Goodleaf CEO Calls for Urgent Changes to Medicines Act while Government Gets Its Act Together on Broad Cannabis Policy
Current CBD scheduling restrictions are not evidence-based
Brett Hilton Barber
4 May 2022, 22:00:00
Current CBD scheduling restrictions are not evidence-based
Goodleaf CEO Warren Schewitz says the current CBD dosages allowed by the Medicines Act are “illogical” and have no “rational or scientific basis” and are “out of line with international regulations. In a hard-hitting opinion piece in Business Day, the founder of one of the largest CBD consumer brands in Africa called on Government to urgently amend the Medicines Act in order to meet its own goals of developing a cannabis economy.
Read Warren Shewitz’s full opinion piece here
He wrote that “the government needs to tackle the red tape that is impeding the sector in SA, in particular the medicinal cannabis sector. Perhaps most restrictive are the CBD dosage regulations contained in the Medicines Act.
On May 22 2020, the health minister, acting on the recommendation of the SA Health Products Regulatory Authority, decided to change these regulations. While CBD is generally classified as a schedule 4 substance, the following preparations of CBD substances were reclassified as schedule 0 substances:
Cannabidiol “in complementary medicines containing no more than 600mg cannabidiol per sales pack, providing a maximum daily dose of 20mg of cannabidiol, and making a general health enhancement, health maintenance or relief of minor symptoms [low-risk] claim”.
Cannabidiol “processed products made from cannabis raw plant material intended for ingestion containing 0.0075% or less of cannabidiol where only the naturally occurring quantity of cannabinoids found in the source material are contained in the product”.
Going backwards thinking its forwards
“While on the face of it this would appear to have been a progressive move by the government, the 20mg maximum daily dose restriction is illogical, has no rational or scientific basis, and is out of line with international regulations. Naturally occurring CBD is safe and well tolerated in humans (and animals) and is not associated with any negative public health effects, with oral doses of up to 800mg a day having been proven to be safe.”
He wrote: “the World Health Organization (WHO) report that found no adverse health outcomes and several medical applications for CBD. The report states that CBD does not induce physical dependence and is “not associated with abuse potential”. It further notes that “unlike THC (the main psychoactive compound in cannabis), people are not getting high off of CBD, either”. The report concludes that “there is no evidence of recreational use of CBD or any public health related problems associated with the use of pure CBD. In fact, evidence suggests that CBD mitigates the effects of THC (whether joyous or panicky).
“We hope SA’s cannabis master plan, published in 2021, will create more policy certainty and an environment that is conducive for the development and growth of the local cannabis industry over the longer term. However, the government could take some immediate steps to increase the competitiveness of the industry, in particular the medicinal cannabis sector, over the short term, while the longer-term policy framework is finalised and implemented.
‘Increase 20 mg threshold to 150 mg’
Critically, the government should amend the Medicines Act to increase the 20mg maximum daily dose threshold of CBD to 150mg, for it to be classified as a schedule 0 substance. There also needs to be far more clarity on the disbursement and regulation of medical cannabis, including the opening of licensed dispensaries for medical cannabis products as well as the cutting of red tape that is preventing the movement of cannabis products within the country.
Schewitz said there were “a number of restrictive and misplaced regulations in place that were hobbling the local commercial cannabis value chain, including the manufacture of cannabis products and their sale locally and overseas. This is where billions of rand in revenue and thousands of new jobs could be created”.
The WHO has determined that CBD has been demonstrated as an effective treatment for epilepsy, and there is preliminary evidence that it can be useful for treating a number of other serious conditions, including cancer, psychosis, Alzheimer’s disease and Parkinson’s disease. It is for these reasons that countries across the world have approved much higher maximum daily dosage thresholds. For example, the Australian Therapeutic Goods Administration has approved low-dose CBD containing products up to a maximum of 150mg a day.
However, despite the SA public health system being under severe pressure, with many citizens struggling to access treatment and medication, they do not have the alternative option of access to over-the-counter products that contain enough CBD to be of benefit to their health. This heavy-handed restrictive approach is also being followed by the government when it comes to foodstuffs and cosmetics containing cannabis, another missed opportunity for the local industry and the SA economy.
Goodleaf says, “Make it easier for us to create more jobs!”
He wrote that Goodleaf, SA’s first commercial cannabis operation, is “committed to contributing towards the growth of the local cannabis industry and has already invested significantly in the sector, creating more than 100 jobs. With an enabling environment, the company plans to invest an additional R250m into the local industry over the next few years, which will create a further 150 jobs across the cannabis value chain.
We are also committed to working with the government to ensure an inclusive and responsible cannabis medicinal and recreational market, and have several proposals in this regard. For example, to ensure the inclusion, sustainability and profitability of small-scale cannabis growers in the Eastern Cape and KwaZulu-Natal, there should be a clause in the regulatory framework that stipulates that a percentage of inputs for the extract market are purchased from rural growers.
As a country, we have what it takes to make SA’s cannabis sector flourish. If the government and private sector work together to create a progressive and enabling policy and regulatory framework, nothing should hold us back”.
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