Health Freedom at a Crossroads: How SAHPRA’s Continued Overreach Threatens Your Right to Choose Natural Health

An Open Letter to the Minister of Health

An Urgent Constitutional Call to Restore Legality, Accountability, and Health Freedom

Dear Honourable Minister Motsoaledi,

We write on behalf of the Traditional & Natural Health Alliance (TNHA) to place on record, with urgency, a matter of profound constitutional and public concern. This letter addresses not only your office but also Members of Parliament, regulators, the media, and most importantly, the South African public.

The natural health products sector is currently experiencing an ongoing regulatory crisis with serious implications for constitutional governance, economic livelihoods, and the rights of millions of South Africans who rely on natural health products. The matter is urgent and requires your direct intervention.

The Supreme Court of Appeal Judgment and Its Obligation

In April 2022, the Supreme Court of Appeal (SCA) unanimously declared the 2017 Complementary and Alternative Medicines (CAM) regulations invalid and unconstitutional. The Court suspended the declaration of invalidity for 12 months to allow corrective action. That corrective action was never undertaken. When the suspension period lapsed, the regulations automatically ceased to exist, carrying no legal force or effect. 

In April 2024, we formally alerted your predecessor, Dr Joe Phaahla in another Open Letter about this ongoing failure. To date, we have received no acknowledgment or substantive response from your Ministry.

Despite this clear legal position, SAHPRA continues to enforce, apply, and extend aspects of the struck-down framework, including:

• Detaining imports under defunct regulatory regimes;

• Demanding “Category D” licenses with no lawful basis;

• Applying invalid regulations and their associated guidelines;

• Ignoring formal legal objections from importers and businesses;

• Issuing “amended” draft amendments of extinguished regulations, when its the limitations of the statute (Act) that is at issue;

• Holding stakeholder workshops on continued regulation on a false legal premise;

• Coercing retailers to trade only in products backed by non-existent ‘Category D’ (CAM) licenses;

• Arbitrarily declaring innocuous nutrients (e.g., zinc picolinate, selenium, bioflavonoids, pycnogenol) potentially harmful for children without evidence of harm, yet some are essential to proper immune function and largely deficient in local diets. 

This conduct is not bureaucratic inefficiency, it is defiance of the courts, a direct affront to the rule of law, and a violation of constitutional obligations.

Bill of Rights Implications

SAHPRA’s conduct implicates multiple constitutional rights:

1. Just Administrative Action (Section 33)
   The Constitution guarantees lawful, reasonable, and procedurally fair administrative action, including written reasons when rights are affected. SAHPRA’s ongoing enforcement of non-existent regulations constitutes unlawful administrative action.

2. Equality Before the Law (Section 9)
   Arbitrary enforcement against certain natural health product categories, while granting evidence of efficacy exemptions to other modalities such as homeopathy, may constitute unfair discrimination and unequal treatment under the law. Equally, African Traditional Medicines, which have demonstrated considerable harms, especially to babies and infants, are a hot potato which SAHPRA continue to turn a blind eye to, due to the potential of sociopolitical fallout.

3. Freedom of Trade, Occupation, and Profession (Section 22)
   Businesses are threatened with seizures, detentions, and fines for engaging in lawful trade under a defunct regulatory framework, undermining their constitutional right to operate freely.

4. Access to Courts and Enforcement of Rights (Sections 34 & 38)
   Disregard of a binding SCA judgment undermines the judiciary, prevents affected parties from exercising their rights, and erodes public trust in the rule of law.

5. Freedom and Security of the Person (Section 12)
   Arbitrary restriction of access to lawful natural health products interferes with bodily autonomy and personal health choice.

6. Access to Information (Section 32)
   SAHPRA’s opaque operations and refusal to provide transparent reasoning obstruct stakeholders’ ability to protect their rights. Additionally, information relating to the health promoting effects of consuming such substances are effectively outlawed, despite basic biochemistry textbooks stating the same.

Consequences of SAHPRA’s Overreach

The practical impact on South Africans includes:

• Erosion of constitutional rights including equality, bodily autonomy, and freedom of trade;

• Economic harm to small and medium enterprises with product shortages, price increases, and company closures;

• Deprivation of consumer choice, forcing reliance on pharmaceutical monopolies;

• Undermined public trust in democratic institutions;

• Market distortion, favouring large incumbents while penalizing traditional and natural health sectors.

At ports of entry, SAHPRA has weaponized import controls, effectively committing administrative extortion and depriving consumers and businesses of lawfully purchased goods.

Contradictory and Arbitrary Regulatory Practices

• Homeopathy, despite minimal evidence of efficacy, is allowed to proceed with minimal regulation;

• African Traditional Medicine, with documented risks, remains unregulated almost thirty years after the advent of democracy and equal rights for all;

• Herbal and nutritional products, which are widely recognized as safe internationally, face the harshest scrutiny.

This contradiction violates principles of equality, legality, and rational regulation. SAHPRA is enforcing a “broken stool” of regulation with selective application, creating arbitrary and unconstitutional outcomes.

SAHPRA has imposed bans, seizures, and restrictions on numerous natural health products without presenting credible scientific evidence that these substances pose actual harm. These actions have been based on theoretical or assumed risks rather than verified safety concerns. The false risk narrative often misinterprets or exaggerates cherry-picked scientific data, labeling safe and historically used natural substances as dangerous, without proper clinical validation. Ever since the pharmacovigilance program of our regulator started capturing data on reported adverse effects for natural health products in 2011, SAHPRA has been unable to provide any verifiable data relating harms caused by locally sold health supplements. The CAM sector’s risk profile is extraordinarily low, safer than common foods, infinitely safer than pharmaceuticals, and almost inconsequential when compared to the genuine harms arising from certain unregulated African Traditional Medicines.

SAHPRA’S ASTROTURF DIALOGUE

SAHPRA’s so-called “Captains of Industry” meetings which take place frequently, and by selective invitation only, along with their occasional open stakeholder workshops have become a sham.

These gatherings are not about dialogue, nor an open discussion of ideas. No, they’re full-blown theatrical productions, complete with choreographed PowerPoints, pseudo-legal jargon confetti, and enough smoke and mirrors to obscure reality. Call it “confidence on stilts built over a foundation of illegality.”

Affected stakeholders bravely submit genuine questions, only to be serenaded by a symphony of non-answers and obfuscation. Tough questions, relating to key issues are ignored, with only easy softball questions relating to compliance being fielded. In many cases questions need to be sent to SAHPRA in advance of these meetings, before people have seen the content of the presentations, or are heavily moderated by senior gatekeepers in the administration.

The convenors promise to answer unanswered questions in writing in the following days are weeks, yet no answers ever come.

SAHPRA isn’t there to inform, they’re there to condition, to make everyone believe the regulations that were long repealed are still in full force.

A lie repeated loudly remains a lie. But a lie repeated by a regulator? Suddenly, it’s almost policy. This is unacceptable.

The Dukes-Hill Independent Review Precedent

Honourable Minister, decisive intervention in regulatory crises is not without precedent.

In 2000, your predecessor, Dr Nkosazana Dlamini-Zuma, confronted misconduct and opacity within SAHPRA’s predecessor, the Medicines Control Council (MCC). She established an independent, international review panel, including:

• Professor Graham Dukes, Emeritus Professor of Drug Policy Studies (Netherlands);

• Dr Suzanne Hill, senior Australian regulatory expert.

Their mandate was to examine MCC governance, regulatory conduct, and compliance with statutory obligations. Within months, senior officials were removed, and systemic reforms were implemented.

This panel sets a clear precedent: when a medicines regulator acts rogue and outside its lawful authority, the Minister must act decisively. The present situation is even more severe: SAHPRA is actively defying a binding SCA judgment, violating constitutional rights, and harming the public and private sectors.

Pathways to Lawful, Proportionate Regulation

The natural health sector does not oppose regulation, but regulation must meet these essential, reasonable and appropriate principles:

1. Lawful foundation — grounded in valid statute (Act);

2. Risk-proportionate — based on evidence;

3. Transparent and procedurally fair;

4. Clear and implementable — supporting innovation and consumer choice;

5. Respectful of sector-specific science and cultural health practices.

A new statutory framework, separate from pharmaceutical regulation, is urgently needed, similar to the independent statutory bodies that oversee Allied Health Practitioners and Traditional Health Practitioners. We believe that improving access to natural health products, along with providing clear and accurate information on their use, could form the foundation of a strategy to enhance health outcomes for South Africans.

The use of natural health products often encourages positive lifestyle changes, which can help reduce illness and lower healthcare costs. Supporting this, the report Smart Prevention – Health Care Cost Savings Resulting from the Targeted Use of Dietary Supplements 2022–2030, published by the U.S. Council for Responsible Nutrition and Frost & Sullivan, demonstrates that promoting and providing access to specific natural health substances can lead to substantial healthcare savings. These savings arise from fewer hospitalizations and a reduction in costly medical interventions related to chronic diseases, benefiting both individuals and society as a whole. As a doctor, and a man of science, I urge you to read it.

Formal Call to Action

We call upon you, Honourable Minister, to:

1. Acknowledge publicly the constitutional status of the SCA ruling and its implications;

2. Institute an independent, impartial review committee to investigate SAHPRA’s conduct;

3. Remedy the defects identified by the SCA, ensuring compliance with the Constitution, administrative law, and judicial authority;

4. Engage stakeholders in a lawful, transparent, and evidence-based process.

Failure to act will leave affected parties with no option but to pursue legal enforcement, including potential contempt proceedings against the respondents in their personal capacities relating to the SCA judgment.

Conclusion: If Nature Is Illegal, Freedom Does Not Exist

This is not a dispute over technical policy. It is a matter of:

• Constitutional supremacy;

• Rule of law;

• Personal and public health autonomy;

• Economic and social justice.

SAHPRA has crossed legal, ethical, and administrative boundaries. Continued inaction will deepen public harm, erode confidence in democratic institutions, and violate constitutional obligations.

The precedent of the Dukes-Hill panel leaves no excuse: when the regulator becomes the problem, the Minister must become the solution.

Lawmakers, such as yourself, must now decide whether they will continue to tolerate a regulatory authority acting beyond its lawful mandate, or whether they will intervene to stop a slide into technocratic tyranny disguised as “public safety.”

More and more stakeholders are now ignoring SAHPRA’s dictates, and refusing to accept their unlawful dictates and arbitrary enforcement of struck down law, and perhaps justly so.
This sector needs a new vision from your office. It needs an appropriate regulatory framework and the certainty it provides.

You have previously spoken publicly about the influence and “evil plots” of Big Pharma. We submit that what is unfolding in the natural health products sector bears all the hallmarks of precisely such an agenda.

Now is the time for decisive action.
Nothing for us, without us.
Our health, our rights, and our freedom depend on it.

Yours sincerely,

Anthony Rees
National Chairman
Traditional & Natural Health Alliance (TNHA)