SAHPRA, Edibles and the Unfinished Regulatory Puzzle

South African consumers and entrepreneurs continue to encounter a confusing and incomplete regulatory landscape when it comes to cannabis and hemp edibles. Gummies, chocolates, infused drinks, baked goods and related products sit at the intersection of three legal regimes: the Medicines and Related Substances Act (administered in practice by SAHPRA), the Foodstuffs, Cosmetics and Disinfectants Act, and the Cannabis for Private Purposes Act. None of these instruments was written primarily to create a coherent adult-use or low-risk edible market. The result is a patchwork that leaves most commercial edibles in a legal grey zone or outright prohibited pathway.

This article sets out the current position as clearly as the available instruments allow, explains the role SAHPRA plays, and outlines the practical implications for consumers, home producers and anyone considering commercial activity.

1. The Core Scheduling Framework (SAHPRA / Medicines Act)

SAHPRA’s scheduling decisions, particularly those reflected in Government Notice 586 of 2020 and subsequent updates, form the backbone of how cannabinoids are treated as medicines or complementary medicines.

CBD

•  Default status: Schedule 4.

•  Exception for Schedule 0 (lowest control): complementary medicines containing no more than 600 mg CBD per sales pack, providing a maximum daily dose of 20 mg, and making only low-risk claims (general health enhancement, health maintenance, or relief of minor symptoms).

•  Products that exceed those limits remain Schedule 4 and require the corresponding controls.

THC

•  Listed in Schedule 6.

•  Narrow exceptions exist for certain low-THC industrial/processed products and for private adult use of raw plant material in accordance with the Constitutional Court judgment and the Cannabis for Private Purposes Act framework.

•  Psychoactive THC levels typical of recreational or strong medicinal edibles fall under Schedule 6 controls.

In short, SAHPRA’s framework is designed for products that are positioned and regulated as medicines or complementary medicines. It is not a general licence for confectionery or beverages.

2. The Foodstuffs Act Problem

Cannabinoids (including CBD and THC) are not approved food additives under the Foodstuffs, Cosmetics and Disinfectants Act. This has been the consistent legal analysis of specialist practitioners: even a product that meets the Schedule 0 CBD limits cannot simply be sold as ordinary food or drink because the Foodstuffs Act does not authorise cannabinoids as food ingredients.

In March 2025 the Minister of Health published regulations that expressly prohibited the sale, importation and manufacture of foodstuffs containing any part of the cannabis plant or hemp-derived components (including hemp seed oil and flour). The regulations triggered strong industry and stakeholder reaction. Following engagement with the Presidency, the regulations were withdrawn pending further consultation. The withdrawal did not create a new positive pathway; it returned the position to the prior state of uncertainty and prohibition under the general Foodstuffs Act rules.

As of the most recent available reporting, no comprehensive, SAHPRA-led authorisation system for cannabis or hemp edibles sold as food has been finalised and brought into force. Products that make health claims or exceed the low CBD thresholds are expected to be channelled through SAHPRA’s medicines processes. Ordinary food positioning remains blocked.

3. Private Use versus Commercial Sale

The Cannabis for Private Purposes Act and the 2018 Prince judgment protect private adult use, possession and cultivation. An adult may lawfully make and consume edibles at home for personal use within the private-purpose framework. What remains prohibited is commercial dealing — selling, offering for sale, or otherwise placing cannabis or cannabis products (including edibles) into the market without the appropriate licence or authorisation.

This distinction is critical. Home preparation for personal consumption is one legal category. Manufacturing and selling gummies, chocolates or drinks is another, and currently lacks a clear, accessible commercial route outside the medicinal complementary-medicine pathway for low-dose CBD products that meet all Schedule 0 conditions and are properly registered.

4. Practical Consequences

•  Low-dose CBD complementary medicines that stay within the 20 mg daily / 600 mg pack limits, carry only low-risk claims, and are manufactured and registered in accordance with SAHPRA requirements have a defined (if demanding) pathway.

•  THC-containing edibles intended for psychoactive effect have no general commercial pathway. They fall under Schedule 6 controls and the broader prohibition on unlicensed dealing.

•  Hemp seed and hemp-derived food ingredients remain subject to the unresolved Foodstuffs Act position and the policy process that followed the withdrawn 2025 regulations.

•  Unregulated imported products continue to raise public-health and child-safety concerns, which the Department of Health has repeatedly cited as justification for tighter controls.

Commentators across the legal, industry and advocacy spectrum have noted that the current arrangement creates a lacuna: products that are neither clearly regulated as medicines nor permitted as food, yet appear in the market. This situation is unsatisfactory from a consumer-protection, child-safety and regulatory-certainty perspective.

5. What Is Still Missing

Several elements remain outstanding or incomplete:

•  Final, coherent regulations under the Foodstuffs Act (or a dedicated instrument) that either prohibit or permit specific categories of cannabis/hemp food products under defined conditions.

•  Clear packaging, labelling, age-gating and dosing standards tailored to edible formats.

•  An accessible, proportionate authorisation route for low-risk products that does not force every edible through full medicines registration.

•  Alignment between the private-use rights recognised in the Prince judgment and the Cannabis for Private Purposes Act on the one hand, and commercial food and complementary-medicine rules on the other.

Until these pieces are in place, commercial activity in cannabis edibles remains high-risk. Consumers who prepare products at home for private use operate under a different legal umbrella from anyone who manufactures or sells them.

6. Looking Forward

The Department of Health has indicated that further consultation will precede any revised regulations. Parallel work continues on the broader cannabis regulatory architecture, including draft regulations under the Cannabis for Private Purposes Act and ongoing discussions around the National Cannabis Master Plan. SAHPRA’s role is likely to remain central for any product that makes health claims or contains cannabinoids above the lowest thresholds.

For the time being, the safest characterisation is this: private adult preparation and consumption of edibles at home is protected; commercial manufacture and sale of cannabis or hemp edibles lacks a clear, fully operational pathway outside the narrow complementary-medicine route for compliant low-dose CBD products; and the Foodstuffs Act continues to present a significant barrier to treating cannabinoids as ordinary food ingredients.

Anyone considering commercial activity should obtain specialised legal advice that takes account of the latest gazetted instruments, SAHPRA guidance and the current status of the withdrawn 2025 foodstuffs regulations. The landscape remains dynamic and incomplete.