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Australia looks at switching CBD as an OTC medicine, CBDepot becomes the first European firm with an EU Novel Food validation and the UK's Vitality CBD gets a boost from the global, coronavirus-driven wellness trend.
Australia could become the first country to regulate cannabidiol as an OTC medicine, rather than as a food supplement like in the rest of the world.
Currently a Schedule 4 (prescription-only) medicine, Australia’s Therapeutic Goods Administration is currently consulting on whether to switch CBD in preparations for therapeutic use to Schedule 3 (pharmacist-only) under the following conditions:
The CBD is either plant derived, or when synthetic only contains the (-) CBD enantiomer;
The maximum recommended daily dose is 60 mg or less of cannabidiol;
It is sold in packs containing not more than 30 days' supply;
CBD comprises 98 per cent or more of the total CBD content of the preparation;
Any cannabinoids, other than CBD, must be only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the preparation;
For adults aged 18 years and over.
The consultation – which is open until 22 May – follows a five-month TGA “Review on the safety of low dose cannabidiol” which established that CBD had an “acceptable safety and tolerability profile at the proposed dose,” the regulator explained.
Nevertheless, TGA said that down-scheduling to Schedule 3 was more appropriate than Schedule 2 (pharmacy medicine) as “pharmacist advice is necessary to mitigate safety risks associated with CBD's high potential for drug-drug interactions when used concomitantly with many other commonly prescribed drugs that are metabolized via CYP pathways.”
Czech firm CBDepot claims that its synthetic CBD product is the first CBD product in Europe to be associated with a valid European Union Novel Food (NF) Application.
Structurally identical to the pure CBD derived from the cannabis sativa plant, CBDepot received confirmation at the end of March that the European Commission gave a mandate to the European Food Safety Authority to perform a Risk Assessment on CBDepot’s NF Dossier (2019/1371).
The news had “very interesting” implications for the UK market, CBDepot suggested, where the Food Safety Authority recently gave firms operating in the country until March 2021 to submit valid NF applications for their products.
CBDepot has been supplying CBD to UK sellers for several years, the company said, as well to clients in almost every EU member state.
“We believe if CBD’s food use gains full legitimacy, there will be an increase of demand from the long-established food business operators who have not yet offered and CBD-enriched products,” a representative for the firm told HBW Insight.
The UK's Vitality CBD has seen online sales of its CBD oils, sprays and cosmetics rise significantly as a result of the coronavirus pandemic.
Claiming to be the market leader for CBD products in the UK, Vitality said that trade through its Vitalitycbd.co.uk website had more than tripled since mid-March, with this boost continuing into April with an additional 30% rise.
“Without easy access to their local pharmacists and healthcare stores, people are taking action themselves online,” the firm told HBW Insight. “They're also looking for easily accessible natural alternatives to supplement their day-to-day routines.”
Asked whether it thought this trend was sustainable, given the crash in sales of OTC medicines in Europe as countries entered their third month of coronavirus lockdown, Vitality said “we believe that this is a definite sign of things to come.”
“We believe in CBD as a long-term solution and we've consistently seen solid consumer retention,” the company added.
Vitality said it had also seen a marked uptake in its online chat service, as British consumers increasingly turned to wellness solutions as an alternative to pharmaceuticals.
“During this difficult time, people are assessing their wellness routines more than ever before,” the firm explained. “We've found that many users are discovering CBD for the first time as part of a newfound well-balanced lifestyle.”
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