Everyone seems to be getting in on the business. Mainstream retailers, spas and corner shops are selling cannabidiol (CBD) products - and you’d be hard-pressed to find a market in most parts of the country where cannabis “edibles”, lotions and oils aren’t being offered for sale.
But before starting your own home-grown industry, selling space cakes, lotions and potions, a prominent lawyer, specialising in food science and technology, has warned it’s not a free-for-all.
The law is unambiguous about the allowable levels of CBD and tetra-hydrocannabinol (THC), which are among at least 113 CBDs found in cannabis. And people are falling foul of the law by brazenly selling high-dose CBD products with questionable levels of THC.
On May 27, the SA Health Products Regulatory Authority (Sahpra), the old Medicines Control Council, issued an exclusion notice, stating that the health minister had moved CBD from Schedule 7 classification to Schedule 4 (therapeutic use). This is only for a 12-month period, though, to allow the Health Department and Sahpra time to consult with stakeholders and decide on scheduling.
Schedule 4 medicines and substances are only available on a doctor’s prescription, while Schedule 7s are not generally available to the public.
The minister also removed low-dose CBD from scheduling, because it was normally well tolerated and had a good safety profile, meaning that products with a maximum daily dose of 20mg of CBD and 0.001% of THC are not controlled substances.
Sahpra said it would “closely monitor the compliance with requirements relating to labelling, advertising, manufacture, dosing, purported benefits and sale of CBD-containing products. Based on this monitoring, it would consider any need to call up any CBD products as medicines for registration in terms of section 14(2) of the Medicines Act as may be required.
Erring on side of caution
Last week, online retailer Faithful to Nature removed some of its high-dose CBD products from sale when it was discovered that its Very Strong version of the Swiss oil Cibdol had CBD levels higher than allowable. The recommended dose of Very Strong, 20%, is three to four drops a day, delivering 10mg of pure CBD per drop.
Chief executive Katrien Grobler explained: “All the CBD products available for purchase on Faithful to Nature are well within the 20mg CBD daily limit."
Last week, she issued a press release, stating: “We carefully reviewed the indications of 39 different CBD products to ensure that they meet the new standards, and made updates (on the usage indications) where necessary.
“We really do want to inform and educate consumers on the new regulation, and we are very happy that regulation has been passed. Sadly and paradoxically, a regulation that was passed to make CBD more mainstream and available has resulted in a reduction of availability.”
Ignorance of the law is not an excuse, said lawyer Janusz Luterek. He knew of a well-intentioned couple who thought they might want to get into business by selling unprocessed cannabis and were arrested. “Since the Constitutional Court ruling, they thought it was legal, but the Drugs and Drug Trafficking Act is still in place.”
Luterek has also been approached by a cautious food retailer who wanted to start selling foodstuffs containing CBD, but these are governed by the Foodstuffs, Cosmetics and Disinfectants Act (FCD).
“A key aspect of the FCD is the definition of a foodstuff. A key provision is that a foodstuff is "any article or substance that is ordinarily eaten or drunk by persons" - what we expect to eat - except if it is permitted under the Medicines and Related Substances Control Act as a medicine or a complementary medicine.
The Sahpra notice does not appear to co-ordinate with the FCD Act.
“CBD and cannabis aren’t ordinarily eaten by people. Spirulina, too, is illegal under the act, and it’s widely used as a natural colourant in foods. We’ve had little enforcement of the FCD Act and regulation. As an example, spirulina is not a real risk, and although it might not be legal, no one does anything about it.”
Luterek said the Sahpra notice excluded products with minuscule doses of THC, below 0.001%, and small CBD doses of 20mg for daily use but “your local home industry and grower won’t be able to determine that.
"You need to get a certificate of analysis to determine levels, because if you don’t you could be prosecuted.”
Testing and certification are expensive, so people are taking chances.
If the authorities decide to prosecute, you have to fight it out in court. And once you sell it, it’s no longer considered private use.