‘Dramatic’ scheduling exemption for cannabidiol

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The legal status of cannabidiol (CBD), a compound derived from dagga that is showing up in everything from sore-muscle creams to beer, just changed in South Africa – rather more dramatically than had been expected, reports Business Insider. For the next 12 months at least “preparations” containing CBD will fall entirely outside the scheduling system that controls drugs in South Africa, in terms of an exemption gazetted by health minister Aaron Motsoaledi.

That makes such CBD preparations legal to sell – by anyone, not just pharmacists – without prescription.

The report says this exemption comes with two conditions: the maximum daily dose of CBD must be 20 milligrams or less, and the product cannot claim to cure or treat any specific condition. It may only advertise “general health enhancement”, or “health maintenance”, or promise “relief of minor symptoms”, as long as those symptoms are not linked to a disease or disorder.

Alternatively, manufacturers and retailers can also claim the protection of the exemption for products made “from cannabis raw plant material and processed products” as long as no extra CBD is added, and the final product contains only a tiny fraction of CBD (0.0075%) and a maximum of 0.001% tetrahydrocannabinol (THC), the main psychoactive in marijuana.

Unless renewed, the exemption will expire on 15 May 2020.

The report says the exemption is a dramatic change from the previous status quo, under which special dispensation was required to use any dagga-derived medicine in South Africa – which meant that as of February this year, only 56 people in South Africa had fully legal access to such preparations.

As anticipated, Motsoaledi simultaneously struck CBD from schedule 7 of South Africa’s drug classification system, where it was controlled as strictly as heroin. Instead it is now – outside the temporary exemption – rated as a schedule 4 drug, available from pharmacists under prescription, alongside antibiotics.

The report says potential providers of CBD products in South Africa have objected vociferously to CBD becoming a schedule 4 substance, arguing it should be available freely over the shelf.

 

The Government Gazette notice was published on 23 May but came into effect on 15 May – “for a period of not exceeding 12 months”, says Pam Saxby in a Legalbrief Policy Watch report. The categories of preparations affected include “processed products made from cannabis raw plant material” and any other processed products containing “the naturally occurring quantity of cannabinoids found in the source material”. Such products should contain no more than 0,001% tetrahydrocannabinol and 0,0075% total cannabidiol.

Saxby writes that the other preparations now excluded from the 1965 Medicines and Related Substances Act’s lists of scheduled substances are those containing ‘a maximum daily dose of 20mg cannabidiol with an accepted low-risk … or health claim’. In this regard, reference is made to ‘general health enhancement’ unrelated to ‘specific diseases’, ‘health maintenance’ and the ‘relief of minor symptoms not related to a disease or disorder’. It is not clear from the notice how these preparations or the processed products made from cannabis raw plant material were classified under amendments to the principal statute made by section 1 of the 1991 amendment Act.

 

The Fields of Green for All non-profit company has welcomed in part the announcement, says a Cape Times report. Fields of Green for All director of social activism Julian Stobbs said: “We see it as another incremental step to normalising the plant in South African society. But the schedule change does nothing to stop the sweeping powers the police now have since the Concourt ‘privacy’ judgment. And the fact that there are still cannabis users being harassed, arrested, detained, extorted and treated like animals in cages means we still have a lot of work to do at Fields of Green for All.”

“The South African Health Products Regulatory Authority (SAHPRA) capitulated and the Health Department gazetted a rescheduling of all CBD products. CBD is still in schedule 4 of the Medicines and Related Substances Act. It has, however, been removed from schedule 7, but is now to be considered a no claims health supplement. Really confusing, but it seems like a huge win for the Traditional and Natural Health Alliance and CBD, and may well usher in a more rational approach to the classification of dagga in general,” Stobbs said in the report.

The department said the new exemption was a significant change to the original restrictions of dagga-derived medicine in South Africa, which only allowed a select number of registered people or companies legal access to sell and make such products.

Business Insider report
Legalbrief Policy Watch report
Government Gazette notice
Cape Times report (subscription needed)


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