CBD edibles, beverages and cosmetic imports are being blocked at ports of entry into South Africa despite a legal exemption for certain CBD-containing products by our medicines regulator.
It has been eight months since our medicines regulator, the SAHPRA, in consultation with the Minister of Health created a special exemption for CBD as an over-the-counter substance for human consumption. This came after our organization broke the CBD’s schedule 6 and 4 prescription-only scheduling status deadlock by instituting court action and reaching an agreement with the SAHPRA to make CBD available to the public without a doctor’s prescription under certain exemption conditions.
Since then, CBD has been freely available under the conditions of the gazetted exemption notice as an over-the-counter or non-prescription substance. A plethora of new CBD-containing products have emerged in our local market, many of which are imported from countries where CBD is also freely available to the public. These are to be found on the shelves of local pharmacies, health shops, as well as online and on the trestle tables of flea markets. As in other parts of the world where CBD has become freely available, importers, manufacturers and marketers of CBD have come up with a myriad of novel ways to market the substance to a broad base of consumers wanting to try it out for themselves. Enter infused edibles and drinkables.
Soon after our local exemption notice was gazetted some CBD importers took advantage of importing CBD-containing foodstuffs (CBD edibles), while others decided to infuse it into locally manufactured alcoholic and non-alcoholic beverages (CBD drinkables). Some companies have also added CBD to freshly prepared meals and beverages at restaurants (Remember the nationally publicized Col‘Cacchio CBD pizza offer?), into baked goods at bakeries and even in coffee served at coffee shops to capitalize on the must-try hype generated in the media about CBD.
In late June 2019 a number of our association’s members began reporting to us in panic and confusion about their imported shipments of CBD edibles, drinkables and cosmetics being blocked at ports of entry by the Port Health Authority.
The Port Health Authority is tasked with checking all imported medicines, foodstuffs, beverages and cosmetics entering our country, and that they are compliant with our Medicines and Related Substances Act (Act 101 of 1965), the Food, Cosmetics and Disinfectants Act (Act 54 of 1972) and their dense thickets of regulations.
Our initial inquiries in this regard led the TNHA to discover that the Food Control Directorate, which is a specialized unit housed within the National Department of Health in Pretoria has instructed the Port Health inspectorate to seize all imported foods, cosmetics and beverages containing CBD and Cannabis-derived ingredients declared on the labels or associated marketing materials. Electronic customs manifests and declarations are easily red-flagged and intercepted based on key worlds these days.
Initially our inquiries were sent to the South African Health Products Regulatory Authority (SAHPRA) as they are the statutory body that had just previously exempted CBD from the medicine schedules and had declared the substance safe to consume.
Importers had made sure that their imports were compliant with all the exemption conditions, for instance certifying the maximum THC content (0.001%/vol), maximum CBD mg per daily serving (20mg), and that no health claims relating to diseases or their symptoms were expressed on labels of associated marketing materials.
One of our importer members contacted Dr Keizer Thembo of the SAHPRA on the 24th of July with a list of the EU-imported CBD cookies, CBD muffins and CBD chewing gums which his company imported from the EU, and were subsequently impounded without reason. He asked for clarification on whether the SAHPRA deemed them registerable medicines, complementary medicines or health supplements. On the following day Dr Thembo responded in writing that in terms of the Medicines Act, its regulations, schedules and the CBD exemption notice published earlier in May, his products were neither medicines, complementary medicines nor health supplements. In reality, they are consumed and therefore must be foods ….. right?
Initial inquiries to the Food Control Directorate were responded to by Malose Daniel Matlala who is the Deputy Director of the Inter-Agency Liaison and Regulatory Nutrition, according to his email signature.
He expressed the current thinking of the Food Control Directorate, which was that Cannabis and parts thereof [including oils and isolates] were scheduled medicines (schedule 4 and 7) in terms of the Medicines Act, and therefore were expressly prohibited in foodstuffs and beverages as per the definition of a foodstuff in Section 1 of the Food, Cosmetics and Disinfectants Act (Act 54 of 1972), which his statutory body enforces.
The food Control Directorate also took the position that the overarching Drugs and Drug Trafficking Act (Act 140 of 1992) prohibited Cannabis and all parts of the plant in products which they regulate, despite no mention of the Drugs and Drug Trafficking Act contained in the Food, Cosmetics and Disinfectants Act at all.
In one phone call with another CBD-importing member of the TNHA a very senior member of the Food Control Directorate [name withheld], asked this of him – “What kind of ethics do companies have displaying the word Cannabis and displaying graphics of Cannabis leaves on their products?. We can’t be displaying this to our children”.
This kind of questioning makes one wonder if these decisions are based on sound and current science in a rapidly growing international CBD market, or a personal bias against all things related to that evil dagga plant.
Below are the legal definitions of a foodstuff (including beverages), and a cosmetic in terms of Section 1 of the Food, Cosmetics and Disinfectants Act.
‘foodstuff’ means any article or substance (except a medicine as defined in the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) ordinarily eaten or drunk by a person or purporting to be suitable, or manufactured or sold, for human consumption, and includes any part or ingredient of any such article or substance, or any substance used or intended or destined to be used as a part or ingredient of any such article or substance.
‘cosmetic‘ means any article or substance [except a medicine as defined in the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) intended to be rubbed, poured, sprinkled or sprayed on or otherwise applied to the human body for purposes of cleansing, beautifying, promoting attractiveness or improving or altering the appearance, and includes any part or ingredient of any such article or substance.
For the Food Control Directorate to use the excuse that CBD is a scheduled substance (medicine), and therefore may not be used as a food ingredient is unsustainable, as many vitamins, minerals, amino acids, probiotics and other natural health substances are also found in the medicines schedules yet allowed to be used to fortify common foodstuffs in low daily dosages. CBD under 20mg per day in foods, beverages and cosmetics should be no different, according to its well-established safety profile.
Despite the May 2019 exemption notice for CBD within certain perimeters clearly exempting CBD from the “medicines” schedules, and not being deemed a medicine within the exemption perimeters based upon current scientific facts relating to its safety and de minimus risk presented by the TNHA in High Court documents lodged in the review of the 2017 scheduling of CBD, and for the products in question being declared neither medicines, complementary medicines or food supplements by the SAHPRA, the Food Control Directorate point blank refuses to allow CBD to be used as a food, beverage or cosmetic ingredient (additive). No succinct substantiation for their blockade frustratingly enforced by the Port Health Authority has been forthcoming for over seven months now.
All through to August the Food Control Directorate continued to impose its import embargo on CBD-containing foodstuffs, beverages and cosmetics without any written reasons. At one point the police (SAPS) took samples of imported CBD-containing foodstuffs on the instruction of Mr Jean Le Roux a senior inspector of the Port Health Authority, and had them tested in their laboratories in Pretoria. Captain Marshall of SAPS ordered the relevant testing. The State forensic lab results indicated that all the CBD-containing imports tested were within the legal exemption notice perimeters and were NOT medicines. He then called for the release of the products. The Food Control Directorate refused to sign the authority to release the shipment. Due to the perishable nature of these types of goods, they were returned to the sender at the importer’s own cost. Others have not been so lucky, with many products perishing and becoming worthless.
Later in September, CBD-importing members attempted to engage with the Food Control Directorate to try ascertain when their ‘experts’ would reconsider their actions after a broad-based consultative forum called by the Director General of the Department of Health few weeks prior in order to review the way forward for Cannabis and Cannabis-derived products. The SAHPRA, Food Control Directorate and a representative our TNHA CBD team attended. To date there has been no response and CBD-containing foodstuffs, beverages and cosmetics are still being blocked. Importers are given the option to legally challenge the blockade (an expensive and time-consuming exercise), or return the goods to the sender (the cheaper and easier option). Costly storage fees are also levied at the state warehouse if products are not released.
The result of this blockade is that the South African public are being denied access to imported CBD-containing edibles, drinkables and cosmetics, which are ubiquitous and consumed by millions of people in many parts of the developed world.
It is estimated that the CBD edible market will be worth U.S. $4.1 billion by 2022 in the USA alone, as the popularity of the ingredient in functional foods increases. The Google annual search report in 2018 showed that CBD gummies was the third most searched-for term under the food category, proving the popularity of CBD in this form. From chocolate and sweets to beer, wine, and even hummus, the list is ever-growing. The health benefits of CBD and tax benefits to the fiscus are denied due to an out-of-date and out-of-touch bureaucracy dictated by 1965 and 1992 apartheid legislation and apparent bias against the cannabis plant.
The TNHA is handling matter in a serious light. The Food Control Directorate is a creature of its statute (Act) and is clearly overreaching in its mandate by blocking imports of foodstuffs, beverages and cosmetics containing CBD, considering the reasonableness and science-based SAHPRA exemption framework.
There is no justifiable reason or rationale to place a blanket ban on a substance which has an unblemished safety record in low daily intakes without psychoactive or dependence-forming properties. CBD is NOT a medicine or a drug. CBD is arguably safer and more tolerable than alcohol and many other questionably approved food ingredients, preservatives, colourants and allowable food pesticide and herbicide residues allowed commercially.
The TNHA is considering taking legal action against the Food Control Directorate and the Department of Health to review their obstructionist actions in this regard.
If you or your company imports, manufactures, distributes or retails CBD-containing foodstuffs, beverages or cosmetics you need to join the TNHA in order to keep abreast of these developments. You can rely on the TNHA and its experts to act on your behalf in these matters. It is clear that the Food Control Directorate deems all of these products illegal and will do whatever is necessary to stop their import and sale in South Africa.
We are concerned that the Directorate may soon institute enforcement action against local producers and purveyors of CBD-containing foods, beverages and cosmetics. The TNHA stands ready to rigorously oppose any such action, but more importantly to have the decisions of the regulator legally reviewed and to work proactively in drafting new guidelines for future regulation with stakeholders. To join the TNHA and support its legal actions, click here.
This is an unfolding story.
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