“It Makes No Sense!” Private Sector Bewildered and Dismayed By SAHPRA’s Definition of CBG as a Psycho-Active Substance.
Leading stakeholders say SAHPRA’s classification of CBG as a Schedule 6 substance adds to regulatory confusion and has set back prospects for growth. In addition there appears to be little evidence-based thinking behind the scheduling which further blurs lines between Government departments.
15 February 2023 at 11:00:00
Quotes in this story are sourced from a BusinessLive. article by Thabiso Mochiko on 12 February 2023.
The South African Health Regulatory Authority (SAHPRA) has yet again come under fire from the private sector, who have accused the body of nonsensical thinking after it classified a cannabis oil compound as a prescription medicine.
“We've moved backwards because now they are saying even the non-psychoactive cannabinoids are schedule 6, which makes zero sense and is outside what's happening globally,” said Gabriel Theron, CEO and founder of Cilo Cybin.
Theron said hemp farmers started producing CBG because it was not regulated and is in high demand globally.
Labat Healthcare Business Development Director Hershel Maasdorp has pointed out that hemp produces CBG and that hemp regulations fall under the Department of Agriculture, Land Reform and Rural Development (DALRRD). Even though CBG may be categorized as a medicine, it was a compound prevelant in hemp.
“By strict definition, SAHPRA does not preside over hemp cultivation,” he said.
Warren Schewitz, CEO of Goodleaf Wellness, which recently listed some of its products on US e-commerce group Amazon, said the dosage limitations could also hamper local companies' ability to grow globally. It also deprived consumers of experiencing the calming effects of CBD. He said South Africa has the lowest recommended daily dosage of CBD while, for example, Australia is on 150mg and the UK on 60mg.
“Its surprising that this has not been reviewed,” he said.
“There is a huge opportunity in the industry and it needs to be enabled by the government. But we recognise that it is a challenging process [as] there are multiple stakeholders involved and we hopeful that with co-ordination we will get there.”
Shewitz said while the Government has put focus on the sector, “unfortunately, globally, things are moving quickly, and South Africa could lose out on investment opportunities because of a lack of a clear road map”.
Maasdorp said the sluggish regulatory process was due to cannabis’s stigma as a narcotic tied to illicit trading. Development banks and potential financiers were reluctant to invest in cannabis because of its legacy reputation, which is not yet dealt with as a new and emerging economic sector.
“They do not yet have a clear picture of what the commodity can bring to the economy.
“It is a double-edged sword where the government must ensure it creates an enabling environment and that the industry collaborates and brings the funders and financiers, still reluctant to invest due to its reputation, into the fold,” said Maasdorp adding that the absence of a “sophisticated policy framework is an absolute indictment on government and state agencies”.
SAHPRA spokesperson Yuven Gounden said “the industry or any other person or association may make submission to SAHPRA to request review of the scheduling status of a substance, in line with existing published guidelines”.
He said all cannabinoids structurally related to THC fall under schedule 6. CBG “is a homologue” of THC, meaning it also produces a psychoactive effect.
SAHPRA’s classification of CBG as a psychoactive compound means that a doctor’s prescription is required for any application for use as a medicine, even though there’s no CBG product on the shelves that has any mind-altering effect.
President Ramaphosa’s commitment in his State of the Nation Address (SONA) on 9 February 2023 to “unlock enormous economic energy in the rural areas of the country, especially in the Eastern Cape, KwaZulu-Natal and Mpumalanga,” will be all the harder to fill given the SAHPRA decision on CBG.
He said urgent work was being finalised by government to create an enabling regulatory framework for complimentary medicines, food, cosmetics and industrial products, aligned to international conventions and best practices.
Somebody should tell SAHPRA!
Regulatory Uncertainty Bites SA's Biggest CBD Brand, Goodleaf Temporarily Pulls It Range From The Shelves
Goodleaf says SAHPRA restrictions on dosages and packaging have pushed it into an uncompetitive corner. It says it's pulling its range off the shelves until there's more regulatory certainty in the cannabis market.
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