On 11 April 2022, the Supreme Court of Appeal in Bloemfontein handed down a significant judgment in the matter of Minister of Health and Another v Alliance of Natural Health Products South Africa. The ruling has become one of the key modern authorities on the limits of SAHPRA’s regulatory power over natural health products.

The court did not rule that vitamins, herbal remedies, or wellness products are unregulated or unsafe. What it made clear is that regulators cannot declare products to be “medicines” by regulation if they fall outside the statutory definition contained in the Medicines and Related Substances Act.

The regulations in question were found to be ultra vires, beyond the powers granted by the Act. The Minister and SAHPRA had attempted to bring a broad range of complementary products under the full medicines regime. The SCA ruled that this overreach was unlawful.

Importantly, the court suspended the declaration of invalidity for 12 months, recognising the public interest in proper safety and consumer protection while giving government time to fix the defective framework.

The judgment was officially handed down on 11 April 2022 by the Supreme Court of Appeal in the case: Minister of Health and Another v Alliance of Natural Health Products South Africa Case No. 256/2021 Citation: [2022] ZASCA 49

Following the judgment, SAHPRA confirmed that the existing regulatory system would continue operating during the twelve-month suspension period granted by the Supreme Court of Appeal. Applications, licensing procedures, Section 21 authorisations, complementary medicine registrations, and health supplement reviews continued under the prevailing framework while government prepared amendments intended to address the legal defects identified by the court.

In March 2023, the Department of Health published proposed amendments to the General Regulations to realign the framework with the findings of the SCA.

Among the most significant proposed changes was the restructuring of complementary medicines into a more formalised Category D regulatory model. The amendments represented an attempt to preserve oversight of the sector while narrowing the gap between the wording of the regulations and the statutory powers contained in the Medicines and Related Substances Act.

The proposed amendments, however, triggered continued concern within parts of the natural health, wellness, and supplement industries. Critics argued that aspects of the revised framework continued to extend beyond the powers granted by the Medicines Act and raised questions regarding enforceability after the expiry of the twelve-month suspension period in April 2023. This debate further exposed the growing tension between public health regulation, consumer access, constitutional rights, and the rapid expansion of the wellness economy.

Despite the legal uncertainty, SAHPRA continued exercising oversight over health supplements, complementary medicines, imported wellness products, and Category D formulations through licensing systems, transitional measures, regulatory guidance, and administrative review processes. This ongoing regulatory position carried substantial implications for the cannabis and broader natural health sectors, particularly in relation to CBD wellness products, herbal tinctures, mushroom formulations, nutraceuticals, vitamins, terpene blends, and functional wellness products entering the South African market.

The central legal and policy question emerging after the 2022 judgment remains unresolved: where does wellness end and medicine legally begin? That distinction now sits at the centre of South Africa’s cannabis, complementary medicines, and wellness product industries, shaping the future of regulation, market access, consumer protection, and commercial development across the sector.

H3 Legal Solutions has consistently maintained in its cannabis policy submissions and white paper proposals that clear packaging, labelling, and product classification standards are essential to resolving the regulatory uncertainty identified in the Alliance judgment.

The H3 framework directly addresses the distinction between medicines, complementary products, and wellness formulations by promoting truthful product representation, transparent cannabinoid disclosure, responsible dosage guidance, consumer safety warnings, and strict limitations on unlawful therapeutic claims. Rather than relying on broad regulatory assumptions, the proposed model supports a risk-based system in which product classification is determined by measurable factors including cannabinoid content, intended use, route of administration, and the nature of the claims made to consumers.

The framework further recognises that compliant businesses require legal certainty in order to operate responsibly within the cannabis economy while consumers require accurate information capable of distinguishing between wellness support products, complementary health formulations, and products intended for therapeutic or medical use. In this respect, the H3 white paper seeks to provide a practical regulatory bridge between constitutional rights, consumer protection, lawful market participation, and the realities of South Africa’s emerging cannabis sector.

Why is This Judgment Critical for Cannabis Products

Cannabis-derived products sit squarely at the intersection this case addresses. Whether a product is treated as a medicine, a complementary product, a wellness supplement, or a controlled substance depends on several practical factors: its ingredients, THC and CBD levels, dosage form, and most importantly the claims made about it.

1.       Medicines

A cannabis product is regulated as a medicine when it is presented as diagnosing, treating, mitigating, preventing, or modifying any disease or condition. Claims like “treats anxiety”, “provides pain relief”, “helps with epilepsy”, or “treats insomnia” trigger full SAHPRA registration and oversight under the Medicines Act.

2.       Complementary Medicines (Category D) Some cannabinoid products have historically been positioned in this category, particularly lower-risk herbal extracts and tinctures. The SCA judgment reinforces that even these must still fit within the legal definition of a medicine — they cannot be swept in by regulation.

3.        Health Supplements & Wellness Products that avoid disease-treatment claims and focus on general wellness can often operate outside the strict medicines regime. Responsible wording includes phrases like “supports calm”, “promotes relaxation”, or “assists overall wellness”. These must still comply with applicable cannabinoid thresholds, the Cannabis for Private Purposes Act, and foodstuff or supplement requirements where relevant.

4.       Scheduled / Controlled Substances THC content remains the strictest boundary. Products exceeding exemption limits fall under scheduled substance controls regardless of how they are marketed.

The Real Regulatory Challenge

The biggest trigger for stricter regulation is almost always the claim, not the presence of the plant. This is precisely why the Alliance judgment matters for the cannabis sector. It limits the ability of regulators to classify products as medicines through broad regulatory wording rather than clear statutory authority.

South Africa operates with overlapping and sometimes conflicting laws: the Medicines Act, the Drugs and Drug Trafficking Act, the Cannabis for Private Purposes Act, foodstuff regulations, and SAHPRA scheduling.

This creates ongoing uncertainty for tinctures, edibles, topicals, terpene blends, and functional wellness formulations.

A Practical Way Forward

The SCA ruling does not weaken consumer protection. It demands clearer, more proportionate, and legally sound regulation.

For the cannabis industry this means:

• Strict separation between therapeutic/medical claims (medicine pathway) and general wellness support (supplement/wellness pathway)
• Disciplined product development and truthful marketing
• Continued push for coherent, risk-based regulatory frameworks that close the “missing middle” between lawful cultivation and consumer access

H3 Legal Solutions has maintained before Parliament and in our policy work that South Africa needs regulatory clarity, not over-regulation by default.

The 2022 judgment provides a solid legal foundation for building exactly that.

The constitutional position on private cannabis use is settled. The economic potential of a properly structured industry is well documented. What South Africa now needs is practical execution lawful, transparent pathways that distinguish meaningfully between medicines, complementary products, and wellness offerings while protecting consumers and unlocking rural economic value.

Until these frameworks are properly aligned, uncertainty will continue to hurt compliant businesses and consumers alike.

The Alliance of Natural Health Products judgment reminds us that sound policy must begin with respect for the limits of the law and end with frameworks that reflect South African realities on the ground.

The central unresolved issue after the 2022 judgment remains where wellness ends and medicine legally begins. That distinction continues to shape the cannabis, complementary medicines, and natural health sectors in South Africa today.

It is precisely this regulatory gap that the H3 White Paper on Packaging, Labelling, and Product Classification seeks to address.

The framework provides a practical regulatory skeleton capable of opening lawful trade and market participation within the existing legal environment, without requiring entirely new primary legislation before implementation can begin.

 By focusing on product categorisation, transparent labelling, cannabinoid disclosure, dosage guidance, consumer protection measures, and the separation of wellness claims from therapeutic medical claims, the H3 model creates a structured pathway for compliant trade while remaining aligned with the constitutional framework, the Medicines Act, and existing regulatory powers.

The approach recognises that the immediate challenge facing South Africa is no longer the absence of constitutional recognition, but the absence of coherent execution capable of distinguishing responsibly between medicine, wellness, and consumer cannabis products in a manner that protects consumers while unlocking economic participation.

Charl Botha is a legal strategist with a B.Proc degree, cannabis policy specialist, and co-founder of H3 Legal Solutions (Pty) Ltd. He has briefed Parliament and writes on the practical alignment of constitutional rights, industrial policy, and responsible cannabis commercialisation in South Africa.

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