Regulatory experts at Webber Wentzel educate us on the recent change in CBD regulation: if CBD products contain less than 20mg for a daily dose, they will be considered over the counter products.
Constitutional Court ruling
Since the Constitutional Court, in September 2018, effectively decriminalised the possession, use and cultivation of cannabis in private dwellings in South Africa, there has been a rapid surge of cannabidiol (CBD)-containing products on the South African market.
CBD is an active non-psychoactive ingredient within cannabis which cannot make users of the product “high” as is the case with THC. THC is the other ingredient found within cannabis. The reported therapeutic benefits of CBD have resulted in it being featured in products, ranging from wellness, to dog treats and even in your morning smoothie.
The surge in CBD products was also spurred on by the uncertain and difficult regulatory regime that suppliers and distributers found themselves navigating.
Change in CBD regulation: from scheduled substance to OTC
CBD was considered a scheduled substance in terms of the schedules to the Medicines Act. This meant that products that contained CBD and were intended for therapeutic purposes could only be sold by pharmacists to consumers who held a prescription. This view was emphatically publicised by the South African Health Products Regulatory Authority (SAHPRA) in the media.
The Department of Health has since made a turnaround, by creating a significant space for CBD products to be sold to consumers. As of 23 May 2019, all products that contain a maximum daily dose of 20 mg of CBD, and are intended for general health enhancement or relief, are exempted from the operation of the schedules to the Medicines Act.
Arguably, products that fall within this threshold that are intended for therapeutic uses may still be required to register as complementary medicines with SAHPRA. But, once registered, will be capable of being sold directly to a consumer. In other words, CBD products which contain less than 20mg for a daily dose will be considered over the counter (OTC) products and may be sold openly in pharmacies, wellness stores and other outlets.
All products that contain a daily dose of more than 20mg of CBD will still be considered a scheduled substance in schedule 4 of the Medicines Act and would require a prescription to be sold.
Implications for commercial use of new CBD regulation
Notably, all processed products that contain naturally occurring CBD and THC (provided that no more than 0,0075% of the product contains CBD and not more than 0,001% of the product contains THC) may now be sold to consumers without any restrictions.
This change in the CBD regulations has implications for the commercial use of CBD in the manufacture of other products, including foodstuffs and alcohol. Before the recent amendment, consumer products, such as beer brewed from hemp seeds; hemp seed protein; hemp cooking oil; and even flax seeds were classified as scheduled substances by the authorities due the presence of trace amounts of CBD in these products.
The Department of Health’s announcement changes the legal status of these products and removes them from the strict regulation of the Medicines Act. These products may still, however, be subject to other regulatory regimes that govern foodstuffs and liquor.
These changes in the CBD regulations are exciting to the consumer sector and are music to the ears of suppliers of CBD products giving them scope to introduce their products into South Africa more easily. It will be interesting to keep an eye on SAHPRA’s attitude to the changes given that they will no doubt be flooded with registration applications in the coming months.
Exemption applies for one year only
While these changes signify the Department of Health’s relaxation of the regulation of CBD, the exemption applies for one year only. This signals that government is adopting a wait-and-see-approach before committing firmly to a policy position on CBD.
After last year’s Constitutional Court ruling, cannabis will also be squarely on Parliament’s agenda as they have been ordered to make changes to the laws regulating the private use of cannabis. This presents an opportunity for the public’s voices to be heard, not only regarding the private use of cannabis but also in shaping the approach to the commercialisation of cannabis derived products in South Africa going forward.
The recent change to the legal status of CBD, together with the issue of the first three licences to cultivate cannabis for medical use earlier this year by SAHPRA, signals a shifting perspective on the role of cannabis which will hopefully pave the way for the expansion of the cannabis market in South Africa in the near future.
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Megan Adderley has experience in judicial review proceedings in the High Courts and litigation relating to municipal powers and functions, providing strategic advice to private sector clients in negotiations with organs of state, preparing and presenting training workshops for local government officials, assisting in drafting the legal aspects of various government policies, advising on co-operative governance responsibilities of various organs of state and conducting due diligence investigations on potential projects and developments. She advises a wide range of clients including all spheres of government and private sector on the administrative and criminal enforcement of environmental, heritage and planning laws. Megan also advises non-profit clients on a wide variety of administrative appeals and reviews, and industry associations on the constitutionality of proposed amendments to legislation.
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Rodney Africa specialises in all matters relating to procurement, local government and general administrative law. He also practices constitutional, public private partnership and general regulatory and compliance law. Rodney has advised clients from both the public and private sectors, and has been involved in various matters relating to procurement, access to information, public decision making, public finance management, the valuation and rating of properties, and all aspects of land use planning and development law. He is an expert in matters involving the public sector and has advised on regulatory matters in a variety of industries. Rodney has extensive experience in litigation in respect of the above areas of law, with a specific focus on judicial review and mandamus applications, tender disputes, interdicts and declaratory relief. He has been a member of the audit committees of various local government departments.
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Deerah Pillay-Lungoomiah focuses on of public and regulatory law, administrative and constitutional law. She also has experience in advising on procurement law related matters. From a regulatory perspective, she has particular expertise in transport, renewables, tourism, tobacco and fishing.
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Adriano Esterhuizen is an expert in procurement, local government law, administrative law and constitutional law. He has extensive experience in dealing with matters relating to property rights, procurement, environmental law, land use planning law, legislation relevant to municipal governance, as well as general statutory and regulatory compliance matters. His services are open to public and private sector clients. He regularly litigates in both the Magistrates’ and High Courts and is able to assist clients with specialist review applications, tender disputes, interdicts and declaratory relief.