The South African consumer’s non-prescription access to CBD has legally come to an end.
On the stroke of midnight on Friday the 15th of May, over-the-counter Cannabidiol (CBD) containing products which have been freely traded in South Africa reverted back to being Schedule 4 medications requiring them to be registered and sold with a doctor’s prescription, despite there being no registered (legally approved) prescription CBD medicines available in South Africa.
This situation is due to the 12-month exemption notice for certain CBD products expiring without an extended exemption despite the substances impeccable safety profile.
This places importers, contract manufacturers, wholesalers, distributors and retailers which sell CBD products in a precarious position, not knowing whether they may continue to sell CBD products legally or not. By default CBD now reverts to being a schedule 4 substance exclusively in terms of the Schedules of the Medicines Act.
Selling unregistered medicines is a criminal offense under Section 29 of the Medicines and Related Substances Act (Act 101 of 1965).
The entire CBD product value chain now requires pharmaceutical trade licenses or pharmacy licenses to sell CBD products legally.
The only legal means now for consumers to obtain CBD products is to first obtain a prescription from a doctor and then have their doctor make an application to the Director-General of the Department of Health for a Section 21 Exemption permit to import the product legally for a three month period.
In May last year a special exempted category of CBD products was created after our organization took the South African Health Products Regulatory Authority (SAHPRA) and Minister of Health to court. In a last minute round-table meeting between the SAHPRA and the TNHA’s legal representatives, a historic agreement was reached in good faith to exempt CBD from the schedules under specific trade conditions. These included:
- The daily CBD dosage of the product could not exceed 20mg.
- The amount of tetrahydrocannabinol (THC) could not exceed 1 part per million (0.001%) by volume.
- The product labels and associated marketing materials could not contain health claims for diseases or serious symptoms, and could only refer to approved low risk ‘well-being’ claims.
In a short space of a year under the liberalized exemption framework the CBD marketplace in South Africa has grown considerably. There has been a plethora of new local and imported CBD products entering the market, and a vibrant, fast maturing marketplace has ensued. This brought about many entrepreneurial success stories and employment opportunities.
The public have enjoyed the freedom to choose CBD products freely, and have gained many health benefits from them.
To date the SAHPRA has not conveyed any reservations about new safety concerns related to CBD products in the market, nor raised any compliance issues with industry bodies. The TNHA are not aware of any reported harms relating to CBD containing products in South Africa which warrants the substance being tossed back into the legal basket of high risk medications requiring a doctor’s prescription and supervision.
The only stumbling block for the local CBD industry over the past year has been the reluctance of the National Department of Health’s Food Control Directorate to approve CBD as an ingredient (additive) in foodstuffs and beverages, bringing us into alignment with other countries who have developed safe and varied ‘edibles and drinkables’ markets.
WHERE TO NOW FOR CBD?
The SAHPRA has received various regulatory proposals for CBD and hemp-seed oil from representative industry associations leading up to the expiry of the exemption notice.
With the expiry date of the exemption notice having come and gone our organization will now urgently attempt to engage with the SAHPRA and Minister of Health to seek the reasons for this lapse.
With the regulator’s heads wrapped up by COVID-19 and lockdown creating logistical challenges it is possible the deadline was merely an oversight, or the result of the SAHPRA and Minister not having the time to consider stakeholder proposals for the continued use of CBD as an over-the-counter substance in consumer products.
The CBD industry and millions of CBD consumers need clarity on the future status of CBD and its continued access Now!
Many South Africans now rely on CBD for the maintenance of good health and will undoubtedly suffer without continued free access to the substance. Other users may have experienced the reversal of serious health conditions. We therefore argue that the harm created by arbitrarily removing the product from the free market without a cogent scientific or risk-based reason being expressed could result in being deleterious to the health of CBD users. This is a risk which we believe far outweighs any demonstrable risk the substance poses itself under the existing low risk exemption framework.
Should no answers be forthcoming from the SAHPRA and Minister of Health after our inquiries are made, the TNHA will have no choice but to proceed with the court case we launched before the exemption, and on an urgent basis.
If you are a CBD user and have experienced benefits from CBD, please let us know by means of a testimonial. If you import, manufacture, wholesale, distribute or retail CBD we would like to hear from you, so we can keep you abreast of the latest developments and receive your feedback.
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