD for oral use extracted from cannabis is listed in the table of drugs and can only be produced with the authorization of the AIFA (the Italian Medicines Agency)”, told the website Fanpage.it Giacomo Bulleri, a lawyer who analyzes the Italian cannabis industry and is a member of the board of directors of Federcanapa, an Italian hemp trading group. “Therefore, oils on the market for indefinite use are illegal,” Mr. Bulleri said.
These measures created an apparent conflict in Italy following a recent decree from the Ministry of Agriculture which classified hemp flowers for “extraction” as an agricultural product, not as a drug.
Epidiolex about to enter the market
Observers noted that the decree establishing the narcotic drug status for CBD is, in part, a preparation for the introduction of Epidiolex, a drug based on CBD whose manufacturer, GW Pharmaceuticals, headquartered in the United Kingdom, has applied for approval to start selling this product in the Italian market. GW is slowly expanding its distribution of Epidiolex in Europe, with deployments also underway in the UK, Germany, Spain and France.
Epidiolex has been shown to be effective in patients with Dravet syndrome and Lennox-Gastaut syndrome, two forms of debilitating epilepsy. GW made cannabis history in 2018 by obtaining approval for Epidiolex from the United States Food & Drug Administration (FDA), making it the first cannabis-derived prescription drug to gain approval federal government in the United States.
What about smokable hemp?
It remains to be seen what will happen in Italy with smokable hemp, which is made from hemp flowers (“inflorescences”) and therefore not extracted, under the stop sale order of the Customs Agency. and monopoly. Sold as pre-rolled cigarettes and loose in pouches, smokable hemp has rapidly gained popularity in Italy and Switzerland over the past two years.
Hemp flowers may also contain hemp seeds, which are technically legal in Italy, further increasing the potential for confu