Labat aims high with launch of new cannabis products in SA despite FDA’s safety concerns
The cannabidiol or CBD market in South Africa is set to expand after Labat Africa’s recent acquisition of Miami-owned CBD lifestyle brand Echo Life and the exclusive rights to distribute US pre-rolled hemp smokables Ace & Axle. However, concerns have been raised about the safety of some of the products the company plans to launch.
Herschel Maasdorp, Labat’s group executive for business development, says the company will launch delta-8 products in SA soon. Delta-8 THC (tetrahydrocannabinol) is found in the Cannabis sativa plant.
The US Food and Drug Administration (FDA) cautioned in September last year that delta-8 THC products were not FDA-approved and were considered to carry serious health risks.
A statement on the FDA’s website says it had, between December 2020 and July 2021, received “adverse event reports” from consumers and law enforcement, which involved 22 patients who had consumed delta-8 THC products. Adverse events include vomiting, hallucinations, trouble standing as well as loss of consciousness. Of the 22 patients, 14 had gone to a hospital or emergency room for treatment after ingesting the product; 19 reported adverse effects after ingesting delta-8 THC-containing food products, such as brownies or gummies.
The FDA also states that US poison control centres received 661 “exposure cases” related to delta-8 THC products between 1 January 2018 and 31 July 2021. There was also a single case before this period. Of the 661 cases:
41% involved unintentional exposure to delta-8 THC, and 77% of these unintentional exposures affected patients under 18;
39% involved patients under 18; and
18% required being admitted to hospital, including children who required ICU admission following exposure.
A legal loophole has led to delta-8 still being sold in some states in the US, despite the FDA’s warnings.
‘Toned down’
Maasdorp admits delta-8 is psychoactive but says, “You can think of it as a toneddown kind of psychoactive effect. The possible results of delta-8 include a euphoric high and reduced stress and anxiety. Most people describe a sense of calm [and] increased sensory perception.”
Responding to the FDA statement, Maasdorp says that after consultation with Labat’s medical and technical director, the company decided to include delta-8 in its scientific inquiry into active pharmaceutical ingredients (APIs) by researching various cannabinoids, including the combination of all these APIs to treat various ailments.
“All our products are trialled with our research company Biodata to ensure the safety and efficacy of the medicine and recommended protocols. Delta-8 will not be available on the shelves before it has been cleared by relevant regulations and stakeholders,” he says.
Products of Labat’s SA brand Cannafrica, which include cannabidiol medicinal drops, edibles and supplements, are aligned to SA Health Products Regulatory Authority regulations, whereas Echo Life adheres to standards set out by the US’s FDA.
Labat has several irons in the South African fire, including the imminent acquisition of a fully licensed and operational cannabis cultivation facility.
Maasdorp says the facility would soon receive a permit for full extraction of the plant. Acquisition of the facility will see Labat continuing to supply cannabis flowers to the international market.
“We are establishing part of our Ace Genetics African Genome & Landrace Project at this facility. The … programme deals with essential heritage and landrace genetics that will begin to ensure that the ownership of our indigenous knowledge systems remains in southern Africa. This year will also see the construction of a Labat Healthcare EU-GMP [good manufacturing practice] facility next to the cultivation site,” he says.
Maasdorp estimates that the company will create 2,500 jobs over the next three years via direct and indirect employment on the back of expanding its franchise stores, industrial hemp roll-out plans, redistribution opportunities and farm operations.
Pending regulations
In terms of the Medicines Act, CBD can be freely sold in SA without a prescription as long as it is a complementary medicine that: contains no more than 600mg of CBD per sales pack; provides a daily dose of 20mg; and makes a general health enhancement, health maintenance or relief of minor symptoms claim.
Mirren Sharp, an associate at law firm Webber Wentzel, says processed products made from raw plant material intended for ingestion and containing 0.0075% or less of CBD can also be freely sold. She says there has been a “substantial increase” in CBD products on the market since around May 2019, when the minister of health initially excluded certain CBD preparations from the Schedules to the Medicines Act.
Sharp says certain people were invited to make submissions on the draft Cannabis for Private Purposes Bill in September last year.
“The general tenor of these submissions [suggests] that the bill has not been well received. It is not clear what effect this will have when the bill may ultimately be passed,” she says.
South Africa has several players in the CBD field. Distell and Remgro entered into a joint venture in January 2021, each purchasing a 20% stake in cannabis wellness brand Rethink to form a three-way partnership.
Sharp says there have been incremental shifts in the regulation of the cannabis industry and the state has indicated, via the Draft National Cannabis Master Plan, that the commercialisation of the industry would be desirable for several reasons.
“It isn’t clear at this stage where precisely we’ll end up in terms of regulation, but I think most are hopeful for a framework that facilitates rather than impedes what could be a successful industry,” she says. The African cannabis industry does not just serve domestic consumption. Canadian Instadose Pharma Corp shipped 2,125 tonnes of medicinal cannabis from SA to Macedonia in December 2021.
In August last year, Highland Investments shipped 8.5 tonnes of medicinal cannabis from an outdoor cannabis cultivation facility in Lesotho to Europe. Highland Investments’ MD Mark Corbett told UK-based Cannabis Wealth that he believed this to be one of the largest legal shipments of medical-grade cannabis to date.
Labat recently listed on the Frankfurt Stock Exchange (FSE) with a R300-million cash injection from California-based GR Global Ventures in exchange for ordinary shares, funds of which will be allocated over a three-year period.
David Roque, Labat’s director of retail, says that, as with any emerging industry, there are a lot of new players, some of whom may not comply with regulations.
“Consumers are unaware of the contents of those products and its effects. We place great value in compliance so that the customer knows that Cannafrica and Echo Life products are safe and can be trusted.”
Maasdorp says the “substantial evidence” that supports CBD’s antiviral, anti-anxiety and anti-inflammatory properties make it highly attractive in a global pandemic, although education and research into CBD benefits are ongoing.