By Anthony Rees – National Chairman (TNHA)
There hasn’t been a week which has gone by recently where I haven’t fielded regulatory queries from frustrated importers and local manufacturers of CBD-containing products. They all want guidance on how to legally sell foods and drinks (edibles) containing CBD, or complain about shipments of imported CBD products being detained by either the Port Health Authority, the South African Health Products Regulatory authority [SAHPRA] and/or the Food Control Directorate of the National Department of Health. Hopefully, this article will assist local CBD product purveyors to navigate the dense thicket of current legalities and the unresolved issues at the government level which frustrate all involved.
CBD IN HEALTH PRODUCTS
Even though CBD [cannabidiol] was removed from schedule 4 drug status under certain limited conditions as a result of our organisation’s efforts through court action and a settlement in May 2019, and conditions thereto were later unilaterally tweaked by the SAHPRA to become ‘complementary medicines’ twelve months later in May 2020, there are still companies selling non-compliant CBD products in the country.
With the recently increased enforcement capacity of SAHPRA, and their placement of inspection staff permanently at an increasing number of ports of entry into South Africa since April this year, an increasing number of shipments of imported CBD products are being inspected for compliance. They are also now enforcing the requirement to obtain SAHPRA import licences to import ‘medicines’.
As a stand-alone CBD-containing product in a pharmaceutical dosage form which may be sold without a prescription to the general public in schedule 0, the following strict conditions apply, according to SAHPRA’s May 2020 gazette notice.
- DAILY DOSAGE – The product may not advise the usage of over 20 milligrams of CBD per day. Product labels must reflect this daily upper limit.
- MAXIMUM PACK CONTENT – A single product sales pack may not exceed 600 milligrams of CBD in total. (20 mg X 30 days)
- MAXIMUM THC LEVELS – The THC [tetrahydrocannabinol] content of any CBD product must be below 1 part per million by volume (0.001%).
- LIMITED HEALTH CLAIMS – Health claims may be placed on product labels, packaging and associated marketing materials, however, these claims are limited to low-risk claims without any reference to specific diseases or symptoms related to these diseases. Only claims for ‘general health enhancement’ and ‘relief of minor symptoms’ are permissible.
All CBD products not within the above-defined exemption limitations are, by default, schedule 4 prescription medicines, and need pre-market authorization (registration) before being sold.
In March 2021 the SAHPRA released a new guideline for comment named “7.06 Complementary Medicines – Specified Substances v3.1“, in which a whole new set of requirements in terms of mandatory labelling and Patient Information Leaflets (PILs) for schedule 0 CBD products will have to conform to. The comments period closed on the 30th of June 2021, however, the final guideline has not yet been released.
We urge all CBD importers and local manufacturers to adhere to the four specific schedule 0 exemption criteria listed above. Failure to do so may result in products being detained, as they will be legally deemed schedule 4 (prescription) medicines. Without products being registered as schedule 4 medicines, importers will have their products seized and may be criminally charged in terms of being in violation of the Medicines and Related Substances Act [Act 101 of 1965]. This means facing heavy fines and/or imprisonment of up to ten years.
* These provisions apply to products in pharmaceutical dosage forms.
SAHPRA are now requiring all schedule 0 health product manufacturers, importers, wholesalers and distributors to apply for Section 22(C) pharmaceutical import licences in order to lawfully participate in the value chain of selling ‘medicines’, irrespective of their scheduling status from schedule 0 to schedule 6.
Although CBD products under the above exemption limitations in schedule 0 were categorised as ‘Complementary Medicines’ in May 2020, and for the fact that the regulations for complementary medicines gazetted in 2017 were declared ultra-vires (unconstitutional and unlawful) by both the North Gauteng High Court and the Supreme Court of Appeal in October 2020 and April 2022 respectively, they remain ‘medicines’ and are being regulated in accordance with the licencing requirements of the Medicines Act.
Therefore if your company currently selling schedule 0 CBD-containing products does not possess a Section 22(C) licence, or has not yet applied for such a licence, your CBD manufacturing, importing, wholesaling, or distributing business is deemed noncompliant, necessitating your CBD products be withdrawn from the market.
This is one of the new reasons SAHPRA inspectors at our ports of entry are blocking shipments of CBD products currently.
CBD IN FOODSTUFFS & DRINKS (EDIBLES)
Now that I have shared the details on how to legally sell schedule 0 CBD-containing products in pharmaceutical dosage form, I’m the bearer of bad news (don’t shoot the messenger) for all those importing and selling CBD-infused foods and drinks, hereafter referred to collectively as “edibles”.
Since our January 2020 article detailing the illegality of selling such products, the unfortunate status quo remains. To date, the Food Control Directorate of the National Department of Health deems CBD edibles illegal and has not provided definitive or rational reasons for their delay in making an informed policy decision in this regard.
They still have not reached a decision on whether to approve CBD as an ‘approved additive’ in terms of the Foodstuffs, Cosmetics and Disinfectants Act [Act 54 of 1972]. Various members of the industry have been actively lobbying for CBD under SAHPRA’s schedule 0 limitations to be included in the official list of approved additives in foods and drinks, however, the Directorate is not budging. The result of the decision to not approve CBD edibles is now leading to a significant increase in shipment seizures of these products at ports of entry by the Port Health inspectorate.
The TNHA are aware of many companies which have recently had their shipments seized and have found no resolution between themselves and the Food Control Directorate in this regard. This has led to millions of Rands of CBD edibles having to be returned the foreign suppliers or being forfeited and destroyed. Return shipping fees and product destruction costs are carried by importers.
Over and above this, seized shipments are stored in State warehousing, where storage fees of up to R20,000 per day are being levied while parties haggle over legalities. Obviously, this is an untenable situation for any unsuspecting importer.
Further, we have received new information that local manufacturers of CBD edibles are being targetted with letters from the Food Control Directorate informing them that CBD edibles may not be legally sold and that they must immediately cease distributing such products or face enforcement action under the Foodstuffs, Cosmetics and Disinfectants Act. Whether the Food Control Inspectorate carries out its threat to inspect local distributors and charge offenders remains to be seen.
If your company has had CBD edibles seized by the Port Health Authority in terms of the Foodstuffs, Cosmetics and Disinfectants Act, or been subject to local enforcement action as a manufacturer or distributor, please contact us and let us know. The TNHA and its partner organisations are currently investigating all these issues in order to take up these ongoing challenges at higher levels of government.
We do not believe that the Food Control Directorate of the National Department of Health is acting responsibly, appropriately or lawfully by delaying proper consultation on this issue and in making its final decisions in relation to CBD edibles. We have yet to see any verifiable, scientific reasons for the delay in the approval of CBD edibles in an appropriate, risk-based framework three years after the SAHPRA approved schedule 0 CBD products as daily supplements.